Methotrexate 25 mg/ml solution for injection, pre-filled syringe
Country: United Kingdom
Language: English
Source: myHealthbox
Patient Information leaflet
(PIL)
25-04-2024
Summary of Product characteristics
(SPC)
25-04-2024
Active ingredient:
Methotrexate
Available from:
hameln pharmaceuticals ltd
ATC code:
L01BA01
INN (International Name):
Methotrexate
Dosage:
25 mg/ml
Pharmaceutical form:
Solution for injection in pre-filled syringe
Administration route:
subcutaneous or intramuscular route
Units in package:
0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml, 1.0 ml pre-filled syringe, in a pack of 1.
Prescription type:
POM - Prescription Only Medicine
Manufactured by:
hameln rds a.s
Therapeutic group:
Antineoplastic and immunomodulating agents, antimetabolites, folic acid analogues
Therapeutic indications:
Active rheumatoid arthritis in adult patients where treatment with disease modifying antirheumatic drugs (DMARD) is indicated; Polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate; Severe forms of psoriasis vulgaris, particularly of the plaque type, which cannot be sufficiently treated with conventional therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis
Authorization status:
Authorised
Authorization date:
2015-07-20
Patient Information leaflet
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PACKAGE LEAFLET: INFORMATION FOR THE USER
METHOTREXATE 25 MG/ML SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
Methotrexate
HAMELN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or pharmacist.
- 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 or pharmacist.
This includes any possible side effect not listed in this leaflet,
METHOTREXATE 25 MG/ML SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR
HEALTHCARE PROFESSIONALS ONLY:
PREPARATION GUIDE FOR:
HAMELN
IN THIS LEAFLET:
1. What Methotrexate is and what it is used for
2. What you need to know before you use Methotrexate
3. How to use Methotrexate
4. Possible side effects
5. How to store Methotrexate
6. Contents of the pack and other information
1. WHAT METHOTREXATE IS AND WHAT IT IS USED
FOR
Methotrexate is a drug with the following properties:
- it interferes with the growth of certain cells in the body that
reproduce quickly (anti-tumour agent),
- it reduces undesired reactions of the body’s own defence
mechanism (immunosuppressant), and
- it has anti-inflammatory effects.
Methotrexate is used for the treatment of:
- active rheumatoid arthritis (RA) in adult patients
where
treatment with disease modifying antirheumatic drugs
(DMARDs) is indicated.
- polyarthritic forms (when five or more joints are involved)
of severe, active juvenile idiopathic arthritis (JIA)
when
the response to so-called
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Summary of Product characteristics
Methotrexate 25 mg/ml solution for injection, prefilled syringe
Summary of Product Characteristics Updated 05Aug2015 | hameln pharmaceuticals ltd
1. Name of the medicinal product
Methotrexate 25 mg/ml solution for injection, prefilled syringe
2. Qualitative and quantitative composition
1 ml solution for injection contains 25 mg methotrexate.
1 prefilled syringe of 0.3 ml solution for injection contains 7.5 mg methotrexate.
1 prefilled syringe of 0.4 ml solution for injection contains 10 mg methotrexate.
1 prefilled syringe of 0.6 ml solution for injection contains 15 mg methotrexate.
1 prefilled syringe of 0.8 ml solution for injection contains 20 mg methotrexate.
1 prefilled syringe of 1.0 ml solution for injection contains 25 mg methotrexate.
The medicinal product contains maximum 5.21 mg per ml sodium (see section 4.4).
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for injection in prefilled syringe
The medicinal product is a clear, yellowish solution for injection with a pH of 7.0 – 9.0.
4. Clinical particulars
4.1 Therapeutic indications
Active rheumatoid arthritis in adult patients where treatment with disease modifying antirheumatic drugs (DMARD) is
indicated.
Polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when the response to nonsteroidal anti
inflammatory drugs (NSAIDs) has been inadequate.
Severe forms of psoriasis vulgaris, particularly of the plaque type, which cannot be sufficiently treated with
conventional therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis.
4.2 Posology and method of administration
Important warning with reference to methotrexate dosage
Methotrexate for the therapy of rheumatic or skin diseases must only be used once weekly.
In
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