PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY ILIUM PROPERCILLIN ANTIBIOTIC INJECTION

Similar documents
EXCEDE Sterile Suspension

DEPOSEL Slow Release Selenium Injection for Cattle and Sheep

Summary of Product Characteristics

Summary of Product Characteristics

PFIZER ANIMAL HEALTH Product Name: LINCO-SPECTIN"" ANTIBIOTIC INJECTABLE SOLUTION Date: 1 November 2011 Page 1 of 9

B. PACKAGE LEAFLET 1

SUMMARY OF PRODUCT CHARACTERISTICS. Procaine penicillin Dihydrostreptomycin Sulfate

Active Constituent: Each tablet contains 500 mg cephalexin (as monohydrate) Contents: 12 [100, 300] Tablets

Active Constituent: Each tablet contains 1000 mg cephalexin (as monohydrate) Contents: 8 [100, 300] Tablets

BOX 1. NAME OF THE VETERINARY MEDICINAL PRODUCT. Hymatil 300 mg/ml solution for injection for cattle and sheep Tilmicosin

SUMMARY OF PRODUCT CHARACTERISTICS

For the treatment of infections caused by a wide range of Gram-positive and Gramnegative pathogenic bacteria including:

FASINEX 100 Oral Flukicide for Sheep, Cattle and Goats

Fenbender 100 CAUTION. Oral Anthelmintic for cattle & horses. ACTIVE CONSTITUENT: 100 g/l FENBENDAZOLE

SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX III LABELLING AND PACKAGE LEAFLET

SUMMARY OF PRODUCT CHARACTERISTICS. NUFLOR 300 mg/ml solution for injection for cattle and sheep

LABELLING AND PACKAGE LEAFLET

Copy in the header and footer will not appear on the final printed label LAB0042 Prepared: 28/02/01 SYRINGE LABEL

Error! Reference source not found. I. SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

Fasimec Cattle Oral Flukicide and Broad Spectrum Drench

SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS 1.B.1 SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS. Cephacare flavour 50 mg tablets for cats and dogs. Excipients: For a full list of excipients, see section 6.1.

[Version 8.1,01/2017] ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

Withdrawal period: 93 days Milk: Not authorised for use in animals producing milk for human consumption.

Summary of Product Characteristics

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS. Medicinal product no longer authorised

Summary of Product Characteristics

SUMMARY OF PRODUCT CHARACTERISTICS. Bottle of powder: Active substance: ceftiofur sodium mg equivalent to ceftiofur...

B. PACKAGE LEAFLET 1

A long-acting, broad spectrum, injectable antibiotic for the treatment and control of

Day 90 Labelling, PL LABELLING AND PACKAGE LEAFLET

SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

POISON KEEP OUT OF REACH OF CHILDREN READ SAFETY DIRECTIONS BEFORE OPENING OR USING FOR ANIMAL TREATMENT ONLY SWISH POUR-ON

SUMMARY OF PRODUCT CHARACTERISTICS

FLOXYME 50 mg/ml SOLUTION FOR USE IN DRINKING WATER

SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

Summary of Product Characteristics

SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS

MARBOCYL 10% SUMMARY OF PRODUCT CHARACTERISTICS

LUTEOSYL(d)-Cloprostenol mg/ml Solution for injection for cattle and pigs

SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1/12

CAUTION KEEP OUT OF REACH OF CHILDREN READ SAFETY DIRECTIONS BEFORE OPENING OR USING FOR ANIMAL TREATMENT ONLY JETGARD TM

SUMMARY OF PRODUCT CHARACTERISTICS. Florgane 300 mg/ml Suspension for Injection for Cattle and Pigs

SUMMARY OF PRODUCT CHARACTERISTICS

4.5. Special precautions for use Special precautions to be taken by person administering the veterinary medicinal product to animals

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS. CEFOKEL 50 mg/ml, suspension for injection for pigs and cattle

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Summary of Product Characteristics

SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

Irish Medicines Board

SUMMARY OF PRODUCT CHARACTERISTICS. Pentoject, Pentobarbitone Sodium 200 mg/ml Solution for Injection

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

Irish Medicines Board

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

CAUTION KEEP OUT OF REACH OF CHILDREN READ SAFETY DIRECTIONS FOR ANIMAL TREATMENT ONLY DECTOMAX. Injectable endectocide. DORAMECTIN 10 mglml

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS. Medicinal product no longer authorised

SUMMARY OF PRODUCT CHARACTERISTICS. 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Emdocam 20 mg/ml solution for injection for cattle, pigs and horses

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

BAYTRIL 25 FLAVOUR ANTIBACTERIAL ORAL SUSPENSION

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1/33

= 0.5 mg. In vitro toxin neutralisation test based on haemolysis of sheep erythrocytes. For a full list of excipients, see section 6.1.

