| - | - | - |
|---|---|---|
| Product Group | : | Vitamins |
| Pharmaceutical Form | : | Solution for Injection |
| Active Ingredient | : | Vitamin B12 (Cyanocobalamin), Butafosfan |
| Target Species | : | Cattle, Horse, Cat, Dog |
| Package Form | : | 100 - 250 ml |
For Veterinary Use Only
For Veterinary Use Only
Solution for Injection
Veterinary Mineral-Vitamin
COMPOSITION
Klifos- B12 is pink colored clear solution containing 100 mg Butaphosphan (equivalent to 17,30 mg phosphor) and 0,05 mg Vitamin B12 (Cyanocobalamin) and methyl paraben as and excipient per ml.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic Properties
Butaphosphan is an organic source phosphorus for metabolism. Among other functions, phosphorus is important for energy metabolism and has stimulating properties. It is also a component of bone tissue. It is an essential element for the process of neoglycogenesis as it is used in the phosphorylation of most intermediates.
Cyanocobalamine is a co-enzyme used in the sythesis of glycose from propionate. Also, it acts as a cofactor for enzymes important in the synthesis of fatty acids and is important for maintaining normal hematopoiesis, protecting the liver and muscle tissue, healthy skin, brain and metabolism. It is also involved in the formation of red blood cells and the synthesis of methionine. It is a water-soluble B group vitamin synthesized by the flora of the digestive tract (reticulo-rumen and large intestine) in animals. It is also involved in the formation of red blood cells and the synthesis of methionine. It is a water-soluble B group vitamin synthesized by the flora of the digestive tract (reticulo-rumen and large intestine) in animals. Synthesis is usually not at a level to meet the needs of the animal organism as a whole due to the specific needs of the flora. Significant deficiencies are rare, even in cases where cyanocobalamin intake is inadequate.
Pharmacokinetics Properties
Butafosfan is distributed into the extravascular space within minutes and rapidly excreted unchanged from the body following intravenous administration of a single dose in cattle. The elimination half-life is 83 minutes. 70-90% of the dose is excreted in the urine, 1% in the feces twelve hours after intravenous administration. Only traces of butafosfan are found in milk. No metabolic changes have been detected.
The metabolism of cyanocobalamin is complex and is closely related to folic acid and ascorbic acid. Vitamin B12 is stored in significant amounts in the liver, other storage sites include the kidney, heart spleen and brain. The tissue half-life of vitamin B12 is 32 days. In ruminants, vitamin B12 is primarily excreted in the feces and smaller amounts are excreted in the urine.
USE OF AREA / INDICATIONS
Klifos-B12 is used as a supplement in disorders of muscular, metabolic or reproductive system disorders in cattle, horse, cat, dog where the use of phosphorus and cyanocobalamin is necessary.
It is used to aid recovery of rumination activities after surgical treatment of abomasum displacement associated with secondary ketosis in cattle. It should be used in addition to magnesium and calcium in prenatal metabolic disorders, tetany and paresis (milk fever).
USAGE AND DOSAGE
Recommended dose is given below. Dosage and application intervals may vary according to the condition and needs of the animals and are at the discretion of the physician.
Cattle;
It is used intravenously.
Treatment for defficiency of phosphor and/or Vitamin B12;
2-5 mg butaphosphan and 0,001 – 0,0025 mg cyanocobalamine per kg body weight (2-5 ml/100 kg body weight) are administered in cattle.
10-25 mg butaphosphan and 0,005 – 0,0125 mg cyanocobalamine per kg body weight (10-25 ml/100 kg body weight) are administered in calves.
Injections are repeated daily if necessary.
To aid recovery of rumination activities after surgical treatment of abomasal displacement associated with secondary ketosis;
5 ml per 100 kg body weight, three days and one injection per day. The first administration should be done on the day of operation.
Horse;
Intravenously,
2-5 mg butaphosphan and 0,001 – 0,0025 mg cyanocobalamine per kg body weight (2-5 ml/100 kg body weight) are administered in horses.
0,35 – 0,6 ml per 10 kg body weight in foals.
Cat and Dog;
Intravenously, intramuscularly, subcutaneously.
2,5-25 mg butaphosphan and 1,0 – 2,5 mg cyanocobalamine per kg body weight (0,25-2,5 ml/10 kg body weight) are administered in dogs.
10-50 mg butaphosphan and 5 – 25 mg cyanocobalamine per kg body weight (0,5-5 ml/5 kg body weight) are administered in cats.
In chronic cases, half of the doses are administered, the other half is administered 1-2 weeks later.
SPECIAL CLINICAL INFORMATION AND SPECIAL WARNINGS FOR TARGET SPECIES
It is recommended to determine the exact cause of metabolic or reproductive disorders in order to determine the need for this product and the most appropriate treatment option.
It is recommended to bring the product to body temperature before administration.
Use during pregnancy, lactation and ovulation
No problems are expected if used during pregnancy and lactation although the safety of the product in pregnant animals has not been studied.
ADVERSE EFFECTS
Reactions (swelling, edema, erythema, stiffness) may be observed at the injection site as a result of subcutaneous application to the interscapular region in cats.
DRUG INTERACTIONS
Do not mix with the other medicinal products.
WITHDRAWAL PERIODS
‘0’ day for meat and milk in cattle.
CONTRAINDICATIONS
Not for use in animals known to be sensitive to its components.
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
People known to be sensitive to its components should not come into contact with the product. The product may cause mild eye or skin irritation, so contact should be avoided. In case of accidental contact, the area should be washed with plenty of water.
STORAGE CONDITIONS AND SHELF LIFE
Before and after opening, it should be stored below 25˚C, in the original package without being frozen and refrigerated, protect from light. Shelf life is 2 years. It should be consumed in 28 days after opening.
COMMERCIAL PRESENTATION FORM
Offered for sale in 100 ml and 250 ml amber colored glass flacons with box.
PLACE AND CONDITIONS OF SALE
Sold with Veterinary Surgeon’s prescription in pharmacies and veterinary surgeries.
APPROVAL DATE OF PACKAGE INSERT: 07.09.2022
MARKETING AUTHORIZATION DATE AND NO: 12.07.2010 – 023/0004
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
1- Pİ FARMA İLAÇ SAN. VE TİC. A.Ş.
Malıköy Başkent OSB Mah. 26. Cad. No:34/A Sincan/Ankara-Türkiye
2- FDN İLAÇ SAN. VE TİC. LTD. ŞTİ.
Büyükkayacık OSB Mah. İnsu Sokak No:3 Selçuklu/Konya-Türkiye
