Nchi: Uingereza
Lugha: Kiingereza
Chanzo: VMD (Veterinary Medicines Directorate)
Heparin Sodium, Hydroxyethyl Salicylate, Menthol Levo
Boehringer Ingelheim Animal Health UK Ltd
QM02AC99
Heparin Sodium, Hydroxyethyl Salicylate, Menthol Levo
Gel
POM-V - Prescription Only Medicine – Veterinarian
Horses
Anti Inflammatory
Authorized
2008-08-15
Revised: November 2018 AN: 00959/2018 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Compagel gel for horses 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 100 g gel contains: ACTIVE SUBSTANCES: Heparin sodium 50 000 IU Levomenthol: 0.5 g Hydroxyethyl salicylate: 5.0 g EXCIPIENTS: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gel, clear green 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of local inflammatory swellings and bruising, including tendonitis, tenosynovitis, bursitis and other acute inflammatory conditions of the musculo-skeletal system in the horse. Compagel also promotes the early reabsorption of haematoma and oedematous swelling resulting from such conditions. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substances or to any of the excipients. Do not apply to broken skin. Do not apply to open wounds or fresh or encrusted skin lesions. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Revised: November 2018 AN: 00959/2018 Page 2 of 5 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Avoid contact with the eyes or mucous membranes. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Avoid contact with open wounds or with the eyes. Impervious gloves should be worn when applying the product. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) If side effects occur, treatment should be discontinued. 4.7 USE DURING PREGNANCY, LACTATION OR LAY No clinical data are available on the topical use of Compagel during pregnancy. The use is not recommended during pregnancy and lactation. 4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.9 AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE Up to a total daily quantity of 50 g gel per day is applied using finger tip pressure onto the affected area according to the veterinary surgeon Soma hati kamili