SUMMARY OF PRODUCT CHARACTERISTICS
|
|
- Daniel Craig
- 5 years ago
- Views:
Transcription
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Cefuroxime 250mg Powder for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 250mg cefuroxime (as sodium salt) 3. PHARMACEUTICAL FORM Powder for solution for injection Powder for suspension for injection Vial containing white sterile powder 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Cefuroxime 250mg Powder for Injection is indicated for the treatment of infections caused by susceptible strains of the designated micro-organisms, or before the infecting organism has been identified, in the diseases listed below: Respiratory tract infections for example, acute and chronic bronchitis, infected bronchiectasis. bacterial pneumonia, lung abscess and post operative chest infections. Ear, nose and throat infections for example, sinusitis, tonsillitis and pharyngitis. Urinary tract infections for example acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria. Soft-tissue infections such as cellulitis, erysipelas, peritonitis and wound infections Bone and joint infections for example, osteomyelitis and septic arthritis Obstetric and gynaecological infections pelvic inflammatory disease Gonorrhoea particularly where penicillin is not suitable Other infections including septicaemia and meningitis Prophylaxis against infection in abdominal, pelvic, orthopaedic, cardiac, pulmonary, oesophageal and vascular surgery where there is increased risk from infection. Consideration should be given to official local guidance (e.g. national recommendations) on the appropriate use of antibacterial agents. 1
2 Susceptibility of the causative organism to the treatment should be tested (if possible), although therapy may be initiated before the results are available. 4.2 Posology and method of administration Usually cefuroxime is effective when administered alone, but when appropriate it may be used in combination with metronidazole or an aminoglycoside. General Dosage Adults: Many infections will respond to 750mg three times daily by intramuscular or intravenous injection. For more severe infections, this dose should be increased to 1.5g three times daily intravenously. The frequency of dosage may be increased to six-hourly injections (intramuscular or intravenous) giving total daily doses of 3g to 6g. Infants and Children: Doses of 30 to 100mg/kg/day given as three or four divided doses. A dose of 60 mg/kg/day will be appropriate for most infections. Neonates: Doses of 30 to 100mg/kg/day given as two of three divided doses. In the first weeks of life the serum half-life of cefuroxime can be three to five times that in adults. Elderly: See dosage in adults Gonorrhoea: 1.5g should be given as a single dose or as two 750mg injections into different sites e.g. each buttock. Meningitis: Cefuroxime Powder for Injection is suitable for sole therapy of bacterial meningitis due to sensitive strains. The following dosages are recommended. Infants and children: 200 to 240mg/kg/day intravenously in three or four divided doses. This dosage may be reduced to 100mg/kg/day after three days or when clinical improvement occurs. Neonates: The initial dose should be 100mg/kg/day intravenously. This may be reduced to 50mg/kg/day when clinically indicated. Adults: 3g intravenously every eight hours. No data are currently available to recommend a dose for intrathecal administration. Prophylaxis: The usual dose is 1.5g intravenously with induction of anaesthesia. For abdominal, pelvic and orthopaedic operations this may be followed with two 750mg doses 8 and 16 hours later. For cardiac pulmonary, oesophageal and vascular operations, this may be supplemented with 750mg intramuscularly three times a day for a further 24 to 48 hours. In total joint replacement, 1.5g cefuroxime powder may be mixed dry with each pack of methyl methacrylate cement polymer before adding the liquid monomer. 2
3 Dosage in impaired renal function As cefuroxime is excreted by the kidneys, the dosage should be reduced to allow for slower excretion in patients with impaired renal function, once creatinine clearance falls below 20ml/min, as follows: Marked impairment (creatinine clearance 10 20ml/min): 750mg twice daily Severe impairment (creatinine clearance <10ml/min): 750mg once daily For patients on haemodialysis, a further 750mg dose should be given at the end of each dialysis. Continuous peritoneal dialysis: 750mg twice daily. Renal failure on continuous arteriovenous haemodialysis or high-flux haemofiltration in intensive therapy units: 750mg twice daily. Low-flux haemofiltration: as for impaired renal function. 4.3 Contraindications Hypersensitivity to cefuroxime or other cephalosporin antibiotics. Cephalosporins are contraindicated in patients who have had a previous immediate and/or severe hypersensitivity reaction to any penicillin or to any other beta-lactam drug. 4.4 Special warnings and precautions for use Before therapy with cefuroxime is initiated, careful enquiry should be made to determine whether the patient has had any previous hypersensitivity reactions to cefuroxime, cephalosporins, penicillins or other beta-lactam drugs. Cefuroxime is contraindicated in patients who have had a previous immediate and/or severe hypersensitivity reaction to a penicillin or other beta-lactam drug. It should therefore be given with caution to patients who have had any other type of hypersensitivity reaction to a penicillin or any other beta-lactam drug. As with other antibiotics, prolonged use of cefuroxime may result in the overgrowth of nonsusceptible organisms (e.g. Candida, Enterococci, Clostridium difficile), which may require interruption of treatment. Pseudomembranous colitis has been reported with the use of broadspectrum antibiotics, therefore, it is important to consider its diagnosis in patients who develop serious diarrhoea during or after