What Abseamed contains
- The active substance is epoetin alfa. Abseamed 1,000 IU/0.5 ml solution for injection in a pre-filled syringe: one pre-filled syringe of 0.5 ml solution for injection contains 1,000 international units (IU) corresponding to 8.4 micrograms epoetin alfa Abseamed 2,000 IU/1 ml solution for injection in a pre-filled syringe: one pre-filled syringe of 1 ml solution for injection contains 2,000 international units (IU) corresponding to 16.8 micrograms epoetin alfa Abseamed 3,000 IU/0.3 ml solution for injection in a pre-filled syringe: one pre-filled syringe of 0.3 ml solution for injection contains 3,000 international units (IU) corresponding to 25.2 micrograms epoetin alfa Abseamed 4,000 IU/0.4 ml solution for injection in a pre-filled syringe: one pre-filled syringe of 0.4 ml solution for injection contains 4,000 international units (IU) corresponding to 33.6 micrograms epoetin alfa Abseamed 5,000 IU/0.5 ml solution for injection in a pre-filled syringe: one pre-filled syringe of 0.5 ml solution for injection contains 5,000 international units (IU) corresponding to 42.0 micrograms epoetin alfa Abseamed 6,000 IU/0.6 ml solution for injection in a pre-filled syringe: one pre-filled syringe of 0.6 ml solution for injection contains 6,000 international units (IU) corresponding to 50.4 micrograms epoetin alfa Abseamed 7,000 IU/0.7 ml solution for injection in a pre-filled syringe: one pre-filled syringe of 0.7 ml solution for injection contains 7,000 international units (IU) corresponding to 58.8 micrograms epoetin alfa Abseamed 8,000 IU/0.8 ml solution for injection in a pre-filled syringe: one pre-filled syringe of 0.8 ml solution for injection contains 8,000 international units (IU) corresponding to 67.2 micrograms epoetin alfa Abseamed 9,000 IU/0.9 ml solution for injection in a pre-filled syringe: one pre-filled syringe of 0.9 ml solution for injection contains 9,000 international units (IU) corresponding to 75.6 micrograms epoetin alfa Abseamed 10,000 IU/1 ml solution for injection in a pre-filled syringe: one pre-filled syringe of 1 ml solution for injection contains 10,000 international units (IU) corresponding to 84.0 micrograms epoetin alfa Abseamed 20,000 IU/0.5 ml solution for injection in a pre-filled syringe: one pre-filled syringe of 0.5 ml solution for injection contains 20,000 international units (IU) corresponding to 168.0 micrograms epoetin alfa Abseamed 30,000 IU/0.75 ml solution for injection in a pre-filled syringe: one pre-filled syringe of 0.75 ml solution for injection contains 30,000 international units (IU) corresponding to 252.0 micrograms epoetin alfa Abseamed 40,000 IU/1 ml solution for injection in a pre-filled syringe: one pre-filled syringe of 1 ml solution for injection contains 40,000 international units (IU) corresponding to 336.0 micrograms epoetin alfa
- The other ingredients are sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, glycine, polysorbate 80, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment), and water for injections.
What Abseamed looks like and contents of the pack
Abseamed is presented as a clear, colourless solution for injection in a pre-filled syringe. The syringes are sealed in a blister.
Abseamed 1,000 IU/0.5 ml solution for injection in a pre-filled syringe
The syringes contain 0.5 ml (1,000 IU) of solution.
Abseamed 2,000 IU/1 ml solution for injection in a pre-filled syringe
The syringes contain 1 ml (2,000 IU) of solution.
Abseamed 3,000 IU/0.3 ml solution for injection in a pre-filled syringe
The syringes contain 0.3 ml (3,000 IU) of solution.
Abseamed 4,000 IU/0.4 ml solution for injection in a pre-filled syringe
The syringes contain 0.4 ml (4,000 IU) of solution.
Abseamed 5,000 IU/0.5 ml solution for injection in a pre-filled syringe
The syringes contain 0.5 ml (5,000 IU) of solution.
Abseamed 6,000 IU/0.6 ml solution for injection in a pre-filled syringe
The syringes contain 0.6 ml (6,000 IU) of solution.
Abseamed 7,000 IU/0.7 ml solution for injection in a pre-filled syringe
The syringes contain 0.7 ml (7,000 IU) of solution.
Abseamed 8,000 IU/0.8 ml solution for injection in a pre-filled syringe
The syringes contain 0.8 ml (8,000 IU) of solution.
Abseamed 9,000 IU/0.9 ml solution for injection in a pre-filled syringe
The syringes contain 0.9 ml (9,000 IU) of solution.
Abseamed 10,000 IU/1 ml solution for injection in a pre-filled syringe
The syringes contain 1 ml (10,000 IU) of solution.
Abseamed 20,000 IU/0.5 ml solution for injection in a pre-filled syringe
The syringes contain 0.5 ml (20,000 IU) of solution.
Abseamed 30,000 IU/0.75 ml solution for injection in a pre-filled syringe
The syringes contain 0.75 ml (30,000 IU) of solution.
