Celsentri

País: Nova Zelândia

Língua: inglês

Origem: Medsafe (Medicines Safety Authority)

Ingredientes ativos:

Maraviroc 150mg;  

Disponível em:

GlaxoSmithKline NZ Limited

DCI (Denominação Comum Internacional):

Maraviroc 150 mg

Dosagem:

150 mg

Forma farmacêutica:

Film coated tablet

Composição:

Active: Maraviroc 150mg   Excipient: Calcium hydrogen phosphate Magnesium stearate Microcrystalline cellulose Opadry blue 85G20583 Sodium starch glycolate

Unidades em pacote:

Blister pack, PVC/Al, 60 tablets

Classe:

Prescription

Tipo de prescrição:

Prescription

Fabricado por:

Ajinomoto OmniChem SA

Indicações terapêuticas:

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.

Resumo do produto:

Package - Contents - Shelf Life: Blister pack, PVC/Al - 60 tablets - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE with PP closure - 180 tablets - 24 months from date of manufacture stored at or below 30°C

Data de autorização:

2008-01-04

Folheto informativo - Bula

Celsentri
 ® 

1 
CELSENTRI 
®

_maraviroc _
CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 
Please read this leaflet carefully 
before you start taking Celsentri. 
This leaflet answers some common 
questions about Celsentri. 
It does not contain all the available 
information.  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 taking Celsentri 
against the benefits they expect it 
will have for you.  
IF YOU HAVE ANY CONCERNS ABOUT 
TAKING 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 
Celsentri is used in combination with 
other anti-HIV medicines in the 
treatment of HIV-1 infection.  Its 
active ingredient, maraviroc, belongs 
to a group of medicines called CCR5 
blockers. 
Celsentri prevents the entry of HIV-1 
into the cells in your blood that are 
attacked by the HIV virus (called 
CD4 or T-cells).  Celsentri works by 
blocking the CCR5 receptor which is 
the most common gateway the HIV 
virus uses to gain entry into these 
cells.  
Celsentri reduces the amount of HIV 
in your body and enhances your 
immune system. 
You should be aware that Celsentri is 
not a cure for HIV or AIDS and that 
appropriate precautions should be 
taken to prevent transmission. 
Celsentri should be taken in 
combination with other medicines 
used to treat HIV. 
ASK YOUR DOCTOR IF YOU HAVE ANY 
QUESTIONS ABOUT WHY CELSENTRI HAS 
BEEN PRESCRIBED FOR YOU. 
 Your doctor may have prescribed 
Celsentri for another reason.   
This medicine is only available with 
a doctor’s prescription. 

BEFORE YOU TAKE 
CELSENTRI 
_WHEN YOU MUST NOT USE IT  _
Do not take CELSENTRI if you have 
an allergy to: 
  any medicine containing 
mara

Características técnicas

_THE MEDICINE IS NOT CURRENTLY MARKETED IN NEW ZEALAND_
_ _

Page 1 of 23 
DATA SHEET 
CELSENTRI

 (MARAVIROC) 
NAME OF THE MEDICINE 
CELSENTRI

 150 mg and 300 mg film-coated tablets. 
DESCRIPTION 
Maraviroc is a white to pale coloured powder with a molecular weight
of 513.67. It is highly 
soluble across the physiological pH range (pH 1.0 to 7.5). Maraviroc
is chemically described 
as
4,4-difluoro-_N_-{(1_S_)-3_-_[_exo_-3-(3-isopropyl-5-methyl-4_H_-1,2,4-triazol-4-yl)-8-
azabicyclo[3.2.1]oct-8-yl]-1-phenylpropyl}cyclohexanecarboxamide. 
The molecular formula is C
29
H
41
F
2
N
5
O and the structural formula is: 
N H
O
F
F
N
N
N
N
C
H
3
C
H
3
C H
3

CAS no.: 376348-65-1 
CELSENTRI is supplied for oral administration in two strengths: 150
and 300 mg blue, 
biconvex, oval film-coated tablets debossed with “MVC 150” or
“MVC 300” on one side. 
Each film-coated tablet contains either 150 or 300 mg of maraviroc
and the following 
inactive ingredients: microcrystalline cellulose, calcium hydrogen
phosphate (anhydrous), 
sodium starch glycollate, magnesium stearate. The film-coat [Opadry
 II Blue (85G20583)] 
contains indigo carmine CI73015, soya lecithin, macrogol 3350,
polyvinyl alcohol, talc and 
titanium dioxide. 
PHARMACOLOGY 
PHARMACOLOGICAL ACTIONS 
Pharmacotherapeutic group: Antivirals for systemic use, Other
Antivirals 
ATC code: J05AX09 
Mechanism of action: 
Maraviroc is a member of a therapeutic class called CCR5 antagonists.
Maraviroc selectively 
binds to the human chemokine receptor CCR5,
preventing CCR5-tropic HIV-1 from entering 
cells. 
_THE MEDICINE IS NOT CURRENTLY MARKETED IN NEW ZEALAND_
_ _

Page 2 of 23 
Antiviral activity in vitro: 
Maraviroc inhibits the entry and replication of CCR5-tropic laboratory
strains and clinical 
isolates of HIV-1 in models of acute T-cell infection. The in vitro IC
50
 (50% inhibitory 
concentration) for maraviroc against the replication of HIV-1 group M
isolates (subtypes A 
to J and