Pharmaceutical particulars : מידע רוקחי

6.       PHARMACEUTICAL PARTICULARS

6.1      List of excipients
Phosphate buffered saline consisting of:

Sodium chloride
Potassium dihydrogen phosphate
Disodium hydrogen phosphate
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

Store in a refrigerator (2°C - 8°C).
Do not freeze.
Store in the original package in order to protect from light.

6.5     Nature and contents of container
0.5 ml of suspension in a pre-filled syringe (Type I glass) with a plunger stopper (chlorobutyl elastomer). Pack size of 1 syringe with or without a separate needle.

6.6     Special precautions for disposal and other handling

The pre-filled syringe is for single use only and should not be used for more than one person. The pre-filled syringe is ready to use. If a needle is not provided, use a sterile needle.

Do not use if the blister foil is not intact or packaging is damaged.

Upon storage, a fine white deposit with a clear, colourless supernatant can be observed.
Before administration, shake the syringe well to obtain a white, opaque, homogeneous suspension.
Do not administer if particulate matter remains following shaking or if discoloration is observed or if the syringe appears to be physically damaged.

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

Information on the administration of a 0.5 ml dose of IXIARO for persons 3 years of age and above 
For administration of the full 0.5 ml dose follow the steps below:

1. Shake the syringe to obtain a homogeneous suspension.
2. Remove the syringe tip cap by gently twisting it. Do not attempt to snap or pull the tip off as this may damage the syringe.
3. Attach a needle to the pre-filled syringe.
Information on the preparation of a 0.25 ml dose of IXIARO for use in children below 3 years of age
For administration of a 0.25 ml dose in children aged 2 months to < 3 years, follow the steps below:
1. Shake the syringe to obtain a homogeneous suspension.
2. Remove the syringe tip cap by gently twisting it. Do not attempt to snap or pull the tip off as this may damage the syringe.
3. Attach a needle to the pre-filled syringe.
4. Hold the syringe in an upright position.
5. Push the plunger stopper up to the edge of the red line on the syringe barrel, indicated by a red arrow (see Figure 1)*, to discard excess volume.
6. Attach a new sterile needle prior to injection of the remaining volume.
* If you pushed the plunger stopper beyond the red line, a 0.25 ml dose is not guaranteed and a new syringe should be used.

Figure 1:



Preparation for
Administration of 0.25 ml Dose