Rapibloc 300 mg 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 300 mg

Farmacevtska oblika:

POWDER FOR SOLUTION FOR INFUSION

Sestava:

LANDIOLOL 300 mg

Tip zastaranja:

POM

Terapevtsko območje:

BETA BLOCKING AGENTS

Status dovoljenje:

Withdrawn

Datum dovoljenje:

2017-02-07

Navodilo za uporabo

1
PACKAGE LEAFLET
PAGE 2 OF 10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RAPIBLOC 300 MG POWDER FOR SOLUTION FOR INFUSION
landiolol hydrochloride
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 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 called “severe heart block”. Heart block is a
problem with the electrical messages
that control your heartbeat.
•
You have a problem with the blood supply to your heart (a problem
called “cardiogenic shock”).
•
You have very low blood pressure.
•
You have serious h

Lastnosti izdelka

PAGE 1 OF 14
SUMMARY OF PRODUCT CHARACTERISTICS
PAGE 2 OF 14
1.
NAME OF THE MEDICINAL PRODUCT
Rapibloc 300 mg powder for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
A vial contains 300 mg landiolol hydrochloride which is equivalent to
280 mg landiolol.
After reconstitution (see section 6.6), each ml contains 6 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.
The infusion is usually started with an infusion rate of 10 - 40
micrograms/kg/min, which will establish the
heartrate lowering effect within 10 - 20 min.
If rapid onset of the heartrate lowering effect is desired (within 2
to 4 min), an optional loading dose of
100 micrograms/kg/min for 1 min can be considered, followed by
continuous intravenous infusion of
10 - 40 micrograms/kg/min.
Lower doses should be used for patients with cardiac dysfunction.
Dosing instructions are provided under
“special populations” and in the integrated dosing scheme.
_Maximum dose_
: The maintenance dose may be increased up to 80 micrograms/kg/min for
a limited time
period (see section 5.2), if the cardiovascular status of the patient
requires and allows such an increase of the
dose and the