Milrinone 1mg/ml Solution for Injection/Infusion

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

MILRINONE

Dostopno od:

Pinewood Laboratories Limited Ballymacarbry, Clonmel, Co. Tipperary, Ireland

Koda artikla:

C01CE02

INN (mednarodno ime):

MILRINONE 1 mg/ml

Farmacevtska oblika:

SOLUTION FOR INFUSION OR INJECTION

Sestava:

MILRINONE 1 mg/ml

Tip zastaranja:

POM

Terapevtsko območje:

CARDIAC THERAPY

Status dovoljenje:

Withdrawn

Datum dovoljenje:

2016-07-29

Navodilo za uporabo

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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.
•
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 1mg/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 hea

Lastnosti izdelka

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Milrinone 1mg/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
0.375μg/kg/min and 0.75μg/kg/min according to haemodynamic and
clinical response, but
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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