PEMETREXED JUNO pemetrexed (as disodium) 100mg powder for injection vial

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

pemetrexed disodium hemipentahydrate, Quantity: 120.81 mg (Equivalent: pemetrexed, Qty 100 mg)

Dostupno od:

Juno Pharmaceuticals Pty Ltd

INN (International ime):

pemetrexed disodium hemipentahydrate

Farmaceutski oblik:

Injection, powder for

Sastav:

Excipient Ingredients: sodium hydroxide; nitrogen; mannitol; hydrochloric acid

Administracija rute:

Intravenous Infusion

Jedinice u paketu:

1 vial

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

PEMETREXED JUNO, in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma. Non-Small Cell lung Cancer PEMETREXED JUNO 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 JUNO 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.

Proizvod sažetak:

Visual Identification: White to either light-yellow or green-yellow lyophilized powder or cake.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Status autorizacije:

Licence status A

Datum autorizacije:

2015-05-21

Uputa o lijeku

PEMETREXED JUNO
1
PEMETREXED JUNO
_pemetrexed disodium hemipentahydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PEMETREXED
JUNO. It does not contain all the
available information. It does not take
the place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date shown on the
final page. More recent information on
this medicine may be available. Make
sure you speak to your pharmacist,
nurse or doctor to obtain the most up to
date information on this medicine.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking PEMETREXED JUNO
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT PEMETREXED
JUNO IS USED FOR
PEMETREXED JUNO is used to treat:
•
mesothelioma, a rare cancer of
the lungs often related to
exposure to asbestos
•
non-small cell lung cancer, a type of
lung cancer.
It belongs to a group of
medicines called cytotoxic or
antineoplastic agents. They may
also be called chemotherapy
medicines.
It affects enzymes within cancer cells
to kill cancer cells or prevent them
growing and multiplying.
Your doctor may have prescribed it
for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
PEMETREXED JUNO
may be used in
combination with other
chemotherapy drugs.
BEFORE YOU ARE GIVEN
PEMETREXED JUNO
_ _
_ _
_WHEN YOU MUST NOT BE GIVEN _
_IT_
DO NOT TAKE PEMETREXED
JUNO IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
pemetrexed disodium
hemipentahydrate
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing; swelling of the face, lips,
tongue or other parts of the bo

Svojstava lijeka

Juno Pharmaceuticals Pty Ltd
Australian Product Information
Pemetrexed Juno PI
Page | 1
AUSTRALIAN PRODUCT INFORMATION
PEMETREXED JUNO _(PEMETREXED DISODIUM HEMIPENTAHYDRATE) _
_ _
1 NAME OF THE MEDICINE
Pemetrexed disodium hemipentahydrate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
PEMETREXED JUNO is supplied in 500 mg and 100 mg vials.
Each 500 mg vial of PEMETREXED JUNO contains pemetrexed disodium
hemipentahydrate
equivalent to 500 mg pemetrexed.
Each 100 mg vial of PEMETREXED JUNO contains pemetrexed disodium
hemipentahydrate
equivalent to 100 mg pemetrexed.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
PEMETREXED JUNO is supplied as a sterile lyophilised powder for
intravenous infusion
available in single dose vials. The product is a white to either light
yellow or green-yellow
lyophilized powder or cake.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_MALIGNANT PLEURAL MESOTHELIOMA _
PEMETREXED JUNO, in combination with cisplatin, is indicated for the
treatment of patients
with malignant pleural mesothelioma.
_NON-SMALL CELL LUNG CANCER _
PEMETREXED JUNO 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 JUNO 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 DOSE AND METHOD OF ADMINISTRATION
PEMETREXED JUNO should be administered under the supervision of a
qualified physician
experienced in the use of antineoplastic agents.
PEMETREXED JUNO in combination use with cisplatin:
e003055
Product information - clean
1.3.1.1 Pg. 1
Juno Pharmaceuticals Pty Ltd
Australian Product Information
Pemetrexed Juno PI
Page | 2
Adults - The recommended dose of PEMETREXED JUNO injection is 500 mg/m
2
as body
surface area (BSA) administered as an intravenous infusion ove