METOJECT 50 MGML S.C

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

METHOTREXATE

متاح من:

TZAMAL BIO-PHARMA LTD

ATC رمز:

L01BA01

الشكل الصيدلاني:

SOLUTION FOR INJECTION

تركيب:

METHOTREXATE 50 MG/ML

طريقة التعاطي:

S.C

نوع الوصفة الطبية :

Required

المصنعة من قبل:

MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH, GERMANY

المجموعة العلاجية:

METHOTREXATE

المجال العلاجي:

METHOTREXATE

الخصائص العلاجية:

Psoriasis in adult patients :because of the high risk attending its use, Methotrexate is indicated only in the symptomatic control of severe recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, and only when the diagnosis has been established, as by biopsy and/or after dermatological consultation. Rheumatoid Arthritis: Methotrexate can be used in the treatment of selected adults with severe rheumatoid arthritis, only when the diagnosis has been well estabished according to rheumatological standards, with inadequate response to other forms of antirheumatic therapy, including full dose NSAIDs and usually a trial of at least one or more disease-modifying antirheumatic drugs.Juvenile Idiopathic Arthritis:Treatment of Polyarthritic forms of severe, active juvenile idiopathic arthritis in patients 3 years of age and above when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequateCrohn’s Disease: Mild to moderate Crohn's disease either alone or in combination with corticosteroids in adult patients refractory or intolerant to thiopurines.

تاريخ الترخيص:

2016-01-31

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor's prescription only
METOJECT 50 MG/ML S.C.
SOLUTION FOR INJECTION
PRE-FILLED SYRINGE
Active ingredient and concentration:
methotrexate 50 mg/ml
For information about inactive ingredients and allergens in this
medicine see section 2 under
‘Important information about some of this medicine’s
ingredients’, and section 6 ‘Additional
information'.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. This leaflet contains
concise information about the medicine. If you have any further
questions, contact your doctor or
pharmacist.
This medicine has been prescribed for your illness. Do not pass it on
to others. It may harm
them, even if you think that their illness is the same as yours.
For the treatment of rheumatoid arthritis, psoriasis and Crohn's
disease – the medicine is
intended for use in adults only.
For the treatment of juvenile idiopathic arthritis (JIA) - the
medicine is intended for children over
3 years of age.
Metoject S.C. is given once a week, by injection under the skin.
Do not use this medicine daily. Daily use can cause side effects and
serious complications
which could lead to death.
Choose a weekday with your doctor. To help you remember on which day
you are given
Metoject, you are advised to keep a diary.
1. WHAT IS THE MEDICINE USED FOR?
•
In cases of severe rheumatoid arthritis in adult patients that was
properly diagnosed
according to rheumatological standards and when the patients did not
respond to other forms
of antirheumatic therapy, including non-steroidal anti-inflammatory
drugs (NSAIDs) and
usually a trial of at least one or more disease-modifying
antirheumatic drugs (DMARDs).
•
Active and severe juvenile idiopathic arthritis in patients over 3
years of age that involves
several joints, and when treatment with non-steroidal
anti-inflammatory drugs (NSAIDs) is not
sufficient.
•
For the symptomatic control of severe recalcit

خصائص المنتج

METOJECT 50 MG/ML S.C.
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Metoject 50 mg/ml S.C.
solution for injection, pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 50 mg methotrexate.
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
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection, pre-filled syringe.
Clear, yellow-brown solution.
IMPORTANT WARNING ABOUT THE DOSAGE OF METOJECT (METHOTREXATE)
In the treatment of rheumatoid arthritis, juvenile idiopathic
arthritis, psoriasis and Crohn’s disease,
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 'Posology and method
of administration' section very carefully.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid Arthritis:
Methotrexate can be used in the treatment of selected adults with
severe rheumatoid arthritis, only when
the diagnosis has been well established according to rheumatological
standards, with inadequate response
to other forms of antirheumatic therapy, including full dose NSAIDs
and usually a trial of at least one or
more disease-modifying antirheumatic drugs.
Juvenile Idiopathic Arthritis:
−
Treatment of Polyarthritic forms of severe, active juvenile idiopathic
arthritis in patients 3 years of
age and above when the response to non-steroidal anti-infla