Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sodium hydroxide (pH adjustment)
Phosphoric acid (pH adjustment)
Water for injections

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.
Once the vial is opened, the medicinal product should be used immediately.


6.4   Special precautions for storage

Store below 25 °C.
Keep vial in the outer carton to protect from light.

6.5   Nature and contents of container
Glass vial with a fluoropolymer-coated rubber stopper and a flip-off aluminium seal. Each vial contains 1 mL solution for injection.


Pack size of one vial.
6.6   Special precautions for disposal and other handling

This medicinal product is for single use only.

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


6.7 Instructions for use

For subcutaneous use only.

•     Collect materials not included in the pack that are needed for administration which will include a sterile syringe (1 mL or 3 mL), 21-gauge (G) or a larger needle, 25 G or 27 G needle and a sharps container.
•     Calculate the required volume of Givlaari based on the recommended weight-based dose. If the dose is more than 1 mL, more than one vial will need to be used and more than one subcutaneous injection may need to be given. The maximum acceptable single injection volume to be administered is 1.5 mL.
•     To withdraw Givlaari, hold the vial upright or tilt at a slight angle and ensure the flat edge of the needle is pointed downwards.
•     Draw up the indicated injection volume with the 21 G or larger needle.
•     Divide doses requiring volumes greater than 1.5 mL equally into multiple syringes, with each injection containing approximately the same volume.
•     Point the needle and syringe straight up and tap the syringe to move any bubbles to the top.
Once the bubbles are at the top, gently push the plunger to force the bubbles out of the syringe.
Check to make sure you still have the correct amount of medicine in the syringe.
•     Once the dose is prepared and in the administration syringe, replace the 21 G or larger needle with either a 25 G or 27 G needle.
•     Note: Do not push this medicine into the 25 G or 27 G needle.
•     Injection can be into the abdomen, or if required, the back or side of the upper arms, or the thighs. Consider rotating injection sites. Do not administer into scar tissue or areas that are reddened, inflamed, or swollen.
•     Note: When administering subcutaneous injections into the abdomen, a 5.0 cm diameter circle around the navel should be avoided.
•     Clean the area you intend to inject with an alcohol swab and wait for the area to dry completely.
•     Ensure proper injection technique. Do not inject into a vein or muscle.
•     Pinch and elevate the skin at the selected injection site. Insert the needle at a right angle (90 degrees) to deliver the injection just below the skin. In patients with little subcutaneous tissue or if the needle size is longer than 2.5 cm, the needle should be inserted at a 45-degree angle.
•     Do not press down on the plunger while piercing the skin. Once the needle is inserted through the skin, release the pinched skin and administer the dose in a slow and steady manner. Once this medicine has been administered count for at least 5 seconds before withdrawing the needle from the skin. Lightly press gauze or cotton ball on the injection site as needed. Do not put the needle cap back on.
•    Note: Don’t aspirate after inserting the needle to prevent tissue damage, haematoma and bruising.
•    If more than one injection is needed for a single dose of Givlaari, the injection sites should be at least 2 cm apart from previous injection locations.
•    Only use the vial once. After you inject the dose, dispose of any unused medicine in the vial according to local regulations.
•    Use the syringes, transfer needles and injection needles only once. Dispose of any used syringes and needles in accordance with local requirements.