Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe.
Retacrit 2 000 IU/0.6 ml solution for injection in pre-filled syringe.
Retacrit 3 000 IU/0.9 ml solution for injection in pre-filled syringe.
Retacrit 4 000 IU/0.4 ml solution for injection in pre-filled syringe.
Retacrit 5 000 IU/0.5 ml solution for injection in pre-filled syringe.
Retacrit 6 000 IU/0.6 ml solution for injection in pre-filled syringe.
Retacrit 8 000 IU/0.8 ml solution for injection in pre-filled syringe.
Retacrit 10 000 IU/1 ml solution for injection in pre-filled syringe.
Retacrit 20 000 IU/0.5 ml solution for injection in pre-filled syringe.
Retacrit 30 000 IU/0.75 ml solution for injection in pre-filled syringe.
Retacrit 40 000 IU/1 ml solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection in pre-filled syringe (injection). Clear, colourless solution. |
Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe: 1 pre-filled syringe with 0.3 ml solution for injection contains 1 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 3 333 IU epoetin zeta per ml.
Excipients with known effect: Each pre-filled syringe contains 0.15 mg phenylalanine.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free’.
Retacrit 2 000 IU/0.6 ml solution for injection in pre-filled syringe: 1 pre-filled syringe with 0.6 ml solution for injection contains 2 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 3 333 IU epoetin zeta per ml.
Excipients with known effect: Each pre-filled syringe contains 0.30 mg phenylalanine.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free’.
Retacrit 3 000 IU/0.9 ml solution for injection in pre-filled syringe: 1 pre-filled syringe with 0.9 ml solution for injection contains 3 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 3 333 IU epoetin zeta per ml.
Excipients with known effect: Each pre-filled syringe contains 0.45 mg phenylalanine.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free’.
Retacrit 4 000 IU/0.4 ml solution for injection in pre-filled syringe: 1 pre-filled syringe with 0.4 ml solution for injection contains 4 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 10 000 IU epoetin zeta per ml.
Excipients with known effect: Each pre-filled syringe contains 0.20 mg phenylalanine.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free’.
Retacrit 5 000 IU/0.5 ml solution for injection in pre-filled syringe: 1 pre-filled syringe with 0.5 ml solution for injection contains 5 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 10 000 IU epoetin zeta per ml.
Excipients with known effect: Each pre-filled syringe contains 0.25 mg phenylalanine.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free’.
Retacrit 6 000 IU/0.6 ml solution for injection in pre-filled syringe: 1 pre-filled syringe with 0.6 ml solution for injection contains 6 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 10 000 IU epoetin zeta per ml.
Excipients with known effect: Each pre-filled syringe contains 0.30 mg phenylalanine.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free’.
Retacrit 8 000 IU/0.8 ml solution for injection in pre-filled syringe: 1 pre-filled syringe with 0.8 ml solution for injection contains 8 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 10 000 IU epoetin zeta per ml.
Excipients with known effect: Each pre-filled syringe contains 0.40 mg phenylalanine.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free’.
Retacrit 10 000 IU/1 ml solution for injection in pre-filled syringe: 1 pre-filled syringe with 1.0 ml solution for injection contains 10 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 10 000 IU epoetin zeta per ml.
Excipients with known effect: Each pre-filled syringe contains 0.50 mg phenylalanine.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free’.
Retacrit 20 000 IU/0.5 ml solution for injection in pre-filled syringe: 1 pre-filled syringe with 0.5 ml solution for injection contains 20 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 40 000 IU epoetin zeta per ml.
Excipients with known effect: Each pre-filled syringe contains 0.25 mg phenylalanine.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free’.
Retacrit 30 000 IU/0.75 ml solution for injection in pre-filled syringe: 1 pre-filled syringe with 0.75 ml solution for injection contains 30 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 40 000 IU epoetin zeta per ml.
Excipients with known effect: Each pre-filled syringe contains 0.38 mg phenylalanine.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free’.
Retacrit 40 000 IU/1 ml solution for injection in pre-filled syringe: 1 pre-filled syringe with 1 ml solution for injection contains 40 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). The solution contains 40 000 IU epoetin zeta per ml.
Excipient with known effect: Each pre-filled syringe contains 0.50 mg phenylalanine.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium free’.
* Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Epoetin zeta |
Epoetin zeta is a recombinant human erythropoietin. Erythropoietin (EPO) is a glycoprotein hormone produced primarily by the kidney in response to hypoxia and is the key regulator of red blood cell (RBC) production. The 2 are indistinguishable on the basis of functional assays. |
| List of Excipients |
|---|
|
Disodium phosphate dihydrate |
Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe:
Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device.
Each pre-filled syringe contains 0.3 ml solution.
Each pack contains 1 or 6 pre-filled syringes.
Retacrit 2 000 IU/0.6 ml solution for injection in pre-filled syringe:
Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device.
Each pre-filled syringe contains 0.6 ml solution.
Each pack contains 1 or 6 pre-filled syringes.
Retacrit 3 000 IU/0.9 ml solution for injection in pre-filled syringe:
Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device.
Each pre-filled syringe contains 0.9 ml solution.
Each pack contains 1 or 6 pre-filled syringes.
Retacrit 4 000 IU/0.4 ml solution for injection in pre-filled syringe:
Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device.
Each pre-filled syringe contains 0.4 ml solution.
Each pack contains 1 or 6 pre-filled syringes.
Retacrit 5 000 IU/0.5 ml solution for injection in pre-filled syringe:
Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device.
Each pre-filled syringe contains 0.5 ml solution.
Each pack contains 1 or 6 pre-filled syringes.
Retacrit 6 000 IU/0.6 ml solution for injection in pre-filled syringe:
Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device.
Each pre-filled syringe contains 0.6 ml solution.
Each pack contains 1 or 6 pre-filled syringes.
Retacrit 8 000 IU/0.8 ml solution for injection in pre-filled syringe:
Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device.
Each pre-filled syringe contains 0.8 ml solution.
Each pack contains 1 or 6 pre-filled syringes.
Retacrit 10 000 IU/1 ml solution for injection in pre-filled syringe:
Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device.
Each pre-filled syringe contains 1 ml solution.
Each pack contains 1 or 6 pre-filled syringes.
Retacrit 20 000 IU/0.5 ml solution for injection in pre-filled syringe:
Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device.
Each pre-filled syringe contains 0.5 ml solution.
Each pack contains 1, 4 or 6 pre-filled syringes.
Multipacks contain 6 (6 × 1) pre-filled syringes.
Retacrit 30 000 IU/0.75 ml solution for injection in pre-filled syringe:
Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device.
Each pre-filled syringe contains 0.75 ml solution.
Each pack contains 1, 4 or 6 pre-filled syringes.
Multipacks contain 4 (4 × 1) pre-filled syringes.
Retacrit 40 000 IU/1 ml solution for injection in pre-filled syringe:
Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device.
Each pre-filled syringe contains 1 ml solution.
Each pack contains 1, 4 or 6 pre-filled syringes.
Multipacks contain 4 (4 × 1) pre-filled syringes.
Not all pack sizes may be marketed.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe:
EU/1/07/431/001 1 pre-filled syringe
EU/1/07/431/002 6 pre-filled syringes
EU/1/07/431/026 1 pre-filled syringe with needle guard
EU/1/07/431/027 6 pre-filled syringes with needle guard
EU/1/07/431/054 1 pre-filled syringe with needle-trap
EU/1/07/431/055 6 pre-filled syringes with needle-trap
Retacrit 2 000 IU/0.6 ml solution for injection in pre-filled syringe:
EU/1/07/431/003 1 pre-filled syringe
EU/1/07/431/004 6 pre-filled syringes
EU/1/07/431/028 1 pre-filled syringe with needle guard
EU/1/07/431/029 6 pre-filled syringes with needle guard
EU/1/07/431/056 1 pre-filled syringe with needle-trap
EU/1/07/431/057 6 pre-filled syringes with needle-trap
Retacrit 3 000 IU/0.9 ml solution for injection in pre-filled syringe:
EU/1/07/431/005 1 pre-filled syringe
EU/1/07/431/006 6 pre-filled syringes
EU/1/07/431/030 1 pre-filled syringe with needle guard
