PEMETREXED EVER PHARMA pemetrexed (as disodium) 500 mg/20 mL concentrated solution for infusion vial

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

pemetrexed disodium hemipentahydrate, Quantity: 604.1 mg (Equivalent: pemetrexed, Qty 500 mg)

Доступна с:

Interpharma Pty Ltd

Фармацевтическая форма:

Injection, concentrated

состав:

Excipient Ingredients: trometamol; hydrochloric acid; sodium hydroxide; water for injections; monothioglycerol; citric acid

Администрация маршрут:

Intravenous Infusion

Штук в упаковке:

1 vial

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

Malignant Pleural Mesothelioma,PEMETREXED EVER PHARMA, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma.,Non-Small Cell Lung Cancer,PEMETREXED EVER PHARMA 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 EVER PHARMA 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.

Обзор продуктов:

Visual Identification: Clear, slighlty yellow to green-yellow solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Статус Авторизация:

Registered

Дата Авторизация:

2022-10-25

тонкая брошюра

InterPharma Pemetrexed Ever Pharma CMI V1.1 Oct 2022
Page 1 of 5
PEMETREXED EVER PHARMA
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 EVER PHARMA?
PEMETREXED EVER PHARMA contains the active ingredient pemetrexed_
_disodium hemipentahydrate. PEMETREXED EVER
PHARMA is used to TREAT mesothelioma, a rare cancer of the lungs often
related to exposure to asbestos and non-small cell
lung cancer, a type of lung cancer.
For more information, see Section 1. Why am I using PEMETREXED EVER
PHARMA? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PEMETREXED EVER PHARMA?
Do not use if you have ever had an allergic reaction to PEMETREXED
EVER PHARMA 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 EVER PHARMA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with PEMETREXED EVER PHARMA 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 PEMETREXED EVER PHARMA?
Pemetrexed is given as an infusion (drip) into your veins over a 10
minute period. Pemetrexed is given once every three weeks
(1 treatment cycle). Your doctor will advise how many treatment cycles
you need.
More instructions can be found in Section 4. How do I use PEMETREXED
EVER PHARMA? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PEMETREXED EVER PHARMA?
THINGS YOU
SHOULD DO
Remind any doctor, dentist or pharmacist you visit that you are using
PEMETREXED EVER PHARMA.
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's appoin

Характеристики продукта

InterPharma Pemetrexed Ever Pharma PI V1.8 Oct 2022
Page 1 of 25
AUSTRALIAN PRODUCT INFORMATION
PEMETREXED EVER PHARMA
(PEMETREXED DISODIUM HEMIPENTAHYDRATE)
CONCENTRATED SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Pemetrexed disodium hemipentahydrate.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PEMETREXED EVER PHARMA is supplied as a sterile concentrated solution
for injection of
pemetrexed (as disodium hemipentahydrate) 25 mg/mL in vials in three
volumes
100 mg in 4 mL
500 mg in 20 mL
1000 mg in 40 mL
For the full list of excipients, see section
6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
PEMETREXED
EVER
PHARMA
is
an aqueous, clear,
slightly
yellow
to
green-yellow
concentrate for solution for infusion with a pH of 7.5 – 8.1
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MALIGNANT PLEURAL MESOTHELIOMA
PEMETREXED EVER PHARMA, in combination with cisplatin, is indicated
for the treatment
of patients with malignant pleural mesothelioma.
NON-SMALL CELL LUNG CANCER
PEMETREXED EVER PHARMA 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 EVER PHARMA 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.
InterPharma Pemetrexed Ever Pharma PI V1.8 Oct 2022
Page 2 of 25
4.2
DOSE AND METHOD OF ADMINISTRATION
PEMETREXED EVER PHARMA should be administered under the supervision of
a qualified
physician experienced in the use of antineoplastic agents.
PEMETREXED EVER PHARMA in combination use with cisplatin:
Adults - The recommended dose of PEMETREXED EVER PHARMA 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