What Biopoin contains
- The active substance is epoetin theta . Biopoin 1,000 IU/0.5 ml: One pre-filled syringe contains 1,000 international units (IU) (8.3 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 2,000 international units (IU) (16.7 micrograms) per ml. Biopoin 2,000 IU/0.5 ml: One pre-filled syringe contains 2,000 international units (IU)
(16.7 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 4,000 international units (IU) (33.3 micrograms) per ml.
Biopoin 3,000 IU/0.5 ml: One pre-filled syringe contains 3,000 international units (IU) (25 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 6,000 international units (IU) (50 micrograms) per ml.
Biopoin 4,000 IU/0.5 ml: One pre-filled syringe contains 4,000 international units (IU) (33.3 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 8,000 international units (IU) (66.7 micrograms) per ml.
Biopoin 5,000 IU/0.5 ml: One pre-filled syringe contains 5,000 international units (IU) (41.7 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 10,000 international units (IU) (83.3 micrograms) per ml..
Biopoin 10,000 IU/1 ml: One pre-filled syringe contains 10,000 international units (IU) (83.3 micrograms) epoetin theta in 1 ml solution for injection corresponding to 10,000 international units (IU) (83.3 micrograms) per ml.
Biopoin 20,000 IU/1 ml: One pre-filled syringe contains 20,000 international units (IU) (166.7 micrograms) epoetin theta in 1 ml solution for injection corresponding to 20,000 international units (IU) (166.7 micrograms) per ml.
Biopoin 30,000 IU/1 ml: One pre-filled syringe contains 30,000 international units (IU) (250 micrograms) epoetin theta in 1 ml solution for injection corresponding to 30,000 international units (IU) (250 micrograms) per ml.
- The other ingredients are sodium dihydrogen phosphate dihydrate, sodium chloride, polysorbate 20, trometamol, hydrochloric acid (6 M) (for pH adjustment) and water for injections.
What Biopoin looks like and contents of the pack
Biopoin is a solution for injection in pre-filled syringe along with an injection needle.
Biopoin 1,000 IU/0.5 ml, Biopoin 2,000 IU/0.5 ml, Biopoin 3,000 IU/0.5 ml, Biopoin 4,000 IU/0.5 ml and Biopoin 5,000 IU/0.5 ml: Each pre-filled syringe contains 0.5 ml of solution. Packs of 6 pre-filled syringes with and without safety device.
Biopoin 10,000 IU/1 ml, Biopoin 20,000 IU/1 ml and Biopoin 30,000 IU/1 ml: Each pre-filled syringe contains 1 ml of solution. Packs of 1, 4 or 6 pre-filled syringes with and without safety device.
Not all pack sizes may be marketed.
Biopoin is a clear and colourless solution.
Marketing Authorisation HolderCT Arzneimittel GmbH
Lengeder Straße 42a
D-13407 Berlin
Germany
info@ct-arzneimittel.de
Manufacturer
Merckle Biotec GmbH
Dornierstraße 10
D-89079 Ulm
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien Teva Pharma Belgium N.V.S.A. TélTel 32 3 820 73 73 LuxembourgLuxemburg Teva Pharma Belgium N.V.S.A., BelgiqueBelgien TélTel 32 3 820 73 73
Te 359 2 489 95 82 Magyarország Teva Magyarország Zrt Tel. 36 1 288 64 00
eská republika Teva Pharmaceuticals CR, s.r.o. Tel 420 251 007 111 Malta Teva .., Il-Greja el 30 210 72 79 099
Danmark Teva Denmark ApS Tlf 45 44 98 55 11 Nederland Teva Nederland B.V. Tel 31 800 0228 400
Deutschland Teva GmbH Tel 49 351 834 0 Norge Teva Sweden AB, Sverige Tlf 46 42 12 11 00
Eesti UAB Sicor Biotec Eesti filiaal Tel 372 611 2409 Österreich Teva GmbH, Deutschland Tel 49 351 834 0
Teva .. 30 210 72 79 099 Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel. 48 22 345 93 00
España Teva Pharma, S.L.U. Tél 34 91 387 32 80 Portugal Teva Pharma - Produtos Farmacêuticos Lda Tel 351 21 423 59 10
France Teva Santé SAS Tél 33 1 55 91 78 00 România Teva Pharmaceuticals S.R.L Tel 40 21 230 65 24
Ireland Teva Pharmaceuticals Ireland Tel 353 42 939 58 92 Slovenija Pliva Ljubljana d.o.o. Tel 386 1 58 90 390
Ísland Teva UK Limited, Bretland Sími 44 1323 501 111 Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel 421 2 57 26 79 11
Italia Teva Italia S.r.l. Tel 39 02 89 17 98 05 SuomiFinland Teva Sweden AB, RuotsiSverige PuhTel 46 42 12 11 00
Teva .., 30 210 72 79 099 Sverige Teva Sweden AB Tel 46 42 12 11 00
Latvija UAB Sicor Biotec filile Latvij Tel 371 677 849 80 United Kingdom Teva UK Limited Tel 44 1323 501 111
Lietuva
UAB "Sicor Biotec"
Tel: +370 5 266 0203
This leaflet was last approved in {MM/YYYY}.
