What Zutectra contains
- The active substance of Zutectra is human hepatitis B immunoglobulin 500 IU/ml.
- Zutectra contains 150 mg/ml of human plasma protein of which at least 96 % is immunoglobulin G (IgG). The maximum immunoglobulin A (IgA) content is 6 mg/ml.
- The other ingredients are glycine and water for injections.
What Zutectra looks like and the contents of the pack
Zutectra is presented as a solution for injection provided in pre-filled syringes (500 IU/ml - pack size of 5 in a blister). The colour of the solution can vary from clear to pale yellow or light brown.
One pre-filled syringe of 1 ml Zutectra contains 500 IU. Zutectra is supplied in a pack size containing 5 pre-filled syringes each in a blister pack.
Marketing Authorisation Holder and Manufacturer
Biotest Pharma GmbH
Tel.: + 49 6103 801-0
Fax: + 49 6103 801-150 / -727
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien Infarama bvba Costermansstede 1 LuxembourgLuxemburg Biotest AG Landsteinerstr. 5
B-1850 Grimbergen TélTel 32 22709522 D-63303 Dreieich TélTel 49 6103 801-0
. 33-35 1606 Te. 359 2 953 1224 Magyarország Biotest Hungaria Kft. Torbágy u. 15A H-2045 Törökbálint Tel. 36 23 511 311
eská republika Reg-Pharm spol.s.r.o. Fialková 45 CZ-10600 Praha 10 Tel 420 2 7265 4004 Malta Rodel Ltd 55, Ravina Triq ir-Russett MT-Kappara SGN 4432 Tel 356 27 386221
Danmark Biotest AG Landsteinerstrasse 5 D-63303 Dreieich Tel 49 6103 801-0 Nederland Infarama bvba Costermansstede 1 B-1850 Grimbergen Tel 32 22709522
Deutschland Biotest AG Landsteinerstrasse 5 D-63303 Dreieich Tel 49 6103 801-0 Norge Biotest AG Landsteinerstrasse 5 D-63303 Dreieich Tel 49 6103 801-0
Eesti Biotest AG Landsteinerstrasse 5 D-63303 Dreieich Tel 49 6103 801-0 Österreich Biotest Austria GmbH Einsiedlergasse 58 A-1053 Wien Tel 43 1 545 15 61-0
BIOTEST ... 25, GR-151 26 30 210 8043-437 Polska Nobipharm Sp. Z.o.o. ul Rydygiera 8 PL01-793 Warszawa Tel. 48 22 8322638
España Biotest Medical, S.L.U. CBeethoven, 15, 4a Planta ES-08021 Barcelona Tel 34 931 838 734 Portugal SPCare Especialidades Farmacêuticas, Lda Rua Luciano Cordeiro, n 123, 1 dto. PT-1600 139 Lisboa Tel 351 21 193 14 20
France Biotest S.a.r.l. 375 rue Morane Saulnier, BP 65 F-78534 Buc Cedex Tél 33 1 3920 2080 România HK ZY Best Pharma Distribution SRL. Str General tefan Burileanu, nr 8 Bucharest 013762 - RO Tel 40 21 4109494
Ireland Intrapharma Ltd. Pharmaceutical Suppliers Unitech House Magna Business Park, Slovenija Blood Transfusion Centre of Slovenia BTC Slajmerjeva 6
SI-1000 Ljubljana Tel 386 1 54 38 100 Magna Drive, Citywest Road IRL-Dublin 24 Tel 353 1 404 8344
Ísland Biotest AG Landsteinerstrasse 5 D-63303 Dreieich Tel 49 6103 801-0 Slovenská republika Reg-Pharm spol.s.r.o. Fialková 45 CZ-10600 Praha 10 Tel 420 2 7265 4004
Italia Biotest Italia S.r.l. Via Leonardo da Vinci 43 I-20090 Trezzano sul Naviglio Tel 39 02 4844 2951 SuomiFinland Biotest AG Landsteinerstrasse 5 D-63303 Dreieich Tel 49 6103 801-0
Sverige Biotest AG Landsteinerstrasse 5 D-63303 Dreieich Tel 49 6103 801-0 . . . 22578 1522 357 22 611 038
Latvija Biotest AG Landsteinerstrasse 5 D-63303 Dreieich Tel 49 6103 801-0 United Kingdom Biotest UK Ltd. 28 Monkspath Business Park, Highlands Road, Shirley, Solihull West Midlands B90 4NZUK Tel 44 121 733 3393
Biotest AGLandsteinerstrasse 5
Tel: + 49 6103 801-0
This leaflet was last approved in
HOW TO INJECT ZUTECTRA BY YOURSELF OR BY CAREGIVER
The following instructions are intended to explain how to inject Zutectra. Please read the instructions carefully and follow them step by step. The doctor or his/her assistant will teach you the process of administration.
