Jylamvo 2mgml oral solution

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Methotrexate sodium

Dostupné z:

Intrapharm Laboratories Ltd

ATC kód:

L04AX03

INN (Medzinárodný Name):

Methotrexate sodium

Dávkovanie:

2mg/1ml

Forma lieku:

Oral solution

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF:

Príbalový leták

1
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 YOU NEED TO KNOW BEFORE Y

Súhrn charakteristických

OBJECT 1
JYLAMVO 2 MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 07-Jun-2018 | Therakind
Limited
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 experience
of the various properties of the
medicinal product and its mode of action.
Posology
_Rheumatological and dermatological diseases _
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 specify the day of intake on the prescription.
The dose and duration of treatment ar