VELETRI Powder for solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
VELETRI 0.5 mg, Powder for Solution for Infusion. VELETRI 1.5 mg, Powder for Solution for Infusion.
Qualitative and quantitative composition
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 ...
Pharmaceutical form
Powder for solution for infusion. White to off-white powder. For the pH of the diluted solution see section 4.4.
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 ...
Posology and method of administration
Posology Pulmonary Arterial Hypertension VELETRI is only indicated for continuous infusion by intravenous route. Treatment should only be initiated and monitored by a physician experienced in the treatment ...
Contraindications
VELETRI is contraindicated in patients: with known hypersensitivity to the active substance or to any of the excipients listed in section 6.1. with congestive heart failure arising from severe left ventricular ...
Special warnings and precautions for use
The pH of the diluted ready-to-use solution decreases with dilution, and ranges from 12.0 for a concentration of 90,000 ng/mL, 11.7 for a concentration of 45,000 ng/mL to 11.0 for a concentration of 3,000 ...
Interaction with other medicinal products and other forms of interaction
When VELETRI is administered to patients receiving concomitant anticoagulants, standard anticoagulant monitoring is advisable. The vasodilator effects of VELETRI may augment or be augmented by concomitant ...
Fertility, pregnancy and lactation
Pregnancy There is limited data from the use of epoprostenol in pregnant women. Animal studies did not indicate harmful effects with respect to reproductive toxicity (see section 5.3). Given the absence ...
Effects on ability to drive and use machines
Pulmonary arterial hypertension and its therapeutic management may affect the ability to drive and operate machinery. There are no data regarding the effect of VELETRI used in renal dialysis on the ability ...
Undesirable effects
Adverse events are listed below by system organ class and frequency. Frequencies are defined as follows: very common ≥1/10 (≥10%); common ≥1/100 and <1/10 (≥1% and <10%); uncommon ≥1/1000 and <1/100 (≥0.1% ...
Overdose
The main feature of overdose is likely to be hypotension. In general, events seen after overdose of VELETRI represent exaggerated pharmacological effects of the drug (e.g. hypotension and complications ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antithrombotic Agents; Platelet aggregation inhibitors excl. heparin ATC code: B01AC09 The pH value of VELETRI is higher than the pH of other epoprostenol products. Compared ...
Pharmacokinetic properties
Due to the chemical instability, high potency and short half-life of epoprostenol, no precise and accurate assay has been identified as appropriate for quantifying epoprostenol in biological fluids. Intravenously ...
Preclinical safety data
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and toxicity to reproduction and development. No long-term ...
List of excipients
Sucrose Arginine Sodium hydroxide (for pH adjustment)
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life: 3 years. In use shelf life reconstituted/diluted solution for infusion: The reconstituted solution should be immediately further diluted to the final concentration. The diluted solution should ...
Special precautions for storage
This medicinal product (powder for solution for infusion) does not require any special temperature storage conditions. Do not freeze. The reconstituted solution should be immediately further diluted to ...
Nature and contents of container
Powder for solution for infusion 10 mL colourless glass type I vial closed with a rubber stopper and an aluminium flip-off cap (with a white disc for the 0.5 mg/vial strength, and a red disc for the 1.5 ...
Special precautions for disposal and other handling
Suitable ambulatory pumps to be used for the administration of VELETRI include: CADD-Legacy 1 CADD-Legacy PLUS CADD-Solis VIP (variable infusion profile) Manufactured by Smiths Medical. Pump accessories ...
Marketing authorization holder
Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
Marketing authorization number(s)
PL 00242/0645 PL 00242/0646
Date of first authorization / renewal of the authorization
Date of first authorisation: 26 April 2013
Date of revision of the text
11 May 2020
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