Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Botulinum toxin type a
Allergan Pharmaceuticals Ireland
M03AX; M03AX01
Botulinum toxin type a
200 Allergan Units
Powder for solution for injection
Product subject to prescription which may not be renewed (A)
Other muscle relaxants, peripherally acting agents; botulinum toxin
Marketed
2008-01-18
BOTOX ® 50/100/200 Allergan Units, Powder for Solution for Injection 1/18 IE/H/xxxx/WS/150 HPRPACKAGE LEAFLET: INFORMATION FOR THE USER BOTOX, 50 Allergan Units, Powder for Solution for Injection BOTOX, 100 Allergan Units, Powder for Solution for Injection BOTOX, 200 Allergan Units, Powder for Solution for Injection Botulinum toxin type A READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What BOTOX is and what it is used for 2. What you need to know before you use BOTOX 3. How to use BOTOX 4. Possible side effects 5. How to store BOTOX 6. Contents of the pack and other information 1. WHAT BOTOX IS AND WHAT IT IS USED FOR BOTOX is a muscle relaxant used to treat a number of conditions within the body. It contains the active substance Botulinum toxin type A and is injected into either the muscles, the bladder wall or deep into the skin. It works by partially blocking the nerve impulses to any muscles that have been injected and reduces excessive contractions of these muscles. When injected into the skin, BOTOX works on sweat glands to reduce the amount of sweat produced. When injected into the bladder wall, BOTOX works on the bladder muscle to reduce leakage of urine (urinary incontinence). In the case of chronic migraine, it is thought that BOTOX may block pain signals which indirectly block the development of a migraine. However, the way BOTOX works in chronic migraine is not fully established. 1) BOTOX can be injected directly into the muscles, and can be used to treat the following condition Pročitajte cijeli dokument
Health Products Regulatory Authority 28 January 2022 CRN00C7R3 Page 1 of 31 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT BOTOX200 Allergan UnitsPowder for solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Botulinum toxin * type A, 200 Allergan Units/vial. * from _Clostridium botulinum_ Botulinum toxin units are not interchangeable from one product to another. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection. White powder. BOTOX product appears as a thin white deposit that may be difficult to see on the base of the vial. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BOTOX is indicated for the management of: NEUROLOGIC DISORDERS: BOTOX is indicated for the symptomatic treatment of: FOCAL SPASTICITY of the ankle and foot in ambulant PAEDIATRIC CEREBRAL PALSY patients, two years of age or older as an adjunct to rehabilitative therapy. FOCAL SPASTICITY of the wrist and hand in ADULT POST STROKE patients. FOCAL SPASTICITY of the ankle and foot in ADULT POST STROKE patients (see section 4.4). BLEPHAROSPASM, HEMIFACIAL SPASM and associated focal dystonias. CERVICAL DYSTONIA (spasmodic torticollis). Symptom relief in adults fulfilling criteria for CHRONIC MIGRAINE (headaches on ≥15 days per month of which at least 8 days with migraine) in patients who have responded inadequately or are intolerant of prophylactic migraine medications (see section 4.4). BLADDER DISORDERS: IDIOPATHIC OVERACTIVE BLADDER with symptoms of urinary incontinence, urgency and frequency in adult patients who have an inadequate response to, or are intolerant of, anticholinergic medication. Urinary incontinence in adults with NEUROGENIC DETRUSOR OVERACTIVITY resulting from neurogenic bladder due to stable sub-cervical spinal cord injury, or multiple sclerosis. SKIN AND SKIN APPENDAGE DISORDER: Persistent severe primary HYPERHIDROSIS OF THE AXILLAE, which interferes with the activities of daily living and is resistant Pročitajte cijeli dokument