Pemetrexed SUN pemetrexed (as disodium) 500mg/vial powder for injection vial

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

pemetrexed disodium, Quantity: 551.4 mg (Equivalent: pemetrexed, Qty 500 mg)

זמין מ:

Sun Pharma ANZ Pty Ltd

INN (שם בינלאומי):

pemetrexed disodium

טופס פרצבטיות:

Injection, powder for

הרכב:

Excipient Ingredients: mannitol; sodium hydroxide; hydrochloric acid

מסלול נתינה (של תרופות):

Intravenous

יחידות באריזה:

1 vial

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

Malignant Pleural Mesothelioma Pemetrexed SUN, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma.,Non-Small Cell lung Cancer Pemetrexed SUN in combination with cisplatin is indicated for initial treatment of patients with locally advance or metastatic non-small cell lung cancer other than predominantly squamous cell histology. Pemetrexed SUN as monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology after prior platinum-based chemotherapy.

leaflet_short:

Visual Identification: White to either light yellow or green yellow lyophilized solid in 50ml colourless glass vial with grey rubber stopper and sealed with ash grey F/O both side clear lacquer coated seal; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

מצב אישור:

Licence status A

תאריך אישור:

2016-06-17

עלון מידע

PEMETREXED SUN
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 PEMETREXED SUN?
Pemetrexed SUN contains the active ingredient pemetrexed disodium.
Pemetrexed SUN is used to treat mesothelioma and
non-small cell lung cancer.
For more information, see Section 1. Why am I using Pemetrexed SUN?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PEMETREXED SUN?
Do not use if you have ever had an allergic reaction to Pemetrexed SUN
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
Pemetrexed SUN?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Pemetrexed SUN 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 PEMETREXED SUN WILL BE GIVEN?
•
Your doctor will decide the dosage of Pemetrexed SUN you should take.
This will depend on your condition and other
factors, such as your weight.
•
Pemetrexed SUN is given as an infusion (drip) into your veins over a
10 minute period.
More instructions can be found in Section 4. How do I use Pemetrexed
SUN?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PEMETREXED SUN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Pemetrexed SUN.
•
Always take your daily folate supplement until your doctor tells you
to stop.
•
Always check with your doctor that your vitamin B12 injections are up
to date.
•
Keep all of your doctor appointments so that your progress can be
checked. Your doctor may do some
tests from time to time to make sure the medicine is working and to
prevent unwanted side effects.
DRIVING OR USING
MACHINES
Pemetrexed SUN may cause tired

מאפייני מוצר

AUSTRALIAN PRODUCT INFORMATION – PEMETREXED SUN
(PEMETREXED DISODIUM)
1
NAME OF THE MEDICINE
Pemetrexed disodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 100 mg, 500 mg or 1000 mg pemetrexed.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
PEMETREXED SUN is supplied as a sterile lyophilised powder for
intravenous infusion available
in single dose clear vials. The product is a white to either light
yellow or green-yellow lyophilised
solid.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
_MALIGNANT PLEURAL MESOTHELIOMA _
Pemetrexed SUN, in combination with cisplatin, is indicated for the
treatment of patients with
malignant pleural mesothelioma.
_NON-SMALL CELL LUNG CANCER _
Pemetrexed SUN in combination with cisplatin is indicated for initial
treatment of patients with
locally advanced or metastatic non-small cell lung cancer other than
predominantly squamous
cell histology.
Pemetrexed SUN as monotherapy is indicated for the treatment of
patients with locally advanced
or metastatic non-small cell lung cancer other than predominantly
squamous cell histology after
prior platinum-based chemotherapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Pemetrexed
SUN
should
be
administered
under
the
supervision
of
a
qualified
physician
experienced in the use of antineoplastic agents. Pemetrexed SUN should
only be used in one
patient on one occasion only and any residue should be discarded.
Pemetrexed SUN in combination use with cisplatin:
Adults - The recommended dose of Pemetrexed SUN is 500 mg/m
2
as body surface area (BSA)
administered as an intravenous infusion over 10 minutes on the first
day of each 21-day cycle.
The recommended dose of cisplatin is 75 mg/m
2
BSA infused over 2 hours approximately 30
minutes after completion of the Pemetrexed SUN infusion on the first
day of each 21-day cycle.
1
Patients must receive adequate anti-emetic treatment and appropriate
hydration prior to and/or
after receiving cisplatin. See cisplatin Product Information document