Methotrexaat Sandoz 15 mg = 1,5 ml, oplossing voor injectie in voorgevulde injectiespuit 10 mg/ml

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

METHOTREXAAT

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

L01BA01

INN (Algemene Internationale Benaming):

METHOTREXATE

farmaceutische vorm:

Oplossing voor injectie

Samenstelling:

NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE,

Toedieningsweg:

Intraveneus gebruik, Intramusculair gebruik, Subcutaan gebruik

Therapeutisch gebied:

Methotrexate

Product samenvatting:

Hulpstoffen: NATRIUMCHLORIDE; NATRIUMHYDROXIDE (E 524); STIKSTOF (HEAD SPACE) (E 941); WATER VOOR INJECTIE;

Autorisatie datum:

2010-02-22

Bijsluiter

Sandoz B.V.
Page 1/18
Methotrexaat Sandoz
®
10 mg=1 ml
RVG 117408-11
1313-V12
1.3.1.3 Bijsluiter
Augustus 2019
PIL for Lantarel FS® 7,5 mg/10 mg/15 mg/20 mg/25 mg Fertigspritze;
Injektionslösung i.m./i.v./s.c. (methotrexate), Pfizer
Pharma GmbH, Germany, dated September 2019
PACKAGE LEAFLET: INFORMATION FOR THE USER
METHOTREXAAT SANDOZ
® 7,5 MG = 0,75 ML, OPLOSSING VOOR INJECTIE IN VOORGEVULDE
INJECTIESPUIT
10 MG/ML
METHOTREXAAT SANDOZ
® 10 MG = 1 ML, OPLOSSING VOOR INJECTIE IN VOORGEVULDE INJECTIESPUIT
10 MG/ML
METHOTREXAAT SANDOZ
® 15 MG = 1,5 ML, OPLOSSING VOOR INJECTIE IN VOORGEVULDE INJECTIESPUIT
10 MG/ML
METHOTREXAAT SANDOZ
® 20 MG = 2 ML, OPLOSSING VOOR INJECTIE IN VOORGEVULDE INJECTIESPUIT
10 MG/ML
methotrexaat
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 your 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 [Nationally completed name] is and what it is used for
2.
What you need to know before you use [Nationally completed name]
3.
How to use [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] is a medicine containing methotrexate.
Methotrexate is a substance 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
_ _
[Nationally comple

Productkenmerken

Sandoz B.V.
Page 1/22
Methotrexaat Sandoz 10 mg=1 ml
RVG 117408-11
1311-V11
1.3.1.1 Samenvatting van de Productkenmerken
Augustus 2020
SmPC for Lantarel FS® 7,5 mg/10 mg/15 mg/20 mg/25 mg Fertigspritze;
Injektionslösung i.m./i.v./s.c. (methotrexate), Pfizer
Pharma GmbH, Germany, dated September 2019
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Methotrexaat Sandoz 7,5 mg = 0,75 ml, oplossing voor injectie in
voorgevulde injectiespuit 10 mg/ml
Methotrexaat Sandoz 10 mg = 1 ml, oplossing voor injectie in
voorgevulde injectiespuit 10 mg/ml
Methotrexaat Sandoz 15 mg = 1,5 ml, oplossing voor injectie in
voorgevulde injectiespuit 10 mg/ml
Methotrexaat Sandoz 20 mg = 2 ml, oplossing voor injectie in
voorgevulde injectiespuit 10 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml solution contains 10 mg of methotrexate (as 10.97 mg of
methotrexate disodium).
Each pre-filled syringe of 0.75 ml contains 7.5 mg of methotrexate.
Each pre-filled syringe of 1 ml contains 10 mg of methotrexate.
Each pre-filled syringe of 1.5 ml contains 15 mg of methotrexate.
Each pre-filled syringe of 2 ml contains 20 mg of methotrexate.
Excipient(s) with known effect
Each ml solution for injection contains 0.16 mmol (3.8 mg) of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe.
Clear, yellow solution, free of particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Active rheumatoid arthritis in adult patients
-
Polyarthritic forms of severe, active juvenile idiopathic arthritis
(JIA) (children > 3 years) when the
response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been
inadequate.
-
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 [NATIONALLY COMPLETED NAME]:
In the treatment of rheumatoid arthriti