Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
epoprostenol sodium, Quantity: 1.593 mg (Equivalent: epoprostenol, Qty 1.5 mg)
Sun Pharma ANZ Pty Ltd
Injection, powder for
Excipient Ingredients: sucrose; sodium hydroxide; glycine
Intravenous
1 vial
(S4) Prescription Only Medicine
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.
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
Registered
2018-07-13
EPOPROSTENOL SUN _EPOPROSTENOL SODIUM_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about EPOPROSTENOL SUN. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using EPOPROSTENOL SUN against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT EPOPROSTENOL SUN IS USED FOR It is used to treat some types of pulmonary arterial hypertension (PAH). PAH is characterised by high blood pressure in the blood vessel that carries blood from the heart to the lungs, and increased resistance in the blood vessels of the lung. The cause of PAH is not known, however there are a number of diseases such as scleroderma that are associated with PAH. EPOPROSTENOL SUN belongs to a group of medicines called prostaglandins. It works by widening the blood vessels in the lungs and so lowering the blood pressure in your lungs (known as a vasodilator action). Your doctor may have prescribed it for another reason. Ask your doctor if you have any questions about why EPOPROSTENOL SUN has been prescribed for you. EPOPROSTENOL SUN is not addictive. BEFORE YOU USE EPOPROSTENOL SUN _WHEN YOU MUST NOT USE IT_ - DO NOT USE EPOROSTENOL SUN IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO EPOPROSTENOL OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction may be mild or severe. They usually include some or all of the following: wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash ("hives") or fainting. - DO NOT USE EPOPROSTENOL SUN IF YOU HAVE HEART DISEASE WITH SHORTNESS OF BREATH, AND SWELLING OF THE FEET OR LEGS DUE TO FLUID BUILD-UP. - DO NOT USE EPOPROSTENOL SUN AFTER THE EXPIRY DATE [EXP.] PRINTED ON THE PACK. If you use it af Läs hela dokumentet
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 Läs hela dokumentet