EPOPROSTENOL SUN epoprostenol (as sodium) 500 microgram powder for injection vial

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

epoprostenol sodium, Quantity: 0.531 mg (Equivalent: epoprostenol, Qty 0.5 mg)

MAH:

Sun Pharma ANZ Pty Ltd

pharmaceutical_form:

Injection, powder for

composition:

Excipient Ingredients: sucrose; sodium hydroxide; glycine

administration_route:

Intravenous

units_in_package:

1 vial

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

Epoprostenol SUN is indicated for the long-term treatment, via continuous intravenous infusion, in WHO functional Class III or Class IV patients with idiopathic pulmonary arterial hypertension, familial pulmonary arterial hypertension and pulmonary arterial hypertension associated with the scleroderma spectrum of diseases.

leaflet_short:

Visual Identification: White to off white lyophilized cake or powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

authorization_status:

Registered

authorization_date:

2018-07-13

SPC

1
AUSTRALIAN PRODUCT INFORMATION EPOPROSTENOL SUN
(EPOPROSTENOL) POWDER FOR INJECTION
1 NAME OF THE MEDICINE
Epoprostenol sodium
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
EPOPROSTENOL SUN for Injection is formulated for intravenous
administration.
EPOPROSTENOL SUN 500 µg powder for injection: Each vial contains 531
µg epoprostenol
sodium equivalent to 500 µg epoprostenol.
EPOPROSTENOL SUN 1.5 mg powder for injection: Each vial contains 1.593
mg epoprostenol
sodium equivalent to 1.5 mg epoprostenol.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
Powder for injection for intravenous infusion.
Sterile white to off-white lyophilised cake or powder.
The reconstituted solution of EPOPROSTENOL SUN has a pH of 12.0 to
13.2 and is increasingly
unstable at a lower pH (see Instructions for use/handling).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
EPOPROSTENOL SUN is indicated for the long-term treatment, via
continuous intravenous
infusion, in WHO functional Class III or Class IV patients with:
•
Idiopathic pulmonary arterial hypertension
•
Familial pulmonary arterial hypertension
•
Pulmonary arterial hypertension associated with the scleroderma
spectrum of diseases.
4.2 DOSE AND METHOD OF ADMINISTRATION
GENERAL
EPOPROSTENOL SUN must be reconstituted before use. Any further
dilution must be
2
performed using the recommended solutions. Infusion sets with an
in-line 0.22 micron filter must
be used (see Instructions for use/handling).
Epoprostenol reconstituted solution (pH 12.0 to 13.2) must not be used
with any preparation or
administration
materials
containing
polyethylene
terephthalate
(PET)
or
polyethylene
terephthalate glycol (PETG) (see SECTION 6.2 INCOMPATIBILITIES).
Suitable ambulatory pumps to be used for the administration of
EPOPROSTENOL SUN include:
•
CADD-Legacy® 1
•
CADD-Legacy® PLUS Manufactured by Smiths Medical.
Other pumps may be used depending on suitability.
Pump accessories found compatible with the administration of
EPOPROSTENOL SUN incl