Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Diprenorphine
Novartis Animal Health UK Ltd
QV03AB92
Diprenorphine
Expired
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Large Animal Revivon Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient: mg/ml Diprenorphine 3.0 (as Diprenorphine hydrochloride 3.26) Preservative: Chlorocresol 1.0 Colouring Agent: Methylthioninium chloride 0.1 For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear blue aqueous solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses and deer. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES To reverse neuroleptanalgesia induced by etorphine hydrochloride. 4.3 CONTRAINDICATIONS Do not use intramuscularly except in the circumstances of an emergency where intravenous injection is not possible. Do not dilute or mix with any other substances. Do not use in animals intended for animal consumption. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Animals MUST be kept stabled, protected from extremes of temperature and under close supervision for at least 24 hours, particularly for the first 8 hours following administration. Care must be taken to avoid hypothermia or hyperthermia (see above). Protect horses eyes from sun or bright light following administration. 4.5 Special precautions for use I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS None known. II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Spillages should be dealt with AFTER PUTTING ON SUITABLE HEAVY DUTY RUBBER GLOVES, neoprene or nitrile of minimum thickness 0.5 mm, using a copious quantity of water, which can then be flushed down a running sink. Broken glass should be washed and disposed of in a recognised manner. The product may induce a hallucinatory state after accidental self-administration. TO AVOID ACCIDENTAL SELF-INJECTION, the following procedure should be adopted: (a) Use two sterile needles, one to fill the syringe from the vial and one to inject the patient. Once the required dose has been withdrawn from the vial, the syringe sho Read the complete document