CELSENTRI maraviroc 300 mg tablets blister packs

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

maraviroc, Quantity: 300 mg

थमां उपलब्ध:

ViiV Healthcare Pty Ltd

INN (इंटरनेशनल नाम):

Maraviroc

फार्मास्यूटिकल फॉर्म:

Tablet, film coated

रचना:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; sodium starch glycollate; calcium hydrogen phosphate; Colour

प्रशासन का मार्ग:

Oral

पैकेज में यूनिट:

60 tablet blister pack

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

CELSENTRI, in combination with other antiretroviral medicinal products, is indicated for adult patients infected with only CCR5-tropic HIV-1.,The use of other active agents with CELSENTRI is associated with a greater likelihood of treatment response.

उत्पाद समीक्षा:

Visual Identification: Blue, biconvex, oval film-coated tablets debossed with "MVC" followed by the tablet strength on one tablet side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

प्राधिकरण का दर्जा:

Licence status A

प्राधिकरण की तारीख:

2008-02-04

सूचना पत्रक

CELSENTRI
_FILM-COATED TABLETS_
_Maraviroc_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CELSENTRI.
It does not contain all the information
available. It does not take the place
of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using CELSENTRI
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CELSENTRI IS
USED FOR
_WHAT CELSENTRI DOES_
CELSENTRI is used in combination
with other anti-HIV medicines to
treat HIV. It reduces the amount of
HIV in your body and helps your
immune system.
CELSENTRI is not a cure for HIV or
AIDS. You should take appropriate
precautions to prevent transmission.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CELSENTRI
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
CELSENTRI for another medical
condition.
This medicine is available only with
a doctor's prescription.
_HOW CELSENTRI WORKS_
CELSENTRI's active ingredient
(maraviroc) belongs to a group of
medicines called 'CCR5 blockers'.
CELSENTRI stops the HIV-1 virus
entering the CD-4 cells in your blood
(also called T-cells). These are the
cells in your immune system that the
HIV virus attacks.
CELSENTRI works by blocking the
most common entry point into the
CD-4 cells – called the 'CCR5
receptor'. Because the virus cannot
enter the cell, it cannot attack it, and
this prevents further damage to your
immune system.
CELSENTRI only stops the HIV-1
virus entering the cell, not HIV-2
(another rarer kind of the HIV virus).
CELSENTRI also only stops types of
HIV-1 that enter using the CCR5
receptor. Because of this, your doctor
would have done a blood test to
check what strain of HIV-1 you have
before they prescribed CELSENTRI.
CELSENTRI has not been studied in
children less than 18 years of age.
More treatment-naïve patients in
clinical stud

उत्पाद विशेषताएं

1
AUSTRALIAN PRODUCT INFORMATION
CELSENTRI (MARAVIROC) TABLETS
1
NAME OF THE MEDICINE
Maraviroc
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains either 150 or 300 mg of maraviroc.
Tablets contain no excipients with a known effect. For the full list
of excipients, see Section
6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
CELSENTRI

150 mg and 300 mg film-coated tablets.
CELSENTRI is supplied for oral administration in two strengths: 150
and 300 mg blue,
biconvex, oval film-coated tablets debossed with “MVC” followed by
the tablet strength on
one tablet side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CELSENTRI, in combination with other antiretroviral medicinal
products, is indicated for
adult patients infected with only CCR5-tropic HIV-1.
The use of other active agents with CELSENTRI is associated with a
greater likelihood of
treatment response.
4.2
DOSE AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
The following points should be considered when initiating therapy with
CELSENTRI:
•
Tropism testing using an assay with appropriate validation and
sensitivity, resistance
testing and treatment history should guide the use of CELSENTRI.
•
Adult patients infected with only CCR5-tropic HIV-1 should use
CELSENTRI.
•
CCR5 tropism should be confirmed using a highly sensitive,
appropriately validated
tropism assay prior to initiation of CELSENTRI therapy. Outgrowth of
pre-existing low-
level CXCR4 or dual/mixed-tropic HIV-1 not detected by tropism testing
at screening
has been associated with virologic failure on CELSENTRI.
•
CELSENTRI is not recommended in patients with dual/mixed or
CXCR4-tropic HIV-1.
•
In treatment-naïve subjects, more subjects treated with CELSENTRI
experienced
virologic failure and developed lamivudine resistance compared to
efavirenz.
2
•
The safety and efficacy of CELSENTRI have not been established in
children younger
than 18 years of age.
ADULTS
The recommended dose of CE