Health Products Regulatory Authority

SUMMARY OF PRODUCT CHARACTERISTICS

MOXIDECTIN SPOT-ON SOLUTION FOR KITTENS AND SMALL CATS. 280 mg/ml FLURALANER 14 mg/ml MOXIDECTIN Also contains: 339 mg/ml DIMETHYLACETAMIDE (solvent)

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT. Ceftiocyl 50 mg/ml, suspension for injection for cattle and pigs

SUMMARY OF PRODUCT CHARACTERISTICS

Oralject P-BUTAZONE* PASTE ORAL ANTI-INFLAMMATORY ANALGESIC AGENT FOR HORSES

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1/18

LABELLING AND PACKAGE LEAFLET A. LABELLING

SUMMARY OF PRODUCT CHARACTERISTICS

Summary of Product Characteristics

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

[Version 8, 10/2012] SUMMARY OF PRODUCT CHARACTERISTICS

SUMMARY OF PRODUCT CHARACTERISTICS

Transcription:

Immediate Container Label_ V2- Propercillin- Front Panel PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY ILIUM PROPERCILLIN ANTIBIOTIC INJECTION RLP Approved ACTIVE CONSITUENT: PROCAINE PENICILLIN: 300mg/mL An aid in the treatment of infections caused by penicillin-sensitive organisms in Horses, Cattle, Sheep, Pigs, Dogs and Cats 1 OOmL [250, 500mL]

Immediate Container Label_ V2 - Propercillin - Side Panel READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT DIRECTIONS FOR USE: SHAKE WELL BEFORE USE. DOSAGE AND ADMINISTRATION: Use the contents of the vial within 6 months of initial broaching and store below 8 C. Discard any unused portion. Give by intramuscular or subcutaneous injection daily for 3-5 days. [inverted] [graphic] [graphic] [graphic] [graphic] [graphic] [graphic] Horse Cow Sheep Pig Dog Cat 500kg- 400kg- 40kg- 40kg- 10kg- 5kg- 20mL 16mL 2mL 2mL 1mL 0.5mL WITHHOLDING PERIODS (WHP): MEAT: 5 days. MILK: 36 hours (single dose) or 72 hours (multiple dose). EXPORT SLAUGHTER INTERVAL (ESI): This product does not have an ESI established. For advice on the ESI, contact the manufacturer on (02) 96779000 before using this product. TROY LABORATORIES PTY LIMITED 31-35 GLENDENNING ROAD, GLENDENNING NSW 2761 W: www.troylab.com.au E: info@troylab.com.au Dispose of empty container by wrapping with paper and putting in the garbage. Store below 25oC (Air conditioning). Once broached store below aoc (Refrigerate). APVMA Approval No.: 60521/55542 Batch & Expiry- see bottom of carton Ll No: XXXX

Carton_ V2, Front and back Panel Propercillin PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY ILIUM PROPERCILLIN ANTIBIOTIC INJECTION ACTIVE CONSITUENT: PROCAINE PENICILLIN: 300mg/mL An aid in the treatment of infections caused by penicillin-sensitive organisms in Horses, Cattle, Sheep, Pigs, Dogs and Cats 1 OOmL [250, 500mL] Ilium

Carton_ V2, Side Pane/1 Propercillin READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT DIRECTIONS FOR USE: SHAKE WELL BEFORE USE. DOSAGE AND ADMINISTRATION: Use the contents of the vial within 6 months of initial broaching and store below aoc (Refrigerate). Discard any unused portion. Give by intramuscular or subcutaneous injection daily for 3-5 days. [graphic] Horse [graphic] Cow [graphic] Sheep 500kg- 20mL 400kg -16mL 40kg- 2mL [graphic] Pig [graphic] Dog [graphic] Cat 40kg- 2mL 10kg -1mL 5kg- 0.5mL Any variation by the prescribing veterinarian to the approved dose, frequency, duration, route, disease or target species may require extending the approved withholding period. WITHHOLDING PERIODS: MEAT: DO NOT USE less than 5 days before slaughter for human consumption. MILK: Milk collected from animals within 36 hours (single dose) or 72 hours (multiple dose) following treatment MUST NOT BE USED for human consumption or processing, or fed to bobby calves. EXPORT SLAUGHTER INTERVAL (ESI): This product does not have an ESI established. For advice on the ESI, contact the manufacturer on (02) 96779000 before using this product. FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 131 126.

