Xolair Caution For Usage





Full Prescribing Info
Caution For Usage
Incompatibilities: Powder and solvent for solution for injection: Xolair should not be mixed with any medication or diluents other than sterile water for injection.
Instructions for Use and Handling: Xolair powder and solvent for solution for injection: The following information is intended for medical or healthcare professionals only.
Xolair 150 mg powder for solution for injection are supplied in a single-use vial and contain no antibacterial preservatives. Chemical and physical stability of the reconstituted product has been demonstrated for 8 hours at 2°C to 8°C and for 4 hours at 30°C. From a microbiological point of view, the product should be used immediately after reconstitution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should normally not be longer than 8 hours at 2°C to 8°C or 2 hours at 25°C.
The lyophilized product takes 15 to 20 minutes to dissolve, although in some cases it may take longer. The fully reconstituted product will appear clear to slightly opalescent, colorless to pale brownish-yellow and may have a few small bubbles or foam around the edge of the vial. Because the reconstituted product is somewhat viscous, care must be taken to WITHDRAW ALL OF THE PRODUCT from the vial before expelling any air or excess solution from the syringe in order to obtain the full 1.2 mL dose.
To prepare Xolair for subcutaneous administration, adhere to the following instructions: For Xolair 150 mg vials: 1. Draw 1.4 mL of water for injection 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 omalizumab vial using standard aseptic techniques, directing the water for injections directly onto the powder.
3. Keeping the vial in an upright position, vigorously swirl the upright vial (do not shake) for approximately 1 minute to evenly wet the powder.
4. To aid in dissolution after completing step 3, gently swirl the upright vial for 5 to 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 product is fully dissolved, there should be no visible gel-like particles in the solution. It is acceptable to have small bubbles or foam around the edge of the vial. The reconstituted product will appear clear or slightly opaque. Do not use if foreign particles are present.
5. Invert the vial for 15 seconds in order to allow the solution to drain towards the stopper. Using a new 3-cc syringe equipped with a large-bore, 18-gauge needle, insert the needle into the inverted vial. Position the needle tip at the very bottom of the solution in the vial stopper 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, the injection may take 5 to 10 seconds to administer. The vial delivers 1.2 mL (150 mg) of Xolair.
8. The injections are administered subcutaneously in the arm, thigh, or lower abdomen (but not the area of 5 centimeters around the navel). Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid areas with scars or stretch marks. If the patient needs to give more than one injection for the full dose, choose a different injection site each time the patient injects.
Special precautions for disposal - Xolair powder and solvent for solution for injection: Any unused product or waste material should be disposed of in accordance with local requirements.
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