Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: TEVA GmbH, Graf-Arco-Straße 3, 89079 Ulm, Germany
Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe.
Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe.
Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe.
Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe.
Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe.
Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe.
Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe.
Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). The solution is clear and colourless. |
Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe:
One pre-filled syringe contains 1,000 international units (IU) (8.3 µg) epoetin theta in 0.5 ml solution for injection corresponding to 2,000 IU (16.7 µg) epoetin theta per ml.
Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe:
One pre-filled syringe contains 2,000 international units (IU) (16.7 µg) epoetin theta in 0.5 ml solution for injection corresponding to 4,000 IU (33.3 µg) epoetin theta per ml.
Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe:
One pre-filled syringe contains 3,000 international units (IU) (25 µg) epoetin theta in 0.5 ml solution for injection corresponding to 6,000 IU (50 µg) epoetin theta per ml.
Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe:
One pre-filled syringe contains 4,000 international units (IU) (33.3 µg) epoetin theta in 0.5 ml solution for injection corresponding to 8,000 IU (66.7 µg) epoetin theta per ml.
Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe:
One pre-filled syringe contains 5,000 international units (IU) (41.7 µg) epoetin theta in 0.5 ml solution for injection corresponding to 10,000 IU (83.3 µg) epoetin theta per ml.
Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe:
One pre-filled syringe contains 10,000 international units (IU) (83.3 µg) epoetin theta in 1 ml solution for injection corresponding to 10,000 IU (83.3 µg) epoetin theta per ml.
Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe:
One pre-filled syringe contains 20,000 international units (IU) (166.7 µg) epoetin theta in 1 ml solution for injection corresponding to 20,000 IU (166.7 µg) epoetin theta per ml.
Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe:
One pre-filled syringe contains 30,000 international units (IU) (250 µg) epoetin theta in 1 ml solution for injection corresponding to 30,000 IU (250 µg) epoetin theta per ml.
Epoetin theta (recombinant human erythropoietin) is produced in Chinese Hamster Ovary Cells (CHO-K1) by recombinant DNA technology.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Epoetin theta |
Epoetin theta is identical in its amino acid sequence and similar in its carbohydrate composition (glycosylation) to endogenous human erythropoietin. After administration of epoetin theta, the number of erythrocytes, the haematocrit values and reticulocyte counts increase. |
| List of Excipients |
|---|
|
Sodium dihydrogen phosphate dihydrate |
Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe:
0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Pack sizes of 6 pre-filled syringes, 6 pre-filled syringes with safety needle or 6 pre-filled syringes with safety device.
Not all pack sizes may be marketed.
Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe:
0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Pack sizes of 6 pre-filled syringes; 6 pre-filled syringes with safety needle or 6 pre-filled syringes with safety device.
Not all pack sizes may be marketed.
Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe:
0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Pack sizes of 6 pre-filled syringes; 6 pre-filled syringes with safety needle or 6 pre-filled syringes with safety device.
Not all pack sizes may be marketed.
Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe:
0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Pack sizes of 6 pre-filled syringes; 6 pre-filled syringes with safety needle or 6 pre-filled syringes with safety device.
Not all pack sizes may be marketed.
Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe:
0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Pack sizes of 6 pre-filled syringes; 6 pre-filled syringes with safety needle or 6 pre-filled syringes with safety device.
Not all pack sizes may be marketed.
Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe:
1 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Pack sizes of 1, 4 and 6 pre-filled syringes; 1, 4 and 6 pre-filled syringes with safety needle or 1, 4 and 6 pre-filled syringes with safety device.
Not all pack sizes may be marketed.
Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe:
1 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Pack sizes of 1, 4 and 6 pre-filled syringes; 1, 4 and 6 pre-filled syringes with safety needle or 1, 4 and 6 pre-filled syringes with safety device.
Not all pack sizes may be marketed.
Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe:
1 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Pack sizes of 1, 4 and 6 pre-filled syringes; 1, 4 and 6 pre-filled syringes with safety needle or 1, 4 and 6 pre-filled syringes with safety device.
Not all pack sizes may be marketed.
TEVA GmbH, Graf-Arco-Straße 3, 89079 Ulm, Germany
Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe:
EU/1/09/565/001
EU/1/09/565/002
EU/1/09/565/029
Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe:
EU/1/09/565/003
EU/1/09/565/004
EU/1/09/565/030
Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe:
EU/1/09/565/005
EU/1/09/565/006
EU/1/09/565/031
Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe:
EU/1/09/565/007
EU/1/09/565/008
EU/1/09/565/032
Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe:
EU/1/09/565/009
EU/1/09/565/010
EU/1/09/565/033
Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe:
EU/1/09/565/011
EU/1/09/565/012
EU/1/09/565/013
EU/1/09/565/014
EU/1/09/565/015
EU/1/09/565/016
EU/1/09/565/034
EU/1/09/565/035
EU/1/09/565/036
Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe:
EU/1/09/565/017
EU/1/09/565/018
EU/1/09/565/019
EU/1/09/565/020
EU/1/09/565/021
EU/1/09/565/022
EU/1/09/565/037
EU/1/09/565/038
EU/1/09/565/039
Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe:
EU/1/09/565/023
EU/1/09/565/024
EU/1/09/565/025
EU/1/09/565/026
EU/1/09/565/027
EU/1/09/565/028
EU/1/09/565/040
EU/1/09/565/041
EU/1/09/565/042
Date of first authorisation: 23 October 2009
Date of latest renewal: 26 August 2014
| Drug | Countries | |
|---|---|---|
| BIOPOIN | Austria, Estonia, Croatia, Ireland, Lithuania, Poland |
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