antibiotic use. There may be some variation in the results of biochemical tests of renal function, but these do not appear to be of clinical importance. As a precaution, renal function should be monitored if this is already impaired. Delayed sterilisation of the CSF in patients with Haemophilus influenzae meningitis may result in an adverse outcome such as deafness and/or neurological sequelae. Persistence of positive CSF cultures of H. influenzae at hours has been noted in some patients treated with cefuroxime injection and as with other therapeutic regimens used in the treatment of meningitis, hearing loss has been reported in some children. With a sequential therapy regime the timing of change to oral therapy is determined by the severity of the infection, clinical status of the patient and susceptibility of the pathogens involved. The change to oral therapy should only be made once there is a clear clinical improvement. If there has been no clinical improvement after 72 hours of parenteral 3
4 treatment, then the patient s treatment should be reviewed. Please refer to the relevant prescribing information for oral cefuroxime axetil before initiating sequential therapy. This medicinal product contains approximately 2.2 mmol (51mg) sodium per gram. This should be taken into consideration for patients on a controlled sodium diet. 4.5 Interaction with other medicinal products and other forms of interaction Concurrent administration of probenecid prolongs the excretion of cefuroxime and produces an elevated peak serum level. Plasma levels of cefuroxime are reduced by dialysis. Cephalosporin antibiotics at high doses should be given with caution to patients receiving concurrent treatment with potent diuretics such as furosemide and aminoglycosides, as these combinations are suspected of adversely affecting renal function. Clinical experience with cefuroxime given by injection has shown that this is not likely to be a problem at the recommended dose levels. A positive Coomb s test has been reported during treatment with cephalosporins. This phenomenon can interfere with cross matching of blood. Cefuroxime does not interfere with enzyme-based tests for glycosuria. Slight interference with copper reduction methods (Benedict s, Fehling s, Clinitest) may be observed. However, this should not lead to false-positive results, as may be experienced with some other cephalosporins. It is recommended that either the glucose oxidase or hexokinase methods are used to determine blood/plasma glucose levels in patients receiving Cefuroxime Powder for injection. This antibiotic does not interfere with the alkaline picrate assay for creatinine. 4.6 Pregnancy and lactation There is no experimental evidence of embryopathic or teratogenic effects attributable to Cefuroxime Powder for injection but, as with all drugs, it should be administered with caution during the early months of pregnancy. Cefuroxime is excreted in human milk and consequently caution should be exercised when Cefuroxime Powder for injection is administered to a nursing mother. 4.7 Effects on ability to drive and use machines Cefuroxime Powder for injection has no reported influence on the ability to drive and use machines. No studies on the effects on the ability to drive and use machines have been performed. 4.8 Undesirable effects Adverse reactions to cefuroxime sodium when given by injection have occurred relatively infrequently and have been generally mild and transient in nature. 4
5 The following convention has been used for the classification of frequency: Very common 1/10, Common 1/100 and <1/10, Uncommon 1/1000 and <1/100, Rare 1/10,000 and <1/1000, Very rare <1/10,000. Infections and infestations Rare: Candida overgrowth from prolonged use. Blood and lymphatic system disorders Common: Neutropenia, eosinophilia. Uncommon: Leukopenia, decreased haemoglobin concentration, positive Coomb s test. Rare: Thrombocytopenia. Very rare: Haemolytic anaemia. Cephalosporins as a class tend to be absorbed onto the surface of red cell membranes and react with antibodies directed against the drug to produce a positive Coomb s Test (which can interfere with cross matching of blood) and very rarely haemolytic anaemia. Immune system disorders Hypersensitivity reactions including: Uncommon: Skin rash, urticaria and pruritus. Rare: Drug fever. Very rare: Interstitial nephritis, anaphylaxis. See also Skin and subcutaneous tissue disorders and Renal and urinary disorders. Gastrointestinal disorders Uncommon: Gastrointestinal disturbance. Very rare: Pseudomembranous colitis. Hepatobiliary disorders Common: Transient rise in liver enzymes. Uncommon: Transient rise in bilirubin. Transient rises in serum liver enzymes or bilirubin occur, particularly in patients with preexisting liver disease, but there is no evidence of harm to the liver. Skin and subcutaneous tissue disorders Very rare: Erythema multiforme, toxic epidermal necrolysis and Stevens Johnson Syndrome. See also Immune system disorders. Renal and urinary disorders Very rare: Elevations in serum creatinine, elevations in blood urea nitrogen and decreased creatinine clearance (See Section 4.4 Special Warnings and Precautions for use). See also Immune system disorders. General disorders and administration site conditions Common: Injection site reactions which may include pain and thrombophlebitis. Pain at the intramuscular injection site is more likely at higher doses. However it is unlikely to be a cause for discontinuation of treatment.. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the yellow card scheme at: 5
