Pharmaceutical particulars : מידע רוקחי

6     PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Lactose monohydrate, human albumin solution
6.2   Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.


DYSP-SPC-1121-V1                                       Page 25 of 27
6.3   Shelf life

Unopened vial:
The expiry date of the product is indicated on the packaging materials.

Reconstituted solution:
Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C.
From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

6.4   Special precautions for storage

Unopened vial:
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Reconstituted solution:
For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5   Nature and contents of container
3 ml vial (type 1 glass) with a stopper (bromobutyl rubber), with an overseal (aluminium), containing 300 or 500 units of botulinum toxin type A powder for solution for injection.

Contents of container:
A white lyophilized powder. After reconstitution, the solution is free from visible particles.

6.6   Special precautions for disposal and other handling
When preparing and handling Dysport solutions, the use of gloves is recommended. If Dysport dry powder or reconstituted solution should come into contact with the skin or mucous membranes, they should be washed thoroughly with water.

Instructions for reconstitution
The exposed central portion of the rubber stopper should be cleaned with alcohol immediately prior to piercing the septum. A sterile 23 or 25 gauge needle should be used.

Each vial is for single use only.

Reconstitution instructions are specific for each of the 300 unit vial and the 500 unit vial. These volumes yield concentrations specific for the use for each indication.

Resulting Dose            Diluent* per            Diluent* per
Unit per ml                500 U vial             300 U vial
500 U                     1 ml                    0.6 ml
200 U                     2.5 ml                  1.5 ml
100 U                     5 ml                    3 ml
*Preservative-free 0.9 % sodium chloride injection

For paediatric cerebral palsy spasticity, which is dosed using unit per body weight, further dilution may be required to achieve the final volume for injection.

Appearance of product after reconstitution:
A clear, colourless solution, free from particulate matter.


DYSP-SPC-1121-V1                                        Page 26 of 27 Disposal
Immediately after treatment of the patient, any residual Dysport which may be present in either vial or syringe should be inactivated with dilute hypochlorite solution (1 % available chlorine).

Spillage of Dysport should be wiped up with an absorbent cloth soaked in dilute hypochlorite solution.

Any unused product or waste material should be disposed of in accordance with local requirements.