This Botox Technical Information Is For Medical Professionals
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:
• 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 and foot 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)
• 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 disorders
• management of severe hyperhidrosis of the axillae, which does not respond to topical treatment with antiperspirants or antihidrotics
• 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.
4.2 Posology and method of administration
Botulinum toxin units are not interchangeable from one product to another. Doses recommended in Allergan Units are different from other botulinum toxin preparations.
Dosages for elderly patients are the same as for younger adults. Initial dosing should begin at the lowest recommended dose for the specific indication. Elderly patients with significant medical history and concomitant medications should be treated with caution.
There is limited data in patients older than 65 years managed with BOTOX for urinary incontinence with neurogenic detrusor overactivity, ankle and foot disability due to lower limb spasticity associated with stroke, and for facial lines (see section 5.1).
The safety and efficacy of BOTOX in indications other than those described for the paediatric population in section 4.1 have not been established. No recommendation on posology can be made for indications other than focal spasticity associated with paediatric cerebral palsy. Currently available data per indication are described in section 4.2, 4.4, 4.8 and 5.1, as shown in the table below.
• Focal spasticity associated with paediatric cerebral palsy
2 years (see section 4.2, 4.4 and 4.8)
• Blepharospasm/Hemifacial spasm/ Idiopathic Cervical dystonia
12 years (see section 4.4 and 4.8)
• Primary hyperhidrosis of the axillae
12 years (limited experience in adolescents between 12 and 17 years, see sections 4.4, 4.8 and 5.1)