Metoject 50 mg/ml Solution for Injection, pre-filled syringe

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Methotrexate

Dostupno od:

medac Gesellschaft für klinische Spezialpräparate mbH

ATC koda:

L04AX; L04AX03

INN (International ime):

Methotrexate

Doziranje:

50 milligram(s)/millilitre

Farmaceutski oblik:

Solution for injection in pre-filled syringe

Tip recepta:

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

Područje terapije:

Other immunosuppressants; methotrexate

Status autorizacije:

Not marketed

Datum autorizacije:

2012-10-12

Uputa o lijeku

pal (IE) Metoject 50 mg/ml Solution for injection, pre-filled syringe
National version: 09/2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
METOJECT 50 MG/ML SOLUTION FOR INJECTION, 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.
•
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 50 mg/ml is and what it is used for
2.
What you need to know before you use Metoject 50 mg/ml
3.
How to use Metoject 50 mg/ml
4.
Possible side effects
5.
How to store Metoject 50 mg/ml
6.
Contents of the pack and other information
1.
WHAT METOJECT 50 MG/ML IS AND WHAT IT IS USED FOR
Metoject 50 mg/ml contains methotrexate as active substance.
Methotrexate is a substance with the following properties:
•
it interferes with the growth of certain cells in the body that
reproduce quickly.
•
it reduces the activity of the immune system (body’s own defence
mechanism).
•
it has anti-inflammatory effects.
Metoject 50 mg/ml 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.
Psoriatic arthritis is a kind of arthritis wi

Svojstava lijeka

Health Products Regulatory Authority
04 October 2023
CRN00D8RL
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Metoject 50 mg/ml Solution for Injection, 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 0.30 ml contains 15 mg methotrexate.
1 pre-filled syringe of 0.40 ml contains 20 mg methotrexate.
1 pre-filled syringe of 0.50 ml contains 25 mg methotrexate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection, pre-filled syringe.
Clear, yellow-brown solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Metoject 50 mg/ml 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 50 MG/ML (METHOTREXATE)
In the treatment of rheumatoid arthritis, psoriasis and psoriatic
arthritis, Metoject 50 mg/ml (methotrexate) MUST ONLY BE USED
ONCE A WEEK. Dosage errors in the use of Metoject 50 mg/ml
(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. The administration should routinely be
done by healthcare professionals. If the clinical situation
permits the treating physician can, in selected cases, delegate the
subcutaneous administration to the patient her/himself.
Patients must be educated and trained in the proper injection
technique when self-