TEMODAL temozolomide 250mg capsule sachet

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

temozolomide, Quantity: 250 mg

Dostupné z:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (Medzinárodný Name):

Temozolomide

Forma lieku:

Capsule, hard

Zloženie:

Excipient Ingredients: sodium lauryl sulfate; lactose; stearic acid; Gelatin; titanium dioxide; sodium starch glycollate; tartaric acid; colloidal anhydrous silica; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; Shellac; iron oxide black; simethicone; strong ammonia solution; potassium hydroxide

Spôsob podávania:

Oral

Počet v balení:

5 capsules

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

TEMODAL capsules are indicated for the treatment of patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment; recurrence of anaplastic astrocytoma and glioblastoma multiforme following standard therapy. TEMODAL capsules are also indicated as first line treatment for patients with advanced metastatic malignant melanoma.

Prehľad produktov:

Visual Identification: Size No 1 capsule with opaque pink cap and opaque white body containing a white to light pink, light tan powder. The cap is imprinted in black ink with TEMODAL, the body is imprinted in black ink with two stripes; 100 mg and the Schering-Plough logo.; Container Type: Sachet; Container Material: Other plastic laminate/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Stav Autorizácia:

Registered

Dátum Autorizácia:

2009-11-13

Príbalový leták

TEMODAL
®
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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 TEMODAL?
TEMODAL contains the active ingredient temozolomide. TEMODAL belongs
to a group of medicines called cytotoxic or
chemotherapy medicines. TEMODAL works by killing cancer cells and
stopping cancer cells from growing and multiplying.
For more information, see Section 1. Why am I using TEMODAL? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TEMODAL?
Do not use if you have ever had an allergic reaction to TEMODAL or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
TEMODAL? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TEMODAL and affect how it works.
Tell your doctor or pharmacist if you are taking any other
medicines, including any medicines, vitamins or supplements that you
buy without a prescription from your pharmacy, supermarket
or health food shop.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE TEMODAL?
•
Your doctor has worked out the exact dose of TEMODAL for you according
to your individual needs.
•
Each time you start a new treatment cycle, be sure you understand
exactly how many capsules of each strength you need to
take on each day of dosing.
More instructions can be found in Section 4. How do I use TEMODAL? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TEMODAL?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
TEMODAL.
•
Tell your doctor if you feel sick or vomit while being treated with
TEMODAL
THINGS YOU
SHOULD NOT DO
•
Do not open the capsules. If a capsule is damaged, avoid contact wi

Súhrn charakteristických

Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION
TEMODAL
(TEMOZOLOMIDE)
CAPSULES
1
NAME OF THE MEDICINE
Temozolomide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Temozolomide is slightly soluble in water (3.1 mg/mL), methanol (4.4
mg/mL) and ethanol (0.6
mg/mL).
Each TEMODAL capsule contains temozolomide (5 mg, 20 mg, 100 mg, 140
mg, 180 mg or
250 mg).
List of excipients with known effect:
-
lactose
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
TEMODAL (temozolomide) 5 mg: Size No. 3 capsule with opaque, green cap
and white,
opaque body. The cap is imprinted in black ink with "TEMODAL". The
body is imprinted in
black ink with two stripes, “5 mg”, and the Schering-Plough logo.
TEMODAL (temozolomide) 20 mg: Size No. 2 capsule with yellow cap and
white, opaque
body. The cap is imprinted in black ink with "TEMODAL". The body is
imprinted in black ink
with two stripes, “20 mg”, and the Schering-Plough logo.
TEMODAL (temozolomide) 100 mg: Size No. 1 capsule with pink, opaque
cap and white,
opaque body. The cap is imprinted in black ink with "TEMODAL". The
body is imprinted in
black ink with two stripes, “100 mg”, and the Schering-Plough
logo.
TEMODAL (temozolomide) 140 mg: Size No. 0 capsule with blue, opaque
cap and white,
opaque body. The cap is imprinted in black ink with "TEMODAL". The
body is imprinted in
black ink with two stripes, “140 mg”, and the Schering-Plough
logo.
TEMODAL (temozolomide) 180 mg: Size No. 0 capsule with orange, opaque
cap and white,
opaque body. The cap is imprinted in black ink with "TEMODAL". The
body is imprinted in
black ink with two stripes, “180 mg”, and the Schering-Plough
logo.
TEMODAL (temozolomide) 250 mg: Size No. 0 capsule with white, opaque
cap and body. The
cap is imprinted in black ink with "TEMODAL". The body is imprinted in
black ink with two
stripes, “250 mg”, and the Schering-Plough logo.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TEMODAL is indicated for the treatment of
Page 2 of 16
•
patients with n