Xolair Caution For Usage

Incompatibilities: This medicinal product must not be mixed with other medicinal products except those mentioned as follows.
Instructions For Use, Disposal and Handling: Vial: Xolair 150 mg powder for solution for injection is supplied in a single-use vial.
From a microbiological point of view, the medicinal product should be used immediately after reconstitution (see Storage).
The lyophilised medicinal product takes 15-20 minutes to dissolve, although in some cases it may take longer. The fully reconstituted medicinal product will appear clear to slightly opalescent, colourless to pale brownish-yellow and may have a few small bubbles or foam around the edge of the vial. Because of the viscosity of the reconstituted medicinal product care must be taken to withdraw all of the medicinal product from the vial before expelling any air or excess solution from the syringe in order to obtain the 1.2 mL.
To prepare Xolair 150 mg vials for subcutaneous administration, adhere to following instructions: 1. Draw 1.4 mL of water for injections from the ampoule into a syringe equipped with a large-bore 18-gauge needle.
2. With the vial placed upright on a flat surface, insert the needle and transfer the water for injections into the vial containing the lyophilised powder using standard aseptic techniques, directing the water for injections directly on to the powder.
3. Keeping the vial in an upright position, vigorously swirl it (do not shake) for approximately 1 minute to evenly wet the powder.
4. To aid in dissolution after completing step 3, gently swirl the vial for 5-10 seconds approximately every 5 minutes in order to dissolve any remaining solids.
Note that in some cases it may take longer than 20 minutes for the powder to dissolve completely. If this is the case, repeat step 4 until there are no visible gel-like particles in the solution.
When the medicinal product is fully dissolved, there should be no visible gel-like particles in the solution. Small bubbles or foam around the edge of the vial are common. The reconstituted medicinal product will appear clear to slightly opalescent, colourless to pale brownish-yellow. Do not use if solid particles are present.
5. Invert the vial for at least 15 seconds in order to allow the solution to drain towards the stopper. Using a new 3-mL syringe equipped with a large-bore, 18-gauge needle, insert the needle into the inverted vial. Keeping the vial inverted position the needle tip at the very bottom of the solution in the vial when drawing the solution into the syringe. Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove all of the solution from the inverted vial.
6. Replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection.
7. Expel air, large bubbles and any excess solution in order to obtain the required 1.2 mL dose. A thin layer of small bubbles may remain at the top of the solution in the syringe. Because the solution is slightly viscous, it may take 5-10 seconds to administer the solution by subcutaneous injection.
The vial delivers 1.2 mL (150 mg) of Xolair. For a 75 mg dose, draw up 0.6 mL into the syringe and discard the remaining solution.
8. The injections are administered subcutaneously in the deltoid region of the arm, the lower abdomen (but not the area 5 centimetres around the navel) or the thigh.
Pre-filled syringe: Xolair 150 mg solution for injection is supplied in a single-use pre-filled syringe for individual use. The syringe should be taken out of the refrigerator 20 minutes before injecting to allow it to reach room temperature.
How to use the Xolair pre-filled syringe: 1. Carefully remove the needle cap from the syringe. Discard the needle cap. A drop of liquid may be seen at the end of the needle. This is normal.
2. Gently pinch the skin at the injection site and insert the needle. Push the needle all the way in to ensure that the medicine can be fully administered.
3. Hold the syringe. Slowly depress the plunger as far as it will go so that the plunger head is completely between the syringe guard wings.
4. Keep the plunger fully depressed while carefully lifting the needle straight out from the injection site.
5. Slowly release the plunger and allow the syringe guard to automatically cover the exposed needle.
There may be a small amount of blood at the injection site. A cotton ball or gauze can be pressed over the injection site and hold it for 30 seconds. Do not rub the injection site. Injection site may be covered with a small adhesive bandage, if needed.
Disposal instructions: Dispose of the used syringe immediately in a sharps container.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.