国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Botulinum toxin type A
AbbVie Ltd
M03AX01
Botulinum toxin type A
50unit
Powder for solution for injection
Intradermal; Intramuscular
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 04090300; GTIN: 5016007202038
OBJECT 1 BOTOX 50 UNITS Summary of Product Characteristics Updated 07-Mar-2018 | Allergan Ltd 1. Name of the medicinal product BOTOX 50 Allergan Units Powder for solution for injection 2. Qualitative and quantitative composition Botulinum toxin* type A, 50 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. 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: NEUROLOGIC DISORDERS: • treatment OF FOCAL SPASTICITY, including: dynamic equinus foot deformity due to spasticity in ambulant PAEDIATRIC CEREBRAL PALSY patients, two years of age or older wrist and hand disability due to UPPER LIMB SPASTICITY associated with stroke in adults ankle disability due to LOWER LIMB SPASTICITY associated with stroke in adults • symptomatic relief of BLEPHAROSPASM, HEMIFACIAL SPASM and IDIOPATHIC CERVICAL DYSTONIA (spasmodic torticollis) • prophylaxis of headaches in adults with CHRONIC MIGRAINE (headaches on at least 15 days per month of which at least 8 days are with migraine) BLADDER DISORDERS: • management of BLADDER DYSFUNCTIONS in adult patients who are not adequately managed with anticholinergics OVERACTIVE BLADDER with symptoms of urinary incontinence, urgency and frequency NEUROGENIC DETRUSOR OVERACTIVITY with urinary incontinence due to subcervical spinal cord injury (traumatic or non-traumatic), or multiple sclerosis SKIN AND SKIN APPENDAGE DISORDER: • management of severe HYPERHIDROSIS OF THE AXILLAE, which does not respond to topical treatment with antiperspirants or antihidrotics • temporary improvement in the appearance of the following facial lines, when the severity of these lines has an important psychological impact in adult patients: moderate to severe vertical lines between the eyebrows seen at maximu 阅读完整的文件