Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
INSULIN, BOVINE
Pfizer Healthcare Ireland
QA10AC02
100 IU/ML
Suspension for Injection
Hormone
Canine
2009-04-24
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Insuvet Protamine Zinc 100 IU/ml Suspension for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Suspension for injection White to nearly white suspension 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of insulin-dependent diabetes mellitus in the dog or cat, where a medium to extended duration of action is required. 4.3 CONTRAINDICATIONS Insulin is contra-indicated in hypoglycaemia. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES When adjusting doses it is recommended that the maximum change made, either increase or decrease, is 2 IU daily. The full effects of a dose change may not be seen until up to 3 days afterwards. Blood glucose should be monitored when changing doses and this potential 3 day delay should be considered before making further changes. The requirements for insulin will vary with changes in diet and exercise, during illness, stress, oestrus, pregnancy, liver and kidney diseases and when other medication with hypo- or hyperglycaemic activity is given. Active substance per 1 ml Insulin, Bovine 100 IU Excipients Phenol 2.50 mg IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/01/2011_ _CRN 7008249_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS For subcutaneous administration only. It is recommended that appropriately graduated syringes are used and a new syringe used for each injection. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Care should be taken Read the complete document