EU/1/07/431/031 6 pre-filled syringes with needle guard
EU/1/07/431/058 1 pre-filled syringe with needle-trap
EU/1/07/431/059 6 pre-filled syringes with needle-trap
Retacrit 4 000 IU/0.4 ml solution for injection in pre-filled syringe:
EU/1/07/431/007 1 pre-filled syringe
EU/1/07/431/008 6 pre-filled syringes
EU/1/07/431/032 1 pre-filled syringe with needle guard
EU/1/07/431/033 6 pre-filled syringes with needle guard
EU/1/07/431/060 1 pre-filled syringe with needle-trap
EU/1/07/431/061 6 pre-filled syringes with needle-trap
Retacrit 5 000 IU/0.5 ml solution for injection in pre-filled syringe:
EU/1/07/431/009 1 pre-filled syringe
EU/1/07/431/010 6 pre-filled syringes
EU/1/07/431/034 1 pre-filled syringe with needle guard
EU/1/07/431/035 6 pre-filled syringes with needle guard
EU/1/07/431/062 1 pre-filled syringe with needle-trap
EU/1/07/431/063 6 pre-filled syringes with needle-trap
Retacrit 6 000 IU/0.6 ml solution for injection in pre-filled syringe:
EU/1/07/431/011 1 pre-filled syringe
EU/1/07/431/012 6 pre-filled syringes
EU/1/07/431/036 1 pre-filled syringe with needle guard
EU/1/07/431/037 6 pre-filled syringes with needle guard
EU/1/07/431/064 1 pre-filled syringe with needle-trap
EU/1/07/431/065 6 pre-filled syringes with needle-trap
Retacrit 8 000 IU/0.8 ml solution for injection in pre-filled syringe:
EU/1/07/431/013 1 pre-filled syringe
EU/1/07/431/014 6 pre-filled syringes
EU/1/07/431/038 1 pre-filled syringe with needle guard
EU/1/07/431/039 6 pre-filled syringes with needle guard
EU/1/07/431/066 1 pre-filled syringe with needle-trap
EU/1/07/431/067 6 pre-filled syringes with needle-trap
Retacrit 10 000 IU/1 ml solution for injection in pre-filled syringe:
EU/1/07/431/015 1 pre-filled syringe
EU/1/07/431/016 6 pre-filled syringes
EU/1/07/431/040 1 pre-filled syringe with needle guard
EU/1/07/431/041 6 pre-filled syringes with needle guard
EU/1/07/431/068 1 pre-filled syringe with needle-trap
EU/1/07/431/069 6 pre-filled syringes with needle-trap
Retacrit 20 000 IU/0.5 ml solution for injection in pre-filled syringe:
EU/1/07/431/017 1 pre-filled syringe
EU/1/07/431/020 4 pre-filled syringes
EU/1/07/431/021 6 pre-filled syringes
EU/1/07/431/042 1 pre-filled syringe with needle guard
EU/1/07/431/045 4 pre-filled syringes with needle guard
EU/1/07/431/046 6 pre-filled syringes with needle guard
EU/1/07/431/051 6 (6 × 1) pre-filled syringes (multipack)
EU/1/07/431/070 1 pre-filled syringe with needle-trap
EU/1/07/431/071 4 pre-filled syringes with needle-trap
EU/1/07/431/072 6 pre-filled syringes with needle-trap
Retacrit 30 000 IU/0.75 ml solution for injection in pre-filled syringe:
EU/1/07/431/018 1 pre-filled syringe
EU/1/07/431/022 4 pre-filled syringes
EU/1/07/431/023 6 pre-filled syringes
EU/1/07/431/043 1 pre-filled syringe with needle guard
EU/1/07/431/047 4 pre-filled syringes with needle guard
EU/1/07/431/048 6 pre-filled syringes with needle guard
EU/1/07/431/052 4 (4 × 1) pre-filled syringes (multipack)
EU/1/07/431/073 1 pre-filled syringe with needle-trap
EU/1/07/431/074 4 pre-filled syringes with needle-trap
EU/1/07/431/075 6 pre-filled syringes with needle-trap
Retacrit 40 000 IU/1 ml solution for injection in pre-filled syringe:
EU/1/07/431/019 1 pre-filled syringe
EU/1/07/431/024 4 pre-filled syringes
EU/1/07/431/025 6 pre-filled syringes
EU/1/07/431/044 1 pre-filled syringe with needle guard
EU/1/07/431/049 4 pre-filled syringes with needle guard
EU/1/07/431/050 6 pre-filled syringes with needle guard
EU/1/07/431/053 4 (4 × 1) pre-filled syringes (multipack)
EU/1/07/431/076 1 pre-filled syringe with needle-trap
EU/1/07/431/077 4 pre-filled syringes with needle-trap
EU/1/07/431/078 6 pre-filled syringes with needle-trap
Date of first authorisation: 18 December 2007
Date of latest renewal: 15 November 2012
| Drug | Countries | |
|---|---|---|
| RETACRIT | Austria, Cyprus, Germany, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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