Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Vitamin A palmitate ; Vitamin D3 ; Vitamin E acetate ; Thiamine hydrochloride ; Riboflavin sodium phosphate ; Pyridoxine Hydrochloride; Nicotinamide; Dexpanthenol; Cyanocobalamin
Norbrook Laboratories Limited
QA11E
Vitamin A palmitate ; Vitamin D3 ; Vitamin E acetate ; Thiamine hydrochloride ; Riboflavin sodium phosphate ; Pyridoxine Hydroch
.
Solution for injection
LM: Licensed Merchant as defined in relevant national legislation
Cattle, Pigs, Sheep
VITAMIN B-COMPLEX, INCL. COMBINATIONS
Vitamins and minerals
Authorised
1991-10-01
Health Products Regulatory Authority 05 December 2017 CRN000WJ6 Page 1 of 5 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Multivitamin Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCES: QUANTITY PER ML: Vitamin A Palmitate 15,000I.U Cholecalciferol (Vitamin D3) 25micrograms Vitamin E Acetate 20mg Thiamine Hydrochloride (Vitamin B1) 10mg Riboflavin Sodium Phosphate (Vitamin B2) 5mg Pyridoxine Hydrochloride (Vitamin B6) 3mg Nicotinamide 35mg Dexpanthenol 25mg Cyanocobalamin (Vitamin B12) 25micrograms EXCIPIENTS: Chlorocresol (preservative) 1.0mg Butylated hydroxyanisole (antioxidant) 0.1mg Butylated hydroxytoluene (antioxidant) 0.1mg For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Solution for injection A gold coloured sterile aqueous solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, Pigs, Sheep 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the prevention and treatment of vitamin deficiencies in animals, particularly during periods of illness, convalescence and general unthriftiness. Health Products Regulatory Authority 05 December 2017 CRN000WJ6 Page 2 of 5 4.3 CONTRAINDICATIONS Do not use in animals known to be hypersensitive to the active substances. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS: None SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT TO ANIMALS: None known. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) In very rare cases (i.e. less than 1 animal in 10,000 animals) allergic type reactions may occur, and in extreme cases these can result in death. 4.7 USE DURING PREGNANCY, LACTATION OR LAY Multivitamin Injection can be safely administered to pregnant and lactating animals. 4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.9 AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE Administer by intramuscular or subcutaneous injection.Avoid the introduction of contamination during use.The Прочетете целия документ