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SPC, UK: METHOTREXATE Solution for Injection (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Methotrexate 2.5 mg/ml Injection.

Qualitative and quantitative composition

Each ml of solution contains 2.5 mg methotrexate (sodium salt formed in situ). Each vial of 2 ml of solution contains 5 mg methotrexate (sodium salt formed in situ). For excipients, see 6.1.

Pharmaceutical form

Solution for Injection. Vials containing a clear yellow solution.

Therapeutic indications

Methotrexate is indicated in the treatment of neoplastic disease, such as trophoblastic neoplasms and leukaemia, and the symptomatic treatment of severe recalcitrant disabling psoriasis which is not adequately ...

Posology and method of administration

Important warning about the dosage of Methotrexate: In the treatment of psoriasis, Methotrexate must only be taken once a week. Dosage errors in the use of Methotrexate can result in serious adverse reactions, ...

Contraindications

Methotrexate is contraindicated in: Patients with significantly impaired renal function (creatinine clearance less than 30 ml/min) for methotrexate doses <100 mg/m², and moderate renal impairment (creatinine ...

Special warnings and precautions for use

Warnings Methotrexate must be used only by physicians experienced in antimetabolite chemotherapy. Because of the possibility of fatal or severe toxic reactions, the patient should be fully informed by ...

Interaction with other medicinal products and other forms of interaction

Methotrexate is extensively protein bound and may be displaced by certain drugs such as salicylates, hypoglycaemics, diuretics, sulphonamides, diphenylhydantoins, tetracyclines, chloramphenicol and p-aminobenzoic ...

Fertility, pregnancy and breast-feeding

Fertility Methotrexate affects spermatogenesis and oogenesis and may decrease fertility. Methotrexate has been reported to cause oligospermia, menstrual dysfunction and amenorrhoea in humans. These effects ...

Effects on ability to drive and use machines

Not applicable.

Undesirable effects

The most common adverse reactions include ulcerative stomatitis, leukopenia, nausea and abdominal distress. Although very rare, anaphylactic reactions to methotrexate have occurred. Others reported are ...

Overdose

Cases of overdose have been reported, sometimes fatal, due to erroneous daily intake instead of weekly intake of oral methotrexate in these cases, symptoms that have been commonly reported are hematological ...

Pharmacodynamic properties

Methotrexate is an antimetabolite which acts principally by competitively inhibiting the enzyme, dihydrofolate reductase. In the process of DNA synthesis and cellular replication, folic acid must be reduced ...

Pharmacokinetic properties

In doses of 0.1 mg (of methotrexate) per kg, methotrexate is completely absorbed from the gastrointestinal tract; larger oral doses may be incompletely absorbed. Peak serum concentrations are achieved ...

List of excipients

Sodium chloride Sodium hydroxide Water for Injections

Incompatibilities

Immediate precipitation or turbidity results when combined with certain concentrations of droperidol, heparin sodium, metoclopramide hydrochloride, ranitidine hydrochloride in syringe.

Shelf life

Shelf life As packaged for sale: 18 months After dilution: Chemical and physical in-use stability has been demonstrated in dextrose 5% and sodium chloride 0.9% infusion solutions for 30 days at 4°C in ...

Special precautions for storage

As packaged for sale: Do not store above 25°C. Do not freeze. Keep container in the outer carton. After dilution: see 6.3.

Nature and contents of container

5 mg/2 ml: Conventional or Onco-Tain Type I glass vial with rubber stopper, aluminium seal and plastic flip-off top. Packs containing 5 vials. Not all presentations and pack sizes listed above may be marketed. ...

Special precautions for disposal and other handling

Single use only. Discard any unused contents.

Marketing authorization holder

Hospira UK Limited, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, UK

Marketing authorization number(s)

PL 04515/0013

Date of first authorization / renewal of the authorization

21<sup>st</sup> March 2003

Date of revision of the text

01/2019

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