6 4.9 Overdose Overdose of cephalosporins can cause cerebral irritation leading to convulsions. Serum levels of cefuroxime can be reduced by haemodialysis or peritoneal dialysis. 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Second generation cephalosporins ATC code: J01D C02 Mechanism of action: Like other beta-lactam drugs, cefuroxime exerts antibacterial activity by binding to and inhibiting the action of certain bacterial cell wall synthetic enzymes namely the penicillin binding proteins. This results in the interruption of cell wall (peptidoglycan) biosynthesis which leads to bacterial cell lysis and death. Mechanisms of Resistance: Bacterial resistance to cefuroxime may be due to one or more of the following mechanisms: hydrolysis by beta-lactamases. Cefuroxime may be efficiently hydrolysed by certain of the extended-spectrum beta-lactamases (ESBLs) and by the chromosomally encoded (AmpC) enzyme that may be induced or stably depressed in certain aerobic gram negative bacterial species. reduced affinity of penicillin-binding proteins for cefuroxime outer membrane impermeability, which restricts access of cefuroxime to penicillin binding proteins in gram-negative organisms drug efflux pumps Breakpoints: The following clinical MIC breakpoints for bacteria have been defined for cefuroxime according to EUCAST: Enterobacteriaceae: 8mg/L for susceptible, >8mg/L for resistant S pneumoniae: 0.5 mg/l for susceptible, >1 mg/l for resistant Streptococcus spp: 0.5 mg/l for susceptible, >0.5 mg/l for resistant H. influenzae and M. catarrhalis: 1 mg/l for susceptible, >2 mg/l for resistant Non-species related breakpoints: 4 mg/l for susceptible, >8 mg/l for resistant Susceptibility: The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence is such that the utility of the agent in at least some types if infections is questionable. Commonly susceptible species Aerobes, Gram positive: Staphylococcus aureus (methicillin susceptible) Coagulase-negative staphylococci (methicillin susceptible) Staphylococcus agalactiae Staphylococcus pneumoniae Staphylococcus pyrogenes Aerobes, Gram negative: 6
7 Escherichia coli Haemophilus influenzae Klebsiella species Moraxella catarrhalis Neisseria gonorrhoeae Proteus mirablis Proteus rettgeri Anaerobes: Peptococcus species Peptostreptococcus species Other organisms: Borrelia burgdorferi Species for which resistance may be a problem Acinetobacter species Citrobacter species Enterobacter species Morganella morganii Resistant: Bacteroides fragilis Clostridium difficile Enterococci Listeria monocytogenes Proteus vulgaris Pseudomonas species Serratia species 5.2 Pharmacokinetic properties Peak levels of cefuroxime are achieved within 30 to 45 minutes after intramuscular administration. The serum half-life after either intramuscular or intravenous injection is approximately 70 minutes. Concurrent administration of probenicid prolongs the excretion of the antibiotic and produces an elevated peak serum level. There is almost complete recovery of unchanged cefuroxime in the urine within 24 hours of administration, the major part being eliminated in the first six hours. Approximately 50% is excreted through the renal tubules and approximately 50% by glomerular filtration. Concentrations of cefuroxime in excess of the minimum inhibitory levels for common pathogens can be achieved in bone, synovial fluid and aqueous humor. Cefuroxime passes the blood-brain barrier when the meninges are inflamed. 5.3 Preclinical safety data No additional data of relevance 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients None 7
8 6.2 Incompatibilities Solutions containing cefuroxime should no be mixed with or added to solutions containing other agents other than those listed below (see section 6.6) The ph of 2.74% w/v sodium bicarbonate injection BP considerably affects the colour of solutions and therefore this solution is not recommended for the dilution of cefuroxime powder. However, if required, for patients receiving sodium bicarbonate injection by infusion, the cefuroxime powder for injection may be introduced into the tube of the giving set. Cefuroxime powder for injection should not be mixed in the syringe with aminoglycoside antibiotics. 6.3 Shelf life Two years. Reconstituted solution: Chemical and physical stability has been demonstrated for 24 hours at 2 C 8 C and for 8 hours at 25 C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally be no longer than 24 hours at 2-8 C unless reconstitution has taken place in controlled and validated aseptic conditions. 6.4 Special precautions for storage Keep vials in the outer carton to protect from light. 6.5 Nature and contents of container 10 ml Type I glass vial with chlorobutyl rubber stopper and aluminium cap containing 250 mg cefuroxime (as sodium salt). Cartons contain 1, 5, 10, 20 or 50 vials. Not all pack sizes may be marketed. 6.6 Instructions for use and handling This medicinal product is for single use only. Discard any unused contents. Intramuscular use Add 1ml water for injections to 250mg Cefuroxime Powder for injection. Shake gently to produce an opaque suspension (final volume: 1.1ml). Intravenous use Dissolve Cefuroxime Powder for injection in water for injections using at least 2ml for 250mg (final volume: 2.1ml), at least 6ml for 750mg (final volume: 6.4ml) or 15ml for 1.5g (final volume: 15.8ml), to produce a clear solution. For short intravenous infusion (e.g. up to 30 minutes), 1.5g may be dissolved in 50ml water for injections (final volume: 50.9ml). 8
9 Reconstituted solutions may be diluted with: 10% dextrose 0.9% sodium chloride injection M/6 sodium lactate injection Ringer's injection Lactated Ringer's injection These solutions may be given directly into the vein or introduced into the tubing of the giving set if the patient is receiving parenteral fluids. 7. MARKETING AUTHORISATION HOLDER Villerton Invest SA 40 Avenue Monterey L-2163 Luxembourg 8. MARKETING AUTHORISATION NUMBER PL 24780/ DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 01/10/ DATE OF REVISION OF THE TEXT 16/04/2015 9
SUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fluclon 250 mg Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 250mg of flucloxacillin as flucloxacillin sodium.
