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SPC: ACCOFIL Solution for injection or infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Accofil 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe.

Qualitative and quantitative composition

Each ml of solution contains 60 million units (MU) (equivalent to 600 micrograms [μg]) of filgrastim. Each pre-filled syringe contains 30 MU (equivalent to 300 micrograms of filgrastim in 0.5 ml solution ...

Pharmaceutical form

Solution for injection or infusion. Clear, colourless solution.

Therapeutic indications

Accofil is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception ...

Posology and method of administration

Accofil therapy should only be given in collaboration with an oncology centre which has experience in granulocyte-colony stimulating factor (G-CSF) treatment and haematology and has the necessary diagnostic ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Special warnings and precautions across indications Filgrastim should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens. Filgrastim should not be administered ...

Interaction with other medicinal products and other forms of interaction

The safety and efficacy of filgrastim given on the same day as myelosuppressive cytotoxic chemotherapy have not been definitively established. In view of the sensitivity of rapidly dividing myeloid cells ...

Fertility, pregnancy and lactation

Pregnancy There are no or limited data from the use of filgrastim in pregnant women. Studies in animals have shown reproductive toxicity. An increased incidence of embryo-loss has been observed in rabbits ...

Effects on ability to drive and use machines

Accofil may have a minor influence on the ability to drive and use machines. Dizziness may occur following the administration of Accofil (see section 4.8).

Undesirable effects

Summary of the safety profile The most serious adverse reactions that may occur during Filgrastim treatment include: anaphylactic reaction, serious pulmonary adverse events (including interstitial pneumonia ...

Overdose

The effects of Accofil overdose have not been established. Discontinuation of filgrastim therapy usually results in a 50% decrease in circulating neutrophils within 1 to 2 days, with a return to normal ...

Pharmacodynamic properties

Pharmacotherapeutic group: cytokines ATC code: L03AA02 Accofil is a biosimilar medicinal product. Pharmacodynamic effects Human G-CSF is a glycoprotein which regulates the production and release of functional ...

Pharmacokinetic properties

Absorption Following subcutaneous administration of recommended doses, serum concentrations were maintained above 10 ng/ml for 8-16 hours. Distribution The volume of distribution in blood is approximately ...

Preclinical safety data

Filgrastim was studied in repeated dose toxicity studies up to 1 year in duration which revealed changes attributable to the expected pharmacological actions including increases in leukocytes, myeloid ...

List of excipients

Acetic acid glacial Sodium hydroxide Sorbitol (E420) Polysorbate 80 Water for injections

Incompatibilities

Accofil must not be diluted with saline solutions. Diluted filgrastim may be adsorbed to glass and plastic materials. This medicinal product must not be mixed with other medicinal products except those ...

Shelf life

Shelf life: 36 months. Chemical and physical in-use stability of the diluted solution for infusion has been demonstrated for 24 hours at 2°C to 8°C. From a microbiological point of view, the product should ...

Special precautions for storage

Store in a refrigerator (2°C–8°C). Do not freeze. Accidental one-time exposure to freezing temperatures does not adversely affect the stability of Accofil. If exposure has been greater than 24 hours or ...

Nature and contents of container

Pre-filled syringe with injection needle, with or without a needle safety guard. Package containing one, three, five, seven or ten pre-filled syringe (s), with or without blister and alcohol swabs. The ...

Special precautions for disposal and other handling

If required, Accofil may be diluted in 5% glucose. Dilution to a final concentration less than 0.2 MU (2 μg) per ml is not recommended at any time. The solution should be visually inspected prior to use. ...

Marketing authorization holder

Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, Spain

Marketing authorization number(s)

EU/1/14/946/001 EU/1/14/946/002 EU/1/14/946/005 EU/1/14/946/006 EU/1/14/946/007 EU/1/14/946/008 EU/1/14/946/009 EU/1/14/946/010 EU/1/14/946/017

Date of first authorization / renewal of the authorization

Date of first authorization: 18.09.2014

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