TIVICAY Film-coated tablet (2023)
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Περιεχόμενα
Name of the medicinal product
Tivicay 10 mg film-coated tablets. Tivicay 25 mg film-coated tablets. Tivicay 50 mg film-coated tablets.
Qualitative and quantitative composition
<u>Tivicay 10 mg film-coated tablets:</u> Each film-coated tablet contains dolutegravir sodium equivalent to 10 mg dolutegravir. <u>Tivicay 25 mg film-coated tablets:</u> Each film-coated tablet contains ...
Pharmaceutical form
Film-coated tablet (tablet). <u>Tivicay 10 mg film-coated tablets:</u> White, round, biconvex tablets approximately 6 mm in diameter debossed with SV 572 on one side and 10 on the other side. <u>Tivicay ...
Therapeutic indications
Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 6 years of ...
Posology and method of administration
Tivicay should be prescribed by physicians experienced in the management of HIV infection. Posology Adults Patients infected with HIV-1 without documented or clinically suspected resistance to the integrase ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Medicinal products with narrow therapeutic windows that are substrates of organic cation transporter 2 (OCT2), ...
Special warnings and precautions for use
Integrase class resistance of particular concern The decision to use dolutegravir in the presence of integrase class resistance should take into account that the activity of dolutegravir is considerably ...
Interaction with other medicinal products and other forms of interaction
Effect of other agents on the pharmacokinetics of dolutegravir All factors that decrease dolutegravir exposure should be avoided in the presence of integrase class resistance. Dolutegravir is eliminated ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential (WOCBP) should be counselled about the potential risk of neural tube defects with dolutegravir (see below), including consideration of effective ...
Effects on ability to drive and use machines
Patients should be informed that dizziness has been reported during treatment with dolutegravir. The clinical status of the patient and the adverse reaction profile of dolutegravir should be borne in mind ...
Undesirable effects
Summary of the safety profile The most severe adverse reaction, seen in an individual patient, was a hypersensitivity reaction that included rash and severe liver effects (see section 4.4). The most commonly ...
Overdose
There is currently limited experience with overdosage in dolutegravir. Limited experience of single higher doses (up to 250 mg in healthy subjects) revealed no specific symptoms or signs, apart from those ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antivirals for systemic use, other antivirals <b>ATC code:</b> J05AJ03 Mechanism of action Dolutegravir inhibits HIV integrase by binding to the integrase active site ...
Pharmacokinetic properties
Dolutegravir pharmacokinetics are similar between healthy and HIV-infected subjects. The PK variability of dolutegravir is low to moderate. In Phase I studies in healthy subjects, between-subject CVb% ...
Preclinical safety data
Dolutegravir was not mutagenic or clastogenic using <em>in vitro</em> tests in bacteria and cultured mammalian cells, and an <em>in vivo</em> rodent micronucleus assay. Dolutegravir was not carcinogenic ...
List of excipients
Tablet core: Mannitol (E421) Microcrystalline cellulose Povidone Sodium starch glycolate Sodium stearyl fumarate Tablet coating: Poly(vinyl alcohol) partially hydrolyzed Titanium dioxide (E171) Macrogol ...
Incompatibilities
Not applicable.
Shelf life
Shelf life Tivicay 10 mg film-coated tablets: 5 years. Tivicay 25 mg film-coated tablets: 4 years. Tivicay 50 mg film-coated tablets: 5 years.
Special precautions for storage
Tivicay 10 mg film-coated tablets: Store in the original package in order to protect from moisture. Keep the bottle tightly closed. Do not remove the desiccant. Do not swallow the desiccant. Tivicay 25 ...
Nature and contents of container
HDPE (high density polyethylene) bottles closed with child resistant polypropylene screw closures, with a polyethylene faced induction heat seal liner. The bottles contain 30 or 90 film-coated tablets. ...
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
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
Marketing authorization number(s)
EU/1/13/892/001 EU/1/13/892/002 EU/1/13/892/003 EU/1/13/892/004 EU/1/13/892/005 EU/1/13/892/006
Date of first authorization / renewal of the authorization
Date of first authorisation: 16 January 2014 Date of latest renewal: 21 September 2018
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