DOPTELET Film-coated tablet (2021)

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

Περιεχόμενα

1. Name of the medicinal product

Doptelet 20 mg film-coated tablets.

2. Qualitative and quantitative composition

Each film-coated tablet contains avatrombopag maleate equivalent to 20 mg of avatrombopag. Excipient with known effect: Each film-coated tablet contains 120.8 mg of lactose monohydrate. For the ...

3. Pharmaceutical form

Film-coated tablet (tablet). Pale yellow, round biconvex film-coated 7.6 mm tablet debossed with AVA on one side and 20 on the other.

4.1. Therapeutic indications

Doptelet is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure. Doptelet is indicated for the treatment ...

4.2. Posology and method of administration

Posology Treatment should be initiated by and remain under the supervision of a physician who is experienced in the treatment of haematological diseases. Doptelet should be taken at the same time of day ...

4.3. Contraindications

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

4.4. Special warnings and precautions for use

Thrombotic/thromboembolic events Patients with chronic liver disease are known to be at increased risk for thromboembolic events. Portal vein thrombosis has been reported at an increased frequency in patients ...

4.5. Interaction with other medicinal products and other forms of interaction

P-gp inhibitors Concomitant use of avatrombopag with P-gp inhibitors resulted in alterations in exposure that were not clinically significant. No dose adjustment is recommended (see section 5.2). CYP3A4/5 ...

4.6. Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of avatrombopag in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). Doptelet is not ...

4.7. Effects on ability to drive and use machines

Doptelet has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Summary of the safety profile Chronic Liver Disease The safety of avatrombopag was evaluated in two randomised, double-blind, placebo-controlled trials, ADAPT-1 and ADAPT-2, in which 430 patients with ...

4.9. Overdose

There is no specific antidote for overdose with avatrombopag. Should overdose occur or be suspected, Doptelet dosing should be stopped and platelet count should be carefully monitored since avatrombopag ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antihemorrhagics, other systemic hemostatics ATC code: B02BX08 Mechanism of action Avatrombopag is an orally active, small molecule thrombopoietin (TPO) receptor ...

5.2. Pharmacokinetic properties

Absorption The plasma concentration-time profiles following the oral administration of avatrombopag were characterised by a short lag time (0.5–0.75 hours) with peak exposure at 6–8 hours post dose. In ...

5.3. Preclinical safety data

Avatrombopag does not stimulate platelet production in mice, rats, monkeys, or dogs because of the unique TPO receptor specificity. Therefore, data from these animal studies do not fully model potential ...

6.1. List of excipients

Tablet core: Lactose monohydrate Microcrystalline cellulose (E460(i)) Crospovidone type B (E1202) Silica, colloidal anhydrous (E551) Magnesium stearate (E470b) Film coating: Poly(vinyl alcohol) ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

Blister (polyamide and polyvinyl chloride-laminated aluminium film with push-through aluminium and polyethylene terephthalate foil) containing either 10 or 15 film-coated tablets. Each carton contains ...

6.6. Special precautions for disposal and other handling

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

7. Marketing authorization holder

Swedish Orphan Biovitrum AB (publ), SE-112 76 Stockholm, Sweden

8. Marketing authorization number(s)

EU/1/19/1373/001 EU/1/19/1373/002 EU/1/19/1373/003

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 20 June 2019

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

application/pdf