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Date: Wednesday, May 29, 2024 19:11

Release 2.114
Revozyn® RTU 400 mg/ml Suspension for Injection for Cattle
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Antimicrobials: Intramammaries: Lactating cow, Pharmaceuticals: Antimicrobials: Injections
Active ingredient: Penethamate Hydriodide
Product:Revozyn® RTU 400 mg/ml Suspension for Injection for Cattle
Product index: Revozyn RTU 400 mg/ml Suspension for Injection for Cattle
Cattle - milk: 4 days
Cattle - meat: Meat and offal: 10 days
Incorporating:
Qualitative and quantitative composition
Each ml suspension contains: Active substance:
308.8 mg penethamate equivalent to 400 mg penethamate hydriodide
Pharmaceutical form
Suspension for injection. A white to yellowish white oily suspension.
Clinical particulars
Target species
Cattle (lactating cows).
Indications for use
Treatment of clinical and subclinical mastitis in lactating cows caused by staphylococci and streptococci, susceptible to penicillin.
Contraindications
Do not use in cases of known hypersensitivity to the active substance, or to any of the excipients.
Do not administer by intravenous injection.
Special warnings for each target species
Cross-resistance has been shown between benzylpenicillin and penicillins and beta-lactam antimicrobials in staphylococci and streptococci. Use of benzylpenicillin should be carefully considered when susceptibility testing has shown resistance to penicillins or beta-lactam antimicrobials because its effectiveness may be reduced.
Special precautions for use in animals
Use of the product should be based on identification and susceptibility testing of the target pathogens. If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at farm level, or at local/regional level.
Use of the product should be in accordance with official, national and regional antimicrobial policies.
The feeding of waste milk containing residues of penicillin to calves should be avoided up to the end of the milk withdrawal period (except during the colostral phase), because it could select antimicrobial-resistant bacteria (e.g. ESBL) within the intestinal microbiota of the calf and increase the faecal shedding of these bacteria.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This veterinary medicinal product can cause sensitisation and contact dermatitis.
Hypersensitivity to penicillins may lead to cross reactions to cephalosporins, and vice versa.
Allergic reactions to these substances may occasionally be serious.
Handle this product with great care to avoid direct skin contact or self-injection.
People with known hypersensitivity to penicillin should avoid contact with the veterinary medicinal product.
Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product.
Wash hands after use.
In case of accidental contact with the skin, wash immediately with plenty of water. If symptoms following exposure such as skin develop or in case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Swelling of the face, lips or eyes, or difficulty with breathing are more serious symptoms and require urgent medical attention.
Adverse reactions
Cattle (lactating cows):
Very rare (<1 animal / 10,000 animals treated, including isolated reports):
Urticaria, Anaphylactic shocka , deatha . Sensitisation against penicillins.
Undetermined frequency (cannot be estimated from the available data):
Skin reactions (mild), such as dermatitis
aAnaphylactic shock can be fatal, very rarely.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for respective contact details.
Use during pregnancy and lactation
Can be used during pregnancy or lactation.
Interactions
The veterinary medicinal product should not be administered concurrently with bacteriostatic antibiotics.
Amounts to be administered and administration route
Shake well before use.
For intramuscular administration only, preferably in the neck.
Administer alternately on the left and the right side.
Administer 10-15 mg penethamate hydriodide per kg body weight per day, once daily for 3 consecutive days, corresponding to 2.5-3.75 ml of the veterinary medicinal product per 100 kg body weight per day, once daily for 3 consecutive days.
Avoid underdosing. To ensure a correct dosage, body weight should be determined as accurately as possible.
Overdose
In case of overdose, no adverse effects other than those mentioned in Adverse reactions are to be expected.
Withdrawal periods
Milk: 4 days.
Meat and offal: 10 days.
Pharmacological particulars
Pharmacotherapeutic group: Beta-lactamase sensitive penicillins.
ATCvet code: QJ01CE90
Pharmacodynamic properties
In aqueous environments, penethamate is hydrolysed to form benzylpenicillin and diethylaminoethanol. The mode of action of benzylpenicillin is by prevention of cell wall synthesis during bacterial cell growth and its activity is primarily bactericidal and time-dependent. The antimicrobial spectrum of the active substance corresponds to that of benzylpenicillin which is active against beta-lactamase negative Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis and Staphylococcus aureus. In 2011 the MIC90 values for penicillin in Sweden were 0.12 μg/ml for S. aureus, 0.12 μg/ml for S. dysgalactiae and 0.12 μg/ml for S. uberis. In 2012 the MIC90 values for penicillin in Germany were 0.031 μg/ml for S. agalactiae, 0.015 μg/ml for S.dysgalactiae and 0.125 μg/ml for S. uberis. In 2013 the MIC90 values for penicillin in Switzerland were 1.0 μg/ml for S. aureus, ≤0.12 μg/ml for S. dysgalactiae and ≤0.12 μg/ml for S. uberis. EUCAST reports an Epidemiological Cut OFF value (ECOFF) of 0.125 μg/ml for S. aureus and an ECOFF of 0.125 μg/ml for S. agalactiae. For S. dysgalactiae and S. uberis no ECOFF values are determined.
The most frequent mechanism of resistance is producing beta-lactamases (more specifically penicillinase especially in S. aureus), which break the beta-lactam ring of penicillins, making them inactive.
Pharmacokinetic properties
Penethamate hydriodide is the diethylaminoethyl ester of penicillin, which contains an acidic carboxylic acid grouping. The ester is non-iodised and has high lipid solubility. The major pharmacokinetic properties of penethamate hydriodide are its rapid absorption with high bioavailability and rapid metabolism in vivo to penicillin, the therapeutically active molecule. In circulation it is rapidly hydrolysed to diethylaminoethanol and penicillin, with approximately 90% existing as penicillin. The parent compound readily penetrates into milk, as a consequence of its high lipid solubility. In milk, it is hydrolysed to penicillin and this maintains the plasma/milk concentration gradient for the parent compound. This is a mechanism of passive diffusion from a fluid of pH 7.4 to a more acid pH in milk. With a pKa value of 2.7, penicillin is highly ionised in both plasma and milk. The pH gradient between plasma (pH 7.4) and milk (pH 6.6-6.8) is reduced in mastitis but nevertheless is not abolished.
Cmax is 682 ng/mL, AUClast is 7770 h*ng/mL and elimination half-life is 6.84 hours. Apart from excretion in the milk, benzylpenicillin is also excreted via the kidneys.
Pharmaceutical particulars
Incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 28 days.
Special precautions for storage
Store below 30°C. Keep upright.
Immediate packaging
Multidose 50 ml uncoloured glass (type II, Ph. Eur.) vials, closed with a fluoropolymer coated rubber type I (Ph. Eur.) stoppers, secured with aluminium caps.
1 vial in a cardboard box.
Disposal
Medicines should not be disposed of via wastewater or household waste.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.
Marketing Authorisation Holder (if different from distributor)
Eurovet Animal Health BV, Handelsweg 25, 5531 AE Bladel, The Netherlands.
Marketing Authorisation Number
GB: Vm 16849/5000
NI: Vm 16849/3000
Significant changes
Date of the first authorisation or date of renewal
10 July 2017
Date of revision of the text
February 2023
NI: Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary).
Any other information
For animal treatment only. To be supplied only on veterinary prescription. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Revozyn RTU 400 mg/ml Suspension for Injection for Cattle:
GTIN:08714225165988