ZEFFIX Lamivudine 5mg/mL oral solution bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lamivudine, Quantity: 5 mg/mL

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Oral Liquid, solution

Composition:

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

Administration route:

Oral

Units in package:

1 x 240mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Zeffix (lamivudine) is indicated for the treatment of children (2 years and above), adolescent and adult patients with chronic hepatitis B and evidence of hepatitis B virus (HBV) replication. This indication is based on changes in serological and histological markers in clinical studies of up to 2 years duration in adult patients with compensated liver disease and serological data up to 18 months in children and adolescents. Children and adolescent also require evidence of active hepatic inflammation. (see Clinical Trials). The safety and efficacy of Zeffix (lamivudine) have not been established in patients with decompensated liver disease in placebo controlled studies. However, Zeffix (lamivudine) has been shown to reduce HBV DNA levels prior to and post liver transplantation.

Product summary:

Visual Identification: Clear colourless/pale yellow liquid with the odour of fruit (strawberry/banana).; Container Type: Bottle; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1999-05-18

Patient Information leaflet

ZEFFIX ORAL SOLUTION
®
1
ZEFFIX ORAL
SOLUTION
®
_Lamivudine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you take Zeffix Oral Solution.
This leaflet answers some common
questions about Zeffix Oral Solution.
It does not contain all of 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 expected benefits of you taking
Zeffix against the risks this medicine
could 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 IS ZEFFIX USED
FOR?
Zeffix belongs to a group of
medicines called antivirals.
Zeffix is used to treat patients 2 years
of age or over with long term
(chronic) viral infection of the liver
caused by hepatitis B.
Hepatitis B is a virus which damages
the liver. Treatment with Zeffix can
reduce the amount of hepatitis B
virus in your body. This should lead
to less liver damage.
Zeffix has not been shown to reduce
the risk of passing hepatitis B to
others. You will still be able to pass
on the hepatitis virus by sexual
contact or through your blood. You
should use appropriate precautions.
Your doctor may have prescribed
Zeffix for another reason.
Zeffix is not addictive.
If you are already taking this
medicine lamivudine for HIV
infection (3TC®, Combivir®), your
doctor will continue to treat you with
the higher dose for that treatment.
BEFORE YOU TAKE ZEFFIX
_DO NOT TAKE IF: _
You must not take Zeffix if:
•
you have ever had an allergic
reaction to lamivudine or any of
the ingredients listed toward the
end of this leaflet. (See
"Ingredients")
•
YOU ARE TAKING ZALCITABINE.
•
THE EXPIRY DATE (EXP) PRINTED
ON THE PACK HAS PASSED.
•
THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING
_TELL YOUR DOCTOR IF: _
You must tell your doctor if:
•
YOU ARE ALLERGIC TO FOODS, DYES,
PRESERVATIVES OR ANY OTHER
MEDICINES.
•
YOU HAVE, OR

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – ZEFFIX® (LAMIVUDINE)
TABLETS & 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.
Zeffix tablets contain 100mg of lamivudine.
Zeffix oral solution contains 5 mg/mL lamivudine.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
TABLETS: Zeffix tablets are butterscotch coloured, film coated,
capsule shaped, biconvex and engraved
“LV” on one side and “100” on the other side.
ORAL SOLUTION: Zeffix oral solution contains 240 mL of Zeffix
solution, for oral use only, and is in a
carton. The pack includes a clear polypropylene oral dosing syringe
and polyethylene syringe-adapter.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Zeffix (lamivudine) is indicated for the treatment of children (2
years and above), adolescent and adult
patients with chronic hepatitis B and evidence of hepatitis B virus
(HBV) replication.
This indication is based on changes in serological and histological
markers in clinical studies of up to 2
years duration in adult patients with compensated liver disease and
serological data up to 18 months
in children and adolescents. Children and adolescents also require
evidence of active hepatic
inflammation. (see 5.1 PHARMACODYNAMIC PROPERTIES – Clinical
Trials).
The
safety
and
efficacy
of
Zeffix
(lamivudine)
have
not
been
established
in
patients
with
decompensated liver disease in placebo controlled studies. However,
Zeffix (lamivudine) has been
shown to reduce HBV DNA levels prior to and post liver
transplantation.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULTS AND ADOLESCENTS 12* YEARS AND OLDER: the recommended dosage of
Zeffix is 100 mg once daily.
CHILDREN FROM TWO TO ELEVEN YEARS*: the recommended dose is 3 mg/kg
once daily up to a maximum
of 100 mg daily.
*The effectiveness of treatment beyond 1 year in children aged from 2
– 17 years and the optimum
duration of treatment for t