Isoprenaline Phagecon 1 mg/5 ml, concentrate for solution for infusion. St

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

ISOPRENALINE HYDROCHLORIDE

Disponible des:

Phagecon - Serviços e Consultoria Farmacêutica, Lda. Avenida José Malhoa, nº2 Edifício Malhoa Plaza, 3º piso, Escritório 3.7 1070-325 Lisboa , Portugal

Codi ATC:

C01CA02

Designació comuna internacional (DCI):

ISOPRENALINE HYDROCHLORIDE 1 mg/5ml

formulario farmacéutico:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composición:

ISOPRENALINE HYDROCHLORIDE 1 mg/5ml

tipo de receta:

POM

Área terapéutica:

CARDIAC THERAPY

Resumen del producto:

Licence number in the source country: NOT APPLICAPABLE

Estat d'Autorització:

Authorised

Data d'autorització:

2021-10-12

Informació per a l'usuari

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ISOPRENALINE PHAGECON 1 MG/5 ML, CONCENTRATE FOR SOLUTION FOR INFUSION
isoprenaline hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
-
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 or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Isoprenaline Phagecon is and what it is used for
2.
What you need to know before you use Isoprenaline Phagecon
3.
How to use Isoprenaline Phagecon
4.
Possible side effects
5.
How to store Isoprenaline Phagecon
6.
Contents of the pack and other information
1.
WHAT ISOPRENALINE PHAGECON IS AND WHAT IT IS USED FOR
This medicine is used as an emergency drug for the treatment of
abnormally slow heart rate and
breathing difficulties (spasmodic contractions of the bronchi).
Isoprenaline Phagecon is used for the treatment of:
-
slow heart rate in patients awaiting the insertion of a temporary or
permanent device
-
sudden fainting with loss of consciousness caused by a slowing of
heart rate (Stokes-Adams
syndrome) in patients awaiting a temporary or permanent device
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ISOPRENALINE PHAGECON
DO NOT USE ISOPRENALINE PHAGECON
-
if you are
ALLERGIC
to isoprenaline hydrochloride or any of the other ingredients of this
medicine
listed in section 6.
-
if you are taking
MONO-AMINE-OXIDASE INHIBITORS (MAOIS)
.
-
if your thyroid gland works too hard and you have heart problems
(chest pain and shortness of
breath (ischemic heart disease), you may experience an excessive
increase in heart rate
-
if you suffer from a faster-than-usual heart rhythm
-
if your heart is stressed (atrial or ventricul

Fitxa tècnica

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Isoprenaline Phagecon 1 mg/5 ml, concentrate for solution for
infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 0.2 mg of Isoprenaline hydrochloride equivalent to 0.17
mg isoprenaline.
Each ampoule of 5 ml contains 1.0 mg isoprenaline hydrochloride
Excipient(s) with known effect: each ampoule contains 16,25 mg sodium
(see also section 4.4)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Emergency drug:
-for Adams-Stokes syndrome by atrioventricular block, while waiting
for temporary or permanent
equipment;
-for extreme bradycardia by sinoatrial syncopal block or
atrioventricular block, while waiting for
temporary or permanent equipment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Administer intravenously by continuous infusion, diluted in 500 ml of
physiological saline solution
or isotonic glucose solution.
Doses can range from 0.2 to 4 mg per 24 hours, that is from 1ml to 20
ml (4 ampoules) per day.
Isoprenaline Phagecon is reserved for adults.
RECOMMENDATIONS:
Do not inject Isoprenaline Phagecon at the same time as epinephrine in
any circumstances.
However,
if
the
administration
of
the
two
products
is
necessary,
they
can
be
administered
alternately every 4 hours (see sections 4.3 and 4.5).
Method of administration
Intravenous use.
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4.3
CONTRAINDICATIONS
Isoprenaline Phagecon is used with caution in cases of hyperthyroidism
and coronary artery disease
when excessive acceleration of the heart rate is expected.
Isoprenaline should not be administered simultaneously with MAOIs.
Isoprenaline Phagecon is contraindicated in the case of:
•
Hypersensitivity to the active substance or to any of the excipients
in section 6.1.
•
Concomitant use with epinephrine (see section 4.2 and 4.5)
•
Sinus tachycardia.
•
Atrial or ventricular hyper-excitability.
•
Digitalis intoxication.
•
Myoca