3TC lamivudine 10mg/mL oral liquid solution bottle

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

lamivudine, Quantity: 10 mg/mL

Disponible desde:

ViiV Healthcare Pty Ltd

formulario farmacéutico:

Oral Liquid, solution

Composición:

Excipient Ingredients: citric acid; sodium hydroxide; propyl hydroxybenzoate; purified water; hydrochloric acid; sodium citrate dihydrate; methyl hydroxybenzoate; propylene glycol; sucrose; Flavour

Vía de administración:

Oral

Unidades en paquete:

240mL

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

3TC (lamivudine) in combination with other antiretroviral agents is indicated for the treatment of HIV infected adults and children.

Resumen del producto:

Visual Identification: Clear, colourless to pale yellow solution, with the odour of fruit.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Estado de Autorización:

Registered

Fecha de autorización:

1998-06-09

Información para el usuario

3TC ORAL SOLUTION
_lamivudine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you start 3TC oral solution.
This leaflet answers some common
questions about 3TC oral solution. It
does not contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist (also
known as a chemist).
All medicines have benefits and
risks. Sometimes new risks are found
even when a medicine has been used
for many years. Your doctor has
weighed the risks of you taking 3TC
against the expected benefits it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE ORAL
SOLUTION.
You may need to read it again.
WHAT 3TC ORAL
SOLUTION IS USED FOR
3TC oral solution contains
lamivudine which belongs to a group
of medicines called antivirals.
3TC is used together with other
antivirals to slow down the
progression of human
immunodeficiency virus (HIV)
infection, which can lead to Acquired
Immune Deficiency Syndrome
(AIDS) and other related illnesses
(eg AIDS-related Complex or ARC).
3TC does not cure AIDS or kill the
HIV virus, but prevents further
damage to the immune system by
stopping production of new viruses.
You can still pass on HIV when
taking this medicine, although the
risk is lowered by effective
antiretroviral therapy. Discuss with
your doctor the precautions needed to
avoid infecting other people. You
will still be able to pass on the HIV
virus by sexual activity or by
contamination with infected blood.
You should still use proper
precautions.
While taking 3TC and/or any other
therapy for HIV disease, you may
continue to develop other infections
and other complications of HIV
infection. You should keep in regular
contact with the doctor who is
looking after you.
3TC oral solution is not addictive.
Your doctor may have prescribed
3TC oral solution for another reason.
Ask your doctor if you have any
questions about why 3TC oral
solution have been prescribed for
you.
BEFORE Y

Ficha técnica

1
AUSTRALIAN PRODUCT INFORMATION
3TC (LAMIVUDINE)
FILM-COATED TABLETS AND ORAL SOLUTION
1
NAME OF THE MEDICINE
Lamivudine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lamivudine is a white to off-white crystalline solid which is highly
soluble in water.
3TC Tablets contain 150 mg or 300 mg lamivudine.
3TC Oral Solution contains 10 mg/mL lamivudine.
3TC Oral Solution also contains 20% (w/v) sucrose, methyl
hydroxybenzoate (218) and
propyl hydroxybenzoate (216).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
TABLETS
3TC 150 mg tablets are available as both scored and unscored tablets.
3TC 150 mg unscored tablets are white, film-coated, diamond-shaped
tablets, engraved 'GX
CJ7' on the upper tablet face. Each tablet contains 150 mg of
lamivudine.
3TC 150 mg scored tablets are white, film-coated, diamond-shaped
tablets, engraved 'GX CJ7'
on both tablet faces. Each tablet contains 150 mg of lamivudine.
3TC 300 mg tablets are grey, film-coated, diamond-shaped, engraved
‘GX EJ7’ on the upper
tablet face. Each tablet contains 300 mg of lamivudine.
ORAL SOLUTION
Strawberry/banana flavoured.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
3TC (lamivudine) in combination with other antiretroviral agents is
indicated for the treatment
of HIV infected adults and children.
4.2
DOSE AND METHOD OF ADMINISTRATION
Food reduces the C
max
and extends the T
max
but the amount of drug absorbed is not reduced.
The clinical significance of this is not known (see Section 5.2
PHARMACOKINETIC
PROPERTIES).
2
Clinical studies indicate that 3TC should be used in combination with
other antiretroviral
therapies. In controlled trials in adults, 3TC was used in combination
with zidovudine 200 mg
tds (see Section 5.1 PHARMACODYNAMIC PROPERTIES - Clinical trials).
Since accurate dosing cannot be achieved with this formulation, dosing
according to weight
bands is recommended for scored tablets. This dosing regimen for
paediatric patients
weighing 14 - 30 kg is based primarily on pharmacokinetic modelli