Temaccord

Страна: Новая Зеландия

Язык: английский

Источник: Medsafe (Medicines Safety Authority)

Активный ингредиент:

Temozolomide 140mg;  

Доступна с:

Douglas Pharmaceuticals Limited

ИНН (Международная Имя):

Temozolomide 140 mg

дозировка:

140 mg

Фармацевтическая форма:

Capsule

состав:

Active: Temozolomide 140mg   Excipient: Colloidal silicon dioxide Gelatin Lactose Sodium starch glycolate Stearic acid Tartaric acid TekPrint black SW-9008

Штук в упаковке:

Bottle, glass, Amber with PP CRC, 5 capsules

класс:

Prescription

Тип рецепта:

Prescription

Производитель:

Shilpa Medicare Limited

Терапевтические показания :

Temaccord capsules are indicated for the treatment of patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment.

Обзор продуктов:

Package - Contents - Shelf Life: Bottle, glass, Amber with PP CRC - 5 capsules - 24 months from date of manufacture stored at or below 25°C. keep in a dry place - Bottle, glass, Amber with PP CRC - 20 capsules - 24 months from date of manufacture stored at or below 25°C. keep in a dry place - Sachet, Polyethylene/aluminium foil/poly film, 1 capsule per sachet - 5 capsules - 24 months from date of manufacture stored at or below 25°C - Sachet, Polyethylene/aluminium foil/poly film, 1 capsule per sachet - 20 capsules - 24 months from date of manufacture stored at or below 25°C

Дата Авторизация:

2010-04-26

тонкая брошюра

CONSUMER MEDICINE INFORMATION
1
TEMACCORD
_Temozolomide Capsules _
5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START
USING TEMACCORD.
This leaflet answers some common questions
about Temaccord. It does not contain all the
available information. It does not take the place
of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your
doctor has weighed the risks of you taking
Temaccord against the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS
MEDICINE, ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY
NEED TO READ IT AGAIN.
WHAT TEMACCORD IS USED FOR
Temaccord is used for the treatment of brain
tumours. Temaccord is also used to treat adult
patients with advanced metastatic malignant
melanoma.
Your doctor, however, may have prescribed
Temaccord for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT
WHY TEMACCORD HAS BEEN PRESCRIBED FOR YOU.
Temaccord belongs to a group of medicines
called cytotoxic or chemotherapy medicines.
Temaccord works by killing cancer cells and
stopping cancer cells from growing and
multiplying.
This medicine is available only with a doctor's
prescription.
_USE IN CHILDREN _
Temaccord capsules are used to treat children 3
years and older, with specific forms of brain
tumour (glioblastoma multiforme or anaplastic
astrocytoma, showing recurrence or progression
after standard therapy).
BEFORE YOU TAKE TEMACCORD
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE TEMACCORD IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
temozolomide or dacarbazine
•
any of the ingredients listed at the end
of this leaflet
Some of the symptoms of an allergic reaction
may include:
•
difficulty in breathing or wheezing
•
shortness of breath
•
swelling of the face, tongue, lips, or other
parts of the body
•
hives on the skin, rash, or itching.
DO NOT TAKE TEMACCORD IF YOU HAVE A VERY LOW
LEVEL OF WHITE BLOOD CELLS, RED BLOOD CELLS OR
PLATELE

Характеристики продукта

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Temaccord Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Temozolomide 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg Capsules.
EXCIPIENT(S) WITH KNOWN EFFECT
Temaccord capsules contain lactose. For the full list of excipients,
see Section 6.1.
3.
PHARMACEUTICAL FORM
STRENGTH
(MG/CAP)
VISUAL
PRODUCT DESCRIPTION
CAPSULE
SIZE
CAPSULE
DIMENSIONS
(MM)
5 mg
Green/White hard gelatin capsules,
size ‘3’ imprinted ‘TMZ’ on cap and ‘5’
on body, containing white to light pink
powder.
Size 3
approx
15.8 ±
0.4
20 mg
Yellow/White hard gelatin capsules,
size ‘5’ imprinted ‘TMZ’ on cap and ‘20’
on body, containing white to light pink
powder.
Size 5
approx
11.4±
0.4
100 mg
Pink/White hard gelatin capsules, size
‘3’ imprinted ‘TMZ’ on cap and ‘100’
on body, containing white to light pink
powder.
Size 3
approx
15.8 ±
0.4
140 mg
Transparent Blue/White hard gelatin
capsules, size ‘1’ imprinted ‘TMZ’ on
cap and ‘140’ on body, containing
white to light pink powder.
Size 1
approx
19.3±
0.4
180 mg
Maroon /White hard gelatin capsules,
size ‘1’ imprinted ‘TMZ’ on cap and ‘180’
on body, containing white to light pink
powder.
Size 1
approx
19.3± 0.4
250 mg
White/White hard gelatin capsules, size
‘0’ imprinted ‘TMZ’ on cap and ‘250’ on
body, containing white to light pink
powder.
Size 0
approx
21.4 ± 0.4
Temaccord 5 mg capsule is larger than Temaccord 20 mg capsule.
2 | P a g e
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Temaccord capsules are indicated for the treatment of

patients with newly diagnosed glioblastoma multiforme concomitantly
with
radiotherapy and then as adjuvant treatment.

patients with recurrent high grade glioma, such as glioblastoma
multiforme or anaplastic
astrocytoma.
Temaccord capsules are also indicated as first line treatment for
patients with advanced
metastatic malignant melanoma.
4.2.
DOSE AND METHOD OF ADMINISTRATION
Anti‐emetic therapy may be administered prior to o