Rapibloc 600mg powder for solution for infusion

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

LANDIOLOL

Dostopno od:

Amomed Pharma GmbH Storchengasse 1, 1150 Vienna, Austria

Koda artikla:

C07AB14

INN (mednarodno ime):

LANDIOLOL 600 mg

Farmacevtska oblika:

POWDER FOR SOLUTION FOR INFUSION

Sestava:

LANDIOLOL 600 mg

Tip zastaranja:

POM

Terapevtsko območje:

BETA BLOCKING AGENTS

Status dovoljenje:

Withdrawn

Datum dovoljenje:

2017-02-07

Navodilo za uporabo

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RAPIBLOC 300 MG POWDER FOR SOLUTION FOR INFUSION
RAPIBLOC 600 MG POWDER FOR SOLUTION FOR INFUSION
Landiolol hydrochloride
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how to
report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 or nurse.

If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
The full name of your medicine is Rapibloc 300 mg / 600 mg powder for
solution for infusion. In this leaflet
the shorter name Rapibloc is used.
WHAT IS IN THIS LEAFLET
1.
What Rapibloc is and what it is used for
2.
What you need to know before you are given Rapibloc
3.
How Rapibloc is given
4.
Possible side effects
5.
How to store Rapibloc
6.
Contents of the pack and other information
1.
WHAT RAPIBLOC IS AND WHAT IT IS USED FOR
Rapibloc contains the active substance landiolol hydrochloride. It
belongs to a group of medicines called
“beta-blockers”. It works by changing your irregular or fast
heartbeat to a normal heartbeat.
This medicine is used in adults to treat heartbeat problems, when your
heart beats too fast.
It is used during or straight after surgery or in other situations
where control of your heartbeat is needed.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN RAPIBLOC
YOUR DOCTOR WILL NOT GIVE YOU RAPIBLOC IF:

You are allergic to landiolol or any of the other ingredients of this
medicine (listed in section 6).

You have a very slow heartbeat (less than 50 beats per minute).

You have a fast or alternating fast and slow heartbeat (a problem
called the “sick sinus” syndrome).

You have a problem call

Lastnosti izdelka

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SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will
allow quick identification
of new safety information. Healthcare professionals are asked to
report any suspected adverse
reactions. See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Rapibloc 300 mg powder for solution for infusion
Rapibloc 600 mg powder for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
A vial contains 300 mg or 600 mg landiolol hydrochloride which is
equivalent to 280 mg or 560 mg
landiolol.
After reconstitution (see section 6.6), each ml contains 6 mg or 12 mg
landiolol hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion.
White to almost white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

Supraventricular tachycardia and for the rapid control of ventricular
rate in patients with atrial
fibrillation or atrial flutter in perioperative, postoperative, or
other circumstances where short-
term control of the ventricular rate with a short acting agent is
desirable.

Non-compensatory sinus tachycardia where, in the physician’s
judgment the rapid heart rate
requires specific intervention.

Landiolol is not intended for use in chronic settings.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Landiolol is intended for intravenous use in a monitored setting. Only
a well-qualified health care
professional should administer landiolol. The dosage of landiolol
should be titrated individually.
Initiate the intravenous infusion by a loading dose of 100
micrograms/kg body weight (BW) for 1
min, followed by continuous intravenous infusion of 10 - 40
micrograms/kg BW/min.
Page 2 of 15
If no rapid onset of the bradycardic effect (within 2 to 4 min) is
required, starting the infusion with
the maintenance infusion rate of 10 - 40 micrograms/kg BW/min will
establish the effect within 10
- 20 min.
_Maximum dose_
: Should the desired therapeutic response