ISENTRESS Chewable tablet (2019)
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Περιεχόμενα
Name of the medicinal product
ISENTRESS 25 mg chewable tablets. ISENTRESS 100 mg chewable tablets.
Qualitative and quantitative composition
Each chewable tablet contains 25 mg of raltegravir (as potassium). Each chewable tablet contains 100 mg of raltegravir (as potassium). Excipients with known effect 25 mg: Each chewable tablet contains ...
Pharmaceutical form
Chewable tablet. Chewable tablet 25 mg: Pale yellow, round, chewable tablet with MSD corporate logo on one side and 473 on the other side. Chewable tablet 100 mg: Pale orange coloured, oval shaped, chewable ...
Therapeutic indications
ISENTRESS is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection (see sections 4.2, 4.4, 5.1 and 5.2).
Posology and method of administration
Therapy should be initiated by a physician experienced in the management of HIV infection. Posology ISENTRESS should be used in combination with other active anti-retroviral therapies (ARTs) (see sections ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
General Patients should be advised that current anti-retroviral therapy does not cure HIV and has not been proven to prevent the transmission of HIV to others through blood contact. While effective viral ...
Interaction with other medicinal products and other forms of interaction
In vitro studies indicate that raltegravir is not a substrate of cytochrome P450 (CYP) enzymes, does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A, does not inhibit UDP glucuronosyltransferases ...
Fertility, pregnancy and lactation
Pregnancy There are no data for the use of raltegravir chewable tablets in pregnant women. A moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes from first trimester exposure) ...
Effects on ability to drive and use machines
Dizziness has been reported in some patients during treatment with regimens containing raltegravir. Dizziness may influence some patients' ability to drive and use machines (see section 4.8).
Undesirable effects
Summary of the safety profile In randomised clinical trials raltegravir 400 mg twice daily was administered in combination with fixed or optimised background treatment regimens to treatment-naïve (N=547) ...
Overdose
No specific information is available on the treatment of overdose with raltegravir. In the event of an overdose, it is reasonable to employ the standard supportive measures, e.g., remove unabsorbed material ...
Pharmacodynamic properties
Pharmacotherapeutic group: antivirals for systemic use, other antivirals ATC code: J05AX08 Mechanism of action Raltegravir is an integrase strand transfer inhibitor active against the Human Immunodeficiency ...
Pharmacokinetic properties
Absorption As demonstrated in healthy volunteers administered single oral doses of raltegravir in the fasted state, raltegravir is rapidly absorbed with a tmax of approximately 3 hours postdose. Raltegravir ...
Preclinical safety data
Non-clinical toxicology studies, including conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, developmental toxicity and juvenile toxicity, have been conducted with raltegravir ...
List of excipients
Chewable tablet 25 mg: Hydroxypropyl cellulose Sucralose Saccharin sodium Sodium citrate dihydrate Mannitol Monoammonium glycyrrhizinate Sorbitol (E420) Fructose Banana flavour Orange flavour Masking flavour ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Keep the bottle tightly closed, with the desiccant in order to protect from moisture.
Nature and contents of container
High density polyethylene (HDPE) bottle with a child-resistant polypropylene closure, induction seal and silica gel desiccant: 60 tablets.
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Marketing authorization number(s)
EU/1/07/436/003 25 mg EU/1/07/436/004 100 mg
Date of first authorization / renewal of the authorization
Date of first authorisation: 20 December 2007 Date of latest renewal: 14 May 2014
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