Methofill 50 mg/mL solution for injection in pre-filled syringe

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Methotrexate

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

L04AX; L04AX03

INN (International Name):

Methotrexate

Dosage:

50 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection in pre-filled syringe

Therapeutic area:

Other immunosuppressants; methotrexate

Authorization status:

Not marketed

Authorization date:

2016-02-19

Patient Information leaflet

SE/H/1431/001/IA/045, ver 002, Dec 2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
METHOFILL 50 MG/ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
methotrexate
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 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 or pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Methofill is and what it is used for
2.
What you need to know before you use Methofill
3.
How to use Methofill
4.
Possible side effects
5.
How to store Methofill
6.
Contents of the pack and other information
1.
WHAT METHOFILL IS AND WHAT IT IS USED FOR
Methofill contains methotrexate as active substance
Methotrexate is a substance with following properties:
•
it interferes with the growth of certain cells in the body that
reproduce quickly
•
it reduces the activity of the immune system (the body’s own defence
mechanism)
•
it has anti-inflammatory effects
Methofill 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 drugs (NSAIDs) has been inadequate,
•
severe recalcitrant disabling psoriasis, which is not adequately
responsive to other forms of therapy
such as phototherapy, PUVA, and retinoids, and severe psoriatic
arthritis in adult patients.
•
mild to moderate Crohn’s Disease in adult patients when adequate
treatment with other medicines is
not possible.
Rheumatoid arthritis (RA)
is a chronic collagen disease, characterised by inflammation of the
synovial
membranes (joint membranes). These membr

Summary of Product characteristics

Health Products Regulatory Authority
12 February 2024
CRN00F3ZK
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Methofill 50 mg/mL solution for injection in pre-filled syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 50 mg methotrexate (as methotrexate
disodium).
1 pre-filled syringe of 0.15 ml contains 7.5 mg methotrexate.
1 pre-filled syringe of 0.20 ml contains 10 mg methotrexate.
1 pre-filled syringe of 0.25 ml contains 12.5 mg methotrexate.
1 pre-filled syringe of 0.30 ml contains 15 mg methotrexate.
1 pre-filled syringe of 0.35 ml contains 17.5 mg methotrexate.
1 pre-filled syringe of 0.40 ml contains 20 mg methotrexate.
1 pre-filled syringe of 0.45 ml contains 22.5 mg methotrexate.
1 pre-filled syringe of 0.50 ml contains 25 mg methotrexate.
1 pre-filled syringe of 0.55 ml contains 27.5 mg methotrexate.
1 pre-filled syringe of 0.60 ml contains 30 mg methotrexate
Excipient with known effect:
Each pre-filled syringe contains <1 mmol sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe.
Clear, yellow to brown solution.
pH: Between 7.0 to 9.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Methotrexate 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 drugs (NSAIDs) has been inadequate,

severe recalcitrant disabling psoriasis, which is not adequately
responsive to other forms of therapy such as
phototherapy, PUVA, and retinoids, and severe psoriatic arthritis in
adult patients.

mild to moderate Crohn's disease either alone or in combination with
corticosteroids in adult patients refractory or
intolerant to thiopurines.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Methotrexate should only be prescribed by physicians with expertise in
the use of methotrexate and a full understanding of the
risks of methotrexate therap