Milrinone 1 mg/ml Solution for Injection/Infusion

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Milrinone

متاح من:

Pinewood Laboratories Ltd

ATC رمز:

C01CE; C01CE02

INN (الاسم الدولي):

Milrinone

جرعة:

1 milligram(s)/millilitre

الشكل الصيدلاني:

Solution for injection/infusion

المجال العلاجي:

Phosphodiesterase inhibitors; milrinone

الوضع إذن:

Marketed

تاريخ الترخيص:

2016-09-16

نشرة المعلومات

P
ACKAGE LEAFLET: INFORMATION FOR THE USER
MILRINONE 1 MG/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.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, nurse or
pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Milrinone is and what it is used for
2. What you need to know before you are given Milrinone
3. How you will be given Milrinone
4. Possible side effects
5. How to store Milrinone
6. Contents of the pack and other information
1. WHAT MILRINONE IS AND WHAT IT IS USED FOR
The name of your medicine is Milrinone 1 mg/ml Solution for
Injection/Infusion (referred to as
Milrinone throughout this leaflet). It contains a medicine called
milrinone. This belongs to a group of
medicines called phosphodiesterase inhibitors. It works by making your
heart muscle contract more
strongly and your blood vessels become wider. This means blood can
flow more easily making your
heart pump blood more successfully.
MILRINONE CAN BE USED IN ADULTS FOR:
•
Short-term treatment of severe congestive heart failure (where the
heart cannot pump enough blood
to the rest of the body) when other medicines have not worked
•
Treatment after a heart operation for when your heart is having
difficulty pumping blood around your
body
MILRINONE CAN BE USED IN CHILDREN FOR:
•
short term treatment (up to 35 hours) of severe congestive heart
failure (where the heart cannot pump
enough blood to the rest of the body) when other medicines have not
worked
•
short term treatment (up to 35 hours) of acute heart failure after a
heart operation i.e. when your heart
is hav

خصائص المنتج

Health Products Regulatory Authority
10 June 2022
CRN00CGCR
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 ml of solution contains 1 mg milrinone. Each 10 ml ampoule
contains 10 mg milrinone.
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 – 319
mOsm/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 50
microgram(s)/kg administered over a period of 10 minutes
usually followed by a continuous infusion at a dosage titrated between
0.375 microgram(s)/kg/min and 0.75
microgram(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
fluid requirements. The duration of therapy should
depend upon the patient's response. In congestive