Primacor 10mg/10ml solution for injection ampoules

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Milrinone

Verfügbar ab:

Sanofi

ATC-Code:

C01CE02

INN (Internationale Bezeichnung):

Milrinone

Dosierung:

1mg/1ml

Darreichungsform:

Solution for infusion

Verabreichungsweg:

Intravenous

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 02010200; GTIN: 5000283606888

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
PRIMACOR 1MG/ML SOLUTION FOR INJECTION
Milrinone
IS THIS LEAFLET HARD TO SEE OR READ?
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
• 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. Do not pass it on to
others.
It may harm them, even if their symptoms are the same as yours.
•
If any of the side effects, talk to your doctor or pharmacist. This
includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Primacor is and what it is used for
2. What you need to know before you take Primacor
3. How to take Primacor
4. Possible side effects
5. How to store Primacor
6. Contents of the pack and other information
1. WHAT PRIMACOR IS AND WHAT IT IS USED FOR
The name of your medicine is Primacor 1mg/ml Solution for
Injection (called Primacor in this leaflet). Primacor 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.
Primacor can be used 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
Primacor 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 having difficulty
pumping blood around your body.
2. WHAT YOU NEED TO KNOW B

Fachinformation

OBJECT 1
PRIMACOR 1MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 29-Jan-2016 | SANOFI
1. Name of the medicinal product
Primacor 1mg/ml Solution for Injection
2. Qualitative and quantitative composition
Each ampoule contains 1mg/ml of the active substance Milrinone.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for Injection.
Clear, colourless to pale yellow liquid.
4. Clinical particulars
4.1 Therapeutic indications
Primacor 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 Primacor 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_: Primacor 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
should not exceed 1.13mg/kg/day
total dose.
The following provides a guide to maintenance infusion delivery rate
based upon a solution containing
milrinone 200µg/ml prepared by adding 40ml diluent per 10ml ampoule
(400ml diluent per 100ml
Primacor Injection). 0.45% saline, 0.9% saline or 5% glucose may be
used as diluents.
PRIMACOR INJECTION DOSE
(ΜG /KG/MIN)
INFUSION DELIVERY RATE
(ML/KG/HR)
0.375
0.11
0.400
0.500
0.600
0.700
0.750
0.12
0.15
0.18
0.21
0.22
Solutions of different concentrations may be used according to patient