| - | - | - |
|---|---|---|
| Product Group | : | Antibacterials |
| Pharmaceutical Form | : | Suspension for Injection |
| Active Ingredient | : | Dihydrostreptomycin Sulphate, Procaine Benzylpenicillin |
| Target Species | : | Cattle, Horse, Sheep, Dog, Cat |
| Package Form | : | 100 ml |
For Veterinary Use Only
For Veterinary Use Only
Suspension for Injection
Veterinary Systemic Antibacterial
COMPOSITION
It is white-cream colored sterile suspension containing 200.000 IU Benzylpenicillin procain and 200 mg Dihydrostreptomicin sulfate per ml.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic Properties
Penicillin G is a beta-lactam antibiotic and, like other penicillins, contains thiazolidine and beta-lactam rings. Beta-lactams act by inhibiting the development of the bacterial cell wall in susceptible Gram-positive bacteria by inhibiting the synthesis of peptidoglycan at the final stage. Inhibits the enzyme transpeptidase. It shows bactericidal effect and causes lysis of developing cells.
Dihydrostreptomycin is an aminoglycoside antibiotic effective against Gram negative bacteria. It acts by binding to receptors on the 30S subunit of bacterial ribosomes. As a result, the codes on the mRNA are misread and bacteriostasis develops. Aminoglycosides act synergistically with betalactams.
Pharmacokinetics Properties
After injection, procaine penicillin is rapidly absorbed from the injection site, with levels achieved approximately 2 hours after administration (1-2 µg/ml in horses, sheep and pigs, 0.5 µg/ml in cattle).
The elimination half-life of penicillin is approximately 2 hours in sheep and pigs, 5 hours in cattle and 11 hours in horses.
Dihydrostreoptomycin is absorbed at similar rates, with maximum plasma levels of approximately 23 µg/ml in pigs and cattle and 15 µg/ml in horses. The elimination half-life is approximately 2 hours in cattle, sheep and pigs and 4 hours in horses.
AREA OF USE/ INDICATIONS
It is used for the treatment of respiratory, digestive, urogenital systems and other soft tissue infections caused by the susceptible microorganisms to the combination in cattle, horse, sheep, dog and cats;
Arcanobacterium pyogenes
Erysipelothrix rhusiopathiae
Klebsiella pneumoniae
Listeria spp.
Mannheimia haemolytica
Pasteurella multocida
Staphylococcus spp. (does not produce penicillinase)
Streptococcus spp.
Salmonella spp.
USAGE AND DOSAGE
Shake well before use. Apply deep intramuscularly.
Cattle, sheep and horse: 8 mg/kg body weight benzylpenicillin procaine and 10 mg/kg body weight dihydrostreptomycin sulfate, practically 1 ml for 25 kg body weight is applied for 3 days. Maximum 15 ml should be applied in horses, 6 ml in cattle and 3 ml in sheep.
Cat, dog: 8-20 mg/kg body weight benzyl penicillin procaine and 10-25 mg/kg body weight dihydrostreptomycin sulfate, practically 0,5 ml for 5 kg body weight for 3 – 5 days.
SPECIAL CLINICAL INFORMATION AND SPECIAL WARNINGS FOR TARGET SPECIES
Use with caution in animals with kidney disease or functional disorder. Do not exceed the recommended dose. Do not use in rabbit and small rodent.
Aminoglycosides have a narrower safety range than penicillins.
Use this product according to the sensitivity results of bacteria obtained from the animals. If it is not possible, the treatment should be based on regional epidemiological data. Use of this product other than as directed may result in the development of betalactam- or aminoglycoside-resistant bacteria and reduced efficacy against other bacteria due to cross-resistance.
Use in pregnancy and lactation: There are no studies on the safe use of the product in pregnant animals. Use in pregnant animals is subject to the benefit/risk assessment of the veterinarian.
