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DELSTRIGO Film-coated tablet (2021)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Delstrigo 100 mg/300 mg/245 mg film-coated tablets.

2. Qualitative and quantitative composition

Each film-coated tablet contains 100 mg of doravirine, 300 mg of lamivudine, and 300 mg of tenofovir disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil. <u>Excipient with known effect:</u> ...

3. Pharmaceutical form

Film-coated tablet. Yellow, oval-shaped, tablet of dimensions 21.59 mm x 11.30 mm, debossed with the corporate logo and 776 on one side and plain on the other side.

4.1. Therapeutic indications

Delstrigo is indicated for the treatment of adults infected with HIV-1 without past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir (see sections 4.4 and 5.1).

4.2. Posology and method of administration

Therapy should be initiated by a physician experienced in the management of HIV infection. Posology The recommended dose of Delstrigo is one 100/300/245 mg tablet taken orally once daily with or without ...

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Co-administration with medicinal products that are strong cytochrome P450 CYP3A enzyme inducers is contraindicated ...

4.4. Special warnings and precautions for use

While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission of HIV-1, a residual risk cannot be excluded. Precautions to prevent ...

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

Delstrigo is a complete regimen for the treatment of HIV-1 infection; therefore, Delstrigo should not be administered with other antiretroviral medicinal products. Information regarding potential medicinal ...

4.6. Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of doravirine in pregnant women. A large amount of data on pregnant women (more than 3,000 outcomes from first trimester) taking the individual ...

4.7. Effects on ability to drive and use machines

Delstrigo may have a minor influence on the ability to drive and use machines. Patients should be informed that fatigue, dizziness, and somnolence have been reported during treatment with Delstrigo (see ...

4.8. Undesirable effects

Summary of the safety profile The most frequently reported adverse reactions considered possibly or probably related to doravirine were nausea (4%) and headache (3%). Tabulated summary of adverse reactions ...

4.9. Overdose

Doravirine There is no information on potential acute symptoms and signs of overdose with doravirine. Lamivudine Because a negligible amount of lamivudine was removed via (4-hour) haemodialysis, continuous ...

5.1. Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> Antivirals for systemic use <b>ATC code:</b> J05AR24 Mechanism of action Doravirine Doravirine is a pyridinone non-nucleoside reverse transcriptase inhibitor of HIV-1 ...

5.2. Pharmacokinetic properties

Single-dose administration of one doravirine/lamivudine/tenofovir disoproxil tablet to healthy subjects (N = 24) under fasted conditions provided comparable exposures of doravirine, lamivudine, and tenofovir ...

5.3. Preclinical safety data

Reproductive toxicity Doravirine Reproduction studies with orally administered doravirine have been performed in rats and rabbits at exposures approximately 9 times (rats) and 8 times (rabbits) the exposure ...

6.1. List of excipients

<u>Tablet core:</u> Croscarmellose sodium (E468) Hypromellose acetate succinate Magnesium stearate (E470b) Microcrystalline cellulose (E460) Silica, colloidal anhydrous (E551) Sodium stearyl fumarate ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

30 months.

6.4. Special precautions for storage

Store in the original bottle and keep the bottle tightly closed to protect from moisture. Do not remove the desiccant. This medicinal product does not require any special temperature storage conditions. ...

6.5. Nature and contents of container

Each carton contains a high density polyethylene (HDPE) bottle with a polypropylene child-resistant closure with silica gel desiccants. The following pack sizes are available: 1 bottle with 30 film-coated ...

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

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

8. Marketing authorization number(s)

EU/1/18/1333/001 EU/1/18/1333/002

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 22 November 2018

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