LAGEVRIO Hard capsule (2021)
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Περιεχόμενα
1. Name of the medicinal product
Lagevrio 200 mg hard capsules.
2. Qualitative and quantitative composition
Each hard capsule contains 200 mg of molnupiravir. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule. Swedish Orange, opaque, size 0 (approximately 21.7 mm x 7.6 mm) hard capsule, printed with MSD corporate logo on the cap and 82 on the body in white ink.
4.1. Therapeutic indications
Lagevrio is indicated for treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults with a positive SARS-COV-2 diagnostic test and who have at least one risk factor for developing severe ...
4.2. Posology and method of administration
Posology Adults The recommended dose of Lagevrio is 800 mg (four 200 mg capsules) taken orally every 12 hours for 5 days. The safety and efficacy of molnupiravir when administered for periods longer than ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose of 4 capsules, that is to say essentially sodium-free.
4.5. Interaction with other medicinal products and other forms of interaction
No drug interactions have been identified based on the limited available data. No clinical interaction studies have been performed withmolnupiravir. Molnupiravir is hydrolysed to n-hydroxycytidine (NHC) ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no data from the use of Lagevrio in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Lagevrio is not recommended during pregnancy. Women of childbearing ...
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8. Undesirable effects
Summary of safety profile In an interim analysis of a Phase 3 trial of subjects with mild to moderate COVID-19 treated with molnupiravir (n=386), the most common adverse reactions (≥1% of subjects) reported ...
4.9. Overdose
There is no human experience of overdosage with Lagevrio. Treatment of overdose with Lagevrio should consist of general supportive measures including the monitoring of the clinical status of the patient. ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antivirals for systemic use, direct acting antivirals <b>ATC code:</b> not yet assigned. Mechanism of action Molnupiravir is a prodrug that is metabolised to the ribonucleoside ...
5.2. Pharmacokinetic properties
Molnupiravir is a 5'-isobutyrate prodrug that is hydrolysed to NHC prior to reaching systemic circulation. The pharmacokinetics of NHC are similar in healthy subjects and patients with COVID-19. The pharmacokinetics ...
5.3. Preclinical safety data
General Toxicity Reversible, dose-related bone marrow toxicity affecting all haematopoietic cell lines was observed in dogs at ≥17 mg/kg/day (0.4 times the human NHC exposure at the recommended human dose ...
6.1. List of excipients
<u>Capsule content:</u> Croscarmellose sodium (E468) Hydroxypropyl cellulose (E463) Magnesium stearate (E470b) Microcrystalline cellulose (E460) <u>Capsule shell:</u> Hypromellose (E464) Titanium dioxide ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
18 months.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions. Store in the original package.
6.5. Nature and contents of container
High-density polyethylene (HDPE) bottles with a polypropylene closure containing 40 capsules.
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 (UK) Limited, 120 Moorgate, London, EC2M 6UR, United Kingdom
8. Marketing authorization number(s)
PLGB 53095/0089
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 4th November 2021
10. Date of revision of the text
4<sup>th</sup> November 2021
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