Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS
6.1 List of excipients

Sodium chloride
L-histidine
Polysorbate 80 (E433)
Sodium borate (E285)
Water for injections

For adjuvant, see section 2.
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.

6.4   Special precautions for storage
Gardasil 9 suspension for injection:

Store in a refrigerator (2 °C - 8 °C).

Do not freeze. Keep the vial in the outer carton in order to protect from light.
Gardasil 9 should be administered as soon as possible after being removed from the refrigerator.

Stability data indicate that the vaccine components are stable for 96 hours when stored at temperatures from 8 °C to 40 °C or for 72 hours when stored at temperatures from 0 °C to 2 °C. At the end of this period Gardasil 9 should be used or discarded. These data are intended to guide healthcare professionals in case of temporary temperature excursion only.

Gardasil 9 suspension for injection in a pre-filled syringe:

Store in a refrigerator (2 °C - 8 °C).
Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light.

Gardasil 9 should be administered as soon as possible after being removed from the refrigerator.

Stability data indicate that the vaccine components are stable for 96 hours when stored at temperatures from 8 °C to 40 °C or for 72 hours when stored at temperatures from 0 °C to 2 °C. At the end of this period Gardasil 9 should be used or discarded. These data are intended to guide healthcare professionals in case of temporary temperature excursion only.

6.5   Nature and contents of container

Gardasil 9 suspension for injection:
0.5 ml suspension in a vial (glass) with stopper West FluroTec-laminated (halobutyl) and a flip-off plastic cap (aluminium crimp band) in a pack size of 1.

Gardasil 9 suspension for injection in a pre-filled syringe:

0.5 ml suspension in a pre-filled syringe (glass) with plunger stopper (BD West 4023/50, FluroTec- laminated), brown plunger Rod and a tip cap (synthetic isoprene-bromobutyl blend) with two needles in pack size of 1 or 10.

Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
Gardasil 9 suspension for injection:

•     Gardasil 9 may appear as a clear liquid with a white precipitate prior to agitation.

•     Shake well before use to make a suspension. After thorough agitation, it is a white, cloudy liquid.
•     Inspect the suspension visually for particulate matter and discolouration prior to administration.
Discard the vaccine if particulates are present and/or if it appears discoloured.

•     Withdraw the 0.5 ml dose of vaccine from the single-dose vial using a sterile needle and syringe.

•     Inject immediately using the intramuscular (IM) route, preferably in the deltoid area of the upper arm or in the higher anterolateral area of the thigh.

•     The vaccine should be used as supplied. The full recommended dose of the vaccine should be used.

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

Gardasil 9 suspension for injection in a pre-filled syringe:

•   Gardasil 9 may appear as a clear liquid with a white precipitate prior to agitation.

•   Shake well before use, the pre-filled syringe, to make a suspension. After thorough agitation, it is a white, cloudy liquid.

•   Inspect the suspension visually for particulate matter and discolouration prior to administration.
Discard the vaccine if particulates are present and/or if it appears discoloured.

•   Two needles of different lengths are provided in the pack, choose the appropriate needle to ensure an intramuscular (IM) administration depending on your patient’s size and weight.

•   Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe.
Administer the entire dose as per standard protocol.

•   Inject immediately using the intramuscular (IM) route, preferably in the deltoid area of the upper arm or in the higher anterolateral area of the thigh.

•   The vaccine should be used as supplied. The full recommended dose of the vaccine should be used.

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