Jylamvo
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
03-04-2023
Produktets egenskaber
(SPC)
03-04-2023
Offentlige vurderingsrapport
(PAR)
31-10-2019
Aktiv bestanddel:
Methotrexate
Tilgængelig fra:
Therakind (Europe) Limited
ATC-kode:
L04AX03
INN (International Name):
methotrexate
Terapeutisk gruppe:
Antineoplastic agents
Terapeutisk område:
Arthritis, Psoriatic; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Psoriasis; Arthritis, Rheumatoid; Arthritis
Terapeutiske indikationer:
In rheumatological and dermatological diseasesActive rheumatoid arthritis in adult patients.Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate.Severe, treatment-refractory, disabling psoriasis which does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, and severe psoriatic arthritis in adult patients.In oncologyMaintenance treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over.
Produkt oversigt:
Revision: 12
Autorisation status:
Authorised
Autorisation dato:
2017-03-29
Indlægsseddel
32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORMATION FOR THE USER
JYLAMVO
2
MG/ML ORAL SOLUTION
methotrexate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Jylamvo is and what it is used for
2.
What you need to know before you take Jylamvo
3.
How to take Jylamvo
4.
Possible side effects
5.
How to store Jylamvo
6.
Contents of the pack and other information
1.
WHAT JYLAMVO
IS AND WHAT IT IS USED FOR
Jylamvo is a medicine that:
-
suppresses the growth of certain cells in the body that multiply
rapidly (an anticancer medicine)
-
reduces unwanted reactions by the body's own defense mechanisms (an
immunosuppressive
agent)
-
has an anti-inflammatory effect
Jylamvo is used in patients with:
-
the following rheumatic and skin diseases:
o
active rheumatoid arthritis (RA) in adults
o
polyarthritic forms (when five or more joints are affected) of active,
severe juvenile
idiopathic arthritis (JIA) in adolescents and children aged 3 years
and over when the
response to non-steroidal anti-inflammatory drugs (NSAIDs) has been
inadequate
o
severe, treatment-resistant, disabling psoriasis that does not respond
sufficiently to
other forms of treatment such as phototherapy, psoralen and
ultraviolet A radiation
(PUVA) therapy and retinoids, as well as in severe psoriasis that also
affects the joints
(psoriatic arthritis) in adult patients
-
acute lymphoblastic leukaemia (ALL) in adults, adolescents and
children aged 3 years and over
You must talk to a doctor if you do not feel better or if you feel
worse
2.
WHAT YO
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Jylamvo 2 mg/ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution contains 2 mg methotrexate.
Excipients with known effect
One ml of solution contains 2 mg methyl hydroxybenzoate (as the sodium
salt), and 0.2 mg ethyl
hydroxybenzoate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Clear yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Jylamvo is for use in the following indications:
In rheumatological and dermatological diseases
•
Active rheumatoid arthritis in adult patients.
•
Polyarthritic forms of active, severe juvenile idiopathic arthritis
(JIA) in adolescents and
children aged 3 years and over when the response to non-steroidal
anti-inflammatory drugs
(NSAIDs) has been inadequate.
•
Severe, treatment-refractory, disabling psoriasis which does not
respond sufficiently to other
forms of treatment such as phototherapy, psoralen and ultraviolet A
radiation (PUVA) therapy
and retinoids, and severe psoriatic arthritis in adult patients.
In oncology
•
Maintenance treatment of acute lymphoblastic leukaemia (ALL) in
adults, adolescents and
children aged 3 years and over
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Methotrexate should only be prescribed by physicians with expertise in
the use of methotrexate and a
full understanding of the risks of methotrexate therapy.
Posology
_Rheumatological and dermatological diseases _
3
_ _
IMPORTANT WARNING ABOUT THE DOSAGE OF JYLAMVO (METHOTREXATE)
In the treatment of rheumatological or dermatological diseases,
Jylamvo (methotrexate)
MUST ONLY BE
TAKEN ONCE A WEEK
. Dosage errors in the use of Jylamvo (methotrexate) can result in
serious adverse
reactions, including death. Please read this section of the summary of
product characteristics very
carefully.
The prescriber should ensure that patients or their carers will be
able to comply with the once weekly
regimen.
The prescriber should specify the day of
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