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PROSTIN VR Concentrate for solution for infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Prostin VR 500 micrograms/ml Concentrate for solution for infusion.

Qualitative and quantitative composition

500 micrograms/ml. Each 1 ml ampoule contains 500 micrograms of alprostadil. Excipient(s) with known effect: Each ml contains 789 mg ethanol. For the full list of excipients, see section 6.1.

Pharmaceutical form

Concentrate for solution for infusion (Sterile concentrate). Clear, colourless solution.

Therapeutic indications

Prostin VR is indicated to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in infants who have congenital defects and who depend upon the ...

Posology and method of administration

Posology The infusion is generally initiated at a rate of 0.05-0.1 micrograms/kg/min. The most experience has been with 0.1 micrograms/kg/min. After a therapeutic response (an increase in pO2 in neonates ...

Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Prostin VR should be administered only by well trained healthcare professionals and in facilities with immediate access to paediatric intensive care. Apnoea may occur in about 10-12% of neonates with congenital ...

Interaction with other medicinal products and other forms of interaction

No drug interactions have been reported to occur between Prostin VR and the standard therapy employed in neonates with congenital heart defects. Standard therapy includes antibiotics (such as penicillin ...

Pregnancy and lactation

Not relevant.

Effects on ability to drive and use machines

Not relevant.

Undesirable effects

The most frequent adverse reactions observed with Prostin VR infusion in neonates with ductal-dependent congenital heart defects are related to the drugs known pharmacological effects. The following undesirable ...

Overdose

Apnoea, bradycardia, pyrexia, hypotension and flushing may be signs of drug overdose. If apnoea or bradycardia occur, the infusion should be discontinued and the appropriate medical treatment initiated. ...

Pharmacodynamic properties

Pharmacotherapeutic group: Prostaglandins ATC code: C01EA01 Prostaglandins are potent vasoactive derivatives of arachidonic acid that exert vasomotor, metabolic and cellular effects on the pulmonary and ...

Pharmacokinetic properties

Distribution Based on studies in several animal species, intravenous or arterially administered prostaglandin E<sub>1</sub> is very rapidly distributed throughout the entire body, with the exception of ...

Preclinical safety data

Long-term carcinogenicity and fertility studies have not been done. The Ames and Alkaline Elution assays reveal no potential for mutagenesis.

List of excipients

Ethanol

Incompatibilities

Diluted solutions of Prostin VR should be infused from glass or hard plastic containers, or PVC infusion bags. If undiluted Prostin VR comes in direct contact with a plastic container, plasticisers are ...

Shelf life

Shelf life: 3 years. Diluted solutions should be used within 24 hours.

Special precautions for storage

Store in a refrigerator.

Nature and contents of container

1ml Type I clear glass ampoule. Multipacks containing 5 1 ml ampoules.

Special precautions for disposal and other handling

Dilution instructions To prepare infusion solutions, dilute 1 ml of Prostin VR with sterile 0.9% sodium chloride intravenous infusion or sterile 5% dextrose intravenous infusion. If undiluted Prostin VR ...

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

Marketing authorization number(s)

PL 00057/1031

Date of first authorization / renewal of the authorization

Date of first authorisation: 23 July 1981 Date of latest renewal: 17 April 1997

Date of revision of the text

09/2019

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