ZIAGEN abacavir (as sulfate) 20mg/mL oral solution bottle

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

abacavir sulfate, Quantity: 23.4 mg/mL (Equivalent: abacavir, Qty 20 mg/mL)

थमां उपलब्ध:

ViiV Healthcare Pty Ltd

फार्मास्यूटिकल फॉर्म:

Oral Liquid, solution

रचना:

Excipient Ingredients: sorbitol solution (70 per cent) (non-crystallising); sorbitol solution (70 per cent) (crystallising); propylene glycol; sodium citrate dihydrate; citric acid; methyl hydroxybenzoate; propyl hydroxybenzoate; saccharin sodium; hydrochloric acid; sodium hydroxide; purified water; Flavour

प्रशासन का मार्ग:

Oral

पैकेज में यूनिट:

240mL

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

Ziagen (abacavir) is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and children (see Clinical Trials). This indication is based on surrogate endpoints in studies up to 48 weeks in duration.

उत्पाद समीक्षा:

Visual Identification: Clear to slightly opalescent, yellowish, aqueous solution with strawberry/banana flavouring.; Container Type: Bottle; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

प्राधिकरण का दर्जा:

Licence status A

प्राधिकरण की तारीख:

1999-06-09

सूचना पत्रक

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, TRIUMEQ,
TRIZIVIR) 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, TRIUMEQ,
TRIZIVIR).
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 STOPPED. IT IS IMPORTANT YOU
READ THE IN

उत्पाद विशेषताएं

1
AUSTRALIAN PRODUCT INFORMATION
ZIAGEN (ABACAVIR)
TABLETS AND ORAL SOLUTION
ZIAGEN (ABACAVIR) IS ASSOCIATED WITH HYPERSENSITIVITY REACTIONS, WHICH
CAN BE LIFE-
THREATENING AND IN RARE CASES FATAL. ZIAGEN, OR ANY OTHER MEDICINAL
PRODUCT
CONTAINING ABACAVIR (TRIUMEQ, TRIZIVIR, KIVEXA), MUST NEVER BE
RESTARTED
FOLLOWING A HYPERSENSITIVITY REACTION (SEE SECTION 4.4 SPECIAL
WARNINGS AND
PRECAUTIONS FOR USE AND SECTION 4.8 ADVERSE EFFECTS (UNDESIRABLE
EFFECTS)).
1
NAME OF THE MEDICINE
Abacavir (as sulfate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Abacavir sulfate is a white to off-white crystalline powder with a
solubility of approximately 77
mg/mL in water at 25°C.
ZIAGEN is supplied in tablets containing 300 mg of abacavir (as
sulfate).
ZIAGEN is supplied in oral solution containing 20 mg/mL of abacavir
(as sulfate). ZIAGEN
oral solution also contains sorbitol solution (70%), saccharin sodium,
methyl
hydroxybenzoate and propyl hydroxybenzoate.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
TABLETS
The unscored film-coated tablets are yellow, biconvex, capsule shaped
and engraved with
“GX 623” on one side.
The scored film-coated tablets are yellow, biconvex, capsule shaped
and engraved with “GX
623” on both sides.
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 (abacavir) is indicated in antiretroviral combination therapy
for the treatment of
Human Immunodeficiency Virus (HIV) infection in adults and children
(see Section 5.1
2
PHARMACODYNAMIC PROPERTIES - Clinical trials). This indication is
based on surrogate
endpoints in studies up to 48 weeks in duration.
4.2
DOSE AND METHOD OF ADMINISTRATION
To ensure administration of the entire dose, the tablet(s) should
ideally be swallowed without
crushing.
For patients who are unable to swallow tablets, the tablet(s) may be
crushed and 100%