Catton_ V2, Side Panel 2 Propercillin TROY LABORATORIES PTY LIMITED 31-35 GLENDENNING ROAD, GLENDENNING NSW 2761 W: www.troylab.com.au E: info@troylab.com.au DISPOSAL: Dispose of empty container by wrapping with paper and putting in the garbage. STORAGE: Store below 25oC (Air Conditioning). Once broached store below soc (Refrigerate). APVMA Approval No.: 60521/55542 Batch: Expiry: BARCODE CD No: XXXX Catton_ V2, Top Propercillin PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY ILIUM PROPERCILLIN ANTIBIOTIC INJECTION 1 OOmL (250, 500mL]

Leaflet_ V2 - Propercillin PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY Ilium PROPERCILLIN ANTIBIOTIC INJECTION ACTIVE CONSITUENT: PROCAINE PENICILLIN: 300mg/mL INDICATIONS: An aid in the treatment of infections caused by penicillin-sensitive organisms in Horses, Cattle, Sheep, Pigs, Dogs and Cats USES: An aid in the treatment of local and systemic infections caused by bacteria sensitive to penicillin in Horses, Cattle, Pigs, Sheep, Dogs and Cats. Penicillin has been shown in vitro to be effective against Gram-positive aerobic bacteria such as Staphylococcus au reus, most Actinomyces (corynebacteria) and Erysipelothrix spp. Sensitive Gram-positive aerobic bacteria include most clostridia. Penicillin has also been shown in vitro to be effective against certain Actinobacillus (Haemphilus) pleuropneumoniae. DIRECTIONS FOR USE: CONTRAINDICATIONS: This product is contraindicated for use in animals that are known to be allergic to penicillin. This product should not be used when it is known that~lactamase producing bacteria are involved. PRECAUTIONS: Persons who are allergic to penicillins should avoid direct contact with the product. This product contains Povidone (PVP) which may cause anaphylaxis in young cattle - antihistamine or adrenalin treatment may be a suitable antidote. SIDE EFFECTS: Occasional allergies to penicillin have been observed in some animals but these are rare. Administration of products containing procaine benzylpenicillin may occasionally cause transient pyrexia, vomiting, shivering, listlessness and incoordination in pigs. Some cases of abortion have been reported in pregnant sows and gilts.

Leaflet_ V2- Propercillin DOSAGE AND ADMINISTRATION: SHAKE WELL BEFORE USE. Use the contents of the vial within 6 months of initial broaching and store below 8 C. Discard any unused portion. PROPERCILLIN should be given by intramuscular injection to large animals. Dogs may be injected by either the subcutaneous or intramuscular routes. Subcutaneous injection is advised in cats. The following dose rates are advised: Horses and Cattle: 12mg/kg bodyweight (20ml/500kg) daily for 3-5 days Pigs and Sheep: 15mg/kg bodyweight (2ml/40kg) daily for 3-5 days Dogs and Cats: 30mg/kg bodyweight (1 ml/1 Okg) daily for 3-5 days [graphic] Horse [graphic] Cow [graphic] Sheep 500kg- 20mL 400kg - 16mL 40kg- 2mL [graphic] Pig [graphic] Dog [graphic] Cat 40kg- 2mL 10kg -1mL 5kg- 0.5mL Treatment duration should be established in consultation with a veterinarian. Repeat injections should be given at a different site. The usual aseptic precautions should be taken when administering the injections. Any variation by the prescribing veterinarian to the approved dose, frequency, duration, route, disease or target species may require extending the approved withholding period. WITHHOLDING PERIODS: MEAT: DO NOT USE less than 5 days before slaughter for human consumption. MILK: Milk collected from animals within 36 hours (single dose) or 72 hours (multiple dose) following treatment MUST NOT BE USED for human consumption or processing, or fed to bobby calves. EXPORT SLAUGHTER INTERVAL (ESI): This product does not have an ESI established. For advice on the ESI, contact the manufacturer on (02) 96779000 before using this product. FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 131 126. TROY LABORATORIES PTY LIMITED 31-35 GLENDENNING ROAD, GLENDENNING NSW 2761 W: www.troylab.com.au E: info@troylab.com.au

Leaflet_ V2- Propercillin Disposal: Dispose of empty container by wrapping with paper and putting in the garbage. Storage: Store below 25 C (Air conditioning). Once broached store below aoc (Refrigerate). Presentation: 1 OOmL, 250ml and 500ml APVMA Approval Number: 60521/55542 SU:XXXX