Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Chugai Pharma UK Ltd, Mulliner House, Flanders Road, Turnham Green, London W4 1NN
GRANOCYTE 13 million IU/mL, powder and solvent for solution for injection/infusion.
GRANOCYTE 13 million IU/mL, powder and solvent for solution for injection/infusion in a pre-filled syringe.
GRANOCYTE 34 million IU/mL, powder and solvent for solution for injection/infusion.
GRANOCYTE 34 million IU/mL, powder and solvent for solution for injection/infusion in a pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for injection/infusion. White powder. |
Lenograstim* (rHuG-CSF) 13.4 million International Units (equivalent to 105 micrograms) per mL after reconstitution.
Lenograstim* (rHuG-CSF) 33.6 million International Units (equivalent to 263 micrograms) per mL after reconstitution.
* Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells.
Excipients with known effect: Phenylalanine.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lenograstim |
Lenograstim belongs to the cytokine group of biologically active proteins which regulate cell differentiation and cell growth. Lenograstim induces a marked increase in peripheral blood neutrophil counts within 24 hours of administration. |
| List of Excipients |
|---|
|
Powder: Arginine Solvent: Water for injections |
105 micrograms of powder in vial (type I glass) with a rubber stopper (type I butyl rubber) + 1 mL of solvent in pre-filled syringe (type I glass) with a tip cap + 2 needles (19G and 26G); pack size of 1 or 5.
263 micrograms of powder in vial (type I glass) with a rubber stopper (type I butyl rubber) + 1 mL of solvent in pre-filled syringe (type I glass) with a tip cap + 2 needles (19G and 26G); pack size of 1 or 5.
or
105 micrograms of powder in vial (type I glass) with a rubber stopper (type I butyl rubber) + 1 mL of solvent in ampoule (type I glass); pack size of 1 or 5.
263 micrograms of powder in vial (type I glass) with a rubber stopper (type I butyl rubber) + 1 mL of solvent in ampoule (type I glass); pack size of 1 or 5.
Not all pack sizes may be marketed.
Chugai Pharma UK Ltd, Mulliner House, Flanders Road, Turnham Green, London
W4 1NN
PL 12185/0002
PL 12185/0005 (Water for Injections in pre-filled syringe)
November 1993
| Drug | Countries | |
|---|---|---|
| GRANOCYTE | Cyprus, Spain, Finland, France, Ireland, Lithuania, Malta, Singapore, Tunisia, Turkey, United Kingdom, South Africa |
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