Milrinone 1 mg/ml Solution for Injection/Infusion
Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
інформаційний буклет
(PIL)
17-08-2019
Характеристики продукта
(SPC)
17-08-2019
Активний інгредієнт:
Milrinone
Доступна з:
Wockhardt UK Limited
Код атс:
C01CE; C01CE02
ІПН (Міжнародна Ім'я):
Milrinone
Дозування:
1 milligram(s)/millilitre
Фармацевтична форма:
Solution for injection/infusion
Тип рецепту:
Product subject to prescription which may not be renewed (A)
Терапевтична области:
Phosphodiesterase inhibitors; milrinone
Статус Авторизація:
Marketed
Дата Авторизація:
2016-09-16
інформаційний буклет
CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
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PACKAGE LEAFLET: INFORMATION FOR THE USER
MILRINONE 1MG/ML SOLUTION FOR INJECTION/INFUSION
MILRINONE
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
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WHAT MILRINONE IS AND WHAT IT IS USED FOR
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MILRINONE CAN BE USED IN ADULTS FOR:
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MILRINONE CAN BE USED IN CHILDREN FOR
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Характеристики продукта
Health Products Regulatory Authority
16 August 2019
CRN00918X
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Milrinone 1 mg/ml Solution for Injection/Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml ampoule contains 10 mg milrinone. Each ml of solution
contains 1 mg milrinone.
Excipient with known effect:
Sodium (this medicinal product contains less than 1 mmol sodium (23
mg) per dose)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear, colourless to pale yellow solution, practically free from
particles.
The pH of the solution is 3.2 - 4.0 and the osmolality is 261 –
319mOsm/Kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Milrinone Injection is indicated for the short-term treatment of
severe congestive heart failure unresponsive to conventional
maintenance therapy, and for the treatment of patients with acute
heart failure, including low output states following cardiac
surgery.
In paediatric population milrinone is indicated for the short-term
treatment (up to 35 hours) of severe congestive heart failure
unresponsive to conventional maintenance therapy (glycosides,
diuretics, vasodilators and/or angiotensin converting enzyme
(ACE) inhibitors), and for the short-term treatment (up to 35 hours)
of paediatric patients with acute heart failure, including low
output states following cardiac surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For intravenous administration.
_Adults_: Milrinone Injection should be given as a loading dose of
50μg/kg administered over a period of 10 minutes usually
followed by a continuous infusion at a dosage titrated between
0.375microgram(s)/kg/min and 0.75microgram(s)/kg/min
according to haemodynamic and clinical response, but should not exceed
1.13mg/kg/day total dose. For instructions on
dilution of the product before administration and a guide to
maintenance infusion delivery rates, see section 6.6.
Solutions of different concentrations may be used according to patient
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