More informationHealth Products Regulatory Authority
1 NAME OF THE VETERINARY MEDICINAL PRODUCT Genta 50 mg/ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active Substances Gentamicin sulphate equivalent to Gentamicin
More informationOral and intestinal candidiasis. As adjuvant treatment with other local nystatin preparations to prevent reinfection.
1. NAME OF THE MEDICINAL PRODUCT Nystatin Orifarm, 100 000 IU/ml oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 100 000 IU nystatin. Excipients with known effect: - Methyl parahydroxybenzoate
More informationMARBOCYL FD SUMMARY OF PRODUCT CHARACTERISTICS
MARBOCYL FD SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT MARBOCYL FD 1 %, powder and solvent for solution for injection, for cats and dogs. 2. QUALITATIVE AND QUANTITATIVE
More informationSUMMARY OF PRODUCT CHARACTERISTICS 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flucloxacillin 250 mg, powder for solution for injection or infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 250
More informationOral and intestinal candidiasis. As adjuvant treatment with other local nystatin preparations to prevent reinfection.
1. NAME OF THE MEDICINAL PRODUCT Nystimex, 100 000 IU/ml oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 100 000 IU nystatin. Excipients: Methyl parahydroxybenzoate 1 mg Sodium
More informationMARBOCYL 10% SUMMARY OF PRODUCT CHARACTERISTICS
MARBOCYL 10% SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT MARBOCYL 10%, solution for injection for cattle and swine 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Marbofloxacin...100.0
More informationSUMMARY OF PRODUCT CHARACTERISTICS. Active substance: cefalexin (as cefalexin monohydrate) mg
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cefaseptin 750 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains: Active substance: cefalexin
More informationStaphylex Flucloxacillin (sodium)
Staphylex Flucloxacillin (sodium) PRODUCT INFORMATION Name of the Medicine Flucloxacillin sodium is the sodium salt of 3-(2'-chloro-6'-fluorophenyl)-5-methyl-4-isoxazolylpenicillin monohydrate. Structural
More informationSUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amoxicillin 500 mg, Powder for Solution for Injection or Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10ml vial contains 500
More informationNEW ZEALAND DATA SHEET
NEW ZEALAND DATA SHEET 1. PRODUCT NAME DBL Flucloxacillin Sodium 1g Powder for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DBL Flucloxacillin Sodium Powder for Injection is the sodium salt of
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Marbocare 20 mg/ml solution for injection for cattle and pigs (UK, IE, FR) Odimar 20 mg/ml solution for injection for cattle
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Amfipen LA 100 mg/ml suspension for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Each ml contains:
More informationSUMMARY OF PRODUCT CHARACTERISTICS. Bottle of powder: Active substance: ceftiofur sodium mg equivalent to ceftiofur...
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT WONDERCEF powder and solvent for solution for injection for horses not intended for the production of foods for human consumption.
More informationSUMMARY OF PRODUCT CHARACTERISTICS. Cephacare flavour 50 mg tablets for cats and dogs. Excipients: For a full list of excipients, see section 6.1.
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cephacare flavour 50 mg tablets for cats and dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Enrocare 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats (UK, IE, FR) Floxadil 50 mg/ml Solution for Injection
More information2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Flucloxacillin 250mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 250 mg flucloxacillin as flucloxacillin
More informationAPPROVED PACKAGE INSERT. Each capsule contains clindamycin hydrochloride equivalent to 150 mg clindamycin base.
