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ARMISARTE Concentrate for solution for infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Armisarte 25 mg/ml concentrate for solution for infusion.

Qualitative and quantitative composition

One ml of concentrate contains 25 mg pemetrexed (as pemetrexed diacid). One vial of 4 ml concentrate contains 100 mg pemetrexed (as pemetrexed diacid). One vial of 20 ml concentrate contains 500 mg pemetrexed ...

Pharmaceutical form

Concentrate for solution for infusion (sterile concentrate). The concentrate is clear, colourless to slightly yellowish or yellow-greenish solution. The pH is between 7.0 and 8.0.

Therapeutic indications

Malignant pleural mesothelioma Pemetrexed in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. Non-small cell lung ...

Posology and method of administration

Posology Pemetrexed must only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy. Pemetrexed in combination with cisplatin The recommended dose of pemetrexed ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Breast-feeding (see section 4.6). Concomitant yellow fever vaccine (see section 4.5).

Special warnings and precautions for use

Pemetrexed can suppress bone marrow function as manifested by neutropenia, thrombocytopenia and anaemia (or pancytopenia) (see section 4.8). Myelosuppression is usually the dose-limiting toxicity. Patients ...

Interaction with other medicinal products and other forms of interaction

Pemetrexed is mainly eliminated unchanged renally by tubular secretion and to a lesser extent by glomerular filtration. Concomitant administration of nephrotoxic drugs (e.g. aminoglycoside, loop diuretics, ...

Fertility, pregnancy and lactation

Contraception in males and females Women of childbearing potential must use effective contraception during treatment with pemetrexed. Pemetrexed can have genetically damaging effects. Sexually mature males ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, it has been reported that pemetrexed may cause fatigue. Therefore patients should be cautioned against driving ...

Undesirable effects

Summary of the safety profile The most commonly reported undesirable effects related to pemetrexed, whether used as monotherapy or in combination, are bone marrow suppression manifested as anaemia, neutropenia, ...

Overdose

Reported symptoms of overdose include neutropenia, anaemia, thrombocytopenia, mucositis, sensory polyneuropathy and rash. Anticipated complications of overdose include bone marrow suppression as manifested ...

Pharmacodynamic properties

Pharmacotherapeutic group: antineoplastic agents, folic acid analogues ATC code: L01BA04 Pemetrexed is a multi-targeted anti-cancer antifolate agent that exerts its action by disrupting crucial folate-dependent ...

Pharmacokinetic properties

The pharmacokinetic properties of pemetrexed following single-agent administration have been evaluated in 426 cancer patients with a variety of solid tumours at doses ranging from 0.2 to 838 mg/m² infused ...

Preclinical safety data

Administration of pemetrexed to pregnant mice resulted in decreased foetal viability, decreased foetal weight, incomplete ossification of some skeletal structures and cleft palate. Administration of pemetrexed ...

List of excipients

Trometamol (for pH adjustment) Anhydrous citric acid Methionine Water for injections

Incompatibilities

Pemetrexed is physically incompatible with diluents containing calcium, including lactated Ringers injection and Ringers injection. In the absence of other compatibility studies this medicinal product ...

Shelf life

Unopened vial: 18 months. Diluted solution: Chemical and physical in-use stability of infusion solution of pemetrexed was demonstrated for 3 days at room temperature and 21 days at refrigerated temperature. ...

Special precautions for storage

Store and transport refrigerated (2°C to 8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light. For storage conditions after dilution of the medicinal product, see section ...

Nature and contents of container

Colourless glass vial (type I) with type I rubber (bromobutyl) serum stopper and an aluminium cap with polypropylene disk. Vials may or may not be sheathed in a protective sleeve. Pack sizes: 1 4 ml vial ...

Special precautions for disposal and other handling

Use aseptic technique during dilution of pemetrexed for intravenous infusion administration. Calculate the dose and the number of Armisarte vials needed. Armisarte must only be diluted with 5% glucose ...

Marketing authorization holder

Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland

Marketing authorization number(s)

EU/1/15/1063/001 EU/1/15/1063/002 EU/1/15/1063/003 EU/1/15/1063/004

Date of first authorization / renewal of the authorization

Date of first authorisation: 18 January 2016

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