Botox 50unit powder for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Botulinum toxin type A

Available from:

AbbVie Ltd

ATC code:

M03AX01

INN (International Name):

Botulinum toxin type A

Dosage:

50unit

Pharmaceutical form:

Powder for solution for injection

Administration route:

Intradermal; Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 04090300; GTIN: 5016007202038

Summary of Product characteristics

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