APPROVED PACKAGE INSERT SCHEDULING STATUS: S4 PROPRIETARY NAMEAND DOSAGE FORM: DALACIN C TM 150 mg (Capsules) COMPOSITION: Each capsule contains clindamycin hydrochloride equivalent to 150 mg clindamycin
More informationNEW ZEALAND DATA SHEET 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
NEW ZEALAND DATA SHEET 1. FLUCLOXACILLIN Flucloxacillin 250 mg capsules. Flucloxacillin 500 mg capsules. Flucloxacillin Oral Solution 125 mg/5 ml powder for oral solution. Flucloxacillin Oral Solution
More informationTherios 300 mg and 750 mg Palatable Tablets for Dogs
Ceva Animal Health Ltd Telephone: 01494 781510 Website: www.ceva.com Email: cevauk@ceva.com Therios 300 mg and 750 mg Palatable Tablets for Dogs Species: Therapeutic indication: Active ingredient: Product:
More informationSUMMARY OF PRODUCT CHARACTERISTICS. 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Emdocam 20 mg/ml solution for injection for cattle, pigs and horses
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Emdocam 20 mg/ml solution for injection for cattle, pigs and horses 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains:
More information1 TRADE NAME OF THE MEDICINAL PRODUCT. Gentamicin Paediatric 20mg/2ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 TRADE NAME OF THE MEDICINAL PRODUCT Gentamicin Paediatric 20mg/2ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2ml contains 20mg of Gentamicin as Gentamicin Sulfate Excipient
More informationFor the treatment of infections caused by a wide range of Gram-positive and Gramnegative pathogenic bacteria including:
SUMMARY OF PRODUCT CHARCTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Amoxycare Suspension for Injection 15% w/v 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains Active Substance(s)
More informationSummary of Product Characteristics
Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Cefenil 50 mg/ml Powder and Solvent for Solution for Injection for and. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Powder vial
More informationIrish Medicines Board
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (No. 2) REGULATIONS 2007 (S.I. No. 786 of 2007) VPA: 10999/056/001 Case No: 7004318 The Irish Medicines Board in exercise of the powers
More informationSUMMARY OF PRODUCT CHARACTERISTICS. NUFLOR 300 mg/ml solution for injection for cattle and sheep
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NUFLOR 300 mg/ml solution for injection for cattle and sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Kelacyl 100 mg/ml, solution for injection for cattle and pigs (BG, CY, CZ, DE, EL, FR, HU, IE, IT, LT, PL, PT, RO, SK, UK)
More informationSUMMARY OF PRODUCT CHARACTERISTICS. Excipients: Contains 4% w/w cetyl alcohol and 7% w/w propylene glycol.
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT FLAMAZINE Cream 1 % w/w 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Contains Silver sulfadiazine 1 % w/w Excipients: Contains 4% w/w
More informationSimilar to Penicillins: -Chemically. -Mechanism of action. -Toxicity.
Similar to Penicillins: -Chemically. -Mechanism of action. -Toxicity. Cephalosporins are divided into Generations: -First generation have better activity against gram positive organisms. -Later compounds
More informationSUMMARY OF PRODUCT CHARACTERISTICS. Enrotron 50 mg/ml Solution for injection for cattle, pigs, dogs and cats
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Enrotron 50 mg/ml Solution for injection for cattle, pigs, dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each
More informationPACKAGE LEAFLET: INFORMATION FOR THE USER. Amikacin 250 mg/ml Injection
PACKAGE LEAFLET: INFORMATION FOR THE USER Amikacin 250 mg/ml Injection Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you
More informationPharmacology Week 6 ANTIMICROBIAL AGENTS
Pharmacology Week 6 ANTIMICROBIAL AGENTS Mechanisms of antimicrobial action Mechanisms of antimicrobial action Bacteriostatic - Slow or stop bacterial growth, needs an immune system to finish off the microbe
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT RONAXAN 20mg Tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active substance : Doxycycline (as doxycycline
More informationIrish Medicines Board
IRISH MEDICINES BOARD ACT 1995, as amended European Communities (Animal Remedies) (No. 2) Regulations 2007 VPA: 10999/033/001A Case No: 7006569 The in exercise of the powers conferred on it by Animal Remedies
More informationAmoxicillin Introduction: Mechanism of action: Pharmacology: Indications: Dosage: 12 Weeks ( 3 Months):
Amoxicillin Introduction: A semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microganisms. Mechanism of action:
More information[Version 8.1,01/2017] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
[Version 8.1,01/2017] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Pneumospectin 50 mg/ml +100 mg/ml solution for injection for cattle (calves), sheep, goat, pig,
More informationSummary of Product Characteristics
Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Melosolute 5 mg/ml solution for injection for cattle, pigs, dogs and cats. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml
More informationEar drops suspension. A smooth, uniform, white to off-white viscous suspension.
