ALLMERCAP mercaptopurine monohydrate 20mg/mL oral liquid suspension bottle

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

mercaptopurine monohydrate, Quantity: 20 mg/mL

Tillgänglig från:

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

INN (International namn):

mercaptopurine monohydrate

Läkemedelsform:

Oral Liquid, suspension

Sammansättning:

Excipient Ingredients: xanthan gum; aspartame; Rubus idaeus; sodium methyl hydroxybenzoate; sodium ethyl hydroxybenzoate; potassium sorbate; sodium hydroxide; purified water

Administreringssätt:

Oral

Enheter i paketet:

1 x 100mL bottle

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

ALLMERCAP oral liquid suspension is indicated for: Treatment of Acute Lymphoblastic Leukaemia (ALL) in paediatric patients.

Produktsammanfattning:

Visual Identification: A pink brown viscous suspension; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Bemyndigande status:

Licence status A

Tillstånd datum:

2014-06-16

Bipacksedel

ALLMERCAP®
1
ALLMERCAP®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ALLMERCAP®?
ALLMERCAP® contains mercaptopurine monohydrate as the active
ingredient. ALLMERCAP® is used solely or in combination
with other medicines to treat acute leukaemia, a cancer of certain
blood cells.
For more information, see Section 1. Why am I using ALLMERCAP®?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE ALLMERCAP®?
Do not use if you have ever had an allergic reaction to mercaptopurine
monohydrate or any of the oral liquid suspension
ingredients listed at the end of this CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, HAVE RECEIVED THE YELLOW FEVER
VACCINE, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE
BREASTFEEDING.
For more information, see Section 2. What should I know before I take
ALLMERCAP®?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may be affected by ALLMERCAP® or may affect how well
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE ALLMERCAP®
•
ALLMERCAP® is taken in the evening as an oral liquid suspension.
•
Your doctor will decide what dose and for how long you will be taking
ALLMERCAP® depending on factors such as your age
and weight, pre-existing medical condition, whether you are taking any
other medications, and your response to
treatment.
More instructions can be found in Section 4. How do I take
ALLMERCAP®?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING ALLMERCAP®?
THINGS YOU
MUST DO
•
Tell your doctor if, for any reason, you have not taken your medicine
exactly as directed.
•
Tell any other specialist, doctor, dentist or pharmacist that you are
on ALLMERCAP®.
•
Tell your doctor if you become pregnant, are trying to become pregnant
or trying to father a child.
•
Use a sunscreen with

Produktens egenskaper

1
AUSTRALIAN PRODUCT INFORMATION – ALLMERCAP
®
(MERCAPTOPURINE MONOHYDRATE)
1
NAME OF THE MEDICINE
Mercaptopurine monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ALLMERCAP oral liquid suspension contains 20 mg/mL mercaptopurine
monohydrate.
EXCIPIENTS WITH KNOWN EFFECT:
hydroxybenzoates, sorbates, and aspartame.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ALLMERCAP is a pink/brown oral liquid suspension.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ALLMERCAP oral liquid suspension is indicated for:
Treatment of Acute Lymphoblastic Leukaemia (ALL) in paediatric
patients.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE (DOSE AND INTERVAL)
ALLMERCAP is only indicated for use in children. For children the
usual dose is 2.5 mg/kg
bodyweight/day, but the dose and duration of administration depend on
the nature and dosage of
other cytotoxic agents given in conjunction with mercaptopurine. The
dosage should be carefully
adjusted to suit the individual patient.
Mercaptopurine has been used in various combination therapy schedules
for acute leukaemia and the
literature should be consulted for details.
When allopurinol and mercaptopurine are administered concomitantly it
is essential that only a quarter
of the usual dose of mercaptopurine is given since allopurinol
decreases the rate of catabolism of
mercaptopurine.
Mercaptopurine is metabolised by the polymorphic Thiopurine Methyl
Transferase (TPMT) enzyme.
Patients with little or no inherited TPMT activity are at increased
risk for severe toxicity from
conventional doses of mercaptopurine and generally require substantial
dose reduction. TPMT
genotyping or phenotyping can be used to identify patients with absent
or reduced TPMT activity.
TPMT testing cannot substitute for haematological monitoring in
patients receiving mercaptopurine.
The optimal starting dose for homozygous deficient patients has not
been established (see
Section 4.4 Special warnings and precautions for use).
2
METHOD OF ADMINISTRATION
ALLMERC