VELETRI POWDER FOR SOLUTION FOR INFUSION 1.5MGVIAL

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Epoprostenol sodium 1.593mg eqv epoprostenol

Available from:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

ATC code:

B01AC09

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

Epoprostenol sodium 1.593mg eqv epoprostenol 1.5mg

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Patheon Italia S.p.A

Authorization status:

ACTIVE

Authorization date:

2018-01-11

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Veletri
®
0.5 mg, Powder for Solution for Infusion
Veletri
®
1.5 mg, Powder for Solution for Infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Veletri
®
0.5 mg, Powder for Solution for Infusion
Each vial contains 0.531 mg epoprostenol sodium equivalent to 0.5 mg
epoprostenol
One mL of reconstituted solution contains 0.1 mg epoprostenol (as
epoprostenol sodium) (0.5 mg
epoprostenol in 5 mL of solvent).
Veletri
®
1.5 mg, Powder for Solution for Infusion
Each vial contains 1.593 mg epoprostenol sodium equivalent to 1.5 mg
epoprostenol
One mL of reconstituted solution contains 0.3 mg epoprostenol (as
epoprostenol sodium) (1.5mg
epoprostenol in 5 mL of solvent).
Excipient(s) with known effect: sodium, (0.03 mg for 0.5 mg/vial and
0.09 mg for 1.5 mg/vial)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion
White to off-white powder
For the pH of the diluted solution see section 4.4
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Veletri
®
is indicated for:
Pulmonary Arterial Hypertension.
Veletri
®
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).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Veletri
®
is only indicated for continuous infusion by intravenous route.
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 equipment.
2
A short-term dose-ranging procedure administered via either a
peripheral or central venous line is required to
determine the long-term infusion rate. The infusion is initiated at 2
ng/kg/min and increased by increments of
2 ng/kg/min every 15 min or longer until maximum haemodynamic benefit
or dose-