Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
 sodium acetate trihydrate acetic acid glacial sorbitol polysorbate 20 water for injection
6.2   Incompatibilities

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.
After opening the vial, chemical and physical in-use stability of idarucizumab has been demonstrated for 6 hours at room temperature.

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

Store in a refrigerator (2 °C-8 °C).
Do not freeze.
Store in the original package in order to protect from light.
Prior to use, the unopened vial may be kept at room temperature (up to 30°C) for up to 48 hours, if stored in the original package in order to protect from light. The solution should not be exposed to light for more than 6 hours (in unopened vial and/or in-use).
For storage conditions after opening of the medicinal product, see section 6.3.

6.5   Nature and contents of container
Praxbind                                                                     Updated prescribing information Solution for I.V. injection/infusion 50mg/ml                                                    August 2020 
50 mL solution in a glass vial (type I glass), with a butyl rubber stopper, an aluminium cap and a label with integrated hanger.

Pack size of 2 vials.

6.6   Special precautions for disposal and other handling
Parenteral medicinal products such as Praxbind should be inspected visually for particulate matter and discoloration prior to administration.

Praxbind must not be mixed with other medicinal products. A pre-existing intravenous line may be used for administration of Praxbind. The line must be flushed with sodium chloride 9 mg/ml (0.9 %) solution for injection prior to and at the end of infusion. No other infusion should be administered in parallel via the same intravenous access.

Praxbind is for single-use only and does not contain preservatives (see section 6.3).

No incompatibilities between Praxbind and polyvinyl chloride, polyethylene or polyurethane infusion sets or polypropylene syringes have been observed.

7.    MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Israel Ltd.,
#89 Medinat Ha’Yehudim St.,
Hertzliya Pituach 4676672
8.    MARKETING AUTHORISATION NUMBER

156-51-34626-00