SUMMARY OF PRODUCT CHARACTERISTICS EN SmPC VA additional container type approved: 1 von 7
1. NAME OF THE VETERINARY MEDICINAL PRODUCT, 300 mg/ml, Suspension for injection for cattle, pigs and horses 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml suspension for injection contains Active substance: Benzylpenicillin, procaine 1 H 2 O Excipients: Methyl-4-hydroxy benzoate (E 218) Propyl-4-hydroxy benzoate (E 216) Excipient(s): For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection White to yellowish suspension 300.00 mg 2.84 mg 0.32 mg 4. CLINICAL PARTICULARS 4.1 Target species Cattle, pigs (adult pigs) and horses 4.2 Indications for use, specifying the target species For the treatment of bacterial infectious diseases, caused by Benzylpenicillin sensitive pathogens. Cattle, calves, and horses: General bacterial infections (septicaemias) Primary and secondary infections of the - respiratory system - urinary and genital apparatus - skin and the claws - joints Pigs (adult pigs): Primary and secondary infections of the - urogenitary tract (infections with ß-haemolytic Streptococcus spp.) - musculoskeletal system (infections with Streptococcus suis) - skin (infections with Erysipelotrix rhusiopathiae) The use should be based on the result of an antibiogram. 4.3 Contraindications Do not use in case of: - resistance against Penicillins - infections with ß-lactamase producing pathogens - hypersensitivity to Penicillins or Cephalosporins, Procain or against any other ingredient of EN SmPC VA additional container type approved: 2 von 7
- severe disturbances of kidney functions with anuria or oliguria Do not use in mares, from which the milk is used for human consumption Do not apply intravenously. 4.4 Special warnings <for each target species> None. 4.5 Special precautions for use Special precautions for use in animals Special precautions to be taken by the person administering the veterinary medicinal product to animals Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin may lead to cross reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious. Do not handle this product if you know you are sensitised to penicillins or cephalosporins or if you have been advised not to work with such preparations. Handle this product with great care to avoid exposure by accidental contact with the skin or eyes. Persons developing a reaction after contact with the product should avoid handling the product (and other penicillin and cephalosporin containing products) in future. It is recommended to wear gloves when handling or administering the product. Wash exposed skin after use. In case of any eye contact, wash the eyes thoroughly with copious amounts of clean running water. If you develop symptoms following exposure such as skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention. 4.6 Adverse reactions (frequency and seriousness) Cattle In Penicillin-sensitive animals allergic reactions may occur. Because of the excipient Polyvidon, in seldom cases anaphylactic shocks may occur in cattle. Horses In horses, because of the excipient Procain, symptoms like restlessness, loss of coordination and muscle tremors, sometimes with fatal outcome may occur. Pigs Vomitus, coughing and a little swelling at the injection site may occur. Signs of intolerance such as elevation of body temperature, trembling, vomiting, incoordination, and inappetence may occur within 24 hours after injection of benzylpenicillin procain, which may be caused by the release of procain. In pregnant sows abortion may occur. Less common adverse reactions include haemolytic anaemia and thrombocytopenia. Penicillins must not be used in animals known to be sensitive. All species In case of side effects the animal has to be treated symptomatically. Counter measures for the treatment of allergic reactions are: EN SmPC VA additional container type approved: 3 von 7
Anaphylaxia: Epinephrin (Adrenalin) and glucocorticoids i.v. Allergic skin reactions: Antihistaminica and/or glucocorticoids 4.7 Use during pregnancy, lactation or lay The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Use during pregnancy and lactation only accordingly to the benefit/risk assessment by the responsible veterinarian. 4.8 Interaction with other medicinal products and other forms of inte raction The mixing with other drugs in one syringe has to be avoided because of possible chemical-physical incompatibilities. Water-soluble Penicillins are not compatible with metal ions, aminoacids, ascorbin acid, heparin and the vitamins of the B-complex. The bactericidal efficacy of Penicillin is counteracted by bacteriostatic pharmaceuticals such as erythromycin and tetracyclines. Penicillins may increase the efficacy of Aminoglycosides. The excretion of Benzylpenicillin is extended due to Phenylbutazon and Acetylsalicylacid. Inhibitors of the cholinesterase delay the degration of Procain. 