Abseamed 40,000 IU/1 ml solution for injection in a pre-filled syringe
The syringes contain 1 ml (40,000 IU) of solution.
Pack size of 1 or 6 pre-filled syringe(s) with or without a needle safety guard. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Medice Arzneimittel Pütter GmbH & Co KG
Kuhloweg 37
D-58638 Iserlohn
Germany
Manufacturer
Sandoz GmbH
Biochemiestr. 10
A-6250 Kundl
Austria
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien Eurocept B.V. TélTel 31-035 5288377 LuxembourgLuxemburg Medice Arzneimittel Pütter GmbH Co. KG TélTel 49-02371 937 0
Medice Arzneimittel Pütter GmbH Co. KG Te. 49-02371 937 0 Magyarország Medice Arzneimittel Pütter GmbH Co. KG Tel 36-01 3187160
eská republika Medice Arzneimittel Pütter GmbH Co. KG Tel 420-02 44403003 Malta Medice Arzneimittel Pütter GmbH Co. KG Tel 49-02371 937 0
Danmark Medice Arzneimittel Pütter GmbH Co. KG Tlf 49-02371 937 0 Nederland Eurocept B.V. Tel 31-035 5288377
Deutschland Medice Arzneimittel Pütter GmbH Co. KG Tel 49-02371 937 0 Norge Medice Arzneimittel Pütter GmbH Co. KG Tlf 49-02371 937 0
Eesti Medice Arzneimittel Pütter GmbH Co. KG Tel 49-02371 937 0 Österreich Medice Arzneimittel GmbH Tel 43-0800 29 5193
MEDICE HELLAS .. 30-0210 620 4257 Polska Medice Arzneimittel Pütter GmbH Co. KG Tel. 48-022 642 2673
España Medice Arzneimittel Pütter GmbH Co. KG Tel 49-02371 937 0 Portugal Medice Arzneimittel Pütter GmbH Co. KG Tel 49-02371 937 0
France Medice Arzneimittel Pütter GmbH Co. KG Tel 49-02371 937 0 România Medice Arzneimittel Pütter GmbH Co. KG Tel 49-02371 937 0
Ireland Medice Arzneimittel Pütter GmbH Co. KG Tel 49-02371 937 0 Slovenija Medice Arzneimittel Pütter GmbH Co. KG Tel 49-02371 937 0
Ísland Medice Arzneimittel Pütter GmbH Co. KG Sími 49-02371 937 0 Slovenská republika Medice Arzneimittel Pütter GmbH Co. KG Tel 420-02 44403003
Italia FIDIA Farmaceutici S.p.A. Tel 39-049 823 2111 SuomiFinland Medice Arzneimittel Pütter GmbH Co. KG PuhTel 49-02371 937 0
MEDICE HELLAS .. 30-0210 620 4257 Sverige Medice Arzneimittel Pütter GmbH Co. KG Tel 49-02371 937 0
Latvija Medice Arzneimittel Pütter GmbH Co. KG Tel 49-02371 937 0 United Kingdom Medice Arzneimittel Pütter GmbH Co. KG Tel 49-02371 937 0
Lietuva
Medice Arzneimittel Pütter GmbH & Co. KG
Tel: + 49-(0)2371 937 0
This leaflet was last approved in {MM/YYYY}.
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Instructions on how to inject yourself (for patients receiving chemotherapy, adult patients donating their own blood before surgery or adult patients scheduled for orthopaedic surgery only)
This section contains information on how to give yourself an injection of Abseamed. It is important that you do not try to give yourself the injection unless you have received special training from your doctor or nurse. Abseamed is provided with or without a needle safety guard and you will be shown how to use this by your doctor or nurse. If you are not sure about giving the injection or you have any questions, please ask your doctor or nurse for help.
1. Wash your hands. 2. Remove one syringe from the pack and remove the protective cap from the injection needle. Syringes are embossed with graduation rings in order to enable partial use if required. Each graduation ring corresponds to a volume of 0.1 ml. If partial use of a syringe is required, remove unwanted solution before injection. 3. Clean the skin at the injection site using an alcohol wipe. 4. Form a skin fold by pinching the skin between thumb and forefinger. 5. Insert the needle into the skin fold with a quick, firm action. Inject the Abseamed solution as you have been shown by your doctor. You should check with your doctor or pharmacist if you are not sure. Pre-filled syringe without needle safety guard 6. Always keeping your skin pinched, depress the plunger slowly and evenly. 7. After injecting the liquid, remove the needle and let go of your skin. Apply pressure over the injection site with a dry, sterile pad. 8. Discard any unused product or waste material. Only use each syringe for one injection.
Pre-filled syringe with needle safety guard
6. Always keeping your skin pinched, depress the plunger slowly and evenly until the entire dose has been given and the plunger cannot be depressed any further. Do not release the pressure on the plunger 7. After injecting the liquid, remove the needle while maintaining pressure on the plunger and then let go of your skin. Apply pressure over the injection site with a dry, sterile pad. 8. Let go of the plunger. The needle safety guard will rapidly move to cover the needle. 9. Discard any unused product or waste material. Only use each syringe for one injection.