DOVATO 50/300 dolutegravir (as sodium) 50 mg/lamivudine 300 mg tablet bottle

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

lamivudine, Quantity: 300 mg; dolutegravir sodium, Quantity: 52.6 mg (Equivalent: dolutegravir, Qty 50 mg)

から入手可能:

ViiV Healthcare Pty Ltd

医薬品形態:

Tablet, film coated

構図:

Excipient Ingredients: sodium starch glycollate type A; povidone; mannitol; titanium dioxide; microcrystalline cellulose; sodium stearylfumarate; magnesium stearate; hypromellose; macrogol 400

投与経路:

Oral

パッケージ内のユニット:

30

処方タイプ:

(S4) Prescription Only Medicine

適応症:

DOVATO (a fixed dose combination of dolutegravir and lamivudine) is indicated for the treatment of Human Immunodeficiency Virus-1 (HIV-1) infection in adults and adolescents (from 12 years of age weighing at least 40kg): ? in antiretroviral treatment-na?ve patients with no antiretroviral treatment history who have no known or suspected resistance to either antiretroviral component; or ? to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to the integrase inhibitor class or lamivudine (see section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials).

製品概要:

Visual Identification: Oval, biconvex, white, film-coated tablet, debossed with SV 137 on one face; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

認証ステータス:

Registered

承認日:

2019-09-12

情報リーフレット

DOVATO
_Dolutegravir/lamivudine combination tablet_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DOVATO. 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 DOVATO
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 DOVATO IS USED
FOR
DOVATO is used to treat HIV
(human immunodeficiency virus)
infection in adults and in children
over the age of 12 years.
DOVATO contains two active
ingredients that are used to treat HIV
infection: dolutegravir and
lamivudine. Dolutegravir belongs to
a group of anti-retroviral medicines
called integrase inhibitors (INIs).
Lamivudine belongs to a group of
anti-retroviral medicines called
nucleoside analogue reverse
transcriptase inhibitors (NRTIs).
DOVATO does not cure HIV
infection, it reduces the amount of
virus in your body and keeps it at a
low level. DOVATO also increases
the CD4 cell count in your blood.
CD4+ cells are a type of white blood
cell that are important in helping
your body to fight infection.
Not everyone responds to treatment
with DOVATO in the same way.
Your doctor will monitor the
effectiveness of your treatment.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
DOVATO is not addictive.
DOVATO is not recommended for
children under the age of 12 years as
the dosage cannot be modified.
DOVATO is only available with a
doctor's prescription.
DOVATO is not expected to affect
your ability to drive a car or operate
machinery.
BEFORE YOU TAKE
DOVATO
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE DOVATO IF:
•
you have ever had an allergic
reaction to any medicine
containing dolutegravir or
lamivudine.
•
you are allergic to any of the
ingredients listed at the end of

製品の特徴

1
AUSTRALIAN PRODUCT INFORMATION
DOVATO (DOLUTEGRAVIR/LAMIVUDINE FIXED-DOSE COMBINATION)
FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Dolutegravir (as dolutegravir sodium) and lamivudine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DOVATO film-coated tablets contain 50 mg of dolutegravir (as
dolutegravir sodium) and 300
mg of lamivudine. Product information for dolutegravir and lamivudine
contain additional
information.
Dolutegravir sodium is a white to light yellow powder.
Lamivudine is a white to off-white crystalline solid.
DOVATO tablets also contain mannitol.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Oval, biconvex, white, film-coated tablet, debossed with “SV 137”
on one face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DOVATO (a fixed dose combination of dolutegravir and lamivudine) is
indicated for the
treatment of Human Immunodeficiency Virus-1 (HIV-1) infection in
adults and adolescents
(from 12 years of age weighing at least 40 kg):
•
in antiretroviral treatment-naïve patients with no antiretroviral
treatment history who have
no known or suspected resistance to either antiretroviral component;
or
•
to replace the current antiretroviral regimen in those who are
virologically suppressed
(HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral
regimen with no history
of treatment failure and with no known or suspected resistance to the
integrase inhibitor
class or lamivudine (see section 5.1 PHARMACODYNAMIC PROPERTIES,
Clinical
trials).
4.2
DOSE AND METHOD OF ADMINISTRATION
DOVATO therapy should be initiated by a physician experienced in the
management of HIV
infection.
DOVATO can be taken with or without food.
DOVATO is a fixed-dose tablet and should not be prescribed for
patients requiring dosage
adjustments, such as those with creatinine clearance less than 50
mL/min.
2
Separate preparations of dolutegravir or lamivudine should be
administered in cases where
discontinuation or dose adjustments are required. In these cases, the
physic