Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Clostridium botulinum neuro-toxin type a (150 kd), free from complexing proteins
Merz Pharmaceuticals GmbH
M03AX; M03AX01
Clostridium botulinum neuro-toxin type a (150 kd), free from complexing proteins
100
Powder for solution for injection
Product subject to prescription which may not be renewed (A)
Other muscle relaxants, peripherally acting agents; botulinum toxin
Marketed
2014-01-31
• marginally varying effectiveness of the active substance of XEOMIN • non-response/therapy failure during the course of treatment _EYELID SPASM (BLEPHAROSPASM)AND SPASMS AFFECTING ONE SIDE OF THE FACE _ _(HEMIFACIAL SPASM)_ Talk to your doctor before XEOMIN is used, if you: • have had an eye surgery. Your doctor will then take additional precautions. • are at risk of developing a disease called narrow angle glaucoma. This disease can cause the inner eye pressure to rise and may lead to a damaging of your optic nerve. Your doctor will know if you are at risk. During treatment, small punctuated bleedings may occur in the soft tissues of the eyelid. Your doctor can limit these by immediately applying gentle pressure at the injection site. After you receive a XEOMIN injection into your eye muscle your blinking rate may be reduced. This can lead to a prolonged exposure of the transparent front part of the eye (cornea). This exposure may lead to a damaging of the surface and an inflammation (corneal ulceration). _TWISTED NECK (SPASMODIC TORTICOLLIS)_ After the injection you may develop mild to severe swallowing difficulties. This may lead to problems with breathing and you may have a higher risk of inhaling foreign substances or fluids. Foreign substances in your lungs may lead to an inflammation or infection (pneumonia). Your doctor will give you special medical treatment if needed (e.g. in the form of artificial nutrition). Swallowing difficulties can last for up to two to three weeks after injection, for one patient a duration of up to five months is known. If you have been inactive for a long period of time, any activity should be started gradually after the XEOMIN injection. _INCREASED MUSCLE TENSION/UNCONTROLLABLE MUSCLE STIFFNESS_ XEOMIN can be used to treat increased muscle tension/uncontrollable muscle stiffness in parts of your upper limb, e.g. your arm or hand. XEOMIN is effective in combination with the usual standard treatment methods. XEOMIN should be used together with these other methods. It is Прочитайте повний документ
Health Products Regulatory Authority 11 April 2022 CRN00CW6X Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT XEOMIN 100 units powder for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _XEOMIN 100 units powder for solution for injection_ One vial contains 100 units of Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins*. *_Botulinum neurotoxin type A, purified from cultures of Clostridium Botulinum (Hall strain)_ For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection White powder 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS XEOMIN is indicated for the symptomatic treatment in adults of blepharospasm and hemifacial spasm, cervical dystonia of a predominantly rotational form (spasmodic torticollis), spasticity of the upper limb, chronic sialorrhea due to neurological disorders. XEOMIN is indicated for the symptomatic treatment in children and adolescents aged 2 to 17 years and weighing ≥ 12 kg of chronic sialorrhea due to neurological / neurodevelopmental disorders. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DUE TO UNIT DIFFERENCES IN THE POTENCY ASSAY, UNIT DOSES FOR XEOMIN ARE NOT INTERCHANGEABLE WITH THOSE FOR OTHER PREPARATIONS OF BOTULINUM TOXIN TYPE A. For detailed information regarding clinical studies with XEOMIN in comparison to conventional Botulinum toxin type A complex (900 kD), see section 5.1. XEOMIN may only be administered by physicians with suitable qualifications and the requisite experience in the application of Botulinum toxin type A. The optimum dose, frequency and number of injection sites should be determined by the physician individually for each patient. A titration of the dose should be performed. _The recommended single doses of XEOMIN should not be exceeded._ Posology _Blepharospasm and hemifacial spasm_ Health Products Regulatory Authority 11 April 2022 CRN00CW6X Page 2 of 18 The initial recommended dose is 1.25 to 2.5 units per inje Прочитайте повний документ