4.9 Amounts to be administered and administration route Intramuscular application: Cattle: 20 mg Benzylpenicillin, procaine per kg bodyweight, corresponding to 1 ml for 15 kg bodyweight. Per each injection site not more than 20 ml of injectable suspension should be applied. Calves: 15-20 mg Benzylpenicillin, procaine per kg bodyweight corresponding to 0,75-1 ml for 15 kg bodyweight. Per each injection site not more than 20 ml of injectable suspension should be applied. Pigs: 20 mg Benzylpenicillin, procaine per kg bodyweight corresponding to 1 ml for 15 kg bodyweight. Per each injection site not more than 10 ml of injectable suspension should be applied. Horses: 15 mg Benzylpenicillin, procaine per kg bodyweight corresponding to 0.5 ml for 10 kg bodyweight. Per each injection site not more than 20 ml of injectable suspension should be applied. Per each injection site not more 20 ml (horse, cattle) resp. 10 ml (pigs) of injectable suspension should be applied. The duration of treatment is 3 days, applying one injection every 24 hours. A clinical response is normally observed within 24 hours. It is important to continue treatment for 2 more days. If no distinct clinical response is seen within 3 days, then a check of the diagnosis and eventually a change of treatment are required. Shake well before use. EN SmPC VA additional container type approved: 4 von 7
4.10 Overdose (symptoms, emergency procedure s, antidotes), if necessary In the case of overdosing central nervous excitations and convulsions may occur. The use of has to be terminated immediately and a symptomatic treatment (e.g. barbiturates) should be initiated. A premature termination of the treatment with should be done only after consultation of the veterinarian to avoid the development of resistant bacterial strains. 4.11 Withdrawal period(s) Cattle: Meat and offal Milk Pigs (adult pigs): Meat and offal 14 days 6 days 15 days Horse: Meat and offal 14 days Not permitted for use in lactating mares producing milk for human consumption. 5. PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: Beta-lactamase sensitive penicillins ATCvet-code: QJ01CE09 5.1 Pharmacodynamic properties Benzylpenicillin, procaine is a hardly water-soluble depot-penicillin. In the organism Benzylpenicillin and Procain are released by dissociation. The free Benzylpenicillin is particularly effective against grampositive pathogens. In case of sensitive germs the minimum inhibitory concentration (MIC) is below 0.06 µg/ml. Bactericidal concentrations of Penicillin are in vivo about 5 to 20 fold higher than the minimum inhibitory concentrations. Penicillins act bactericidal on proliferating germs by inhibition of the synthesis of the cell walls. Benzylpenicillin is acid-unstable and it is inactivated by ß-lactamases. 5.2 Pharmacokinetic particulars As Benzylpenicillin procaine is a depot penicillin, absorption is delayed when compared to easy water soluble penicillin salts and therapeutic serum levels are maintained over a prolonged period. In pigs, maximum serum levels are reached within 30 min after parenteral injection of Benzylpenicillin procaine. 5.3 Environmental properties Not applicable. 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Methyl-4-hydroxybenzoate (E 218) Propyl-4-hydroxybenzoate (E 216) (3-sn-Phosphatidyl)cholin(Lecithin) Povidone K 25 Sodium citrate 2 H2O Sodium thiosulphate 5 H2O Propylene glycol EN SmPC VA additional container type approved: 5 von 7
Disodium edetate 2 H2O Potassium-dihydrogen phosphate Water for injections 6.2 Incompatibilities In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products. 6.3 Shelf life Shelf-life of the veterinary medicinal product as packaged for sale: Shelf-life after first opening the immediate packaging: 4 years 28 days 6.4. Special precautions for storage Store in a refrigerator (2 C 8 C) Protect from light 6.5 Nature and composition of immediate packaging Siliconised bottle of glass type II/ PP-bottle with bromobutyl rubber stopper and aluminium flip-off seal. Pack sizes: 1 glass vial with 100 ml suspension for injection 12 glass vials with 100 ml suspension for injection 1 PP vial with 100 ml suspension for injection. 12 PP vials with 100 ml suspension for injection. Not all pack sizes may be marketed. 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. 7. MARKETING AUTHORISATION HOLDER animedica GmbH Im Südfeld 9 48308 Senden-Bösensell Germany 8. MARKETING AUTHORISATION NUMBER(S) 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION <{DD/MM/YYYY}> <{DD month YYYY}> EN SmPC VA additional container type approved: 6 von 7
10 DATE OF REVISION OF THE TEXT 19.02.2014 PROHIBITION OF SALE, SUPPLY AND/OR USE EN SmPC VA additional container type approved: 7 von 7