What Xolair contains
- The active substance is omalizumab. One syringe of 0.5 ml solution contains 75 mg omalizumab. One syringe of 1 ml solution contains 150 mg omalizumab.
- The other ingredients are L-arginine hydrochloride, L-histidine hydrochloride, L-histidine, Polysorbate 20 and water for injections.
What Xolair looks like and contents of the pack
Xolair solution for injection is supplied as a clear to opalescent, slightly yellow to brown solution in a pre-filled syringe, and is available as 75 mg and 150 mg solution for injection.
Xolair 75 mg solution for injection is available in packs containing 1 pre-filled syringe and in multipacks comprising 4 or 10 intermediate packs, each containing 1 pre-filled syringe.
Xolair 150 mg solution for injection is available in packs containing 1 pre-filled syringe and in multipacks comprising 4 or 10 intermediate packs, each containing 1 pre-filled syringe.
Not all pack sizes may be marketed in your country.
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:
Before using the syringe, please read the following information carefully.
Each Xolair pack contains a pre-filled syringe individually sealed in a plastic wrapper.
Parts of the pre-filled syringe
Needle cap Needle guard Finger flange Activation clips Plunger rod Viewing window Label and expiration date Fill line Xolair syringes are intended to be used by a healthcare professional only.
Preparing the syringe for use
Prior to completion of the injection, avoid contact with the device activation clips (see first illustration) to keep from prematurely covering the needle with the needle guard.
1. Take the box containing the syringe out of the refrigerator and leave it unopened for about 20 minutes so that it reaches room temperature.
2. When you are ready to use the syringe, wash your hands thoroughly with soap and water.
3. Clean the injection site.
4. Remove the plastic tray from the box, peel back the paper cover, and remove the syringe.
5. Inspect the syringe. DO NOT USE if it is broken or if the liquid looks cloudy or contains particles. In all these cases, return the entire pack to the pharmacy.
6. Holding the syringe horizontally (as shown below), look into the viewing window to check the dose (75 mg or 150 mg) of medicine and the expiry date printed on the label. Note: Rotate the inner part of the syringe assembly as shown below so that the label can be read in the viewing window.
DO NOT USE if the product has expired or if the dose is incorrect. In both these cases, return the entire pack to the pharmacy. 7. Hold the syringe vertically with the plunger uppermost and tap the side of the syringe against your finger to allow the air bubble to rise. Slowly push the plunger up to force the air bubble out of the syringe without inadvertently expelling solution.
8. Check to see if the liquid level is at or above the minimum fill line. If the liquid is below the fill line, return the entire pack to the pharmacy.
Using the syringe
Carefully pull off the needle cap from the syringe and discard it. Do not touch the exposed needle. Gently pinch the skin at the injection site and insert the needle. Holding onto the finger flange, slowly depress the plunger as far as it will go. If any solution leaks from the injection site, insert the needle further. Keeping the plunger fully depressed, carefully lift the needle straight out from the injection site.
Slowly release the plunger and allow the needle guard to automatically cover the exposed needle. Hold gauze on the injection site for approximately 30 seconds.
Dispose of the used syringe immediately in a sharps container.