Allmercap

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Mercaptopurine 20 mg/mL

Предлага се от:

Link Pharmaceuticals Ltd

INN (Международно Name):

Mercaptopurine 20 mg/mL

дозиране:

20 mg/mL

Лекарствена форма:

Oral suspension

Композиция:

Active: Mercaptopurine 20 mg/mL Excipient: Aspartame Potassium sorbate Purified water Raspberry flavour - concentrated juice (nova) Sodium ethyl hydroxybenzoate Sodium hydroxide Sodium methyl hydroxybenzoate Xanthan gum

Вид предписание :

Prescription

Произведено от:

Fermion Oy

Терапевтични показания:

Allmercap is indicated for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients.

Каталог на резюме:

Package - Contents - Shelf Life: Bottle, glass, Amber glass bottle with a tamper evident child resistant closure (component) - 100 mL - 18 months from date of manufacture stored at or below 25°C protect from light 56 days opened stored at or below 25°C - Combination pack, Bottle + syringe adapter + 1 mL and 5 mL oral dosing syringes - 100 mL - 18 months from date of manufacture stored at or below 25°C protect from light 56 days opened stored at or below 25°C - Syringe, plastic, Graduated 1 mL oral dosing syringe - 1 mL -   - Syringe, plastic, Graduated 5 mL oral dosing syringe - 5 mL -   - Unknown, Syringe adapter for use wtih an oral dosing syringe, original cap replacement - 1 pieces -  

Дата Оторизация:

2016-06-08

Листовка

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

Данни за продукта

ALLMERCAP® NEW ZEALAND DATA SHEET
ALLMERCAP Data Sheet
August 2022
Page 1 of 11
1 PRODUCT NAME
ALLMERCAP 20mg/mL oral suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ALLMERCAP oral suspension contains 20 mg/mL mercaptopurine
monohydrate.
The chemical name of mercaptopurine monohydrate is
1,7-dihydro-6H-purine-6-thione hydrate.
Relative molecular mass: 170.2
Molecular formula is C
5
H
4
N
4
S
⋅
H
2
O
CAS No.: 6112-76-1 (monohydrate)
Chemical structure is:
Mercaptopurine is odourless or practically odourless, yellow
crystalline powder, with a solubility of
0.26 mg/mL in water at 37°C.
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
ALLMERCAP is a pink/brown oral liquid suspension.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ALLMERCAP oral suspension is indicated for:
Treatment of Acute Lymphoblastic Leukaemia (ALL) in paediatric
patients.
4.2
DOSE AND METHOD OF ADMINISTRATION
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
ALLMERCAP® NEW ZEALAND DATA SHEET
ALLMERCAP Data Sheet
August 2022
Page 2 of 11
genotyping or phenotyping can be used to identify patients with absent
or