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

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

pemetrexed, Quantity: 100 mg

제공처:

Teva Pharma Australia Pty Ltd

INN (국제 이름):

Pemetrexed

약제 형태:

Injection, powder for

구성:

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

관리 경로:

Intravenous

패키지 단위:

1 vial

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

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

제품 요약:

Visual Identification: PEMETREXED-TEVA powder for injection is available in sterile single-use vials containing 100mg pemetrexed.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Licence status A

승인 날짜:

2016-04-07

제품 특성 요약

AUSTRALIAN PI –PEMETREXED-TEVA (PEMETREXED DISODIUM)
POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Pemetrexed disodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in Pemetrexed-Teva powder for injection is
pemetrexed disodium. Pemetrexed
disodium has the chemical name
L
-glutamic acid, _
N_-[4-[2-(2-amino-4,7-dihydro-4-oxo-1_H_-pyrrolo[2,3-
_d_]pyrimidin-5-yl)ethyl]benzoyl]-,
disodium
salt,
heptahydrate.
It
has
an
empirical
formula
of
C
20
H
19
N
5
O
6
●2Na●7H
2
O and a molecular weight of 597.49.
Pemetrexed disodium is a white to almost white solid.
Each 100 mg vial of Pemetrexed-Teva contains pemetrexed disodium
equivalent to 100 mg pemetrexed.
Each 500 mg vial of Pemetrexed-Teva contains pemetrexed disodium
equivalent to 500 mg pemetrexed.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
The product is a white to either light yellow or green-yellow
lyophilised solid. Pemetrexed-Teva is
supplied as a powder for injection in 100mg vials and 500mg vials.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
MALIGNANT PLEURAL MESOTHELIOMA
Pemetrexed, in combination with cisplatin, is indicated for the
treatment of patients with malignant
pleural mesothelioma.
NON-SMALL CELL LUNG CANCER
Pemetrexed 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 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 should be administered under the supervision of a qualified
physician experienced in the
use of antineoplastic agents
Teva Pharma Australia Pty Limited Version 3.0
1
Pemetrexed in combination use with cisplatin:
Adults - The recommended dose of pemetrexed is 500 mg/m
2
as body surface area (BSA) administe