Isoptin 5mg/2mL Injection Ampoule

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

verapamil hydrochloride, Quantity: 5 mg

Disponible desde:

Viatris Pty Ltd

formulario farmacéutico:

Injection, solution

Composición:

Excipient Ingredients: sodium chloride; water for injections; hydrochloric acid

Vía de administración:

Intravenous

Unidades en paquete:

5 x 2 mL ampoules

clase:

Medicine Registered

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

INDICATIONS AS AT 17 JAN 2005 : Tachycardias, such as paroxysmal supraventricular tachycardia, atrial fibrillation with rapid ventricular response, (except in WPW syndrome, see "Precautions"), atrial flutter with rapid conduction, extrasystoles. For the prophylaxis and/or therapy of ectopic arrhythmias (predominantly ventricular extrasystoles) in halothane anaesthesia and in the application of adrenaline in halothane anaesthesia, respectively. Acute hypertension. Acute coronary insufficiency.,Tachycardias, such as paroxysmal supraventricular tachycardia, atrial fibrillation with rapid ventricular response, (except in WPW syndrome, see "Precautions"), atrial flutter with rapid conduction, extrasystoles. For the prophylaxis and/or therapy of ectopic arrhythmias (predominantly ventricular extrasystoles) in halothane anaesthesia and in the application of adrenaline in halothane anaesthesia, respectively. Acute hypertension. Acute coronary insufficiency.

Resumen del producto:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Estado de Autorización:

Registered

Fecha de autorización:

1991-10-08

Información para el usuario

ISOPTIN
® INJECTION
_verapamil hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Isoptin Injection.
It does not contain all the available
information.
It does not take the place of talking to
your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given Isoptin
Injection against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT ISOPTIN INJECTION
IS USED FOR
Isoptin Injection is used to:
•
treat unusual fast heart beat
•
treat high blood pressure, also
called hypertension
•
treat poor blood flow to the heart
•
prevent certain heart problems
occurring during surgery
Your doctor may have prescribed
Isoptin Injection for another reason.
Ask your doctor if you have any
questions about why Isoptin Injection
has been prescribed for you.
Isoptin Injection belongs to a group
of medicines called calcium channel
blockers or calcium antagonists.
They work by widening blood
vessels which lets more blood and
oxygen reach the heart and at the
same time lowers high blood
pressure. Isoptin Injection also helps
control fast heart rate.
Isoptin does not change the amount
of calcium in your blood or bones.
Calcium in your diet or in calcium
supplements will not interfere with
the way Isoptin Injection works.
Isoptin is available only with a
doctor's prescription.
Isoptin Injection is not addictive.
BEFORE YOU ARE GIVEN
ISOPTIN INJECTION
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU SHOULD NOT BE GIVEN ISOPTIN
INJECTION IF YOU HAVE AN ALLERGY TO
VERAPAMIL HYDROCHLORIDE OR ANY OF
THE INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
YOU SHOULD NOT BE GIVEN ISOPTIN
INJE

Ficha técnica

AUSTRALIAN PRODUCT INFORMATION
ISOPTIN
®
_Verapamil hydrochloride injection solution _
1
NAME OF THE MEDICINE
Verapamil hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule contains 2.5 mg/mL of verapamil hydrochloride as the
active ingredient. (equivalent to 2.3
mg/mL verapamil).
For the full list of excipients,
SEE SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Verapamil
hydrochloride
injection
is
a
sterile,
nonpyrogenic
solution.
The
solution
contains
no
bacteriostat or antimicrobial agent and is intended for single-dose
intravenous administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Tachycardias, such as paroxysmal supraventricular tachycardia, atrial
fibrillation with rapid
ventricular response, (except in WPW syndrome,
SEE SECTION 4.4 SPECIAL WARNINGS
AND PRECAUTIONS FOR USE)
, atrial flutter with rapid conduction, extrasystoles.
•
For the prophylaxis and/or therapy of ectopic arrhythmias
(predominantly ventricular extrasystoles)
in halothane anaesthesia and in the application of adrenaline
(epinephrine) in halothane anaesthesia,
respectively.
•
Acute hypertension.
•
Acute coronary insufficiency.
4.2
DOSE AND METHOD OF ADMINISTRATION
Adults
5 mg slowly intravenously, in tachycardias and hypertensive crises
repeated, if necessary, after 5 to
10 minutes. Drip infusion to maintain the therapeutic effect: 5-10
mg/hour in physiological saline,
glucose, laevulose or similar solutions, on average up to a total dose
of 100 mg/day.
Children
Newborn
0.75-1 mg (= 0.3-0.4 mL)
Infants
0.75-2 mg (= 0.3-0.8 mL)
Children
(aged 1-5 years)
2-3 mg (= 0.8-1.2 mL)
(aged 6-14 years)
2.5-5 mg (= 1-2 mL)
of Isoptin, given intravenously, depending on age and action. The
injection should be made slowly
under electrocardiographic control and only until onset of the effect.
Intravenous infusion in
hypertensive crises; initially 0.05-0.1 mg/kg/hour; if the effect
proves to be insufficient, the dose is
increased at 30-60 minute intervals until twice the dose or more is
reached. Average t