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Penidro®

Penidro®

Product Group:Antibacterials
Pharmaceutical Form:Suspension for Injection
Active Ingredient:Dihydrostreptomycin Sulphate, Procaine Benzylpenicillin
Target Type:Cattle, Horse, Sheep, Dog
Package Form:100 ml

For Animal Use Only

For Animal Use Only

 

PENİDRO

Suspension for Injection

Veterinary Systemic Antibacterial

 

COMPOSITION

Penidro Suspension for Injection s a ready-to-use, sterile suspension for injection containing 200,000 IU of Benzylpenicillin procaine and 200 mg of Dihydrostreptomycin sulfate in 1 ml.

 

PHARMACOLOGICAL PROPERTIES

Penidro Suspension for Injection is a broad-spectrum formulation effective against many gram-positive and gram-negative bacteria sensitive to the combination of penicillin and dihydrostreptomycin. Benzylpenicillin procaine acts by inhibiting cell wall synthesis of susceptible bacteria, especially during the growth phase. This also allows higher levels of streptomycin to enter the bacteria. Thus, dihydrostreptomycin, which passes to bacteria at higher concentrations, acts by disrupting protein synthesis. This joint and complementary synergistic effect is bacteriostatic and bactericidal even at very low doses. Since penicillin is effective against gram-positive and dihydrostreptomycin gram-negative bacteria, its spectrum widens considerably with a synergistic effect in combination.

It proved to be effective against the following bacteria in vitro, thanks to the synergistic effect resulting from the combination of penicillin-dihydrostreptomycin: Corynebacterium pyonegenes, Listeria spp., Pasteurella haemolytica, P.multocida, Staphylococcus spp., Streptococcus spp., Peptostreptococcus spp. spp., E.coli, Proteus spp., Moraxella spp., Actinobacilus lignieresi, Haemophilus spp., Fusobacterium necrophorum, Salmonella spp., Klebsiella spp., and Leptospira species.

It reaches its maximum concentration in the blood 1-3 hours after intramuscular administration, some of it is free and some are protein-bound (80-90% of penicillin, 30% of dihydrostreptomycin). It passes through the kidney, lung, liver, skin and soft tissue, mucosa, serosa, and connective tissue. It is partially metabolized into penicyloic acid, but the majority (90%) is excreted by the kidneys without any metabolic change, and to a lesser extent by milk, bile, and sweat.

AREA OF USE / INDICATIONS

Penidro Suspension for Injection is used in the treatment of local and systemic infections caused by bacteria sensitive to penicillin and dihydrostreptomycin in horses, cattle, sheep, and dogs.

 

USAGE AND DOSAGE

Unless advised otherwise by the veterinarian

Pharmacological dose:

Penicillin procaine: 10,000 I.U/kg ca/day,

Dihydrostreptomycin sulfate: 10 mg/kg bw/day

Practical dose:

1 ml per 20 kg body weight intramuscularly.

Animal TypeBody weight (kg)Recommended daily dose (ml)
Cattle - Horse400 kg20 ml
Calf - heifer200 kg10 ml
Calf - Foal100 kg5 ml
Sheep60 kg3 ml
Dog5 kg0,25 ml

 

Depending on the clinical course, the treatment can be repeated once a day for 3-5 days.

The suspension should be homogenized by vigorously shaking the bottle before use.

Intravenous administration is contraindicated.

Repeated injections into the same area, especially in horses, should be avoided. When using, asepsis and antisepsis should be followed.

 

SPECIAL CLINICAL INFORMATION AND SPECIAL WARNINGS FOR TARGET SPECIES

As with other penicillins, it should not be used on small herbivorous animals such as hamsters, rabbits, and guinea pigs, and on animals such as geese and ducks. Due to their sensitivity to streptomycin, this preparation should not be used in cats.

UNDESIRED EFFECTS

Allergic and anaphylactic side effects such as urticaria, skin lesions, nausea, vomiting, respiratory distress, pulmonary and laryngeal edema, vasomotor central paralysis and coma, and death may occur in sensitive animals.