Do not attempt to inject Zutectra until you are sure that you understand how to prepare the injection solution and give the injection.
- Keep the syringes and syringe disposal unit out of the reach of children; lock the supplies if possible.
- Try to take the injection at the same time of day. This makes it easier to remember it.
- Always double-check the dosage.
- The solution must be brought to room temperature before use.
- Open each syringe only when you are ready for an injection. You should administer the injection immediately after opening the syringe.
- The colour of the solution can vary from clear to pale yellow up to light brown. Do not use solutions that are cloudy or have particles.
- This medicine must not be mixed with other medicines.
Before the injection:
1. Wash your hands. It is important to have your hands and the items you use as clean as possible.
2. Lay out everything you need in advance. Find a clean place where you can spread out all the items
you are going to use:
- two alcohol swabs,
- one syringe of Zutectra,
- one needle suitable for subcutaneous injection.
Please note that alcohol swabs and needles are not contained in the pack and you need to supply them yourself.
3. Before preparing the injection, decide where you are going to inject. You should inject Zutectra into
the fatty layer between the skin and muscle (about 8 to 12 mm under the skin). The best places for injections are where the skin is loose and soft for example in the abdomen, arm, thigh or buttocks, and away from joints, nerves, bones.
Important: Do not use on any area where you can feel lumps, bumps, firm knots, pain or on an area that is discoloured, indented, scabbed, or where the skin is broken. Talk to the doctor or healthcare professional about these or any other unusual conditions you may find. You should rotate the injection site at every injection. If some areas are too difficult for you to reach, you may need a caregiver to help you with these injections.
4. Prepare the Zutectra syringe:
Take the syringe out of the pack. Examine the solution carefully. It should be clear and contain no particles. If the solution is discoloured, cloudy or contains particles, discard it and start again with a new syringe. Remove the protective cap from the syringe.
Take the needle out of its sterile pack and fit the needle onto the syringe.
5. Get rid of any air bubbles there may be in the syringe.
Hold the syringe with the needle pointing upwards, and tap the syringe gently with your fingers until the air has collected at the tip. Carefully push the plunger in until the air bubbles have disappeared.
1. Choose the area where you will make the injection and make a note of it in the diary.
Abdomen stomach Do not use the area within one inch around the navel. Avoid using the belt line area, as rubbing may irritate the injection site. Avoid surgical scars. This is likely to be the easiest place to inject if you are doing it yourself. Thighs Use middle and outer areas where you can pinch up tissue. You are likely to have more fatty tissue the closer you are to the hip and the further you are from the knee. Arms The back of the upper arm should be used. It is hard to pinch up the tissue and inject Zutectra yourself using this site. If you do choose to inject your arm yourself, try to pinch up the tissue by placing your upper arm over the back of a chair or brace it against a wall. It is much easier for someone else to use this site if you do need help. Buttocks Use any area where you can pinch up tissue. Its harder to give yourself an injection here. Try standing in front of a mirror to locate the site or you may want to ask your caregiver to give you the injection.
It's important tochange (rotate) the injection sites. This will help the skin stay supple and help the medicine be absorbed evenly. Rotating sites means starting at one site and using all other sites before going back to the first site you used. Then start the rotation again. It may be helpful to keep a record of where you had the last injection to avoid problems.
The administration in thighs is shown as an example in the following pictures:
2. Wipe the intended area with an alcohol swab. Let the skin air-dry.
3. Gently pinch the skin together around the disinfected injection site to raise it up a little and push the needle into the skin with a rapid, confident movement at an angle of 45 to 90 degrees. Inject beneath the skin as you have been shown by the doctor or nurse.
4. Inject the liquid by pressing gently on the plunger. Allow yourself enough time to inject the whole of the solution until the syringe is empty.
5. Then pull the needle out immediately and let go of the pinched skin.
6. Clean the injection site by wiping it in a circular motion with the alcohol swab.
Dispose of all used items
Once the injection has been completed, dispose of all needles and empty glass containers without delay in a container intended for sharp objects.