Methotrexate 2mg/ml oral solution sugar free

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Methotrexate sodium

Saatavilla:

Rosemont Pharmaceuticals Ltd

ATC-koodi:

L04AX03

INN (Kansainvälinen yleisnimi):

Methotrexate sodium

Annos:

2mg/1ml

Lääkemuoto:

Oral solution

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 10010300; GTIN: 5016119270697 5016119270093

Pakkausseloste

Methotrexate 2mg/ml Oral Solution
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P0799
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35ml / 65ml
Pack Size:
45ml / 75ml
Bottle Size:
2mg/ml
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PACKAGE LEAFLET: INFORMATION FOR THE USER
METHOTREXATE 2MG/ML ORAL SOLUTION
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.

Valmisteyhteenveto

OBJECT 1
METHOTREXATE 2MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 11-May-2018 | Rosemont
Pharmaceuticals Limited
1. Name of the medicinal product
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.
INCORRECT DOSING OF METHOTREXATE CAN RESULT IN SERIOUS POTENTIALLY
FATAL ADVERSE DRUG REACTIONS.
HEALTH CARE PROFESSIONALS AND THE PATIENTS SHOULD BE ADVISED
ACCORDINGLY
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