Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sucrose, human serum albumin

6.2   Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3   Shelf life

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 to 8°C.

From a microbiological point of view, 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 and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

6.4 Special precautions for storage
Do not store above 25°C.

For storage conditions after reconstitution of the medicinal product, see section 6.3.
6.5 Nature and contents of container
Clear glass vial (type 1 glass) with a bromobutyl rubber stopper sealed and crimped with an aluminium cap. Pack size:1, 2, 3 or 6 vials
Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling

Reconstitution
XEOMIN is reconstituted prior to use with sodium chloride 9 mg/ml (0.9%) solution for injection.
Reconstitution and dilution should be performed in accordance with good clinical practice guidelines, particularly with respect to asepsis.

It is good practice to reconstitute the vial contents and prepare the syringe over plastic-lined paper towels to catch any spillage. An appropriate amount of sodium chloride solution (see dilution table) is drawn up into a syringe. A 20-27 gauge needle is recommended for reconstitution. After vertical insertion of the needle through the rubber stopper, the solvent is injected gently into the vial in order to avoid foam formation. If the vacuum does not pull the solvent into the vial, the vial should be discarded. The syringe should be removed from the vial and XEOMIN should be mixed with the solvent by carefully swirling and inverting/flipping the vial – The solution should not be shaken vigorously. If needed, the needle used for reconstitution should remain in the vial and the required amount of solution should be drawn up with a new sterile syringe suitable for injection.



Reconstituted XEOMIN is a clear, colourless solution.

XEOMIN must not be used if the reconstituted solution has a cloudy appearance or contains floccular or particulate matter.

Care should be taken to use the correct solvent volume for the presentation chosen to prevent accidental overdose. If different vial sizes of XEOMIN are being used as part of one injection procedure, care should be taken to use the correct amount of solvent when reconstituting a particular number of units per 0.1 ml. The amount of solvent varies between XEOMIN 50 units and XEOMIN 100 units. Each syringe should be labelled accordingly.

Possible concentrations for XEOMIN 50 and 100 units are indicated in the following table: 


Solvent added
Resulting dose                   (sodium chloride 9 mg/ml (0.9%) solution for injection) (in units per 0.1 ml)
Vial with 50 units                      Vial with 100 units
20 units                         0.25 ml                                   0.5 ml
10 units                         0.5 ml                                     1 ml 8 units                        0.625 ml                                  1.25 ml 5 units                          1 ml                                      2 ml 4 units                         1.25 ml                                   2.5 ml
2.5 units                         2 ml                                      4 ml
2 units                         2.5 ml                                     5 ml
1.25 units                        4 ml                                 Not applicable 
Any solution for injection that has been stored for more than 24 hours as well as any unused solution for injection should be discarded.

Procedure to follow for a safe disposal of vials, syringes and materials used Any unused vials or remaining solution in the vial and/or syringes should be autoclaved. Alternatively, the remaining XEOMIN can be inactivated by adding one of the following solutions: 70% ethanol, 50% isopropanol, 0.1% SDS (anionic detergent), diluted sodium hydroxide solution (0.1 N NaOH), or diluted sodium hypochlorite solution (at least 0.1% NaOCl).

After inactivation used vials, syringes and materials should not be emptied and must be discarded into appropriate containers and disposed of in accordance with local requirements.

Recommendations should any incident occur during the handling of botulinum toxin type A •    Any spills of the product must be wiped up: either using absorbent material impregnated with any of the above listed solutions in case of the powder, or with dry, absorbent material in case of reconstituted product.
•    The contaminated surfaces should be cleaned using absorbent material impregnated with any of the above solutions, then dried.
•    If a vial is broken, one should proceed as mentioned above by carefully collecting the pieces of broken glass and wiping up the product, avoiding any cuts to the skin.
•    If the product comes into contact with skin, the affected area should be rinsed abundantly with water.
•    If product gets into the eyes, they should be rinsed thoroughly with plenty of water or with an ophthalmic eyewash solution.
•    If product comes into contact with a wound, cut or broken skin, the skin should be rinsed thoroughly with plenty of water . Appropriate medical steps according to the dose injected should be taken.

These instructions for use, handling and disposal should be strictly followed.