Methotrexate 25 mg/ml solution for injection, pre-filled syringe

国: イギリス

言語: 英語

ソース: myHealthbox

有効成分:

Methotrexate

から入手可能:

hameln pharmaceuticals ltd

ATCコード:

L01BA01

INN（国際名）:

Methotrexate

投薬量:

25 mg/ml

医薬品形態:

Solution for injection in pre-filled syringe

投与経路:

subcutaneous or intramuscular route

パッケージ内のユニット:

0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml, 1.0 ml pre-filled syringe, in a pack of 1.

処方タイプ:

POM - Prescription Only Medicine

製:

hameln rds a.s

治療群:

Antineoplastic and immunomodulating agents, antimetabolites, folic acid analogues

適応症:

Active rheumatoid arthritis in adult patients where treatment with disease modifying antirheumatic drugs (DMARD) is indicated; Polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate; Severe forms of psoriasis vulgaris, particularly of the plaque type, which cannot be sufficiently treated with conventional therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis

認証ステータス:

Authorised

承認日:

2015-07-20

情報リーフレット


-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
PACKAGE LEAFLET: INFORMATION FOR THE USER
METHOTREXATE 25 MG/ML SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
Methotrexate
HAMELN
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 effect not listed in this leaflet,
METHOTREXATE 25 MG/ML SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR
HEALTHCARE PROFESSIONALS ONLY:
PREPARATION GUIDE FOR:
HAMELN
IN THIS LEAFLET: 
1.  What Methotrexate is and what it is used for
2.  What you need to know before you use Methotrexate
3.  How to use Methotrexate
4.  Possible side effects
5.  How to store Methotrexate
6.  Contents of the pack and other information
1.  WHAT  METHOTREXATE  IS  AND  WHAT  IT  IS  USED 
FOR 
Methotrexate is a drug with the following properties:
-  it interferes with the growth of certain cells in the body that
reproduce quickly (anti-tumour agent),
-  it reduces undesired reactions of the body’s own defence
mechanism (immunosuppressant), and
-  it has anti-inflammatory effects.
Methotrexate is used for the treatment of:
-  active  rheumatoid  arthritis  (RA)  in  adult  patients
 where
treatment  with  disease  modifying  antirheumatic  drugs
(DMARDs) is indicated.
-  polyarthritic forms (when five or more joints are involved)
of  severe,  active  juvenile  idiopathic  arthritis  (JIA)
 when
the  response  to  so-called  

製品の特徴

Methotrexate 25 mg/ml solution for injection, pre­filled syringe
Summary of Product Characteristics Updated 05­Aug­2015 | hameln pharmaceuticals ltd
1. Name of the medicinal product
Methotrexate 25 mg/ml solution for injection, pre­filled syringe
2. Qualitative and quantitative composition
1 ml solution for injection contains 25 mg methotrexate.
1 pre­filled syringe of 0.3 ml solution for injection contains 7.5 mg methotrexate.
1 pre­filled syringe of 0.4 ml solution for injection contains 10 mg methotrexate.
1 pre­filled syringe of 0.6 ml solution for injection contains 15 mg methotrexate.
1 pre­filled syringe of 0.8 ml solution for injection contains 20 mg methotrexate.
1 pre­filled syringe of 1.0 ml solution for injection contains 25 mg methotrexate.
The medicinal product contains maximum 5.21 mg per ml sodium (see section 4.4).
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for injection in pre­filled syringe
The medicinal product is a clear, yellowish solution for injection with a pH of 7.0 – 9.0.
4. Clinical particulars
4.1 Therapeutic indications
­ Active rheumatoid arthritis in adult patients where treatment with disease modifying antirheumatic drugs (DMARD) is
indicated.
­ Polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when the response to non­steroidal anti­
inflammatory drugs (NSAIDs) has been inadequate.
­ Severe forms of psoriasis vulgaris, particularly of the plaque type, which cannot be sufficiently treated with
conventional therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis.
4.2 Posology and method of administration
Important warning with reference to methotrexate dosage
Methotrexate for the therapy of rheumatic or skin diseases must only be used once weekly.
In