NEUROBLOC Solution for injection Ref.[6588] Active ingredients: Botulinum toxin type B

NeuroBloc should only be administered by a physician who is familiar with and experience in the treatment of cervical dystonia and in the use of botulinum toxins.

Restricted to hospital use only.

Posology

The initial dose is 10,000 U and should be divided between the two to four most affected muscles. Data from clinical studies suggest that efficacy is dose dependent, but these trials, because they were not powered for a comparison, do not show a significant difference between 5000 U and 10,000 U. Therefore an initial dose of 5000 U may also be considered, but a dose of 10,000 U may increase the likelihood of clinical benefit.

Injections should be repeated as required to maintain good function and minimise pain. In long term clinical studies, the average dosing frequency was approximately every 12 weeks, however this may vary between subjects, and a proportion of patients maintained a significant improvement relative to baseline for 16 weeks or longer. The dosing frequency should therefore be adapted based on the clinical assessment/response of an individual patient.

For patients with reduced muscle mass the dose should be adjusted according to individual patient need.

The potency of this medicinal product is expressed in NeuroBloc 5000 U/ml. These units are not interchangeable with the units used to express the potency of other botulinum toxin preparations (see section 4.4).

Special populations

Elderly

No dose adjustment is required in older people ≥65 years of age.

Renal and hepatic impairment

Studies have not been carried out in patients with hepatic or renal impairment. However, the pharmacological characteristics do not indicate any need to adjust the dose.

Paediatric population

The safety and efficacy of NeuroBloc in children aged less than 18 years have not yet been established. No data are available.

Method of administration

NeuroBloc must only be administered by intramuscular injection. Particular caution should be paid to ensure that it is not injected into a blood vessel.

The initial dose of 10,000 U should be divided between the two to four most affected muscles.

To allow division of the total dose between several injections, NeuroBloc may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection and the solution used immediately. For instructions on dilution of the product before administration, see section 6.6.

Cases of overdose (some with signs of systemic toxicity) have been reported. In the event of an overdose, general medical supportive measures should be instituted. Doses of up to 15,000 U have infrequently resulted in clinically significant systemic toxicity in adults. If botulism is clinically suspected, hospitalisation for the monitoring of respiratory function (incipient respiratory failure) may be required.

In the event of an overdose or injection into a muscle that normally compensates for the cervical dystonia, it is conceivable that the dystonia may worsen. As with other botulinum toxins spontaneous recovery will occur over a period of time.

Paediatric use (non approved): in children, clinically significant systemic toxicity has occurred at doses approved for the treatment of adult patients. The risk of spreading of effect is greater than in adults, and more frequently severe. This can be due to the high dosages usually used in this population.

5 years, as packaged for sale.

Use immediately if diluted (see section 4.2 and section 6.6).

From a microbiological point of view, unless the method of opening/dilution precludes the risk of microbial contamination the product should be used immediately.

Store in a refrigerator at 2°C-8°C.

Do not freeze.

Keep the container in the outer carton in order to protect from light.

Within its shelf-life, the product may be removed from the refrigerator for a single period of up to 3 months at a temperature not above 25°C, without being refrigerated again. At the end of this period, the product should not be put back in the refrigerator and should be disposed of.

For storage conditions after dilution of the medicinal product, see section 6.3.

0.5 ml, 1 ml or 2 ml solution in a 3.5 ml Type I glass vial, with siliconised butyl rubber stoppers oversealed by aluminium crimped caps.

Pack size of 1.

NeuroBloc is provided in vials for single use only.

The medicinal product is ready to use and no reconstitution is required. Do not shake.

To allow division of the total dose between several injections, NeuroBloc may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection (see section 4.2). Such dilutions with sodium chloride should be done in a syringe, pulling out the desired amount of Neurobloc into the syringe first, and then adding sodium chloride to the syringe. In non clinical experiments, NeuroBloc solution has been diluted up to 6-fold without any resulting change in potency. Once diluted, the medicinal product must be used immediately as the formulation does not contain a preservative.

Any unused solution, all vials of expired NeuroBloc and equipment used in the administration of the medicinal product should be carefully discarded as Medical Bioharzardous Waste in accordance with local requirements. Vials should be visually inspected prior to use. If the NeuroBloc solution is not clear and colourless/light yellow or if the vial appears damaged, the product should not be used, but discarded as Medical Biohazardous Waste in accordance with local requirements.

Decontaminate any spill with 10% caustic solution, or sodium hypochlorite (household chlorine bleach – 2 ml (0.5%): 1 litre water) solution. Wear waterproof gloves and soak up the liquid with an appropriate absorbent. Place the absorbed toxin in an autoclave bag, seal it and process as Medical Biohazardous Waste in accordance with local requirements.