Epoprostenol 1.5mg powder and solvent (pH10.5) for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Epoprostenol sodium

Available from:

pH10.5) for solution for infusion vials (Sandoz Ltd

ATC code:

B01AC09

INN (International Name):

Epoprostenol sodium

Dosage:

1.5mg

Pharmaceutical form:

Powder and solvent for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02080100

Summary of Product characteristics

EPOPROSTENOL SODIUM 1.5 MG POWDER AND SOLVENT
FOR SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 27-May-2015 | Sandoz
Limited
1. Name of the medicinal product
Epoprostenol Sodium 1.5 mg Powder and Solvent for Solution for
Infusion
2. Qualitative and quantitative composition
Epoprostenol Sodium 1.5 mg Powder and Solvent for Solution for
Infusion:
Each vial contains epoprostenol sodium equivalent to 1.5 mg
epoprostenol.
Excipient(s) with known effect: contains 0.054 mmol sodium (1.25 mg).
Solvent for Epoprostenol Sodium 1.5 mg Powder and Solvent for Solution
for Infusion:
Each vial contains 50ml sterile glycine buffer solution.
Excipient(s) with known effect: contains 1.25 mmol sodium (28,82 mg).
For the full list of excipients, see section 6.1.
One ml of reconstituted concentrate solution contains epoprostenol (as
epoprostenol sodium) 30 000
nanogram.
3. Pharmaceutical form
Powder and solvent for solution for infusion
− White to almost white freeze dried powder
− Clear solution (pH 10.3-10.8)
4. Clinical particulars
4.1 Therapeutic indications
Epoprostenol is indicated for:
Pulmonary Arterial Hypertension
Epoprostenol is indicated for the treatment of pulmonary arterial
hypertension (PAH) (idiopathic or
heritable PAH and PAH associated with connective tissue diseases) in
patients with WHO Functional
Class III-IV symptoms to improve exercise capacity (see section 5.1).
Renal Dialysis
Epoprostenol is indicated for use in haemodialysis in emergency
situations when use of heparin carries a
high risk of causing or exacerbating bleeding or when heparin is
otherwise contraindicated (see section
5.1).
4.2 Posology and method of administration
Posology
Epoprostenol is only indicated for continuous infusion by intravenous
route.
PULMONARY ARTERIAL HYPERTENSION
Treatment should only be initiated and monitored by a physician
experienced in the treatment of
pulmonary arterial hypertension.
Short-term (acute) dose ranging:
This procedure should be conducted in a hospital with adequate
resuscitation equipme