TEMOZOLOMIDE JUNO temozolomide 5 mg capsule sachet

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

temozolomide, Quantity: 5 mg

Prieinama:

Juno Pharmaceuticals Pty Ltd

INN (Tarptautinis Pavadinimas):

Temozolomide

Vaisto forma:

Capsule, hard

Sudėtis:

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

Vartojimo būdas:

Oral

Vienetai pakuotėje:

5 Capsules, 20 Capsules

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

Treatment of newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment.,Treatment of 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.

Produkto santrauka:

Visual Identification: Green/White hard capsule, size 3, printed in black ink with 'TMZ' on the cap and '5' on the body.; Container Type: Sachet; Container Material: Other composite material; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Autorizacija statusas:

Licence status A

Leidimo data:

2013-06-14

Pakuotės lapelis

Temozolomide Juno
1
TEMOZOLOMIDE JUNO
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 TEMOZOLOMIDE JUNO?
Temozolomide Juno contains the active ingredient temozolomide.
Temozolomide belongs to a group of medicines called
cytotoxic or chemotherapy medicines. Temozolomide works by killing
cancer cells and stopping cancer cells from growing and
multiplying.
For more information, see Section 1. Why am I using Temozolomide Juno?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TEMOZOLOMIDE JUNO?
Do not use if you have ever had an allergic reaction to 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
Temozolomide Juno?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with temozolomide and affect how 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 USE TEMOZOLOMIDE JUNO?
•
Your doctor has worked out the exact dose of Temozolomide Juno 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 Temozolomide
Juno?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TEMOZOLOMIDE JUNO?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Temozolomide Juno.
•
Tell your doctor if you feel sick or vomit while being treated with
Temozolomide Juno.
THINGS YOU
SHOULD NOT DO
•
Do not open the capsules. If a capsule is damaged, avoid contact with
your skin, eyes and nose. Avoid
inhaling the powder. If you touc

Prekės savybės

Australian Product Information
Temozolomide JUNO PI v 7.0
Page | 1
AUSTRALIAN PRODUCT INFORMATION
_TEMOZOLOMIDE JUNO _
_(TEMOZOLOMIDE) _
_ _
1 NAME OF THE MEDICINE
Temozolomide.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
TEMOZOLOMIDE JUNO capsules come in 6 strengths and contain 5 mg, 20
mg,
100 mg, 140 mg, 180 mg or 250 mg of temozolomide.
List of excipients with known effect: contains sugars as lactose. For
the full list of
excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
TEMOZOLOMIDE JUNO (temozolomide) 5 mg: Green and white hard capsules,
printed
in black ink with
“TMZ” on the cap and “5” on the body.
TEMOZOLOMIDE JUNO (temozolomide) 20 mg: Yellow and white hard
capsules, printed
in black ink with “TMZ” on the cap and “20” on the body.
TEMOZOLOMIDE JUNO (temozolomide) 100 mg: Pink and white hard capsules,
printed
in black ink with “TMZ” on the cap and “100” on the body.
TEMOZOLOMIDE JUNO (temozolomide) 140 mg: Blue and white hard capsules,
printed
in black ink with “TMZ” on the cap and “140” on the body.
TEMOZOLOMIDE JUNO (temozolomide) 180 mg: Maroon and white hard
capsules,
printed in black ink with “TMZ” on the cap and “180” on the
body.
TEMOZOLOMIDE JUNO (temozolomide) 250 mg: White hard capsules, printed
in black
ink with “TMZ” on the cap and “250” on the body.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of newly diagnosed glioblastoma multiforme concomitantly
with radiotherapy
and then as adjuvant treatment.
Treatment of recurrence of anaplastic astrocytoma and glioblastoma
multiforme following
standard therapy.
TEMOZOLOMIDE JUNO is also indicated as a first-line treatment for
patients with
advanced metastatic malignant melanoma.
Australian Product Information
Temozolomide JUNO PI v 7.0
Page | 2
4.2 DOSE AND METHOD OF ADMINISTRATION
Antiemetic
therapy
may
be
administered
prior
to
or
following
administration
of
temozolomide.
Temozolomide should be administered in the fasting state at least one
hour before a meal.
If
vom