TOMUDEX raltitrexed 2mg powder for injection vial

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

raltitrexed, Quantity: 2 mg

থেকে পাওয়া:

Pfizer Australia Pty Ltd

ফার্মাসিউটিকাল ফর্ম:

Injection, powder for

রচনা:

Excipient Ingredients: sodium hydroxide; mannitol; dibasic sodium phosphate dodecahydrate

প্রশাসন রুট:

Intravenous

প্যাকেজ ইউনিট:

1 x 1 vial

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

For use as a single agent in the palliative treatment of advanced colorectal cancer (distant metastases or unresectable local disease).

পণ্য সারাংশ:

Visual Identification: White to cream coloured solid cake practically free from visible impurities.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

1996-07-15

তথ্য লিফলেট

TOMUDEX™
1
TOMUDEX™
_Raltitrexed _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tomudex. 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 Tomudex
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 TOMUDEX IS
USED FOR
Tomudex belongs to a group of
medicines called cytotoxic agents.
These agents are used for the
treatment of cancer. They kill cells
within your body, which cause
certain types of malignant growths or
cancer. Cells which are dividing (or
growing) have to make certain
chemicals. This medicine blocks the
formation of these chemicals.
Tomudex is used to treat cancer
which affects the colon and rectum
(parts of your large intestine or
bowel). Your doctor will help you
understand the benefits of having this
medicine for your particular problem.
Your doctor will have explained why
you are being treated with Tomudex
and told you what dose you will be
given.
FOLLOW ALL DIRECTIONS GIVEN TO YOU
BY YOUR DOCTOR.
They may differ from the
information contained in this leaflet.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may prescribe this
medicine for another use.
Tomudex is not addictive.
BEFORE YOU USE
TOMUDEX
_WHEN YOU MUST NOT USE IT _
DO NOT USE TOMUDEX IF YOU ARE
PREGNANT OR BREASTFEEDING.
We do not know if it is safe for you
to be given it while you are pregnant.
It may affect your baby if you are
given it at any time during
pregnancy.
Your baby may take in Tomudex
from breast milk if you are
breastfeeding.
DO NOT GIVE TOMUDEX TO CHILDREN.
There is no information on its use in
children.
TOMUDEX SHOULD NOT BE GIVEN TO
PATIENTS WITH SEVERE KIDNEY DISEASE.
DO NOT USE AFTER THE

পণ্য বৈশিষ্ট্য

Version: pfptomuv10221
Supersedes: Version 4.0
Page 1 of 16
AUSTRALIAN
PRODUCT
INFORMATION
–
TOMUDEX
 (RALTITREXED)
1.
NAME OF THE MEDICINE
Raltitrexed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Raltitrexed is a pale yellow/brown to brown powder. Its aqueous
solubility is pH dependent,
ranging from slightly soluble at pH 5 to sparingly soluble at pH 9. In
organic solvents it is very
slightly soluble in acetone, diethyl ether, octan-1-ol and chloroform,
slightly soluble in
tetrahydrofuran and 95% ethanol and sparingly soluble in methanol.
TOMUDEX contains 2 mg raltitrexed and includes the following
excipients: mannitol 203mg,
dibasic sodium phosphate dodecahydrate 2.0 mg and sodium hydroxide qs
to pH 7.4.
TOMUDEX contains no preservative or bacteriostatic agent.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
TOMUDEX powder for injection, is a white to cream coloured solid cake
practically free from
visible particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For use as a single agent in the palliative treatment of advanced
colorectal cancer (distant
metastases or unresectable local disease).
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
_USE IN ADULTS _
The dose of TOMUDEX is calculated on the basis of the body surface
area. The recommended
dose is 3 mg/m
2
given intravenously, as a single short, intravenous infusion in 50 to
250 mL of
either 0.9% sodium chloride solution or 5% glucose solution. It is
recommended that the
infusion is given over a 15 minute period. Other drugs should not be
mixed with TOMUDEX
in the same infusion container. In the absence of toxicity, treatment
may be repeated every 3
weeks.
Dose escalation above 3 mg/m
2
is not recommended, since higher doses have been associated
with an increased incidence of life-threatening or fatal toxicity.
Version: pfptomuv10221
Supersedes: Version 4.0
Page 2 of 16
Prior to the initiation of treatment and before each subsequent
treatment a full blood count
(including a differential count and platele