Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
collagenase Clostridium histolyticum
Swedish Orphan Biovitrum AB
M09AB02
collagenase Clostridium histolyticum
Other drugs for disorders of the musculo-skeletal system
Dupuytren Contracture
, The treatment of Dupuytren’s contracture in adult patients with a palpable cord., The treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
Revision: 20
Withdrawn
2011-02-28
37 B. PACKAGE LEAFLET Medicinal product no longer authorised 38 PACKAGE LEAFLET: INFORMATION FOR THE USER XIAPEX 0.9 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION collagenase _clostridium histolyticum _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Xiapex is and what it is used for 2. What you need to know before you are given Xiapex 3. How Xiapex is used 4. Possible side effects 5. How to store Xiapex 6. Contents of the pack and other information 1. WHAT XIAPEX IS AND WHAT IT IS USED FOR Xiapex is used for the treatment of two different conditions: DUPUYTREN’S CONTRACTURE IN ADULT PATIENTS WITH A PALPABLE CORD and PEYRONIE’S DISEASE IN ADULT MEN . DUPUYTREN’S CONTRACTURE This is a disease that causes your finger(s) to bend inward. This bending is called a contracture and is caused by the abnormal formation of a cord containing collagen under your skin. For many people, a contracture causes significant difficulties with performing everyday tasks like driving, shaking hands, playing sports, opening jars, typing or holding objects. PEYRONIE’S DISEASE This is a condition where adult men have a ‘plaque’ that can be felt and a curve to their penis. The disease can cause a change in the shape of the erect penis due to the abnormal build-up of scar tissue, known as a plaque, within the stretchy fibres of the penis. The plaque may interfere with the ability to get a straight erection because the plaque will not stretch as much as the rest of the penis. Men with Peyronie’s disease may have an erection that is curved or bent. The ac tive substance in Xiapex is collagenase _clostridium histolyticum_ , and this collagenase is produced using the microorganism _Clostri Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Xiapex 0.9 mg powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder contains 0.9 mg of collagenase _clostridium histolyticum_ *. *A formulation of two collagenase enzymes co-expressed and harvested from anaerobic fermentation of a phenotypically selected strain of C _lostridium histolyticum _ bacterium. Excipients with known effect Sodium injected per joint in the treatment of Dupuytren’s contracture: Metacarpophalangeal (MP) joints: 0.9 mg. Proximal interphalangeal (PIP) joints: 0.7 mg. Sodium injected per plaque in the treatment of Peyronie’s disease: 0.9 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. The powder is a white lyophilised powder. The solvent is a clear colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xiapex is indicated for: • The treatment of Dupuytren’s contracture in adult patients with a palpable cord. • The treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy (see sections 4.2 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Dupuytren’s contracture _ Xiapex must be administered by a physician appropriately trained in the correct administration of the medicinal product and experienced in the diagnosis and management of Dupuytren’s disease. Posology The recommended dose of Xiapex is 0.58 mg per injection into a palpable Dupuytren’s cord. The volume of solvent required and the volume of reconstituted Xiapex to be administered into the Dupuytren’s cord differs depending on the type of joint being treated (for the reconstitution instructions, see section 6.6, Table 14). • For cords affecting MP joints each dose is administered in an injection volume of 0.25 ml. • For cords affecting PIP joints, each dose is admini Прочетете целия документ