ISENTRESS Film-coated tablet (2019)
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Περιεχόμενα
Name of the medicinal product
ISENTRESS 600 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 600 mg of raltegravir (as potassium). Excipient with known effect: Each 600 mg tablet contains 5.72 mg lactose (as monohydrate). For the full list of excipients, see section ...
Pharmaceutical form
Film-coated tablet. Yellow, oval-shaped, dimensions 19.1 mm x 9.7 mm x 6.1 mm, marked with MSD corporate logo and 242 on one side and plain on the other side.
Therapeutic indications
ISENTRESS 600 mg film-coated tablets is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults, and paediatric ...
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, raltegravir is a weak inhibitor of organic anion transporter (OAT) 1 (IC50 of 109 µM) and OAT3 (IC50 of 18.8 µM). Caution is recommended when co-administering raltegravir 1,200 mg once daily ...
Fertility, pregnancy and lactation
Pregnancy There are no data for the use of raltegravir 1,200 mg once daily 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 T<sub>max</sub> of approximately 3 hours postdose. ...
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
Tablet core: Microcrystalline cellulose Hypromellose 2910 Magnesium stearate Croscarmellose sodium Film-coating: Lactose monohydrate Hypromellose 2910 Titanium dioxide Triacetin Iron oxide yellow Black ...
Incompatibilities
Not applicable.
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 dessicant. Two pack sizes are available: 1 bottle with 60 tablets, and a multipack containing ...
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/1/07/436/006 EU/1/07/436/007
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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