| - | - | - |
|---|---|---|
| Product Group | : | Antibacterials |
| Pharmaceutical Form | : | Suspension for Injection |
| Active Ingredient | : | Dihydrostreptomycin Sulphate, Procaine Benzylpenicillin, Benzathine Benzylpenicillin |
| Target Species | : | Cattle, Horse, Sheep, Dog |
| Package Form | : | 100 ml |
For Veterinary Use Only
For Veterinary Use Only
Suspension for Injection
Veterinary Systemic Antibacterial
COMPOSITION
When it is shaken, it is white colored, ready-to-use, long acting, sterile suspension, containing 100.000 IU Procaine Penicilline G, 100.000 IU Benzathine Penicilline G and 250 mg Dihydrostreptomycin sulfate equivalent to 200 mg Dihydrostreptomycin base per ml.
PHARMACOLOGICAL PROPERTIES
Penidro LA Suspension for Injection is a broad-spectrum, long-acting formulation effective against penicillin- and dihydrostreptomycin-sensitive gram-positive and gram-negative bacteria. The combination of benzathine and procaine penicillin G disrupts cell wall synthesis in sensitive bacteria, particularly during their growth phase, leading to their death. This also allows streptomycin to enter the bacteria at higher concentrations. Thus, dihydrostreptomycin, which passes into the bacteria at higher concentrations, acts by disrupting protein synthesis. This combined and mutually reinforcing synergistic effect is bacteriostatic and bactericidal even at very low doses. Since penicillin is effective against gram-positive bacteria and dihydrostreptomycin is effective against gram-negative bacteria, the spectrum is broadened through synergistic effects.
The synergistic effect resulting from the combination of penicillin and dihydrostreptomycin has a spectrum that includes both gram-positive and gram-negative bacteria. It has been shown to be effective against the following bacteria under in vitro conditions.
Corynebacterium pyogenes, Klebsiella pneumoniae, Listeria spp., Pasteurella haemolytica, P. Multocida, Staphylococcus spp., Streptococcus spp., Peptostreptecoccus spp., Erysipelothrix insidiosa, Clostridium spp., Escherichia coli, Proteus spp., Moraxella spp., Actinobacillus lignieresi, Haemophilus spp., and Salmonella spp.
Due to the depot effect, it is gradually absorbed from the injection site and is found in the blood partly free and partly bound to proteins (penicillin 80-90%, dihydrostreptomycin 3%). It passes into the kidneys, liver, lungs, skin and soft tissue, mucosa, serosa, and connective tissue. 80-90% is excreted unchanged in large amounts by the kidneys and in smaller amounts in bile, milk, and sweat.
AREA OF USE / INDICATIONS
It is used for the treatment of digestive system, respiratory system, urogenital system caused by bacteria sensitive to penicillin and dihydrostreptomycin and secondary bacterial infections in cattle, sheep, horse and dog.
USAGE AND DOSAGE
Pharmacological Dose:
Penicillin: 10.000 IU/kg bw, Dihydrostreptomycin: 10 mg/kg bw
Practical Dose:
1 ml/20 kg bw is administered intramuscularly for all species.
|
Species |
Body weight (kg) |
Dose (ml) |
|
Cattle - Horse |
400 |
20 |
|
Cow - Heifer |
200 |
10 |
|
Calve - Foal |
100 |
5 |
|
Sheep |
40 |
2 |
|
Dog |
10 |
0,5 |
In general, single dose is enough, in severe cases, the administration can be repeated every 48 hours if necessary.
Shake the bottle before use, the suspension must be made homogeneous.
Do not administer intravenously.
Repeated injections into the same area, especially in horses, should be avoided.
Asepsis and antisepsis should be observed during use.
ADVERSE EFFECTS
In sensitive animals, allergic and anaphylactic side effects such as urticaria, skin lesions, nausea, vomiting, respiratory distress, pulmonary and laryngeal edema, vasomotor center paralysis and coma and death may occur. Especially, in animals with renal dysfunction, high plasma concentrations of streptomycin, which are dose-dependent, may exhibit neurotoxic, nephrotoxic, and ototoxic effects. In cases of renal insufficiency, the dosage should be reduced to an adequate level.
DRUG INTERACTIONS
Calcium, sodium, potassium, and dextrose solutions, acids and alkalis, chlorothiazide, phenobarbital, sodium phenytoin, Vitamin C and B vitamins, physical and chemical incompatibility, tetracyclines, ampicillin, cloxacillin, methicillin, carbenicillin, sulfadiazine, and nitrofurantoin exhibit antagonistic interactions. Because of the potential toxic effects, dihydrostreptomycin should not be used in combination with other drugs known to be nephrotoxic, ototoxic, and neurotoxic and/or drugs that may increase these effects of dihydrostreptomycin (other aminoglycosides, furosemide, sulfonamides, tetracyclines, anesthetics, cephalosporins, etc.). Furthermore, it should be noted that the use of penicillin-streptomycin combinations, especially at high doses, in animals under general anesthesia and/or with muscle relaxants may increase the neuromuscular blocking effect and potentially cause death.
SYMPTOMS OF OVERDOSE, PRECAUTIONS AND ANTIDOTE
When used in excess of the recommended dosage and periods, the resulting deafness becomes permanent and untreatable. If sensitivity-related side effects occur, administration of the drug should be discontinued immediately and treatment should be initiated with cardiac and respiratory analeptics, antihistamines, corticosteroids, and adrenaline, depending on the clinical table.
WITHDRAWAL PERIODS
Meat: 60 days for cattle and sheep
Milk: 15 days (30 milkings) for cow and sheep
Because of the long withdrawal period for drug residues in milk, it is not recommended to administer this drug to sheep and cows from which milk is obtained for human consumption.
CONTRAINDICATIONS
It should not be used in animals with hypersensitivity to penicillin, dihydrostreptomycin and cephalosporins or in animals with renal insufficiency. It should not be administered intravenously.
Use during pregnancy: Dihydrostreptomycin should not be used in pregnant animals due to its neurotoxic, nephrotoxic, and ototoxic effects on the fetus.
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
Penicillin sensitivity: Penicillin injection, ingestion, inhalation, or tissue contact may cause sensitivity. Those who are sensitive to penicillin should wear gloves during administration. If swelling of the face, eyes, or lips, or difficulty breathing occurs as a result of penicillin injection, ingestion, inhalation, or contact, seek immediate medical attention.
STORAGE CONDITIONS AND SHELF LIFE
It should be stored between 15°C-25°C protecting from light. Shelf life is 2 years. After opening it should be consumed within 28 days at +4°C.
DISPOSAL AFTER USE AND WARNINGS FOR NON-TARGET SPECIES
As with other penicillins, it should not be used in small herbivorous animals such as hamsters, rabbits, and guinea pigs, or in animals such as geese and ducks. Due to sensitivity to streptomycin, this preparation should not be used in cats.
COMMERCIAL PRESENTATION FORM
Offered for sale in 100 ml colorless Type II glass vials within a cardboard box. It is sealed with Type I grey bromobutyl rubber stoppers and colorless 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 LEAFLET: 10.08.2021
MARKETING AUTHORIZATION DATE AND NO: 12.03.2012-025/0060
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
