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Date: Thursday, May 30, 2024 10:02

Description: MSD-AH
Release 2.75
Depocillin® 300 mg/ml suspension for injection
 
Species: Cats, Dogs, Horses and other equidae, Pigs, Sheep
Therapeutic indication: Pharmaceuticals: Antimicrobials: Injections
Active ingredient: Procaine Benzylpenicillin
Product:Depocillin® 300 mg/ml suspension for injection
Product index: Depocillin®
Cattle - milk: 264 hours
Cattle - meat: 5 days
Sheep - meat: 5 days
Pig - meat: 5 days
Incorporating:
Qualitative and quantitative composition
Active substance per ml:
Procaine benzylpenicillin 300 mg
Preservative:
Methylparahydroxybenzoate 1.10 mg
For the full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Suspension for injection
Clinical particulars
Target Species
Cow, horse, sheep, pig, dog and cat
Indications for use
Depocillin is indicated for the treatment of infections caused by bacteria sensitive to penicillin.
Contraindications
Not to be administered to animals sensitive to penicillin.
Not to be used in rabbits, guinea pigs, hamsters or gerbils. Caution is advised in its use in any other small herbivores.
Not effective against beta-lactamase producing organisms.
Special warnings for each target species
Occasionally in sucking and fattening pigs, administration of products containing procaine penicillin may cause a transient pyrexia, vomiting, shivering, listlessness and incoordination. Additionally in pregnant sows and gilts a vulval discharge which could be associated with abortion has been reported.
Special precautions for use
Not recommended for intravenous or intrathecal administration
Operator warnings
Penicillin 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 are occasionally serious.
1. Do not handle this product if you know you are sensitised or if you have been advised not to work with such preparations.
2. Handle this product with great care to avoid exposure, taking all recommended precautions.
3. If you develop symptoms following exposure, such as a 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.
Wash hands after use.
Adverse Reactions
Hypersensitivity reactions may occur in very rare cases. Such reactions may evolve to a more severe condition (anaphylaxis), which may be life-threatening. Potentially fatal reactions associated with the administration of procaine penicillin in horses have been observed. If such reactions occur appropriate treatment is recommended.
In sucking and fattening pigs, vomiting has been observed in very rare cases.
Injection site reactions such as swelling and pain have been recorded with post-marketing data in very rare cases.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
Use during pregnancy or lactation
No special precautions necessary
Interactions
Antagonism between the product and bacteriostatic preparations may occur.
Resistant bacteria, particularly gram-negative, that show a cross-resistance with other ß-lactam antibiotics might occur.
Amounts to be administered and administration route
Horses and cattle 12 mg/kg bodyweight, sheep and pigs 15 mg/kg by intramuscular injection
Dogs and cats 30 mg/kg (1ml per 10 kg body weight) by subcutaneous administration
Suggested doses are:
Horse 500 kg 20 ml
Cow 500 kg 20 ml
Sheep 50 kg 2.5 ml
Pig 50 kg 2.5 ml
Dog 10 kg 1 ml
Cat 5 kg 0.5 ml
Clean the area of the injection site and swab with spirit. Shake well before use.
Treatment may be repeated at 24 hour intervals for up to 5 administrations.
For organisms highly susceptible to penicillin, such as Streptococcus dysgalactiae in sheep, treatment may be repeated at 48 hour intervals for up to 3 administrations.
DO NOT USE THE SAME INJECTION SITE MORE THAN ONCE DURING A COURSE OF TREATMENT.
Do not inject more than 20 ml per injection site in cattle.
Do not inject more than 5 ml per injection site in pigs and sheep.
Overdose
Penicillin is a compound with a very high therapeutic ratio. It is very unlikely that an overdose of the product will have adverse effects on the treated animal.
Withdrawal periods
Meat: Cattle 5 days
Pigs 5 days
Sheep 5 days
Milk: (Cows only) 264 hours (11 days)
Not to be used in sheep producing milk intended for human consumption.
Not to be used in horses intended for human consumption.
Treated horses may never be slaughtered for human consumption.
The horse must have been declared as not intended for human consumption under national horse passport legislation.
Pharmacological particulars
ATC Vet Code: QJ0ICE09
Pharmacotherapeutic group:
Antibacterials for systemic use, Beta-lactam antibacterials, penicillins, Beta-lactamase sensitive penicillins.
Pharmacokinetic particulars
Penicillin is a beta-lactam antibiotic which has bactericidal activity against mainly Gram-positive bacteria and some Gram-negative aerobes. It is sensitive to beta-lactamase (penicillinase) inactivation. It is widely distributed in the extracellular fluids after absorption, and eliminated almost entirely by the kidneys.
The procaine penicillin gives high initial blood levels; treatment may be repeated at 24 or 48 hour intervals to maintain therapeutic levels.
Pharmaceutical particulars
Excipients
Methyl parahydroxybenzoate
Lecithin (soya)
Povidone (K30)
Sodium Citrate dihydrate
Potassium Acid Phosphate
Disodium Edetate Dihydrate
Sodium hydroxide 32% (for pH adjustment)
Phosphoric acid 85% (for pH adjustment)
Water for injections
Major incompatibilities
None known
Shelf-life
Shelf life: 3 years
Following withdrawal of the first dose, use the product within 28 days.
Special precautions for storage
Store in a refrigerator at between +2oC and +8oC. Do not freeze. Protect from light.
Immediate packaging
Multidose vials of neutral (Ph.Eur. type II) glass or PET closed with halogenated butyl rubber stoppers and aluminium closures, containing 100 ml.
Disposal
Any unused product or waste material should be disposed of in accordance with national requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 01708/4622
Significant changes
Date of the first authorisation or date of renewal
25 September 1996
Date of revision of the text
September 2021
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Depocillin 1x100ml:
GTIN:8713184011053