Ziagen

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Abacavir sulfate 23.4 mg/mL equivalent to 20 mg/ml abacavir base.;  ;  

Available from:

GlaxoSmithKline NZ Limited

INN (International Name):

Abacavir sulfate 23.4 mg/mL (equivalent to 20 mg/ml abacavir base.)

Dosage:

20 mg/mL

Pharmaceutical form:

Oral solution

Composition:

Active: Abacavir sulfate 23.4 mg/mL equivalent to 20 mg/ml abacavir base.     Excipient: Banana flavour 59.256 AP0551 Citric acid Hydrochloric acid Methyl hydroxybenzoate Propyl hydroxybenzoate Propylene glycol Purified water Saccharin sodium Sodium citrate dihydrate Sorbitol Strawberry flavour 057883 AP0551

Units in package:

Bottle, white HDPE, 240 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Piramal Enterprises Limited

Therapeutic indications:

ZIAGEN is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and children.

Product summary:

Package - Contents - Shelf Life: Bottle, white HDPE - 240 mL - 24 months unopened stored at or below 30°C 60 days opened stored at or below 30°C

Authorization date:

1998-07-22

Patient Information leaflet

ZIAGEN ORAL SOLUTION
1
ZIAGEN ORAL SOLUTION
_abacavir (as sulfate) _
CONSUMER MEDICINE INFORMATION
PATIENTS TAKING ZIAGEN, WHICH CONTAINS ABACAVIR, MAY DEVELOP A
HYPERSENSITIVITY
REACTION (SERIOUS ALLERGIC REACTION) WHICH CAN BE LIFE-THREATENING IF
TREATMENT
WITH ZIAGEN IS CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY FOR ADVICE
ON WHETHER
YOU SHOULD STOP TAKING ZIAGEN IF:
1)
YOU GET A SKIN RASH OR
2)
YOU GET ONE OR MORE SYMPTOMS FROM AT LEAST TWO OF THE FOLLOWING
GROUPS:

FEVER

SHORTNESS OF BREATH, SORE THROAT OR COUGH

NAUSEA OR VOMITING OR DIARRHOEA OR ABDOMINAL PAIN

SEVERE TIREDNESS OR ACHINESS OR GENERALLY ILL FEELING
IF YOU HAVE HAD A HYPERSENSITIVITY (ALLERGIC) REACTION TO ZIAGEN NEVER
TAKE ZIAGEN,
OR ANY OTHER MEDICINAL PRODUCT CONTAINING ABACAVIR (KIVEXA,TRIZIVIR
AND TRIUMEQ)
AGAIN AS YOU MAY DEVELOP A LIFE THREATENING REACTION WHICH CAN BE
FATAL.
THERE IS AN ALERT CARD INCLUDED IN THE ZIAGEN PACK, TO REMIND YOU AND
MEDICAL STAFF
ABOUT ABACAVIR HYPERSENSITIVITY. THIS CARD SHOULD BE REMOVED FROM THE
PACK AND
KEPT WITH YOU AT ALL TIMES. SEE MORE DETAILS UNDER BEFORE YOU TAKE
ZIAGEN.
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you start ZIAGEN oral
solution.
This leaflet answers some common
questions about ZIAGEN 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. Your doctor has weighed the
expected benefits of you taking
ZIAGEN 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 ORAL
SOLUTION.
You may need to read it again.
_HYPERSENSITIVITY _
_REACTION _
ZIAGEN CONTAINS ABACAVIR (WHICH
IS ALSO AN ACTIVE INGREDIENT IN
KIVEXA, TRIZIVIR AND
TRIUMEQ).
ABACAVIR CAN CAUSE A SERIOUS
ALLERGIC REACTION KNOWN AS A
HYPERSENSITIVITY REACTION, WHICH
CAN BE LIFE-THREATENING IF TREATMENT
WITH ABACAVIR CONTAINING PRODUCTS
IS NOT S

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
ZIAGEN Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oral solution containing 20 mg/mL of abacavir as abacavir sulfate.
For the full list of excipients, see section 6.1 List of excipients
3.
PHARMACEUTICAL FORM
Oral solution
The oral solution is a clear to slightly opalescent yellowish, aqueous
solution
which may turn into a brown colour over time with strawberry/banana
flavouring.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ZIAGEN is indicated in antiretroviral combination therapy for the
treatment of
Human Immunodeficiency Virus (HIV) infection in adults and children.
4.2_ _
POSOLOGY AND METHOD OF ADMINISTRATION
Adults, adolescents and children weighing at least 25 kg
The recommended dose of ZIAGEN is 300 mg (15 mL) twice daily or 600 mg
(30 mL) once daily.
_ _
Children ≥ three months and weighing less than 25 kg
The recommended dose is 8 mg/kg twice daily or 16 mg/kg once daily up
to a
maximum dose of 300 mg twice daily or 600 mg once daily.
Children less than three months
The data available on the use of ZIAGEN in this age group are limited
(see
section 5.2 Pharmacokinetic Properties).
ZIAGEN can be taken with or without food.
ZIAGEN is also available as a tablet formulation.
Therapy should be initiated by a physician experienced in the
management of
HIV infection.
2
Renal impairment
No dosage adjustment of ZIAGEN is necessary in patients with renal
dysfunction (see section 5.2 Pharmacokinetic Properties).
Hepatic impairment
Abacavir is metabolised primarily by the liver. The recommended dose
of
ZIAGEN in patients with mild hepatic impairment (Child-Pugh score 5-6)
is
200 mg (10 mL) twice a day. Pharmacokinetic and safety data on the use
of
abacavir in patients with moderate and severe hepatic impairment are
not
available (see section 5.2 Pharmacokinetic Properties). Therefore the
use of
abacavir is not recommended in patients with moderate or severe
hepatic
impairment, unless the benefit of use outweighs the risk.
4.3
CONTRAINDICATIONS
ZIAGEN is