 

DRUG INTERACTIONS

It shows physical and chemical incompatibility with calcium, sodium, potassium, and dextrose solutions, acid and alkalis, chlorothiazide, phenobarbitone, phenytoin sodium, Vitamin C and B group vitamins, antagonist interactions with tetracyclines, ampicillin, cloxacillin, methicillin, carbenicillin, sulfadiazine, and nitrofurantoin. Due to the possible toxic effects of dihydrostreptomycin, it should not be used together with other drugs (other aminoglycosides, furosemide, sulfonamides, tetracyclines, anesthetics, cephalosporins etc.) In addition, it should be kept in mind that the use of penicillin-streptomycin combinations, especially in high doses, in animals treated with general anesthesia and/or muscle relaxants may increase the neuromuscular blocking effect and may cause death.

 

SYMPTOMS OF OVERDOSE, PRECAUTIONS, AND ANTIDOTE

When the deafness that occurs when it is used in more than the recommended doses and times becomes permanent, it cannot be treated. In case of sensitization-related side effects, drug administration should be stopped immediately and treatment with cardiac and respiratory analeptics, antihistamines, corticosteroids, and adrenaline should be started according to the clinical picture.

 

RESIDUAL WARNINGS FOR FOOD PRODUCING ANIMALS

Drug Residue Elimination Period: During the treatment and after the last drug administration, cattle and sheep should not be sent to slaughter until 60 days have passed. Cow and sheep milk obtained during the treatment and for 16 milkings (8 days) days following the last drug administration should not be offered for human consumption. It is not recommended to be applied to cows and sheep from which milk is obtained for human consumption due to the long recovery time of drug residues in milk.

 

CONTRAINDICATIONS

It should not be used in animals hypersensitive to penicillin, dihydrostreptomycin, and cephalosporin and in animals with kidney failure. It should not be administered intravenously.

Use in pregnancy: Dihydrostreptomycin should not be used in pregnant animals due to its neurotoxic, nephrotoxic, and ototoxic effects on the fetus.

 

GENERAL PRECAUTIONS

Consult your veterinarian before use and in case of an unexpected effect. Keep out of reach of children.

 

PRECAUTIONS TO BE TAKEN AND RECOMMENDATIONS FOR PHYSICIANS

Avoid contact with the medicine and wash your hands after use. Persons known to be sensitive to penicillin and cephalosporins should not come into contact with the drug in any way. Immediate medical attention is required if symptoms such as swelling of the face, eyes, or lips, difficulty in breathing occur after sensitized persons have been exposed to the drug through the mouth, skin, or inhalation. In this case, a doctor should be consulted about the medicine and its label.

 

STORAGE CONDITIONS AND SHELF LIFE

It should be stored at temperatures between (15oC-25oC) and protected from light. Shelf life is 2 years from the date of manufacture. Opened bottles should be consumed within 28 days at +4 oC.

 

TRADE DRESS

Penidro Suspension for Injection is offered for sale in 20, 50, 100 ml transparent colored glass bottles and 100, 250 ml plastic bottles with cardboard boxes, and 500 ml plastic bottles without cardboard boxes.

 

PLACE AND CONDITIONS OF SALE

It is sold in pharmacies, veterinary clinics, outpatient clinics ,and animal hospitals with a veterinarian's prescription.

APPROVAL DATE OF THE PROSPECTUS: 10.08.2021

T.R. MINISTRY OF AGRICULTURE AND FORESTRY MARKETING PERMISSION DATE AND NO 12.03.2012-25/062

 

NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER

Pİ FARMA İLAÇ SAN. VE TİC. A.Ş.

Malıköy Başkent OSB Mah. 26. Cad. No: 34/A - Sincan - ANKARA - TÜRKİYE

 

MANUFACTURER COMPANY NAME AND ADDRESS

ARMA İLAÇ SAN. VE TİC. A.Ş.

Malıköy Başkent OSB Mah. Atatürk Bulvarı No: 69 - Sincan - ANKARA - TÜRKİYE

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