INFORMATION FOR INJECTING YOURSELF
This section contains information on how to give yourself an injection of Biopoin under the skin. It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse. If you are not sure about giving yourself the injection or you have any questions, please ask your doctor or nurse for help.
How do I use Biopoin?
You will need to give yourself the injection into the tissue just under the skin. This is known as a subcutaneous injection.
Equipment that I need
To give yourself an injection into the tissue under the skin you will need:
- a pre-filled syringe of Biopoin,
- an alcohol wipe,
- a piece of gauze bandage or a sterile gauze swab,
- a puncture-proof container (plastic container provided by the hospital or pharmacy) so you can dispose of used syringes safely.
What should I do before my injection?
Biopoin is supplied in pre-filled syringes either with or without safety device. The following figures refer either to syringes without (Figures 2a, 3a, 4a) or with (Figures 2b, 3b, 4b, 9) safety device. The other figures (1, 5, 6, 7, 8) apply to both syringes. Your doctor or pharmacist can tell you which pre-filled syringe you have received.
1. Take one blister with an Biopoin pre-filled syringe out of the refrigerator.
2. Take the pre-filled syringe and the needle container out of the blister.
3. Check the expiry date on the pre-filled syringe label (EXP). Do not use it if the date has passed the last day of the month shown.
4. Check the appearance of Biopoin. It must be a clear and colourless liquid. If there are particles in it or if it is cloudy, you must not use it.
5. There is a cap at the end of the needle container. Break the labelled seal and remove the cap (see picture 1).
6. Remove the tip cap from the pre-filled syringe (see picture 2a for syringes without safety device and picture 2b for syringes with safety device).
7. Attach the needle to the syringe (see picture 3a for syringes without safety device and picture 3b for syringes with safety device). Do not remove the needle cover at this time.
8. For a more comfortable injection, let the pre-filled syringe stand for 30 minutes to reach room temperature or hold the pre-filled syringe gently in your hand for a few minutes. Do not warm Biopoin in any other way (for example, do not warm it in a microwave or in hot water).
9. Do not remove the needle cover from the syringe until you are ready to inject.
10. Wash your hands thoroughly.
11. Find a comfortable, well-lit place. Put everything you need where you can reach them (the Biopoin pre-filled syringe, an alcohol wipe, a piece of gauze bandage or a sterile gauze swab and the puncture-proof container).
2a Without safety device
2b With safety device
3a Without safety device
3b With safety device
How do I prepare my injection?
Before you give yourself an Biopoin injection, you must do the following:
1. Hold the syringe and gently remove the cover from the needle without twisting. Pull straight as shown in picture 4a for syringes without safety device and picture 4b for syringes with safety device. Do not touch the needle or push the plunger.
2. You may notice a small air bubble in the pre-filled syringe. If there are air bubbles present, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. With the syringe pointing upwards, expel all air from the syringe by pushing the plunger slowly upwards.
3. The syringe has a scale on the syringe barrel. Push the plunger up to the number (IU) on the syringe that matches the dose of Biopoin that your doctor prescribed.
4. Check again to make sure the correct dose of Biopoin is in the syringe.
5. You can now use the pre-filled syringe.
4a Without safety device
4b With safety device
Where should I give my injection?
The most suitable places to inject yourself are:
- the top of your thighs; and
- the abdomen, except for the area around the navel (see grey areas in picture 5).
If someone else is injecting you, they can also use the back of your arms (see grey areas in picture 6).
It is better to change the injection site every day to avoid the risk of soreness at any one site.
How do I give my injection?
1. Disinfect the injection site on the skin by using an alcohol wipe and pinch the skin between your thumb and forefinger, without squeezing it (see picture 7).
2. Put the needle fully into the skin as shown by your nurse or doctor. The angle between the syringe and skin should not be too narrow (? 45°, see picture 8).
3. Pull slightly on the plunger to check that a blood vessel has not been punctured. If you see blood in the syringe, remove the needle and re-insert it in another place.
4. Inject the liquid into the tissue slowly and evenly, always keeping your skin pinched.
5. Syringe without safety device: After injecting the liquid, remove the needle and let go of your skin. Syringe with safety device: Do not release the plunger fully until after the full dose has been given. The entire needle will be removed automatically from the skin and safely guarded so that you can not prick yourself (see picture 9).
6. Press the injection site with a piece of gauze bandage or a sterile gauze swab for several seconds.
7. Only use each syringe for one injection. Do not use any Biopoin that is left in the syringe.
9 With safety device
Remember
If you have any problems, please do not be afraid to ask your doctor or nurse for help and advice.
Disposing of used syringes
- Do not put the cover back on used needles.
- Put used syringes into the puncture-proof container and keep this container out of the reach and sight of children.
- Dispose of the full puncture-proof container as instructed by your doctor, nurse or pharmacist.
- Never put the syringes that you have used into your normal household rubbish bin.