Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
Insulin human
Boehringer Ingelheim Vetmedica GmbH
QA10AC01
insulin human
Cats; Dogs
Insulins and analogues for injection, intermediate-acting
For the treatment of diabetes mellitus in cats and dogs to achieve reduction of hyperglycaemia and improvement of associated clinical signs.
Revision: 9
Authorised
2013-07-12
24 B. PACKAGE LEAFLET 25 PACKAGE LEAFLET: PROZINC 40 IU/ML SUSPENSION FOR INJECTION FOR CATS AND DOGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer responsible for batch release: Boehringer Ingelheim Vetmedica GmbH Binger Strasse 173 55216 Ingelheim/Rhein GERMANY Manufacturer responsible for batch release: KVP Pharma + Veterinär Produkte GmbH Projensdorfer Str. 324 24106 Kiel GERMANY 2. NAME OF THE VETERINARY MEDICINAL PRODUCT ProZinc 40 IU/ml suspension for injection for cats and dogs insulin human 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS Each ml contains: ACTIVE SUBSTANCE: Insulin human* 40 IU as protamine zinc insulin. One IU (International Unit) corresponds to 0.0347 mg of insulin human. *produced by recombinant DNA technology EXCIPIENTS: Protamine sulfate 0.466 mg Zinc oxide 0.088 mg Phenol 2.5 mg Cloudy, white, aqueous suspension. 4. INDICATION(S) For the treatment of diabetes mellitus in cats and dogs to achieve reduction of hyperglycaemia and improvement of associated clinical signs. 5. CONTRAINDICATIONS Do not use for the acute management of diabetic ketoacidosis. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 26 6. ADVERSE REACTIONS Hypoglycaemic reactions were very commonly reported in clinical studies: 13% (23 of 176) of treated cats and 26.5% (44 of 166) of treated dogs. These reactions were generally mild in nature. Clinical signs may include hunger, anxiety, unstable locomotion, muscle twitching, stumbling or sinking in the rear legs and disorientation. In this case immediate administration of a glucose containing solution or gel and/or food is required. Insulin administration should be temporarily stopped and the next dose of insulin adjusted appropriately. Local injection site reactions were very rarely reported and resolved without cessation of therapy. The frequency of adverse rea Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ProZinc 40 IU/ml suspension for injection for cats and dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Insulin human* 40 IU as protamine zinc insulin. One IU (International Unit) corresponds to 0.0347 mg of insulin human. *produced by recombinant DNA technology EXCIPIENTS: Protamine sulfate 0.466 mg Zinc oxide 0.088 mg Phenol 2.5 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. Cloudy, white, aqueous suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats and dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of diabetes mellitus in cats and dogs to achieve reduction of hyperglycaemia and improvement of associated clinical signs. 4.3 CONTRAINDICATIONS Do not use for the acute management of diabetic ketoacidosis. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Very stressful events, inappetance, concomitant treatment with gestagens and corticosteroids or other concomitant diseases (e.g. gastro-intestinal, infectious or inflammatory or endocrine diseases), might influence insulin effectiveness and therefore the insulin dose may need to be adjusted. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The insulin dose may need to be adjusted or discontinued in case of remission of the diabetic state in cats or 3 after resolution of transient diabetic stages in dogs (e.g. dioestrus-induced diabetes mellitus, diabetes mellitus secondary to hyperadrenocorticism). After the daily insulin dose is established, monitoring for diabetic control is recommended. Treatment with insulin can cause hypoglycaemia, for clinical signs and appropriate treatment, see section 4.10. Special precautions for use in dogs In cases where hypoglycaemia is suspected, blood glucose measurements should be taken at the time of occurr Прочетете целия документ