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT OTOMAX EAR DROPS SUSPENSION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of the veterinary medicinal product contains:
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Oxycare 20 %w/v LA Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance: Oxytetracycline (Equivalent
More informationSummary of Product Characteristics
Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Selectan 300 mg/ml solution for injection for cattle and swine. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:
More information1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Summary of Prodcuct Characteristics 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Enrox Max 100 mg/ml Solution for Injection for Cattle and Pigs Enroxal Max 100 mg/ml Solution for Injection for Cattle and
More informationB. PACKAGE LEAFLET 1
B. PACKAGE LEAFLET 1 PACKAGE LEAFLET NICILAN 400 mg/100 mg tablets for dogs 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
More informationSummary of Product Characteristics
Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Pro Penstrep Suspension for Injection for Cattle, Sheep and Pigs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Metrobactin 500 mg tablets for dogs and cats (AT, BE, BG, CY, CZ, DE, EL, ES, FR, HR, HU, IE, IT, LU, NL, PL, PT, RO, SI,
More informationSummary of Product Characteristics
Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Melosolute 20 mg/ml solution for injection for cattle, pigs and horses. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains:
More informationAMOCLAN HIKMA PHARMACEUTICALS
09-15 AMOCLAN HIKMA PHARMACEUTICALS (Amoxycillin and Clavulanic acid) ACTION Amoxicillin is a semisynthetic antibiotic with a broad spectrum of bactericidal activity against many gram-positive and gram-negative
More informationSummary of Product Characteristics
Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Dipen 100ml Suspension for Injection for cattle, sheep and pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance
More informationSUMMARY OF PRODUCT CHARACTERISTICS. Procaine penicillin Dihydrostreptomycin Sulfate
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Streptacare Suspension for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Substance: Each ml contains: Procaine
More information4.5. Special precautions for use Special precautions to be taken by person administering the veterinary medicinal product to animals
1.B1. SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AMOXYCOL Soluble Powder 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances: Amoxicillin trihydrate 640.0
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Marbocare flavour 80mg tablets for dogs (UK and IE) Marbocare F 80mg tablets for dogs (FR) Odimar 80mg tablets for dogs (BE,
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Acecare 2mg/ml Solution for Injection for Dogs and Cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ENROXIL 100 mg/ml solution for injection for cattle and pigs (AT, IE, NL, UK) ENROXAL 100 mg/ml solution for injection for
More informationSUMMARY OF PRODUCT CHARACTERISTICS. 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vetrisulf powder for oral solution for chickens, turkeys and geese
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Vetrisulf powder for oral solution for chickens, turkeys and geese 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One g contains:
More informationSummary of Product Characteristics
Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Amphen 200 mg/g Granules for use in drinking water for pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each g contains: Active
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NOSEDORM 5 mg/ml Solution for injection for dogs and cats [DE, ES, FR, PT] 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each
More informationDilip ver01 10-March-16 1:00 PM
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEFAZOLIN FOR INJECTION, USP safely and effectively. See full prescribing information for CEFAZOLIN
More informationAPO-FLUCLOXACILLIN CAPSULES. sodium salt of 3-(2'-chloro-6'-fluorophenyl)-5-methyl-4-isoxazolylpenicillin monohydrate.
APO-FLUCLOXACILLIN CAPSULES NAME OF THE MEDICINE Flucloxacillin sodium monohydrate. Chemical Name: sodium salt of 3-(2'-chloro-6'-fluorophenyl)-5-methyl-4-isoxazolylpenicillin monohydrate. Structural Formula:
More informationSUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT. Marbotab P 20 mg tablets for dogs and cats
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Marbotab P 20 mg tablets for dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active substance:
More informationSUMMARY OF PRODUCT CHARACTERISTICS. Lincomycin (as Lincomycin hydrochloride) Neomycin (as Neomycin sulphate) Excipients Disodium edetate
SUMMARY OF PRODUCT CHARACTERISTICS AN: 00221/2013 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Lincocin Forte S Intramammary Solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances Lincomycin
More informationFlucloxacillin as flucloxacillin sodium When reconstituted each 5ml contains 250mg flucloxacillin as flucloxacillin sodium.
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flucloxacillin 250mg/5ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Flucloxacillin as flucloxacillin sodium When reconstituted
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AT, BE, BG, CY, CZ, DE, EE, EL, ES, FR, HR, HU, IE, IT, LT, LU, NL, PT, RO, SK, UK: Kelaprofen 100 mg/ml, solution for injection
More informationReference ID:
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KEFLEX safely and effectively. See full prescribing information for KEFLEX KEFLEX (cephalexin) capsules,
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Synuclav 250 mg Tablets for Dogs (UK) Clavobay 250 mg Tablets for Dogs (BE, FR, IS, IT, PT) Clavubay 250mg Tablets for Dogs
More informationPart II SUMMARY OF PRODUCT CHARACTERISTICS. Each tablet contains 25 mg Clindamycin (as Clindamycin Hydrochloride)
Clindacyl 25mg Tablets Vm 08007/4104 Part II SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CLINDACYL 25 MG TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet
More informationTreatment of Respiratory Tract Infections Prof. Mohammad Alhumayyd Dr. Aliah Alshanwani
Treatment of Respiratory Tract Infections Prof. Mohammad Alhumayyd Dr. Aliah Alshanwani 30-1-2018 1 Objectives of the lecture At the end of lecture, the students should be able to understand the following:
More informationExcipients with known effect: Each 5ml dose contains 3.09g of sucrose and 18.05mg of sodium. For the full list of excipients, see section 6.1.
