Nazione: Israele
Lingua: inglese
Fonte: Ministry of Health
BOTULINUM TOXIN TYPE A
ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL
M03AX01
POWDER FOR SOLUTION FOR INJECTION
BOTULINUM TOXIN TYPE A 100 U/VIAL
INTRADERMAL, I.M
Required
ALLERGAN PHARMACEUTICALS IRELAND
BOTULINUM TOXIN
BOTULINUM TOXIN
Neurologic disorders:• •Focal spasticity associated with dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients two years of age or older. • • Focal spasticity of the wrist and hand in adult • Focal spasticity of the lower limb, including ankle and foot in adult. • •Blepharospasm or VII nerve disorders in patients over 12 years, hemifacial spasm and associated focal dystonias as well as the correction of strabismus in patients 12 years of age and above. • •Reduction of the signs and symptoms of Cervical dystonia (spasmodic torticollis) in adults. • •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. Bladder disorders: •Management of 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: •Management of primary axillary hyperhidrosis in patients who failed other medical symptomatic treatment. •For the temporary improvement in the appearance of: - moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines) and/or, - moderate to severe lateral canthal lines (crow’s feet lines) seen at maximum smile and/or, - moderate to severe forehead lines seen at maximum eyebrow elevation when the severity of the facial lines has an important psychological impact in adult patients.
2022-07-31
Patient leaflet in accordance with the Pharmacists' Regulations (Preparations) - 1986 THIS MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY BOTOX ® 50 / BOTOX ® 100 / BOTOX ® 200 POWDER FOR SOLUTION FOR INJECTION NAME AND QUANTITY OF ACTIVE INGREDIENT: botulinum toxin type A Each vial of BOTOX 50 contains: 50 Allergan units of botulinum toxin type A Each vial of BOTOX 100 contains: 100 Allergan units of botulinum toxin type A Each vial of BOTOX 200 contains: 200 Allergan units of botulinum toxin type A INACTIVE INGREDIENTS AND ALLERGENS: Please see section 6 ‘Additional information’ and section 2 under ‘Important information about some of this medicine’s ingredients’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? _NERVOUS SYSTEM DISORDERS _ - BOTOX is indicated for the treatment of CHILDREN aged two years or older with cerebral palsy who can walk and who have a FOOT DEFORMITY, caused by persistent muscle spasms in the legs. - ADULTS AND CHILDREN AGED 12 YEARS OR OLDER o persistent muscle spasms in the eyelid and half of the face . o crossed eyes . - ADULTS o persistent muscle spasms in the wrist and hand. o persistent muscle spasms in the lower limb including ankle and foot . o persistent muscle spasms in the neck and in the shoulders (torticollis) . o reducing the symptoms of chronic migraine in adults who have headaches on 15 or more days each month of which at least 8 days are with migraine, and who have not responded well to other preventative migraine medications. Page 2 of 17 _BLADDER DISORDERS _ BOTOX is indicated for treatment of the following conditions in ADULTS: o overactive bladder with leakage of urine, sudden urge to empty Leggi il documento completo
BOT API MAR23 CL-2 1/44 BOTOX ® 1. NAME OF THE MEDICINAL PRODUCT BOTOX 50/ BOTOX 100/ BOTOX 200 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Botulinum toxin * type A, 50 Allergan Units/vial, 100 Allergan Units/vial and 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 Neurologic disorders: • Focal spasticity associated with dynamic equinus foot deformity due to spasticity in ambulant paediatric cerebral palsy patients two years of age or older. • Focal spasticity of the wrist and hand in adults. • Focal spasticity of the lower limb, including ankle and foot in adults. • Blepharospasm or VII nerve disorders in patients over 12 years, hemifacial spasm and associated focal dystonias as well as the correction of strabismus in patients 12 years of age and above. • Reduction of the signs and symptoms of Cervical dystonia (spasmodic torticollis) in adults. • 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. Bladder disorders • Management of 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: • Management of primary axillary hyperhidrosis in patients who failed other medical symptomatic treatment. For the temporary improvement in the ap Leggi il documento completo