ADVERSE EFFECTS
Transient local reaction may be observed after intramuscular injection in horses. Rarely allergic reactions may occur. These reactions may range from local swelling to anaphylaxis and death. Hearing and balance disorders and impaired renal function may occur, especially in long-term use. Cramps and difficulty in breathing may occur due to the neuromuscular blocking effect of dihydrostreptomycin. In case of side effects, it is recommended to discontinue treatment and to treat according to the side effect. Neuromuscular blocking effects of aminoglycosides can be partially eliminated with calcium and neostigmine administration.
DRUG INTERACTIONS
It should not be used in combination with antibiotics such as other aminoglycosides and tetracyclines.
It should not be used with pentobarbital and other inhalation anesthetics because of the risk of vascular depression.
Not used with other products that increase neuromuscular blockade (muscle relaxants) and not used with diuretics because of the increased risk of ototoxicity.
Not used in combination with heparin, calcium gluconate, riboflavin and triamquinolone. It is not used in combination with sulfonamides because they reduce the effect of procaine.
This product should not be mixed with other products.
SYMPTOMS OF OVERDOSE, PRECAUTIONS AND ANTIDOTE
Overdose of dihydrostreptomycin may cause muscle weakness and respiratory arrest due to neuromuscular blockade and other effects. Procaine intoxication can cause convulsions, hypotension and psychosis. Horses are the most susceptible species to the side effects of procaine. Other nervous system signs such as muscle weakness, incoordination, imbalance, excitement, convulsions have been seen in other animals.
WITHDRAWAL PERIODS
Meat: 35 days for cattle and sheep.
Milk: 72 hours (6 milkings) for cow. Not for use in sheep from which milk is obtained for human consumption.
CONTRAINDICATIONS
Not used in animals sensitive to betalactams.
GENERAL WARNINGS
Consult your veterinarian before use and in case of an unexpected effect. Keep out of reach of children and foodstuff.
PRECAUTIONS TO BE TAKEN BY THE ADMINISTRATOR AND WARNINGS FOR VETERINARY SURGEON
Take precautions to avoid accidental self-injection. In such a case, seek medical advice immediately.
Penicillin and cephalosporins can cause hypersensitivity (allergy) reactions after skin contact, ingestion by mouth, inhalation or injection. There is a cross-reaction between penicillins and cephalosporins. Allergic reactions are rarely very serious.
1- Do not use the product if you are sensitive or have been told that you should not come into contact with such products.
2-Take the necessary precautions to prevent exposure during the application of the product.
3-If you see symptoms such as skin rash after exposure, consult a doctor immediately with the label and package insert. Symptoms such as swelling of the face, eyes or lips or difficulty breathing are much more serious and require immediate medical attention.
Wash your hands after use.
STORAGE CONDITIONS AND SHELF LIFE
Store between 15 – 25 oC, protect from light. After opening, store at +4 oC for 28 days. Shelf life is 2 years.
COMERCIAL PRESENTATION FORM
Offered for sale in 100 ml transparent Type II glass vials inside a cardboard box. It is sealed with Type I grey bromobutyl rubber stoppers and transparent printed aluminium flip-off caps.
PLACE AND CONDITIONS OF SALE
Sold with Veterinary Surgeon’s prescription in pharmacies, veterinary clinics, polyclinics and animal hospitals (VSP).
APPROVAL DATE OF THE PACKGAGE INSERT: 17.10.2023
MARKETING AUTORIZATION DATE AND NO: 12.03.2012 – 025/0062
MARKETING AUTHORIZATION HOLDER
Pİ FARMA İLAÇ SAN. VE TİC. A.Ş.
Malıköy Başkent OSB Mah. 26. Cad. No:34/A Sincan/Ankara-Türkiye
MANUFACTURER COMPANY
FDN İLAÇ SAN. VE TİC. LTD. ŞTİ.
Büyükkayacık OSB Mah. İnsu Sokak No:3 Selçuklu/Konya-Türkiye
