Metoject 10 mg solution for injection in pre-filled pen

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Methotrexate

Available from:

medac Gesellschaft für klinische Spezialpräparate mbH

ATC code:

L01BA; L01BA01

INN (International Name):

Methotrexate

Dosage:

10 milligram(s)

Pharmaceutical form:

Solution for injection in pre-filled pen

Prescription type:

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

Therapeutic area:

Folic acid analogues; methotrexate

Authorization status:

Marketed

Authorization date:

2018-04-13

Patient Information leaflet

pal (IE) Metoject, solution for injection in pre-filled pen
Version date: 08/2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
METOJECT 7.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
METOJECT 10 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
METOJECT 15 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
METOJECT 20 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
METOJECT 25 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN
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.
•
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
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Metoject is and what it is used for
2.
What you need to know before you use Metoject
3.
How to use Metoject
4.
Possible side effects
5.
How to store Metoject
6.
Contents of the pack and other information
1.
WHAT METOJECT IS AND WHAT IT IS USED FOR
Metoject is indicated for the treatment of
•
active rheumatoid arthritis in adult patients.
•
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.
RHEUMATOID ARTHRITIS
(RA)
is a chronic collagen disease, characterised by inflammation of the
synovial membranes (joint membranes). These membranes produce a fluid
which acts as a lubricant
for many joints. The inflammation causes thickening of the membrane
and swelling of the joint.
PSORIASIS
is a common chronic skin disease, characterised by red patches covered
by thick, dry,
silvery, adherent scales.
PSORIATIC ARTHRITIS
is a kind of arthritis with psoriatic lesions of the skin and nails,
especially

Summary of Product characteristics

Health Products Regulatory Authority
04 October 2023
CRN00D8RL
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Metoject 10 mg solution for injection in pre-filled pen
2 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 0.30 ml solution contains 15 mg methotrexate.
1 pre-filled pen with 0.40 ml solution contains 20 mg methotrexate.
1 pre-filled pen with 0.50 ml solution contains 25 mg methotrexate.
Excipients with known effect: sodium chloride and sodium hydroxide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection in pre-filled pen.
Clear, yellow-brown solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Metoject is indicated for the treatment of
· active rheumatoid arthritis in adult patients,
· 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
IMPORTANT WARNING ABOUT THE DOSAGE OF METOJECT (METHOTREXATE)
In the treatment of rheumatoid arthritis, and psoriasis and psoriatic
arthritis, Metoject (methotrexate) must only be used once a
week. Dosage errors in the use of Metoject (methotrexate) can result
in serious adverse reactions, including death. Please read
this section of the summary of product characteristics very carefully.
Methotrexate should only be prescribed by physicians with expertise in
the use of methotrexate and a full understanding of the
risks of methotrexate therapy. Patients must be educated and trained
in the proper injection technique when
self-administering methotrexate. The first injection of Metoject
should be performed under direct medical supervision.
Metoject is injected ONCE WEEKLY.
The patient must be explicitly informed about the fact that Metoject
is administered ONCE