Botulinum toxin type A

maxDose IS DELIBERATELY EMPTY because the dose field above spans several indications and the SPC sets a DIFFERENT ceiling for each — a single number here would be the wrong ceiling for most readers. The per-indication maxima, verbatim from §4.2, are: ADULT UPPER LIMB SPASTICITY 'Maximum dose: 400 Units in total' (with 'When injecting the shoulder muscles in combination, the recommended maximum dose is 250 U' and 'When injecting both lumbricals and/or interossei, the recommended maximum dose is 50 U per hand'); ADULT LOWER LIMB SPASTICITY 'Maximum dose: 400 Units in total'; BLEPHAROSPASM 'The initial dose should not exceed 25 Units per eye. In the management of blepharospasm total dosing should not exceed 100 Units in total every 12 weeks' (and 'there appears to be little benefit obtainable from injecting more than 5 Units per site'); CERVICAL DYSTONIA 'No more than 50 Units should be given at any one injection site. No more than 100 Units should be given to the sternomastoid. No more than 200 Units in total should be injected for the first course of therapy, with adjustments made in subsequent courses dependent on the initial response, up to a maximum total dose of 300 Units.' CHRONIC MIGRAINE has no separate maximum line — the stated 'Total Dose Range: 155 Units to 195 Units, 31 to 39 sites' is itself the range. BRAND SAFETY, verbatim §4.2 opening line: 'Botulinum toxin units are not interchangeable from one product to another. Doses recommended in Allergan Units are different from other botulinum toxin preparations.' The page lists Botox, Dysport, Xeomin and Bocouture together — NONE of the figures here may be applied to a non-BOTOX product. GENERAL §4.2 CAVEAT: 'Generally valid optimum dose levels and number of injection sites per muscle have not been established for all indications. In these cases, individual treatment regimens should therefore be drawn up by an appropriately qualified healthcare practitioner. Optimum dose levels should be determined by titration but the recommended maximum dose should not be exceeded.' ADMINISTRATION: 'BOTOX should only be administered by an appropriately qualified healthcare practitioner with expertise in the treatment of the relevant indication and the use of the required equipment, in accordance with national guidelines.' Localisation by needle EMG guidance, nerve stimulation or ultrasound is recommended for spasticity. For cervical dystonia, 'To minimise the incidence of dysphagia, the sternomastoid should not be injected bilaterally.' For blepharospasm, 'Avoiding injection near levator palpebrae superioris may reduce the complication of ptosis. Avoiding medial lower lid injections, and thereby reducing diffusion into the inferior oblique, may reduce the complication of diplopia'; at repeat sessions 'the dose may be increased up to two-fold if the response from the initial treatment is considered insufficient - usually defined as an effect that does not last longer than two months.' For overactive bladder the reconstituted solution is 100 Units in 10 ml, injected approximately 2 mm into the detrusor, avoiding the trigone and base, 20 injections of 0.5 ml each spaced approximately 1 cm apart, followed by approximately 1 ml of sterile unpreserved normal saline 'so the full dose is delivered'; afterwards 'the saline used for bladder wall visualisation should not be drained so that the patients can demonstrate their ability to void prior to leaving the clinic.' ELDERLY (§4.2): 'Dosages for elderly patients are the same as for younger adults. Initial dosing should begin at the lowest recommended dose for the specific indication.' CROSS-REFERENCE ONLY, US label for the DIFFERENT product DAXXIFY (do NOT convert): glabellar lines 'the recommended dose is 0.1 mL (8 Units) by intramuscular injection into each of five sites, for a total dose of 40 Units'; cervical dystonia 'ranges from 125 Units to 250 Units given intramuscularly as a divided dose among affected muscles', dose adjustment 'in 50 to 75 Unit increments', administered 'no more frequently than every three months for any indication'. DAXXIFY §2.1 states its units 'are not interchangeable with other preparations of botulinum toxin products'.

dosePerKg IS NULL ON PURPOSE — the SPC gives two DIFFERENT limb-specific per-kilogram ranges, each then sub-allocated muscle by muscle, so there is no single per-dose figure valid across the paediatric range and no figure that a weight calculator could safely multiply. Verbatim §4.2: UPPER LIMB — 'The recommended dose for treating paediatric upper limb spasticity is 3 Units/kg to 6 Units/kg body weight divided among the affected muscles', with per-muscle allocations at the 3 Units/kg level of biceps 1.5 Units/kg (maximum 50 Units, 4 sites), brachialis 1 Unit/kg (30 Units, 2 sites), brachioradialis 0.5 Units/kg (20 Units, 2 sites), flexor carpi radialis 1 Unit/kg (25 Units, 2 sites), flexor carpi ulnaris 1 Unit/kg (25 Units, 2 sites), flexor digitorum profundus 0.5 Units/kg (25 Units, 2 sites), flexor digitorum sublimis 0.5 Units/kg (25 Units, 2 sites) — each doubling at the 6 Units/kg level; and 'The total dose of BOTOX administered per treatment session in the upper limb should not exceed 6 Units/kg body weight or 200 Units, whichever is lower.' LOWER LIMB — 'The recommended dose for paediatric lower limb spasticity is 4 Units/kg to 8 Units/kg body weight divided among the affected muscles', with gastrocnemius medial head, gastrocnemius lateral head, soleus and tibialis posterior each 1 Unit/kg (maximum 37.5 Units, 2 sites) at the 4 Units/kg level and 2 Units/kg (75 Units) at the 8 Units/kg level; and 'The total dose of BOTOX administered per treatment session in the lower limb should not exceed 8 Units/kg body weight or 300 Units, whichever is lower.' COMBINED: 'When treating the upper and lower limbs in combination, the total dose should not exceed the lower of 10 Units/kg body weight or 340 Units, in a 12-week interval.' INDICATION LIMIT (§4.2): '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 paediatric focal spasticity associated with cerebral palsy.' It also 'should only be administered by appropriately qualified healthcare practitioners who are experienced in the assessment and treatment of paediatric focal spasticity and as part of a structured program of rehabilitation.' AGE FLOORS listed in §4.2: focal spasticity from 2 years; blepharospasm/hemifacial spasm/idiopathic cervical dystonia from 12 years; primary hyperhidrosis of the axillae from 12 years; paediatric neurogenic detrusor overactivity 5-17 years; paediatric overactive bladder 12-17 years. Concentration is null because BOTOX is dosed in Units, not milligrams, and the reconstitution volume differs by indication. Cross-check, US DAXXIFY §8.4: 'Safety and effectiveness of DAXXIFY in patients less than 18 years of age have not been established.' Verify all paediatric dosing against a children's formulary and local specialist protocol.