RITONAVIR MYLAN Film-coated tablet (2019)
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
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Ritonavir Mylan 100 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 100 mg of ritonavir. Excipient with known effect: Each film-coated tablet contains 87.75 mg of sodium. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet (tablet). Yellow, capsule shaped film-coated tablet, approximately 19.1 mm x 10.2 mm, debossed with M163 on one side and plain on the other side.
Therapeutic indications
Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infected patients (adults and children of 2 years of age and older).
Posology and method of administration
Ritonavir Mylan should be administered by physicians who are experienced in the treatment of HIV infection. Posology Ritonavir dosed as a pharmacokinetic enhancer When ritonavir is used as a pharmacokinetic ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. When ritonavir is used as a pharmacokinetic enhancer of other PIs, consult the Summary of Product Characteristics ...
Special warnings and precautions for use
Ritonavir is not a cure for HIV-1 infection or AIDS. Patients receiving ritonavir or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV-1 infection. ...
Interaction with other medicinal products and other forms of interaction
Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent Ritonavir has a high affinity for several cytochrome P450 (CYP) isoforms and may inhibit oxidation with the following ranked ...
Fertility, pregnancy and lactation
Pregnancy A large amount (6100 live births) of pregnant women were exposed to ritonavir during pregnancy; of these, 2800 live births were exposed during the first trimester. These data largely refer to ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Dizziness is a known undesirable effect that should be taken into account when driving or using machinery.
Undesirable effects
Summary of the safety profile Ritonavir dosed as a pharmacokinetic enhancer Adverse reactions associated with the use of ritonavir as a pharmacokinetic enhancer are dependent on the specific co-administered ...
Overdose
Symptoms Human experience of acute overdose with ritonavir is limited. One patient in clinical trials took ritonavir 1,500 mg/day for two days and reported paraesthesia, which resolved after the dose was ...
Pharmacodynamic properties
Pharmacotherapeutic group: antivirals for systemic use, protease inhibitors ATC code: J05AE03 Ritonavir dosed as a pharmacokinetic enhancer Pharmacokinetic enhancement by ritonavir is based on ritonavir ...
Pharmacokinetic properties
Absorption There is no parenteral formulation of ritonavir, therefore the extent of absorption and absolute bioavailability have not been determined. The pharmacokinetics of ritonavir during multiple dose ...
Preclinical safety data
Repeated dose toxicity studies in animals identified major target organs as the liver, retina, thyroid gland and kidney. Hepatic changes involved hepatocellular, biliary and phagocytic elements and were ...
List of excipients
Tablet: Copovidone Sorbitan laurate Silica, colloidal anhydrous Sodium chloride Sodium stearyl fumarate Film-coating: Hypromellose Titanium dioxide (E171) Macrogols Hydroxypropylcellulose Talc Iron oxide ...
Incompatibilities
Not applicable.
Shelf life
Shelf-life: 2 years. After first opening, use within 100 days.
Special precautions for storage
Do not store above 30°C. Store in the original bottle in order to protect from moisture.
Nature and contents of container
HDPE bottle with polypropylene screw cap with inbuilt desiccant. Pack sizes: 30, 90, 100 and multipack containing 90 (3 bottles of 30) film-coated tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Mylan S.A.S., 117 Allée des Parcs, Saint-Priest, 69800, France
Marketing authorization number(s)
EU/1/17/1242/001 EU/1/17/1242/002 EU/1/17/1242/003 EU/1/17/1242/004
Date of first authorization / renewal of the authorization
Date of first authorisation: 10 November 2017
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
