PREVYMIS Film-coated tablet (2020)
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Περιεχόμενα
Name of the medicinal product
PREVYMIS 240 mg film-coated tablets. PREVYMIS 480 mg film-coated tablets.
Qualitative and quantitative composition
PREVYMIS 240 mg film-coated tablets: Each film-coated tablet contains 240 mg of letermovir. PREVYMIS 480 mg film-coated tablets: Each film-coated tablet contains 480 mg of letermovir. Excipients with known ...
Pharmaceutical form
Film-coated tablet (tablet). PREVYMIS 240 mg film-coated tablets: Yellow oval tablet of dimensions 16.5 mm x 8.5 mm, debossed with 591 on one side and MSD logo on the other side. PREVYMIS 480 mg film-coated ...
Therapeutic indications
PREVYMIS is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT). Consideration ...
Posology and method of administration
PREVYMIS should be initiated by a physician experienced in the management of patients who have had an allogeneic haematopoietic stem cell transplant. Posology PREVYMIS is also available as concentrate ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant administration with pimozide (see sections 4.4 and 4.5). Concomitant administration with ergot alkaloids ...
Special warnings and precautions for use
Monitoring of CMV DNA The safety and efficacy of letermovir has been established in patients with a negative CMV DNA test result prior to initiation of prophylaxis. CMV DNA was monitored on a weekly basis ...
Interaction with other medicinal products and other forms of interaction
General information about differences in exposure between different letermovir treatment regimens The estimated letermovir plasma exposure is different depending on the dose regimen used (see table in ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of letermovir in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). PREVYMIS is not recommended during pregnancy and in women ...
Effects on ability to drive and use machines
PREVYMIS may have minor influence on the ability to drive or use machines. Fatigue and vertigo have been reported in some patients during treatment with PREVYMIS, which may influence a patients ability ...
Undesirable effects
Summary of the safety profile The safety assessment of PREVYMIS was based on a Phase 3 clinical trial (P001) in HSCT recipients who received PREVYMIS or placebo through Week 14 post-transplant and were ...
Overdose
There is no experience with human overdose with PREVYMIS. During Phase 1 clinical trials, 86 healthy subjects received doses ranging from 720 mg/day to 1440 mg/day of PREVYMIS for up to 14 days. The adverse ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antivirals for systemic use, direct acting antivirals ATC code: J05AX18 Mechanism of action Letermovir inhibits the CMV DNA terminase complex which is required for cleavage and ...
Pharmacokinetic properties
The pharmacokinetics of letermovir have been characterized following oral and IV administration in healthy subjects and HSCT recipients. Letermovir exposure increased in a greater than dose-proportional ...
Preclinical safety data
General toxicity Irreversible testicular toxicity was noted only in rats at systemic exposures (AUC) ≥3-fold the exposures in humans at the recommended human dose (RHD). This toxicity was characterized ...
List of excipients
Tablet core: Microcrystalline cellulose (E460) Croscarmellose sodium (E468) Povidone (E1201) Colloidal anhydrous silica (E551) Magnesium stearate (E470b) Film-coating: Lactose monohydrate Hypromellose ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 30 months.
Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.
Nature and contents of container
240 mg film-coated tablets: Polyamide/Aluminium/PVC – Aluminium blister card. Each carton contains four (4) cardboard cards, each containing a 7-count blister card for a total of 28 tablets. 480 mg film-coated ...
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
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Marketing authorization number(s)
EU/1/17/1245/001 EU/1/17/1245/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 8 January 2018
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