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

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Methotrexate

Disponível em:

PCO Manufacturing Ltd.

Código ATC:

L04AX03

DCI (Denominação Comum Internacional):

Methotrexate

Dosagem:

50 milligram(s)/millilitre

Forma farmacêutica:

Solution for injection in pre-filled syringe

Área terapêutica:

methotrexate

Data de autorização:

2019-03-08

Folheto informativo - Bula

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 with psoriatic lesions of
the skin and nails, especially at the
joints of fingers and toes.
Pso

Características técnicas

Health Products Regulatory Authority
07 November 2023
CRN00DX54
Page 1 of 2
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 0.30 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.
_Product imported from Greece _
Clear, yellow-brown solution
4 CLINICAL PARTICULARS
As per PA0623/014/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0623/014/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sodium chloride
Sodium hydroxide for pH adjustment
Water for injections
6.2 INCOMPATIBILITIES
In the absence of compatibility studies, this medicinal product must
not be mixed with other medicinal products.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 25 °C. Keep the pre-filled syringes in the outer carton
in order to protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
Nature of container
Pre-filled syringes of colourless glass of 1 ml capacity with embedded
injection needle.
Plunger stoppers and rods inserted on the stopper to form the syringe
plunger.
Health Products Regulatory Authority
07 November 2023
CRN00DX54
Page 2 of 2
Pack size
Pre-filled syringes containing 0.30 ml, 0.40 ml, or 0.50 ml solution
are available in packs of 1 syringe with embedded s.c.
injection needle and alcohol pads.
Pre-filled syringes containing 0.30 ml, 0.40 ml, or 0.50 ml solution
are available in packs of 1 syringe with embedded s.c.
injection needle.
All pack sizes are available with graduation marks.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND