Pharmaceutical particulars : מידע רוקחי

6.    Pharmaceutical Particulars
6.1   List of excipients

Hib powder:
Lactose

DTPa-HBV-IPV suspension:
Sodium chloride
Medium 199
(as stabilizer containing amino acids (including phenylalanine), mineral salts (including sodium and potassium), vitamins (including para-aminobenzoic acid) and other substances) 

Water for injections
Adjuvant:
Aluminium - as aluminium hydroxide (AI(OH)3) as aluminium phosphate (AIPO4)


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 vaccine is indicated on the label and packaging.
After reconstitution: an immediate use is recommended. However, the stability has been demonstrated for 8 hours at 21°C after reconstitution.

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.
Stability data indicate that the vaccine components are stable at temperatures up to 25°C for 72 hours. At the end of this period Infanrix hexa should be used or discarded. These data are intended to guide healthcare professionals in case of temporary temperature excursion only.
Do not store the vaccine routinely under these extreme storage conditions, based on this information.
.


For storage conditions after reconstitution of the medicinal product, see section 6.3.
6.5   Nature and contents of container

Powder in a vial (type I glass) containing 1 dose with a stopper (butyl rubber) and 0.5 ml of suspension in a pre-filled syringe (type I glass) with a plunger stopper (butyl rubber) and with a rubber tip cap.

The tip cap and rubber plunger stopper of the pre-filled syringe and the stopper of the vial are made with synthetic rubber.

Pack sizes of 1, 10, 20 and 50 with or without needles.
Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
Upon storage, a clear liquid and white deposit may be observed in the pre-filled syringe containing the DTPa-HBV-IPV suspension. This is a normal observation.

The pre-filled syringe should be well shaken in order to obtain a homogeneous turbid, white suspension.

The vaccine is reconstituted by adding the entire contents of the pre-filled syringe to the vial containing the powder. The mixture should be well shaken until the powder is completely dissolved prior to administration.

The reconstituted vaccine appears as a slightly more cloudy suspension than the liquid component alone. This is a normal observation.

The vaccine suspension should be inspected visually before and after reconstitution for any foreign particulate matter and/or abnormal physical appearance. If either is observed, do not administer the vaccine.


Instructions for the pre-filled syringe


Luer Lock Adaptor Hold the syringe by the barrel, not by the plunger.
Unscrew the syringe cap by twisting it
Plunger                                   anticlockwise.
Barrel
Cap



To attach the needle, connect the hub to the Luer
Needle hub               Lock Adaptor and rotate a quarter turn clockwise until you feel it lock.
Reconstitute the vaccine as described above.
Do not pull the syringe plunger out of the barrel. If it happens, do not administer the vaccine.



Disposal

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