Rapibloc 20mg/2ml concentrate for solution for injection

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

LANDIOLOL

Disponible des:

Amomed Pharma GmbH Storchengasse 1, 1150 Vienna, Austria

Codi ATC:

C07AB14

Designació comuna internacional (DCI):

LANDIOLOL 10 mg/ml

formulario farmacéutico:

CONCENTRATE FOR SOLUTION FOR INJECTION

Composición:

LANDIOLOL 10 mg/ml

tipo de receta:

POM

Área terapéutica:

BETA BLOCKING AGENTS

Estat d'Autorització:

Withdrawn

Data d'autorització:

2017-02-07

Informació per a l'usuari

1
PACKAGE LEAFLET
PAGE 2 OF 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RAPIBLOC 20 MG /2 ML CONCENTRATE FOR SOLUTION FOR INJECTION
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 20 mg /2 ml concentrate for
solution for injection. In this leaflet
the shorter name Rapibloc concentrate is used.
WHAT IS IN THIS LEAFLET
1.
What Rapibloc concentrate is and what it is used for
2.
What you need to know before you are given Rapibloc concentrate
3.
How Rapibloc concentrate is given
4.
Possible side effects
5.
How to store Rapibloc concentrate
6.
Contents of the pack and other information
1.
WHAT RAPIBLOC CONCENTRATE IS AND WHAT IT IS USED FOR
Rapibloc concentrate 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 CONCENTRATE
YOUR DOCTOR WILL NOT GIVE YOU RAPIBLOC CONCENTRATE 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 fast or alternating fast and slow heartbeats (a problem
called “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 su

Fitxa tècnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
PAFGE 2 OF 13
1.
NAME OF THE MEDICINAL PRODUCT
Rapibloc 20 mg/2 ml concentrate for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of the concentrate contains 10 mg landiolol hydrochloride
which is equivalent to 9.35 mg landiolol.
Each ampoule of 2 ml concentrate for solution for injection contains
20 mg landiolol hydrochloride which is
equivalent to 18.7 mg landiolol.
After dilution (see section 6.6) the concentration of the solution is
2 mg/ml landiolol hydrochloride.
Excipients with known effect:
Rapibloc concentrate contains 672 mg ethanol (96%) per maximum single
dose (calculated for a 70 kg
patient). See section 4.4.
This medicine contains less than 1 mmol sodium (23 mg) and less than 1
mmol potassium (39 mg) per
ampoule, that is to say essentially ‘sodium- and potassium- free’.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for injection.
Clear and colourless to yellowish solution free from visible
particles.
Rapibloc concentrate has a pH of 6.9 and an osmolality of 8.13 Osm/l.
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
PAFGE 3 OF 13
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 adjusted individually.
Administer an intravenous bolus injection of 0.1 – 0.3 mg/kg body
weight (BW). As a starting dose 0.1 - 0.2
mg/kg BW is recommended. The bradyca