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flucloxacillin 125mg/5ml Oral Solution Flucloxin 125mg/5ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Flucloxacillin as
More information1. NAME OF THE VETERINARY MEDICINAL PRODUCT. Ceftiocyl 50 mg/ml, suspension for injection for cattle and pigs
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ceftiocyl 50 mg/ml, suspension for injection for cattle and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance: Ceftiofur (as
More informationAnaerobic and microaerophilic gram-positive cocci Peptococcus species, Peptostreptococcus species, Microaerophilic streptococci
CLINDACIN Composition Each capsule contains Clindamycin (as hydrochloride) 150 mg Capsule Action Clindamycin bind exclusively to the 50S subunit of bacterial ribosomes and suppress protein synthesis. Clindamycin
More informationNEW ZEALAND DATA SHEET. FLUCIL Flucloxacillin (as flucloxacillin sodium) Powder for Injection 500 mg & 1 g
NEW ZEALAND DATA SHEET 1 PRODUCT NAME (strength pharmaceutical form) FLUCIL Flucloxacillin (as flucloxacillin sodium) Powder for Injection 500 mg & 1 g 2 QUALITATIVE AND QUANTITATIVE COMPOSITION FLUCIL
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AT, BE, CZ, EE, ES, FR, IE, IS, IT, LT, LU, LV, NO, PL, PT, RO, SE, SI, SK, UK: Genestran 75 micrograms/ml solution for injection
More informationSummary of Product Characteristics
Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Geriflox 500mg Capsules, Hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains flucloxacillin sodium equivalent to 500
More informationMetacam 1.5 mg/ml oral suspension for dogs
Metacam 1.5 mg/ml oral suspension for dogs Species:Dogs Therapeutic indication:pharmaceuticals: Neurological preparations: Analgesics, Other NSAIDs, Locomotor (including navicular and osteoarthritis) Active
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CYTOPOINT 10 mg solution for injection for dogs CYTOPOINT 20 mg solution for injection for dogs CYTOPOINT 30 mg
More informationSUMMARY OF PRODUCT CHARACTERISTICS
[Version 8, 10/2012] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS (Based on the current SPC of the reference product Baytril RSI 100 mg/ml Injektionslösung für Rinder und Schweine) 1 1. NAME OF THE VETERINARY
More informationSummary of Product Characteristics
Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Carofertin 10 mg/ml Emulsion for injection for cattle and pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: Active
More informationSUMMARY OF PRODUCT CHARACTERISTICS 1.B.1 SUMMARY OF PRODUCT CHARACTERISTICS
1.B. SUMMARY OF PRODUCT CHARACTERISTICS 1.B.1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Lamox 800 mg/g powder for use in drinking water for chickens and pigs 2. QUALITATIVE
More informationProtein Synthesis Inhibitors
Protein Synthesis Inhibitors Assistant Professor Dr. Naza M. Ali 11 Nov 2018 Lec 7 Aminoglycosides Are structurally related two amino sugars attached by glycosidic linkages. They are bactericidal Inhibitors
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Convenia 80 mg/ml powder and solvent for solution for injection for dogs and cats 2. QUALITATIVE AND QUANTITATIVE
More informationAugmentin (Amoxicillin-clavulanate) Sachets
Augmentin (Amoxicillin-clavulanate) Sachets TITLE Amoxicillin trihydrate-potassium clavulanate SCOPE Trade Name(s) AUGMENTIN TM Formulation and Strength The following strengths and ratios are currently
More informationSummary of Product Characteristics
Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Boflox flavour 20 mg tablets for dogs and cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active substance:
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT COLICEN 4.000.000 UI/ml solution for use in drinking water/milk 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:
More informationSUMMARY OF PRODUCT CHARACTERISTICS. Pentoject, Pentobarbitone Sodium 200 mg/ml Solution for Injection
SUMMARY OF PRODUCT CHARACTERISTICS Revised: June 2018 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Pentoject, Pentobarbitone Sodium 200 mg/ml Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
More information4 th and 5 th generation cephalosporins. Naderi HR Associate professor of Infectious Diseases
4 th and 5 th generation cephalosporins Naderi HR Associate professor of Infectious Diseases Classification Forth generation: Cefclidine, cefepime (Maxipime),cefluprenam, cefoselis,cefozopran, cefpirome
