Pemetrexed Juno

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Pemetrexed disodium hemipentahydrate 604.05mg equivalent to Pemetrexed 500mg

Available from:

Juno Pharmaceuticals NZ Limited

INN (International Name):

Pemetrexed disodium hemipentahydrate 604.05 mg (equivalent to Pemetrexed 500mg)

Dosage:

500 mg

Pharmaceutical form:

Powder for infusion

Composition:

Active: Pemetrexed disodium hemipentahydrate 604.05mg equivalent to Pemetrexed 500mg Excipient: Hydrochloric acid Mannitol Sodium hydroxide

Prescription type:

Prescription

Manufactured by:

Gland Chemicals Private Limited

Therapeutic indications:

Pemetrexed, in combination with cisplatin is indicated for the treatment of patients with malignant pleural mesothelioma.

Product summary:

Package - Contents - Shelf Life: Vial, 50 mL/20 mm USP Type 1 glass, Closure: 20mm rubber stopper & al flip off seals - 1 dose units - 24 months from date of manufacture stored at or below 25°C. Do not freeze

Authorization date:

2016-02-17

Summary of Product characteristics

Pemetrexed Juno – Datasheet
Page 1 of 26
PEMETREXED JUNO
(pemetrexed disodium) 100 mg and 500 mg
Powder for Injection
_DATASHEET _
1.
PRODUCT NAME
PEMETREXED JUNO contains pemetrexed as disodium hemipentahydrate.
The active ingredient in PEMETREXED JUNO 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, hemipentahydrate. It
has
an empirical formula of C
20
H
19
N
5
O
6

2Na

2.5H2O and a molecular weight of 517.37. The
structural formula is as follows:
The CAS number for pemetrexed disodium (as hemipentahydrate) is
357166-30-4.
Pemetrexed disodium is a white to almost white solid.
PEMETREXED JUNO is supplied in as two strengths - 500 mg and 100 mg.
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
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
lyophilised solid.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
500
mg
vial
of
PEMETREXED
JUNO
contains
604.05
mg
pemetrexed
disodium
hemipentahydrate equivalent to 500 mg pemetrexed and 500 mg of
mannitol. Hydrochloric acid
and/or sodium hydroxide may have been added to adjust pH.
Pemetrexed Juno – Datasheet
Page 2 of 26
Each
100
mg
vial
of
PEMETREXED
JUNO
contains
120.81
mg
pemetrexed
disodium
hemipentahydrate equivalent to 100 mg pemetrexed and 106.0 mg of
mannitol. Hydrochloric
acid and/or sodium hydroxide may have been added to adjust pH
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
lyophilised solid.
4.
CLINICAL PARTICULARS
4.1 THERAPE