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GRANOCYTE Powder and solvent for solution for injection/infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

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 ...

Qualitative and quantitative composition

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) ...

Pharmaceutical form

Powder and solvent for solution for injection/infusion. Powder and solvent for solution for injection/infusion in a pre-filled syringe. White powder. Solvent: clear, colourless solution.

Therapeutic indications

GRANOCYTE is indicated in adults, adolescents and children aged older than 2 years for: The reduction of the duration of neutropenia in patients (with non myeloid malignancy) undergoing myeloablative therapy ...

Posology and method of administration

Method of administration GRANOCYTE can be administered by sub-cutaneous injection or by intravenous infusion. Particular handling of the product or instructions for preparation are given in sections 6.6. ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. GRANOCYTE should not be used to increase the dose intensity of cytotoxic chemotherapy beyond established doses ...

Special warnings and precautions for use

Malignant Cell Growth Granulocyte colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro. The safety and efficacy of GRANOCYTE ...

Interaction with other medicinal products and other forms of interaction

In view of the sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy, the use of GRANOCYTE is not recommended from 24 hours before until 24 hours after chemotherapy ends (see section ...

Pregnancy and lactation

Pregnancy There are no adequate data from the use of lenograstim in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. GRANOCYTE ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

Undesirable effects

The safety profile in children, adolescents, and adults is comparable. In Peripheral Stem Cells or Bone Marrow Transplantation In double-blind placebo-controlled trials the mean platelet count was lower ...

Overdose

The effects of GRANOCYTE overdose have not been established (see section 5.3). Discontinuation of GRANOCYTE therapy usually results in a 50% decrease in circulating, neutrophils within 1 to 2 days, with ...

Pharmacodynamic properties

Pharmacotherapeutic group: Cytokines ATC code: L03AA10 Lenograstim (rHuG-CSF) belongs to the cytokine group of biologically active proteins which regulate cell differentiation and cell growth. Mechanism ...

Pharmacokinetic properties

Absorption and Distribution The pharmacokinetics of GRANOCYTE are dose and time dependent. During repeated dosing (IV and SC routes), peak serum concentration (immediately after IV infusion or after SC ...

Preclinical safety data

In animals, acute toxicity studies (up to 1000 µg/kg/day in mice) and sub-acute toxicity studies (up to 100 µg/kg/day in monkey) showed the effects of overdose were restricted to an exaggerated and reversible ...

List of excipients

Powder: Arginine Phenylalanine Methionine Mannitol (E421) Polysorbate 20 Diluted hydrochloric acid (for pH adjustment) Solvent: Water for injections

Incompatibilities

This medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.

Shelf life

30 months. After reconstitution or dilution, an immediate use is recommended. However, in-use stability of the reconstituted/diluted medicinal product has been demonstrated for 24 hours at 2°C-8°C (in ...

Special precautions for storage

Do not store above + 30°C. Do not freeze. For storage conditions after reconstitution/dilution of the medicinal product, see section 6.3.

Nature and contents of container

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 ...

Special precautions for disposal and other handling

Any unused product/solution or waste material should be disposed of in accordance with local requirements. In view of the possible risk of microbial contamination, pre-filled syringe with solvent is for ...

Marketing authorization holder

Chugai Pharma UK Ltd, Mulliner House, Flanders Road, Turnham Green, London W4 1NN

Marketing authorization number(s)

PL 12185/0002 PL 12185/0005 (Water for Injections in pre-filled syringe)

Date of first authorization / renewal of the authorization

November 1993

Date of revision of the text

December 2019

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