LANVIS TABLETS 40 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

THIOGUANINE

متاح من:

PERRIGO ISRAEL AGENCIES LTD, ISRAEL

ATC رمز:

L01BB03

الشكل الصيدلاني:

TABLETS

تركيب:

THIOGUANINE 40 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

EXCELLA GMBH & CO.KG., GERMANY

المجموعة العلاجية:

TIOGUANINE

المجال العلاجي:

TIOGUANINE

الخصائص العلاجية:

Acute nonlymphocytic leukemia.

تاريخ الترخيص:

2013-07-31

نشرة المعلومات

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with
a doctor’s prescription only
LANVIS TABLETS
40 MG
The active ingredient and its quantity:
THIOGUANINE 40 MG
A list of inactive ingredients is detailed in
section 6.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY
BEFORE USING THE MEDICINE AS IT CONTAINS
IMPORTANT INFORMATION FOR YOU. Keep the
leaflet. You may need to read it again. This
leaflet contains concise information about
the medicine. If you have further questions,
refer to the doctor, nurse or pharmacist.
This medicine has been prescribed for you
only. Do not pass it on to others. It may
harm them even if it seems to you that
signs of their ailment are similar.
1. WHAT IS THE MEDICINE INTENDED
FOR?
Lanvis is a medicine for treating acute
nonlymphocytic leukemia.
THERAPEUTIC GROUP: A cytotoxic medicine
(also called chemotherapeutic) from the
family of purine analogs.
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF:
-
You
are
sensitive
(allergic)
to
thioguanine (the active ingredient) or to
any of the other ingredients contained
in the medicine (see section 6).
- You are pregnant or breastfeeding.
SPECIAL WARNINGS REGARDING USE OF THE
MEDICINE BEFORE TREATMENT WITH LANVIS, CONSULT
THE DOCTOR IF:
∙ You have been using the medicine for a
prolonged period. Prolonged use may
increase the risk of side effects, such
as liver problems.
∙ You suffer from low levels of the thiopurine
methyltransferase (TPMT) enzyme.
∙ You suffer from Lesch-Nyhan Syndrome
– a rare hereditary condition caused by
deficiency of HPRT (hypoxanthine-
guanine-phosphoribosyltransferase).
If you are uncertain if one of the above
sections applies to you, please consult
the doctor, nurse or pharmacist before
taking Lanvis. IF YOU ARE TAKING OR HAVE RECENTLY TAKEN,
OR THERE IS A CHANCE YOU MAY TAKE OTHER
MEDICINES, INCLUDING NON-PRESCRIPTION
MEDICINES, NUTRITIONAL SUPPLEMENTS,
VITAMINS AND HERBAL SUPPLEMENTS, TELL
THE DOCTOR OR PHARMACIST. In particular,
inf

خصائص المنتج

_The format of this leaflet was determined by the Ministry of Health
and its content was checked and approved in _
_December 2016 _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
LANVIS TABLETS 40 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
40 mg thioguanine BP per tablet.
Excipients:
This product contains lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lanvis 40 mg tablets are white to off–white tablet, round, biconvex
scored and imprinting 'T40' on
one side, without score and debossing on the other side.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
_ _
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Thioguanine is indicated for the treatment of acute nonlymphocytic
leukemia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The exact dose and duration of administration will depend on the
nature and dosage of other
cytotoxic drugs given in conjunction with thioguanine.
Thioguanine is variably absorbed following oral administration and
plasma levels may be reduced
following emesis or intake of food.
Thioguanine can be used at various stages of treatment in short term
cycles. However it is not
recommended for use during maintenance therapy or similar long-term
continuous treatments due to
the high risk of liver toxicity (see section 4.4).
Page 1 of 9
_Adults _
_ _
The usual dosage of thioguanine is between 100 and 200 mg/m
2
body surface area, per day.
_ _
_Paediatric population _
Similar dosages to those used in adults, with appropriate correction
for body surface area, have been
used.
_Use in the elderly _
_ _
There are no specific dosage recommendations in elderly patients (See
dosage in
_ _
renal or hepatic
impairment).
Thioguanine has been used in various combination chemotherapy
schedules in elderly patients with
acute leukaemia at equivalent doses to those used in younger patients.
_Dosage in renal or hepatic impairment _
Consideration should be given to reducing the dosage in patients