Land: Europese Unie
Taal: Engels
Bron: EMA (European Medicines Agency)
dibotermin alfa
Zoetis Belgium SA
QM05BC01
dibotermin alfa
Dogs
Bone morphogenetic proteins
Osteoinductive agent for use in the treatment of long-bone fractures as an adjunct to standard surgical care using open fracture reduction in dogs.
Revision: 4
Withdrawn
2011-12-14
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT TruScient 0.66 mg kit for implant for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of lyophilisate contains: Dibotermin alfa (rhBMP-2)* 0.66 mg After reconstitution TruScient contains 0.2 mg/ml of dibotermin alfa (rhBMP-2) *Dibotermin alfa (recombinant human Bone Morphogenetic Protein-2; rhBMP-2) is a human protein derived from a recombinant Chinese Hamster Ovary (CHO) cell line. Two sponges made of Bovine Type I collagen. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Kit for implant White lyophilisate and a clear colourless solvent. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of diaphyseal fractures as an adjunct to standard surgical care using open fracture reduction in dogs. 4.3 CONTRAINDICATIONS Do not use in dogs with a known hypersensitivity to the active substance or to any of the excipients. Do not use in dogs that are skeletally immature, have an active infection at the operative site, pathological fracture, or any active malignancy. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals This veterinary medicinal product should be used by an appropriately qualified veterinarian. Failure to follow the TruScient instructions for preparation and use may compromise safety and effectiveness. Medicinal product no longer authorised 3 In order to avoid excessive postoperative swelling, use only the amount of prepared TruScient sponge needed to achieve coverage of accessible fracture lines and defects (less than one to up to two prepared sponges). TruScient can cause initial resorption of surrounding trabecular bone. Therefore, in the absence of clinical data, the veterinary medicinal product should not be used for direct applications to trabecular bone when transient bone r Lees het volledige document
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT TruScient 0.66 mg kit for implant for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of lyophilisate contains: Dibotermin alfa (rhBMP-2)* 0.66 mg After reconstitution TruScient contains 0.2 mg/ml of dibotermin alfa (rhBMP-2) *Dibotermin alfa (recombinant human Bone Morphogenetic Protein-2; rhBMP-2) is a human protein derived from a recombinant Chinese Hamster Ovary (CHO) cell line. Two sponges made of Bovine Type I collagen. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Kit for implant White lyophilisate and a clear colourless solvent. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of diaphyseal fractures as an adjunct to standard surgical care using open fracture reduction in dogs. 4.3 CONTRAINDICATIONS Do not use in dogs with a known hypersensitivity to the active substance or to any of the excipients. Do not use in dogs that are skeletally immature, have an active infection at the operative site, pathological fracture, or any active malignancy. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals This veterinary medicinal product should be used by an appropriately qualified veterinarian. Failure to follow the TruScient instructions for preparation and use may compromise safety and effectiveness. Medicinal product no longer authorised 3 In order to avoid excessive postoperative swelling, use only the amount of prepared TruScient sponge needed to achieve coverage of accessible fracture lines and defects (less than one to up to two prepared sponges). TruScient can cause initial resorption of surrounding trabecular bone. Therefore, in the absence of clinical data, the veterinary medicinal product should not be used for direct applications to trabecular bone when transient bone r Lees het volledige document