PHARMACOLOGICAL ACTION
Procaine benzylpenicillin: “The penicillin impairs the development of bacterial cell walls by interfering with transpeptidase enzymes responsible for the formation of the cross-links between peptidoglycan strands. During bacterial cell growth, while the peptidoglycan structure is being formed, autolysins continuously cleave the lattice to provide acceptor sites for new strands. Normal bacterial growth depends on a balance between cell wall deposition and autolysis. When penicillin interacts with penicillin-binding proteins (PBP) and inhibits the synthetic enzymes, defective cell walls are formed which lead to abnormal elongation of cells, formation of spheroplasts or osmolysis. The effect of the penicillins is generally bactericidal, although bacteriolysis may also occur.”
They have been shown to be effective in-vitro against Gram-positive bacteria such as Staphylococcus aureus, Streptococci, most Trueperella pyogenes and Erysipelothrix spp. Sensitive anaerobic bacteria include most Clostridia. They are also effective in-vitro against certain Gram-negative bacteria such as Pasteurella multocida, Leptospira and Actinobacillus (Haemophilus) pleuropneumoniae.
INDICATIONS
Depocillin® injection is recommended for the treatment of local and systemic infections caused by bacteria sensitive to penicillin in horses, cattle, sheep, pigs, dogs and cats.
CONTRAINDICATIONS
Not to be administered to animals known to be allergic to penicillin.
Cross-reactions are common with penicillins and in some instances with cephalosporins.
Psittacine birds are sensitive to procaine.
WARNINGS
Withdrawal periods (For food producing animals)
Meat (cattle and sheep): 4 days
Meat (pigs) : 5 days
Milk : 5 milkings
When administered to an animal known to be penicillin sensitive, anaphylactic shock may occur. Adrenaline, corticosteroids and antihistamines should be used to treat anaphylaxis.
Do not administer intravenously.
Use with caution in patients with a known history of allergy.
Do not use in small herbivores (rabbits, guinea pigs, hamsters, chinchillas).
Procaine benzylpenicillin may occasionally cause transient pyrexia, vomiting, shivering, listlessness and incoordination in pigs. Additionally, in pregnant sows and gilts, abortion has been reported in a few cases.
Procaine is detected in urine of horses up to 2 weeks after i.m. administration.
KEEP OUT OF REACH AND SIGHT OF CHILDREN, UNIFORMED PERSONS AND ANIMALS .
DOSAGE AND DIRECTIONS FOR USE – USE ONLY AS DIRECTED
Shake well before use.
Given by intramuscular injection to large animals.
Dogs may be injected by either the subcutaneous or intramuscular route.
Cats should be injected by the subcutaneous route.
Dosage
Horses and Cattle: 20 mℓ/500 kg body weight (1 mℓ/25 kg).
Pigs and Sheep: 2,5 mℓ/50 kg body weight (1 mℓ/20 kg).
Dogs and Cats: 1 mℓ/10 kg body weight.
Injections may be repeated at 24-hour intervals depending on clinical judgement. Repeat injection should be given at a different injection site.
The usual aseptic precautions should be taken when administering the injections.
SIDE EFFECTS AND SPECIAL PRECAUTIONS
Hypersensitivity reactions to penicillins range from mild and transitory skin reactions to fatal anaphylactoid shock.
Pharyngitis or sore throat has been reported in dogs following 4 days of penicillin therapy.
Intrathecal administration of penicillins is not recommended, because it is a potent convulsant when given by this route.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
See “SIDE EFFECTS”.
Treatment is symptomatic and supportive.
IDENTIFICATION
Depocillin® is a white to off-white ready to use aqueous suspension.
Appearance of sediment on standing: White to off-white suspension.
PRESENTATION
100 mℓ and 250 mℓ clear, ready-to-use, colourless, glass vials and 100 mℓ, 250 mℓ and
500 mℓ PET vials.
Vials are sealed with a rubber stopper and a removable aluminium cap.
Not all pack sizes may necessarily be marketed.
STORAGE
Store between 2 °C – 8 °C in a refrigerator.
Do not freeze.
Protect from light.
Do not use Depocillin® after the expiry date which is stated on the container label.
Shelf life after first opening the container: 8 weeks.
REGISTRATION NUMBER
83/659 (Act 101/1965)
Namibia Reg. No. V22/17.1.10/507 NS2
REGISTRATION HOLDER
Intervet South Africa (Pty) Ltd.
20 Spartan Road, Spartan
1619, RSA
Tel: +27 (0) 11 923 9300
E-mail: msdahza@msd.com
www.msd-animal-health.co.za
DATE OF PUBLICATION OF THE PACKAGE INSERT 24 July 2014