What Xolair contains
- The active substance is omalizumab. One vial contains 75 mg of omalizumab. After reconstitution one vial contains 125 mg/ml of omalizumab (75 mg in 0.6 ml).
- The other ingredients are sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 20.
What Xolair looks like and contents of the pack
Xolair 75 mg powder and solvent for solution for injection is supplied as an off-white powder in a small glass vial together with an ampoule containing 2 ml of water for injections. The powder is reconstituted in the water before it is injected by a doctor or nurse.
Xolair is available in packs containing one vial of powder for solution for injection and one ampoule of 2 ml water for injections.
Xolair is also available in vials with 150 mg omalizumab.
Marketing Authorisation Holder
Novartis Europharm Limited
West Sussex, RH12 5AB
Novartis Pharma S.A.S.
Centre de Biotechnologie
8, rue de l-Industrie
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
BelgiëBelgiqueBelgien Novartis Pharma N.V. TélTel 32 2 246 16 11 LuxembourgLuxemburg Novartis Pharma N.V. TélTel 32 2 246 16 11
Novartis Pharma Services Inc. . 359 2 489 98 28 Magyarország Novartis Hungária Kft. Pharma Tel. 36 1 457 65 00
eská republika Novartis s.r.o. Tel 420 225 775 111 Malta Novartis Pharma Services Inc. Tel 356 2298 3217
Danmark Novartis Healthcare AS Tlf 45 39 16 84 00 Nederland Novartis Pharma B.V. Tel 31 26 37 82 111
Deutschland Novartis Pharma GmbH Tel 49 911 273 0 Norge Novartis Norge AS Tlf 47 23 05 20 00
Eesti Novartis Pharma Services Inc. Tel 372 66 30 810 Österreich Novartis Pharma GmbH Tel 43 1 86 6570
Novartis Hellas A.E.B.E. 30 210 281 17 12 Polska Novartis Poland Sp. z o.o. Tel. 48 22 550 8888
España Novartis Farmacéutica, S.A. Tel 34 93 306 42 00 Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Tel 351 21 000 8600
France Novartis Pharma S.A.S. Tél 33 1 55 47 66 00 România Novartis Pharma Services Inc. Tel 40 21 31299 01
Ireland Novartis Ireland Limited Tel 353 1 260 12 55 Slovenija Novartis Pharma Services Inc. Tel 386 1 300 75 50
Ísland Vistor hf. Sími 354 535 7000 Slovenská republika Novartis Slovakia s.r.o. Tel 421 2 5542 5439
Italia Novartis Farma S.p.A. Tel 39 02 96 54 1 SuomiFinland Novartis Finland Oy PuhTel 358 010 6133 200
Novartis Pharma Services Inc. 357 22 690 690 Sverige Novartis Sverige AB Tel 46 8 732 32 00
Latvija Novartis Pharma Services Inc. Tel 371 67 887 070 United Kingdom Novartis Pharmaceuticals UK Ltd. Tel 44 1276 698370
Novartis Pharma Services Inc.
Tel: +370 5 269 16 50
This leaflet was last approved in
INFORMATION FOR THE HEALTHCARE PROFESSIONAL
The following information is intended for medical or healthcare professionals only:
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 or slightly opaque 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 0.6 ml.
To prepare Xolair 75 mg vials for subcutaneous administration, please adhere to the following instructions:
1. Draw0.9 mlof 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 onto 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 or slightly opaque. 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 0.6 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 0.6 ml (75 mg) of Xolair.
8. The injections are administered subcutaneously in the deltoid region of the arm or the thigh.