APO-TEMOZOLOMIDE temozolomide 250 mg capsule bottle

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

temozolomide, Quantity: 250 mg

Disponibil de la:

Arrotex Pharmaceuticals Pty Ltd

INN (nume internaţional):

Temozolomide

Forma farmaceutică:

Capsule, hard

Compoziție:

Excipient Ingredients: colloidal anhydrous silica; purified water; microcrystalline cellulose; sodium starch glycollate; stearic acid; tartaric acid; Gelatin; iron oxide yellow; iron oxide black; titanium dioxide; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; ethanol absolute; ethanol; Shellac; sulfuric acid

Calea de administrare:

Oral

Unități în pachet:

5

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

Temozolomide is 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.,Temozolomide is also indicated as a first-line treatment for patients with advanced metastatic malignant melanoma.

Rezumat produs:

Visual Identification: 250 mg capsules (buff opaque, size 0) marked with black imprint TMZ 250 mg; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Statutul autorizaţiei:

Licence status A

Data de autorizare:

2015-02-19

Prospect

APO-Temozolomide
1
APO-TEMOZOLOMIDE
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 APO-TEMOZOLOMIDE?
APO-Temozolomide contains the active ingredient temozolomide.
APO-Temozolomide belongs to a group of medicines called
cytotoxic or chemotherapy medicines. APO-Temozolomide works by killing
cancer cells and stopping cancer cells from growing
and multiplying.
For more information, see Section 1. Why am I using APO-Temozolomide?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE APO-TEMOZOLOMIDE?
Do not use if you have ever had an allergic reaction to
APO-Temozolomide 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
APO-Temozolomide? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with APO-Temozolomide 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 APO-TEMOZOLOMIDE?
• Your doctor has worked out the exact dose of APO-Temozolomide 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
APO-Temozolomide? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING APO-TEMOZOLOMIDE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
APO-Temozolomide.
•
Tell your doctor if you feel sick or v

Caracteristicilor produsului

1
AUSTRALIAN PRODUCT INFORMATION
APO-TEMOZOLOMIDE (TEMOZOLOMIDE) CAPSULES
1 NAME OF THE MEDICINE
Temozolomide
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 5 mg, 20 mg, 100 mg, 140 mg, 180 mg or 250 mg
temozolomide, as
the active ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose.
Contains trace amounts of sulfites.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
5 mg capsules
Light green opaque, size 4, marked with black imprint “TMZ 5 mg”.
20 mg capsules
Rich yellow opaque, size 1, marked with black imprint “TMZ 20 mg”.
100 mg capsules
Flesh opaque, size 1, marked with black imprint “TMZ 100 mg”.
140 mg capsules
Powder blue opaque, size 1, marked with black imprint “TMZ 140
mg”.
180 mg capsules
Medium orange opaque, size 1, marked with black imprint “TMZ 180
mg”.
250 mg capsules
Buff opaque, size 0, marked with black imprint “TMZ 250 mg”.
4 CLINICAL PARTICULARS
2
4.1
THERAPEUTIC INDICATIONS
Temozolomide is 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.
Temozolomide is also indicated as first line treatment for patients
with advanced metastatic
malignant melanoma.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Temozolomide capsules are intended for oral administration.
DOSAGE
Anti-emetic therapy may be administered prior to or following
administration of
temozolomide.
Temozolomide capsules should be administered in the fasting state at
least one hour before
a meal. If vomiting occurs after the dose is administered, a second
dose should not be
administered that day. Temozolomide capsules must not be opened or
chewed, but are to
be swallowed whole with a glass of water. If a capsule becomes
damaged, avoid contact of
the powder contents with skin or mucous membrane.
NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORME (ADULTS)
Concomitant Phase
Temozo