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REVOLADE Film-coated tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Revolade 12.5 mg film-coated tablets. Revolade 25 mg film-coated tablets. Revolade 50 mg film-coated tablets. Revolade 75 mg film-coated tablets.

Qualitative and quantitative composition

Revolade 12.5 mg film-coated tablets: Each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg eltrombopag. Revolade 25 mg film-coated tablets: Each film-coated tablet contains eltrombopag ...

Pharmaceutical form

Film-coated tablet. Revolade 12.5 mg film-coated tablets: White, round, biconvex film-coated tablet (approximately 7.9 mm in diameter) debossed with GS MZ1 and 12.5 on one side. Revolade 25 mg film-coated ...

Therapeutic indications

Revolade is indicated for the treatment of patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments ...

Posology and method of administration

Eltrombopag treatment should be initiated by and remain under the supervision of a physician who is experienced in the treatment of haematological diseases or the management of chronic hepatitis C and ...

Contraindications

Hypersensitivity to eltrombopag or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

There is an increased risk for adverse reactions, including potentially fatal hepatic decompensation and thromboembolic events, in thrombocytopenic HCV patients with advanced chronic liver disease, as ...

Interaction with other medicinal products and other forms of interaction

Effects of eltrombopag on other medicinal products HMG CoA reductase inhibitors Administration of eltrombopag 75 mg once daily for 5 days with a single 10 mg dose of the OATP1B1 and BCRP substrate rosuvastatin ...

Pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of eltrombopag in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. ...

Effects on ability to drive and use machines

Eltrombopag has negligible influence on the ability to drive and use machines. The clinical status of the patient and the adverse reaction profile of eltrombopag, including dizziness and lack of alertness, ...

Undesirable effects

Summary of the safety profile Immune thrombocytopenia in adult and paediatric patients The safety of Revolade was assessed using the pooled double-blind, placebo-controlled studies TRA100773A and B, TRA102537 ...

Overdose

In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications. In case of an overdose, consideration should be given to oral administration of ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antihemorrhagics, other systemic hemostatics ATC code: B02BX05 Mechanism of action TPO is the main cytokine involved in regulation of megakaryopoiesis and platelet production, ...

Pharmacokinetic properties

Pharmacokinetics The plasma eltrombopag concentration-time data collected in 88 patients with ITP in studies TRA100773A and TRA100773B were combined with data from 111 healthy adult subjects in a population ...

Preclinical safety data

Safety pharmacology and repeat-dose toxicity Eltrombopag does not stimulate platelet production in mice, rats or dogs because of unique TPO receptor specificity. Therefore, data from these animals do not ...

List of excipients

Revolade 12.5 mg film-coated tablets: Tablet core: Magnesium stearate Mannitol (E421) Microcrystalline cellulose Povidone Sodium starch glycolate Tablet coating: Hypromellose (E464) Macrogol 400 (E1521) ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 4 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Film-coated tablets: Aluminum blisters (PA/Alu/PVC/Alu) in a carton containing 14 or 28 film-coated tablets and multipacks containing 84 (3 packs of 28) film-coated tablets. Not all pack sizes may be marketed. ...

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization number(s)

Revolade 12.5 mg film-coated tablets: EU/1/10/612/010 EU/1/10/612/011 EU/1/10/612/012 Revolade 25 mg film-coated tablets: EU/1/10/612/001 EU/1/10/612/002 EU/1/10/612/003 Revolade 50 mg film-coated tablets: ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 11 March 2010 Date of latest renewal: 15 January 2015

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