Fulvestrant-AFT

Երկիր: Նոր Զելանդիա

Լեզու: անգլերեն

Աղբյուրը: Medsafe (Medicines Safety Authority)

Ակտիվ բաղադրիչ:

Fulvestrant 50 mg/mL

Հասանելի է:

AFT Pharmaceuticals Ltd

Դոզան:

250 mg/5mL

Դեղագործական ձեւ:

Solution for injection

Կազմը:

Active: Fulvestrant 50 mg/mL Excipient: Benzyl alcohol Benzyl benzoate Castor oil Ethanol

Ռեկվիզորի տեսակը:

Prescription

Թերապեւտիկ ցուցումներ:

Fulvestrant-AFT is indicated for the treatment of locally advanced or metastatic breast cancer in postmenopausal women of any age previously treated with endocrine therapy (antioestrogen or aromatase inhibitor), irrespective of whether their postmenopausal status occurred naturally or was artificially induced.

Ապրանքի ամփոփագիր:

Package - Contents - Shelf Life: Syringe, glass, Type 1 neutral glass, bromobutyl plunger stopper (fluorocarbon polymer coating) - 5 mL - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 28 days not refrigerated stored at or below 25°C

Հաստատման ամսաթիվը:

2022-04-08

Ապրանքի հատկությունները

NEW ZEALAND DATA SHEET
Page 1 of 13
1 PRODUCT NAME
Fulvestrant-AFT, 250 mg/5 mL, solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 250 mg fulvestrant in 5 mL solution.
EXCIPIENTS WITH KNOWN EFFECT (PER 5 ML)
Ethanol (96%, 500 mg)
Benzyl alcohol (500 mg)
Benzyl benzoate (750 mg)
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection. Clear, colourless to yellow, viscous liquid.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fulvestrant-AFT is indicated for the treatment of locally advanced or
metastatic breast cancer in
postmenopausal women of any age previously treated with endocrine
therapy (antioestrogen or
aromatase inhibitor), irrespective of whether their postmenopausal
status occurred naturally or was
artificially induced.
4.2
DOSE AND METHOD OF ADMINISTRATION
_Adult females (including the elderly) _
The recommended dose is 500 mg to be administered intramuscularly as
two 5 mL injections, one in
each buttock (gluteal area), at intervals of 1 month with an
additional 500 mg dose given 2 weeks after
the initial dose.
It is recommended that the injection be administered slowly (1-2
minutes/injection).
_Children _
Not recommended for use in children or adolescents as safety and
effectiveness have not been
established in this age group.
_Patients with renal insufficiency _
No dose adjustments are recommended for patients with a creatinine
clearance greater than
30 mL/min. Safety and efficacy have not been further evaluated in
patients with creatinine clearance
less than 30 mL/min (see section 4.4).
NEW ZEALAND DATA SHEET
Page 2 of 13
_Patients with hepatic insufficiency _
No dose adjustments are recommended for patients with Child-Pugh
category A and B hepatic
impairment. The use of fulvestrant has not been evaluated in patients
with Child-Pugh C hepatic
impairment (see sections 4.4 and 5.2).
_Elderly _
No dose adjustment is required for elderly patients.
_Interactions requiring dose adjustments _
There are no known drug-