Metoject 25 mg solution for injection in pre-filled pen

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Methotrexate

Disponible depuis:

IMED Healthcare Ltd.

Code ATC:

L01BA; L01BA01

DCI (Dénomination commune internationale):

Methotrexate

Dosage:

25 milligram(s)

forme pharmaceutique:

Solution for injection in pre-filled pen

Domaine thérapeutique:

Folic acid analogues; methotrexate

Date de l'autorisation:

2021-09-10

Notice patient

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 at the joints of fingers
and toes.
Metoject modifies and slows down the progressi

Résumé des caractéristiques du produit

Health Products Regulatory Authority
10 September 2021
CRN00C8N1
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Metoject 25 mg solution for injection in pre-filled pen
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 pre-filled pen with 0.50 ml solution contains methotrexate disodium
equivalent to 25 mg methotrexate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Product imported from _Germany._
Clear, yellow-brown solution.
4 CLINICAL PARTICULARS
As per PA0623/014/006
5 PHARMACOLOGICAL PROPERTIES
As per PA0623/014/006
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sodium chloride
Sodium hydroxide
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 pre-filled pen 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 pens in the outer carton in
order to protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
Pre-filled pen containing 0.50 ml (25 mg) solution. Pack size 1
pre-filled pen.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
The manner of handling and disposal must be in accordance with local
requirements. Pregnant health care personnel should
not handle and/or administer Metoject.
Health Products Regulatory Authority
10 September 2021
CRN00C8N1
Page 2 of 2
Methotrexate should not come into contact with the skin or mucosa. In
the event of contamination, the affected area must be
rinsed immediately with ample amount of water.
For single use only.
Any unused medicinal product or waste should be disposed of in
accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/172/005