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SPC, UK: METOJECT PEN Solution for injection in pre-filled pen (2018)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα

Name of the medicinal product

Metoject PEN 7.5 mg solution for injection in pre-filled pen. Metoject PEN 10 mg solution for injection in pre-filled pen. Metoject PEN 12.5 mg solution for injection in pre-filled pen. Metoject PEN 15 ...

Qualitative and quantitative composition

1 pre-filled pen with 0.15 ml solution contains 7.5 mg methotrexate. 1 pre-filled pen with 0.20 ml solution contains 10 mg methotrexate. 1 pre-filled pen with 0.25 ml solution contains 12.5 mg methotrexate. ...

Pharmaceutical form

Solution for injection in pre-filled pen. Clear, yellow-brown solution.

Therapeutic indications

Metoject PEN is indicated for the treatment of: active rheumatoid arthritis in adult patients, polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to nonsteroidal anti-inflammatory ...

Posology and method of administration

Metoject PEN should only be prescribed by physicians who are familiar with the various characteristics of the medicinal product and its mode of action. Patients must be educated to use the proper injection ...

Contraindications

Metoject PEN is contraindicated in the case of: hypersensitivity to the active substance or to any of the excipients listed in section 6.1, severe liver impairment (see section 4.2), alcohol abuse, severe ...

Special warnings and precautions for use

Patients must be clearly informed that the therapy has to be administered once a week, not every day. Patients undergoing therapy should be subject to appropriate supervision so that signs of possible ...

Interaction with other medicinal products and other forms of interaction

Nitrous oxide The use of nitrous oxide potentiates the effect of methotrexate on folate, yielding increased toxicity such as severe unpredictable myelosuppression and stomatitis. Whilst this effect can ...

Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in females Women must not get pregnant during methotrexate therapy, and effective contraception must be used during treatment with methotrexate and at least ...

Effects on ability to drive and use machines

Metoject PEN has minor or moderate influence on the ability to drive and use machines. Central nervous system symptoms such as tiredness and dizziness can occur during treatment.

Undesirable effects

Summary of the safety profile Most serious adverse reactions of methotrexate include bone marrow suppression, pulmonary toxicity, hepatotoxicity, renal toxicity, neurotoxicity, thromboembolic events, anaphylactic ...

Overdose

Symptoms of overdose Toxicity of methotrexate mainly affects the haematopoietic system. Treatment measures in the case of overdose Calcium folinate is the specific antidote for neutralising the toxic undesirable ...

Pharmacodynamic properties

Pharmacotherapeutic group: Folic acid analogues ATC code: L01BA01 Antirheumatic medicinal product for the treatment of chronic, inflammatory rheumatic diseases and polyarthritic forms of juvenile idiopathic ...

Pharmacokinetic properties

Absorption Following oral administration, methotrexate is absorbed from the gastrointestinal tract. In case of low-dosed administration (doses between 7.5 mg/m² and 80 mg/m² body surface area), the mean ...

Preclinical safety data

Animal studies show that methotrexate impairs fertility, is embryo- and foetotoxic and teratogenic. Methotrexate is mutagenic in vivo and in vitro. As conventional carcinogenicity studies have not been ...

List of excipients

Sodium chloride Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life: 2 years.

Special precautions for storage

Store below 25°C. Keep the pre-filled pens in the outer carton in order to protect from light.

Nature and contents of container

Pre-filled pens containing a colourless pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and embedded injection needle. The syringe is externally equipped with the device for self-administration ...

Special precautions for disposal and other handling

The manner of handling and disposal must be in accordance with local requirements. Pregnant healthcare personnel should not handle and/or administer Metoject PEN. Methotrexate should not come into contact ...

Marketing authorization holder

medac, Gesellschaft für klinische Spezialpräparate mbH, Theaterstr. 6, 22880 Wedel, Germany, Tel.: +49 4103 8006-0, Fax: +49 4103 8006-100

Marketing authorization number(s)

PL 11587/0076-0085

Date of first authorization / renewal of the authorization

Date of first authorisation: 23 August 2013

Date of revision of the text

08/2018

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