3TC

Kraj: Nowa Zelandia

Język: angielski

Źródło: Medsafe (Medicines Safety Authority)

Składnik aktywny:

Lamivudine 10 mg/mL;  

Dostępny od:

GlaxoSmithKline NZ Limited

INN (International Nazwa):

Lamivudine 10 mg/mL

Dawkowanie:

10 mg/mL

Forma farmaceutyczna:

Oral solution

Skład:

Active: Lamivudine 10 mg/mL   Excipient: Banana flavour 59.256 AP0551 Citric acid Methyl hydroxybenzoate Propyl hydroxybenzoate Propylene glycol Purified water Sodium citrate dihydrate Strawberry flavour 057883 AP0551 Sucrose

Sztuk w opakowaniu:

Bottle, plastic, 240 mL

Klasa:

Prescription

Typ recepty:

Prescription

Wyprodukowano przez:

Mylan Laboratories Limited

Wskazania:

3TC in combination with other anti-retroviral agents is indicated for the treatment of HIV infected adults and children.

Podsumowanie produktu:

Package - Contents - Shelf Life: Bottle, plastic, - 240 mL - 18 months from date of manufacture stored at or below 30°C

Data autoryzacji:

1995-08-04

Ulotka dla pacjenta

1
3TC
_Lamivudine tablets 150 mg, 300 mg and oral solution 10 mg/mL _
_ _
___________________________________________________________________________________________________
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking 3TC tablets
or oral solution.
This leaflet answers some common
questions about 3TC. It does not
contain all of the available
information.
It does not take the place of talking
to your doctor or pharmacist.
WHAT 3TC IS USED FOR
3TC contains the active ingredient
lamivudine, which belongs to a
group of medicines called
antiretrovirals.
Please note that the active ingredient
in 3TC, lamivudine, is also available
as a combination medicine,
Combivir, containing another
antiretroviral medicine called
zidovudine.
3TC is used, in combination with
other antiretrovirals, for the
treatment of HIV infected adults and
children.
3TC does not cure AIDS or HIV
infection, but slows down
production of human
immunodeficiency virus. In this way
it stops ongoing damage to the
body’s immune system, which
fights infection.
While taking 3TC and/or any other
therapy for HIV disease, you may
continue to develop further
infections and other complications
of HIV disease. You should keep in
regular contact with your doctor.
The long term risks and benefits of
taking 3TC are not known.
Your doctor may have prescribed
3TC for another reason. Ask your
doctor if you have any questions
about why 3TC has been prescribed
for you.
3TC is not addictive.
BEFORE YOU TAKE 3TC
_WHEN YOU MUST NOT TAKE _
_IT _

Do not take 3TC tablets or oral
solution if you have ever had an
allergic (hypersensitivity)
reaction to lamivudine.


Do not take 3TC tablets or oral
solution if you have ever had an
allergic reaction to any of the
other ingredients in 3TC listed
at the end of this leaflet.


Do not take 3TC tablets or oral
solution if you are pregnant,
trying to become pregnant or
breastfeeding, unless your
doctor says you should.
Your doctor may discuss with you
th

Charakterystyka produktu

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
3TC lamivudine 10 mg/mL oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
3TC oral solution contains 10 mg/mL lamivudine in a solution
containing 20%
(w/v) sucrose.
3TC oral solution is a clear, colourless to pale yellow, strawberry
and banana
flavoured aqueous solution. For the full list of excipients, see
section 6.1 List
of excipients.
3.
PHARMACEUTICAL FORM
Oral Solution
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
3TC in combination with other anti-retroviral agents is indicated for
the
treatment of HIV infected adults and children.
4.2.
DOSE AND METHOD OF ADMINISTRATION
Dose
3TC therapy should be initiated by a physician experienced in the
management of HIV infection.
_Adults, adolescents and children weighing at least 25 kg _
The recommended dose of 3TC is 300 mg (30 mL) daily. This may be
administered as either 150 mg (15 mL) twice daily or 300 mg (30 mL)
once
daily (see section 4.4 Special warnings and precautions for use).
_Children: _
_Less than three months: _The limited data available are insufficient
to propose
specific dosage recommendations (see section 5.2 Pharmacokinetics,
Special
populations).
_Children aged ≥ three months and weighing less than 25 kg: _The
recommended dose is 0.5 mL/kg (5 mg/kg) twice daily or 1 mL/kg (10
mg/kg)
once daily (see section 4.4 Special warnings and precautions for use,
paediatric population).
2
Patients changing between lamivudine oral solution and lamivudine
tablets
should follow the dosing recommendations that are specific for the
formulation
(see section 5.2 pharmacokinetic properties).
Special populations
_Elderly _
No specific data are available, however special care is advised in
this age
group due to age associated changes such as the decrease in renal
function
and alteration of haematological parameters.
_Renal Impairment _
Lamivudine plasma concentrations (AUC) are increased in patients with
moderate to severe renal impairment due to decreased clearance (see
section
5.2 Pharmacokinetics, Special po