Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Human albumin
Sodium chloride

6.2   Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
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 to 8°C, unless reconstitution/dilution (etc) has taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage

BOT API MAR23 CL-2                               42/44
Store in a refrigerator (2°C-8°C), or store in a freezer (-20°C to -5°C).

For storage conditions of the reconstituted medicinal product see section 6.3.

6.5   Nature and contents of container
Uncoloured Type I glass vial, of 5 ml (50 Unit) and 10ml (100 Unit, 200 Unit) nominal capacity, fitted with chlorobutyl rubber stopper and tamper-proof aluminium seal.
Each pack contains 1 vial.

6.6   Special precautions for disposal and other handling

It is good practice to perform vial reconstitution and syringe preparation over plastic-lined paper towels to catch any spillage. Reconstitution should be performed in accordance with good practices rules, particularly for the respect of asepsis

BOTOX must only be reconstituted with sterile unpreserved normal saline solution (0.9% sodium chloride solution for injection). The appropriate amount of diluent should be drawn up into a syringe.
See section 4.2 for dilution instructions.

The central part of the rubber cap has to be cleaned with alcohol.

If different vial sizes of BOTOX are being used as part of one injection procedure, care should be taken to use the correct amount of diluent when reconstituting a particular number of units per 0.1 ml.
The amount of diluent varies between BOTOX 50 Allergan Units, BOTOX 100 Allergan Units and BOTOX 200 Allergan Units. Each syringe should be labelled accordingly.

Since BOTOX is denatured by bubbling or similar vigorous agitation, the diluent should be gently injected into the vial. The vial should be discarded if a vacuum does not pull the diluent into the vial.
Reconstituted BOTOX is a clear colourless to slightly yellow solution free of particulate matter. The reconstituted solution should be visually inspected for clarity and absence of particles prior to use.

When reconstituted in the vial, BOTOX may be stored in a refrigerator (2-8°C) for up to 24 hours prior to use. The date and time of reconstitution should be recorded on the space of the label. If BOTOX is further diluted for intradetrusor injection in a syringe, it should be used immediately. This product is for single use only and any unused solution should be discarded.

It is mandatory that BOTOX is used for one single patient treatment only during a single session.

Procedure to follow for a safe disposal of vials, syringes and materials used: 
For safe disposal, unused vials should be reconstituted with a small amount of water and then autoclaved. Any used vials, syringes, and spillages etc. should be autoclaved, or the residual BOTOX inactivated using dilute hypochlorite solution (0.5%) for 5 minutes.

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

Recommendations in the event of an accident when handling botulinum toxin 
In the event of an accident when handling the product, whether in the vacuum-dried state or reconstituted, the appropriate measures described below must be initiated immediately.
• The toxin is very sensitive to heat and certain chemical agents
• Any spillage must be wiped up: either with an absorbent material soaked in a solution of sodium hypochlorite (Javel solution) in the case of the vacuum-dried product, or with a dry absorbent material in the case of the reconstituted product.


BOT API MAR23 CL-2                                43/44
• Contaminated surfaces must be cleaned with an absorbent material soaked in a solution of sodium hypochlorite (Javel solution) and then dried.
• If a vial is broken, carefully collect up the pieces of glass and wipe up the product as stated above, avoiding cutting the skin.
• If splashed, wash with a solution of sodium hypochlorite and then rinse thoroughly with plenty of water.
• If splashed into the eyes, rinse one’s eyes thoroughly with plenty of water or with an ophthalmic eyewash solution.
• If the operator injures himself (cuts, pricks himself), proceed as above and take the appropriate medical steps according to the dose injected.

This instruction for use and handling, and disposal should be strictly followed.

Identification of the product
In order to verify receipt of actual BOTOX product from Allergan, look for a tamper-evident seal that contains a translucent silver Allergan logo on the top and bottom flaps of the BOTOX cartons, and a holographic film on the vial label. In order to see this film, examine the vial under a desk lamp or fluorescent light source. Rotating the vial back and forth between your fingers, look for horizontal lines of rainbow colour on the label and confirm that the name “Allergan” appears within the rainbow lines.
Do not use the product and contact your local Allergan office for additional information if:
• the horizontal lines of rainbow colour or the word “Allergan” are not present on the vial label
• the tamper-evident seal is not intact and present on both ends of the carton
• the translucent silver Allergan logo on the seal is not clearly visible or has a black circle with a diagonal line through it (i.e., prohibition sign)

Additionally, Allergan has created detachable stickers on the BOTOX vial label, which include the lot number and expiry date of the product you have received. These stickers can be peeled off and placed in your patient’s clinical file for traceability purposes. Note that once you remove the sticker off the BOTOX vial label, the word “USED” will show, which is to provide you with further assurance that you are using an authentic BOTOX product manufactured by Allergan.