METHOTREXATE

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

METHOTREXATE DISODIUM

Dostopno od:

Rosemont Pharmaceuticals Ltd

Koda artikla:

L04AX03

INN (mednarodno ime):

METHOTREXATE DISODIUM

Odmerek:

2 Mg/Ml

Farmacevtska oblika:

Oral Solution

Pot uporabe:

Intravenous and intrathecal administration

Enote v paketu:

35ml or 65ml bottle

Tip zastaranja:

Product subject to prescription which may not be renewed (A)

Izdeluje:

Rosemont Pharmaceuticals Ltd

Terapevtska skupina:

Antineoplastic and immunomodulating agents, antimetabolites, Folic acid analogues

Terapevtsko območje:

methotrexate

Terapevtske indikacije:

It is indicated in the following oncological indications: the maintenance treatment of Acute Lymphocytic Leukaemia (ALL) in children and adults; the treatment of malignant trophoblastic tumours and for the treatment of severe active rheumatoid arthritis in adults and the treatment of severe forms of psoriasis vulgaris including chronic plaque psoriasis, erythrodermic psoriasis, psoriatic arthritis and pustular psoriasis which are not responsive to other conventional therapies such as phototherapy, PUVA and retinoids.

Status dovoljenje:

Authorised

Datum dovoljenje:

2015-06-19

Navodilo za uporabo

METHOTREXATE 2MG/ML ORAL SOLUTION
MODULE 1.3.1
LEAFLET
VERSION: JULY 2018
PAGE
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
METHOTREXATE FOR THE TREATMENT OF PSORIASIS AND RHEUMATOID ARTHRITIS
SHOULD ONLY
BE ADMINISTERED 1X/WEEK. METHOTREXATE ADMINISTERED FOR THE TREATMENT
OF
ONCOLOGICAL DISEASES SHOULD BE ADMINISTERED CAUTIOUSLY TAKING INTO
ACCOUNT THE
BODY SURFACE AREA.
PLEASE NOTE THAT THIS ORAL SOLUTION CONTAINS 2MG METHOTREXATE IN 1ML
SOLUTION AND
THAT THE SCALING OF THE DOSING SYRINGE IS IN ML AND NOT MG.
INCORRECT DOSING OF METHOTREXATE CAN RESULT IN SERIOUS POTENTIALLY
FATAL ADVERSE
DRUG REACTIONS.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE - BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Methotrexate Oral Solution is and what it is used for
2.
What you need to know before you take Methotrexate Oral Solution
3.
How to take Methotrexate Oral Solution
4.
Possible side effects
5.
How to store Methotrexate Oral Solution
6.
Contents of the pack and other information
The full name of your medicine is Methotrexate 2mg/ml Oral Solution.
In this leaflet
the shorter name methotrexate is used.
Methotrexate belongs to a group of medicines called ‘cytotoxics’
which are most
commonly used to kill cells and tumours. It is also known as an
immunosuppressant
which affects the reproduction of the body’s cells and reduces the
activity of the
immune system.
1. WHAT METHOTREXATE ORAL SOLUTION IS AND WHAT IT IS USED FOR
METHOTREXATE 2MG/ML ORAL SOLUTION
METHOTREXATE 2MG/ML ORAL SOLUTION
MODULE 1.3.1
LEAFLET
VERSION: JULY 2

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Methotrexate 2mg/ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 2.19mg methotrexate disodium
equivalent to 2mg methotrexate
Excipients with known effect
Sodium methyl parahydroxybenzoate
Sodium ethyl parahydroxybenzoate
Sulphites (from the flavour)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
A clear yellow oral solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Methotrexate 2mg/ml Oral Solution is indicated in the following
oncological indications:
The maintenance treatment of Acute Lymphocytic Leukaemia (ALL) in
children and adults.
The treatment of malignant trophoblastic tumours.
Methotrexate 2mg/ml Oral Solution is indicated in:
The treatment of severe active rheumatoid arthritis in adults.
The treatment of severe forms of psoriasis vulgaris including chronic
plaque psoriasis, erythrodermic psoriasis,
psoriatic arthritis and pustular psoriasis which are not responsive to
other conventional therapies such as
phototherapy, PUVA and retinoids.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with ‘Methotrexate 2 mg/ml oral should be initiated and
supervised by physicians with experience in
antimetabolite chemotherapy and the management of the approved
indications. The treatment regimen should be
decided on an individual patient basis, with reference to current
treatment protocols.
During treatment with methotrexate patients require careful monitoring
to avoid severe toxicities and to ensure fast
identification of toxic side effects. Measurement of serum
methotrexate level is absolutely essential.
Pharmaceutical forms with lowest possible strength should be used.
Fatal cases of intoxication have been reported after
METHOTREXATE FOR THE TREATMENT OF PSORIASIS AND RHEUMATOID ARTHRITIS
SHOULD ONLY BE
ADMINISTERED 1X/WEEK. METHOTREXATE ADMINISTERED FOR THE TREATMENT OF
ONCOLOGICAL
DISEASES SHOULD BE ADMINISTERED CAUTIOUSLY TAKING INTO ACCOUNT THE
BODY SURFACE ARE