Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

L-Arginine
L-Histidine
Poloxamer 188
L-Aspartic acid
Water for injections

6.2   Incompatibilities
No incompatibilities between Hemlibra and polypropylene or polycarbonate syringes and stainless steel needles have been observed.

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

6.3   Shelf life

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

Once removed from the refrigerator, unopened vials can be kept at room temperature (below 30°C) for up to 7 days.

After storage at room temperature, unopened vials may be returned to the refrigerator. If stored out of and then returned to refrigeration, the total combined time out of refrigeration should not exceed 7 days. The vials should never be exposed to temperatures above 30 °C. Vials that have been kept at room temperature for more than 7 days or exposed to temperatures above 30 °C should be discarded.

Pierced vial and filled syringe

From a microbiological point of view, once transferred from the vial to the syringe, the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

6.4   Special precautions for storage

Store in a refrigerator (2°C - 8°C).
Do not freeze.

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

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


6.5   Nature and contents of container

Hemlibra 30 mg/mL solution for injection

3 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and crimped with an aluminium cap fitted with a sky blue plastic flip-off disk. Each vial contains 30 mg emicizumab in 1 mL of solution for injection. Each carton contains one vial.

Hemlibra 150 mg/mL solution for injection

3 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and crimped with an aluminium cap fitted with a purple plastic flip-off disk. Each vial contains 60 mg emicizumab in 0.4 mL of solution for injection. Each carton contains one vial.

3 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and crimped with an aluminium cap fitted with a turquoise plastic flip-off disk. Each vial contains 105 mg emicizumab in 0.7 mL of solution for injection. Each carton contains one vial.

3 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and crimped with an aluminium cap fitted with a brown plastic flip-off disk. Each vial contains 150 mg emicizumab in 1 mL of solution for injection. Each carton contains one vial.

Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
Hemlibra solution is a sterile, preservative-free, and ready to use solution for subcutaneous injection that does not need to be diluted.

Hemlibra should be inspected visually to ensure there is no particulate matter or discolouration prior to administration. Hemlibra is a colourless to slightly yellow solution. The solution should be discarded if particulate matter is visible or product is discoloured.

Do not shake.

Hemlibra solution for injection vials are for single-use only.
A syringe, a transfer needle and an injection needle are needed to withdraw Hemlibra solution from the vial and inject it subcutaneously.

Please see below recommended features:

A 1 mL syringe should be used for an injection up to 1 mL of Hemlibra solution, whereas a 2 to 3 mL syringe should be used for an injection greater than 1 mL and up to 2 mL.

Refer to the Hemlibra “Instructions for Use” for handling instructions when combining vials in a syringe. Different Hemlibra vial concentrations (30 mg/mL and 150 mg/mL) should not be combined in a single injection to administer the prescribed dose.

1 mL syringe

Criteria: Transparent polypropylene or polycarbonate syringe with Luer-lock tip, graduation 0.01 mL.
2 to 3 mL syringe

Criteria: Transparent polypropylene or polycarbonate syringe with Luer-lock tip, graduation 0.1 mL.

Transfer needle with filter
Criteria for transfer needle with filter: Stainless steel with Luer-lock connection, gauge 18 G, length 35 mm (1½″), containing a 5 µm filter and preferably with semi-blunted tip.

Injection needle

Criteria: Stainless steel with Luer-lock connection, gauge 26 G (acceptable range: 25-27 gauge), length preferably 9 mm (3/8″) or maximally 13 mm (½″), preferably including needle safety feature.

Please see section 4.2 and package leaflet (section 7 Instructions for Use), for additional information on administration.

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

7.    MARKETING AUTHORISATION HOLDER

Roche Pharmaceuticals (Israel) Ltd., P.O. Box 6391, Hod Hasharon, 4524079.
8.    MARKETING AUTHORISATION NUMBER(S)

Hemlibra 30 mg/ml 161-18-35414-00
Hemlibra 150 mg/ml 161-19-35415-00