Mulpleo (previously Lusutrombopag Shionogi)
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
16-02-2024
Karatteristiċi tal-prodott
(SPC)
16-02-2024
Rapport ta 'Valutazzjoni Pubblika
(PAR)
20-11-2019
Ingredjent attiv:
Lusutrombopag
Disponibbli minn:
Shionogi B.V.
Kodiċi ATC:
B02BX
INN (Isem Internazzjonali):
lusutrombopag
Grupp terapewtiku:
Antihemorrhagics
Żona terapewtika:
Thrombocytopenia
Indikazzjonijiet terapewtiċi:
Mulpleo is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures
Sommarju tal-prodott:
Revision: 8
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2019-02-18
Fuljett ta 'informazzjoni
22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MULPLEO 3 MG FILM-COATED TABLETS
lusutrombopag
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, pharmacist, or
nurse.
-
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, pharmacist, or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Mulpleo is and what it is used for
2.
What you need to know before you take Mulpleo
3.
How to take Mulpleo
4.
Possible side effects
5.
How to store Mulpleo
6.
Contents of the pack and other information
1.
WHAT MULPLEO IS AND WHAT IT IS USED FOR
Mulpleo contains the active substance lusutrombopag, which belongs to
a group of medicines called
thrombopoietin receptor agonists. The medicine helps to increase the
number of _platelets_ in your
blood. Platelets are blood components that help the blood to clot and
so prevent bleeding.
Mulpleo is used to REDUCE THE RISK OF BLEEDING DURING SURGERY AND
OTHER PROCEDURES (including
tooth extractions and endoscopy). It is given to adults who have low
numbers of platelets because of
chronic liver disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MULPLEO
DO NOT TAKE MULPLEO:
-
IF YOU ARE ALLERGIC to lusutrombopag or any of the other ingredients
of this medicine (listed in
section 6 under ‘_What Mulpleo contains_’).
➤ CHECK WITH YOUR DOCTOR if this applies to you before you take Mulpleo
WARNINGS AND PRECAUTIONS
Talk to your doctor:
-
IF YOU ARE AT RISK OF BLOOD CLOTS in your veins or arteries, or if you
previously have had blood
clots
-
IF YOU HAVE SEVERE LIVER DISEASE
-
IF YOUR SPLEEN HAS BEEN REMOVED
-
IF YOU ARE HAVING INTERFERON TREATMENT.
➤ TALK TO YOUR DOCTOR before taki
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Mulpleo 3 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 3 mg of lusutrombopag.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Light red, 7.0 mm round film-coated tablets debossed with the Shionogi
trademark above the identifier
code “551” on one side and debossed on the other side with the
strength “3”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mulpleo is indicated for the treatment of severe thrombocytopenia in
adult patients with chronic liver
disease undergoing invasive procedures (see section 5.1)._ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 3 mg lusutrombopag once daily for 7 days.
The procedure should be performed from day 9 after the start of
lusutrombopag treatment. Platelet
count should be measured prior to the procedure.
_Missed dose _
If a dose is missed it should be taken as soon as possible. A double
dose should not be taken to make
up for a missed dose.
_Duration of treatment _
Mulpleo should not be taken for more than 7 days.
Special populations
_Elderly _
No dose adjustment is necessary in patients 65 years of age or older
(see section 5.2).
_Renal impairment _
No dose adjustment is necessary in patients with renal impairment (see
section 5.2).
_Hepatic impairment _
Due to limited information available, the safety and efficacy of
Mulpleo in patients with severe hepatic
impairment (Child-Pugh class C) have not been established (see
sections 4.4 and 5.1). No dose
adjustment is expected for these patients. Lusutrombopag therapy
should only be initiated in patients
3
with severe hepatic impairment if the expected benefit outweighs the
expected risks (see sections 4.4
and 5.2). No dose adjustment is necessary for patients with mild
(Child-Pugh class A) to moderate
(Child-Pugh class B) hepatic impairment.
_Paediatric population _
The safety and efficacy of lusutrombopag in ch
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