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Date: Thursday, March 28, 2024 10:37

Release 2.189
Pen & Strep Suspension for Injection
 
Species: Cattle, Horses and other equidae, Pigs, Sheep
Therapeutic indication: Pharmaceuticals: Antimicrobials: Injections
Active ingredient: Dihydrostreptomycin Sulfate, Procaine Penicillin
Product:Pen & Strep Suspension for Injection
Product index: Pen & Strep Injection
Cattle - milk: See notes
Cattle - meat: 23 days
Sheep - meat: 31 days
Pig - meat: 18 days
Withdrawal notes: Milk for human consumption may only be taken from cows after 60 hours from the last treatment. Not to be used in sheep producing milk for human consumption
Incorporating:
Qualitative and quantitative composition
Active substance(s):
Procaine Penicillin
200 mg
Dihydrostreptomycin Sulphate
250 mg
Excipients:
The product also contains 1.5mg Hydroxybenzoate Esters (as Nipasept Sodium) as antimicrobial preservative and 1.25mg sodium formaldehyde sulphoxylate dihydrate as antioxidant.
For a full list of excipients, see section Pharmaceutical Particulars
Pharmaceutical form
Suspension for Injection.
A white to off-white aqueous suspension for injection.
Clinical particulars
Target species
Cattle, Horses, Sheep, Pigs
Indications for use, specifying the target species
For the treatment of systemic infections in cattle, horses, sheep and pigs caused by or associated with organisms sensitive to penicillin and/or streptomycin including:
Arcanobacterium pyogenes
Erysipelothrix rhusiopathiae
Klebsiella pneumoniae
Listeria spp
Mannheimia haemolytica
Pasteurella multocida
Staphylococcus spp (non-penicillinase producing)
Streptococcus spp
Salmonella spp
and for the control of secondary bacterial infection with sensitive organisms in diseases primarily associated with viral infection.
Contraindications
Contraindicated in known cases of hypersensitivity to penicillins.
Special Warnings for Each Target Species
Use with care in animals known to have kidney disease or defective renal function.
Do not exceed the recommended dosage or duration of treatment.
Special Precautions for Use
Special precautions for use in animals:
Care should be taken not to exceed the recommended dosage. Aminoglycosides have a narrower margin of safety than beta lactam antibiotics.
Special precautions to be taken by the person administering the product to the animals:
Care should be taken to avoid accidental self-injection. In the case of accidental self-injection, seek medical advice immediately.
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross-reactions to cephalosporins and vice versa. Allergic reaction to these substances may occasionally be serious.
Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.
Handle this product with great care to avoid exposure taking all recommended precautions.
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 in breathing are more serious symptoms and require urgent medical attention.
Wash hands after use.
Adverse reactions (frequency and seriousness)
In rare cases, hypersensitivity reactions can occur and very rarely, these can be fatal. Very rarely, in sucking and fattening pigs, administration may cause a transient pyrexia, vomiting, shivering, listlessness and incoordination. A palpable but transient local reaction may occur at the site of intramuscular administration in horses.
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, lactation or lay
Pen & Strep can be safely administered to pregnant and lactating animals. However in pregnant sows and gilts a vulval discharge which could be associated with abortion has been reported.
Interactions with other medicinal products and other forms of interaction
Do not administer with other antibiotics such as tetracyclines or with other aminoglycosides.
Amount to be administered and administration route
Shake the vial before use.
Administer by deep intramuscular injection.
Recommended dosage rate is 8 mg/kg bodyweight procaine penicillin with 10 mg/kg bodyweight dihydrostreptomycin sulphate equivalent to 1 ml per 25 kg bodyweight. Treatment should be given once daily for up to 3 consecutive days. The maximum dose volume administered at one site should not exceed 15 ml for horses, 6 ml for cattle, 3 ml for sheep and 1.5 ml for pigs.
Overdose (symptoms, emergency procedures, antidotes) (if necessary)
No treatment specified.
Withdrawal periods
Animals must not be slaughtered for human consumption during treatment.
Sheep:
Not to be used in sheep producing milk for human consumption.
Sheep intended for human consumption should not be slaughtered until 31 days after the last treatment.
Cattle:
Milk for human consumption must not be taken during treatment.
Milk for human consumption may only be taken from cows after 60 hours from the last treatment.
Cattle intended for human consumption should not be slaughtered until 23 days after the last treatment.
Pigs:
Pigs intended for human consumption should not be slaughtered until 18 days after the last treatment.
Horses:
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
Pharmacotherapeutic group: Antibacterials for intramammary use, Combination of antibacterials for intramammary use, Beta-lactam antibacterials, penicillins, combinations with other antibacterials
ATCvet Code: QJ01RA01
Pharmacodynamic properties
Penicillin G is a beta-lactam antibiotic and its structure contains the beta-lactam ring and thiazolidine ring common to all penicillins. Beta-lactam antibiotics prevent the bacterial cell wall of susceptible Gram-positive bacteria from forming by interfering with the final stage of peptidoglycan synthesis. They inhibit the activity of transpeptidase enzymes, which catalyse cross-linkage of the glycopeptide polymer units that form the cell wall. They exert a bactericidal action but cause lysis only of growing cells.
Dihydrostreptomycin is an aminoglycoside antibiotic active against gram-negative aerobes, which after penetration of the cell envelope binds to receptors on the 30S sub unit of the bacterial ribosome. It induces misreading of the genetic code on the messenger ribonucleic acid (mRNA) template, causing bacteriostasis. Aminoglycosides exert synergistic action in combination with beta-lactam antibiotics.
Pharmacokinetic properties
After injection of Pen & Strep, the procaine penicillin is rapidly absorbed from the site of injection, with maximum penicillin levels of between 1 and 2 µg/ml for horses, sheep and pigs and 0.5 µg/ml for cattle, being obtained within 2 hours of injection.
The penicillin elimination half-lives are approximately 2 hours for sheep and pigs, 5 hours for cattle and 11 hours for horses. Dihydrostreptomycin is absorbed at a similar rate, with maximum plasma levels of 23 µg/ml being obtained for cattle, sheep and pigs, and 15 µg/ml for horses. The elimination half-lives are approximately 2 hours for cattle, sheep and pigs and 4 hours for horses.
Pharmaceutical particulars
List of excipients
Hydroxybenzoate Esters (as Nipasept Sodium)
Sodium Formaldehyde Sulphoxylate Dihydrate
Povidone K12
Polysorbate 80
Sodium Citrate Dihydrate
Disodium Edetate Dihydrate
Cetrimide
Citric Acid Anhydrous
Water for Injections
Incompatibilities
None known.
Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale:
Glass: 9 months, Plastic: 24 months
Shelf life after first opening the immediate packaging: 28 days.
Special precautions for storage
Glass: Do not store above 25°C.
Plastic: Store between 2 - 8°C
Protect from light.
Following withdrawal of the first dose, use the product within 28 days.
Discard unused material.
Nature and composition of immediate packaging
Clear type II multidose glass vials of 50 ml and 100 ml sealed with bromobutyl bungs and aluminium caps.
Clear polyethylene terephthalate plastic vials of 50 ml, 100 ml and 250 ml sealed with bromobutyl bungs and aluminium caps.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Norbrook Laboratories Limited, Station Works, Camlough Road, Newry, Co. Down, BT35 6JP Northern Ireland
Marketing Authorisation Number
Vm 02000/4100
Significant changes
Date of the first authorisation or date of renewal
12th March 1991
Date of revision of the text
September 2022
Any other information
Nil.
Legal category
Legal category: POM-V
GTIN
GTIN description:Pen & Strep Injection: 100ml
GTIN:5023534000297