MOVINAVIR 400

MOVINAVIR 400

202203-0207 • 1397 Views • Box of 2 blister x 10 hard capsules
COMPOSITION

Each hard capsule contains:

Active ingredient:

Molnupiravir  400 mg

Excipients: Pregelatinized starch, Crospovidone, Colloidal silicon dioxide, Sodium stearyl fumarate, Sodium lauryl sulfate;  Pearl pink, size 0 hard capsule, printed with “BOSTON” on the body (Gelatin, purified water, tartrazine, patent blue V, ponceau 4R, mica based titanium dioxide).

Intended Use

Molnupiravir 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 illness.

Dosage

 Adults

- The recommended dose of Molnupiravir is 800 mg (two capsules MOVINAVIR 400) taken orally every 12 hours for 5 days.

- The safety and efficacy of molnupiravir when administered for periods longer than 5 days have not been established (see Pharmacodynamic properties).

- Molnupiravir should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset (see Pharmacodynamic properties).

Missed dose

If the patient misses a dose of Molnupiravir within 10 hours of the time it is usually taken, the patient should take as soon as possible and resume the normal dosing schedule. If a patient misses a dose by more than 10 hours, the patient should not take the missed dose and instead take the next dose at the regularly scheduled time. The patient should not double the dose to make up for a missed dose.

Special populations

- Elderly: No dose adjustment of Molnupiravir is required based on age (see Pharmacokinetic properties).

- Renal impairment: No dose adjustment is required for patients with renal impairment (see Pharmacokinetic properties).

- Hepatic impairment: No dose adjustment is required for patients with hepatic impairment (see Pharmacokinetic properties).

- Paediatric population: The safety and efficacy of Molnupiravir in patients below 18 years of age have not been established. No data are available (see Pharmacodynamic properties).

Method of administration

  • For oral use.
  • Molnupiravir 400 mg capsules can be taken with or without food.
  • The capsules should be swallowed whole with a sufficient amount of fluid (e.g., a glass of water). The capsules should not be opened, crushed or chewed.

Contraindication

  • Hypersensitivity to the active substance or to any of the excipients listed in Composition.

Storage

  • In a dry place, below 30°C, protect from light.

Shelf-life

  • 36 months from the manufacturing date. Do not use after the expiry date.

KEEP OUT OF REACH OF CHILDREN.

READ CAREFULLY THE PACKAGE INSERT BEFORE USING.

For further information, do not hesitate to ask your physicians.

Box of 2 blister x 10 hard capsules.

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