More informationCell Wall Inhibitors. Assistant Professor Naza M. Ali. Lec 3 7 Nov 2017
Cell Wall Inhibitors Assistant Professor Naza M. Ali Lec 3 7 Nov 2017 Cell wall The cell wall is a rigid outer layer, it completely surrounds the cytoplasmic membrane, maintaining the shape of the cell
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Tilmovet 250 mg/ml Concentrate for Oral Solution (BE, BG, CZ, EL, HU, IE, NL, PL, RO, UK) for pigs, chickens, turkeys and
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS. Medicinal product no longer authorised
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Zubrin 50 mg oral lyophilisates for dogs Zubrin 100 mg oral lyophilisates for dogs Zubrin 200 mg oral lyophilisates
More informationSUMMARY OF PRODUCT CHARACTERISTICS 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amoxicillin 125 mg/5 ml Oral Suspension BP 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Amoxicillin oral suspension 125 mg contains 125
More information2 QUALITATIVE AND QUANTITATIVE COMPOSITION
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flucloxacillin 500mg Capsules Flucloxin 500mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 500 mg of flucloxacillin
More informationSUMMARY OF PRODUCT CHARACTERISTICS: Each sachet contains 3g Amoxicillin as Amoxicillin Trihydrate B.P./ Ph.Eur
SUMMARY OF PRODUCT CHARACTERISTICS: 1. NAME OF THE MEDICINAL PRODUCT Amoxicillin 3 g Sachet Sugar Free and Respillin 3g Sachet Sugar Free. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains
More informationSummary of Product Characteristics
Summary of Product Characteristics 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Cemay 50 mg/ml suspension for injection for pigs and cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains: Active
More informationSummary of Product Characteristics 1. NAME OF THE VETERINARY MEDICINAL PRODUCT. Enrotab 50 mg tablets for dogs
Summary of Product Characteristics 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Enrotab 50 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active substance Enrofloxacin
More informationThe β- Lactam Antibiotics. Munir Gharaibeh MD, PhD, MHPE School of Medicine, The University of Jordan November 2018
The β- Lactam Antibiotics Munir Gharaibeh MD, PhD, MHPE School of Medicine, The University of Jordan November 2018 Penicillins. Cephalosporins. Carbapenems. Monobactams. The β- Lactam Antibiotics 2 3 How
More informationSUMMARY OF PRODUCT CHARACTERISTICS
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Maprelin 75 µg/ml solution for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Metrobactin 250 mg tablets for dogs and cats (AT, BE, BG, CY, CZ, DE, EL, ES, FR, HR, HU, IE, IT, LU, NL, PT, RO,
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ophtocycline 10 mg/g eye ointment for dogs, cats and horses (AT, BE, BG, CY, CZ, EL, ES, HR, HU, IE, IT, LU, NL,
More informationStaphylex Flucloxacillin (as sodium) PRODUCT INFORMATION
Staphylex Flucloxacillin (as sodium) PRODUCT INFORMATION NAME OF THE MEDICINE Active ingredient : Flucloxacillin sodium Chemical name : 3-(2'-chloro-6'-fluorophenyl)-5-methyl-4-isoxazolylpenicillin monohydrate
More informationSummary of product characteristics As per Annex C. SUMMARY OF PRODUCT CHARACTERISTICS Doc. No. SPC/71108 Ver.1
Summary of product characteristics As per Annex C SUMMARY OF PRODUCT CHARACTERISTICS Doc. No. SPC/71108 Ver.1 1. NAME OF THE MEDICINAL PRODUCT. ANNEXURE C to MODULE I Tetanus vaccine (Adsorbed) I.P. 2.
More informationVeterinary Medicinal Product
Veterinary Medicinal Product CZ, DE, IT, AT, BE, NL, LUX : Kesium 500 mg / 125 mg Chewable tablets for dogs DK, FI, SE: Kesium vet 500 mg / 125 mg Chewable tablets for dogs UK, IE, FR, EL, PL, HU, RO,
More informationNEW ZEALAND DATA SHEET. Each powder for oral suspension contains 125 mg or 250 mg of amoxicillin (as trihydrate) per 5 ml when reconstituted.
NEW ZEALAND DATA SHEET ALPHAMOX 1. Product Name Alphamox, 125 mg/5 ml & 250 mg/5 ml, powder for oral suspension 2. Qualitative and Quantitative Composition Each powder for oral suspension contains 125
More informationProphylaxis against infections associated with major surgical procedures in adults, such as those involving the:
1. NAME OF THE MEDICINAL PRODUCT Augmentin 500 mg/100 mg powder for solution for injection or infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains sodium amoxicillin equivalent to 500
More information