MULPLEO Film-coated tablet (2021)
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Περιεχόμενα
Name of the medicinal product
Mulpleo 3 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 3 mg of lusutrombopag. For the full list of excipients, see section 6.1.
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.
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).
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 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Thrombotic/thromboembolic complications Patients with chronic liver disease have a risk of portal vein thrombosis and mesenteric vein thrombosis. The risk may be increased due to an invasive procedure. ...
Interaction with other medicinal products and other forms of interaction
P-gp and BCRP inhibitors Lusutrombopag is a substrate of P-gp and BCRP, but not a substrate of OATP1B1, OATP1B3, and OCT1. In the clinical drug-drug interaction study, co-administration of cyclosporine, ...
Fertility, pregnancy and lactation
Women of childbearing potential/contraception Mulpleo should be used with contraception (see sub-section Pregnancy and section 5.3). Pregnancy There are no or limited amount of data from the use of lusutrombopag ...
Effects on ability to drive and use machines
Lusutrombopag has no known influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most common adverse reactions were headache (4.7%, 8/171 patients in the lusutrombopag group; 3.5%, 6/170 patients in the placebo group), nausea (2.3%, 4/171 patients ...
Overdose
Overdose may induce an excessive increase of platelet counts, and it may subsequently provoke a medically susceptible state to cause thrombosis and thromboembolism. There is no specific antidote for lusutrombopag ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antihemorrhagics, other systemic hemostatics ATC code: B02BX07 Mechanism of action Lusutrombopag is an orally active TPO receptor agonist. Lusutrombopag acts on the haematopoietic ...
Pharmacokinetic properties
Absorption Lusutrombopag is absorbed with a peak concentration occurring 6 to 8 hours after oral administration. The accumulation ratios of the C<sub>max</sub> and the AUC are approximately 2 at once-daily ...
Preclinical safety data
Lusutrombopag does not stimulate platelet production in the species used for toxicological testing because of unique human TPO receptor specificity. Thus, the data from the toxicology program in these ...
List of excipients
Tablet core: Mannitol Microcrystalline cellulose Magnesium oxide Sodium lauryl sulfate Hydroxypropylcellulose Carmellose calcium Magnesium stearate Film-coating: Hypromellose Titanium dioxide Triethyl ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.
Nature and contents of container
OPA/Aluminium foil/PVC film blister with push through aluminium lidding foil, packed in a cardboard box. Each box contains 7 film-coated tablets.
Special precautions for disposal and other handling
This medicinal product may pose a risk to the environment (see section 5.3). Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Shionogi B.V., Kingsfordweg 151, 1043GR, Amsterdam, The Netherlands
Marketing authorization number(s)
EU/1/18/1348
Date of first authorization / renewal of the authorization
02/2019
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