ESMOLOL JUNO esmolol hydrochloride100 mg/10 mL solution for injection vial

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

esmolol hydrochloride, Quantity: 10 mg/mL

Доступна с:

Juno Pharmaceuticals Pty Ltd

Фармацевтическая форма:

Injection, solution

состав:

Excipient Ingredients: water for injections; hydrochloric acid; sodium hydroxide; sodium chloride; glacial acetic acid; sodium acetate trihydrate

Администрация маршрут:

Intravenous

Штук в упаковке:

10 x 100 mg/10 mL vials, 5 x 100 mg/10 mL vials, 20 x 100 mg/10 mL vials

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

Supraventricular tachycardia,Esmolol Juno is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. Esmolol Juno is also indicated in non compensatory sinus tachycardia where, in the physician's judgement, the rapid heart rate requires specific intervention. Esmolol Juno is not intended for use in chronic settings where transfer to another agent is anticipated or for treatment periods greater than 24 hours duration.

Обзор продуктов:

Visual Identification: A clear, colourless to light yellow solution; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Статус Авторизация:

Registered

Дата Авторизация:

2022-12-01

тонкая брошюра

ESMOLOL JUNO
1
ESMOLOL JUNO
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ESMOLOL JUNO?
ESMOLOL JUNO contains the active ingredient esmolol hydrochloride.
ESMOLOL JUNO is used as a short-term treatment for
irregular heartbeat before, during or after surgery. It is also used
in emergency situations.
For more information, see Section 1. Why am I using Esmolol Juno? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ESMOLOL JUNO?
Do not use if you have ever had an allergic reaction to esmolol
hydrochloride or any of the ingredients listed at the end of the
CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Esmolol Juno? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with esmolol hydrochloride and affect how
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ESMOLOL JUNO?
•
Your doctor will decide the appropriate dose for you
•
A doctor or nurse will usually prepare and administer the injection,
given as a slow injection into the vein.
•
Follow all instructions given to you by your doctor or pharmacist.
More instructions can be found in Section 4. How do I use Esmolol
Juno? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ESMOLOL JUNO?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
ESMOLOL JUNO
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how esmolol hydrochloride
affects you. Esmolol may cause dizziness in some people.
DRINKING
ALCOHOL
•
Tell your doctor if you drink alcohol. Alcohol may increase the side
effects of some medicines.
LOOKING AFTER
YOUR MEDICINE
•
This medicine

Характеристики продукта

AUSTRALIAN PRODUCT INFORMATION
Juno Pharmaceuticals Pty Ltd
AUSTRALIAN PRODUCT INFORMATION - Esmolol Juno
Page
1
of 16
ESMOLOL JUNO
(ESMOLOL HYDROCHLORIDE SOLUTION FOR INJECTION)
1
NAME OF THE MEDICINE
Esmolol hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Esmolol Juno solution for injection is supplied as 100 mg/10 mL vial.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Esmolol Juno solution for injection is a clear, colourless to light
yellow, sterile, nonpyrogenic, iso-
osmotic solution of esmolol hydrochloride for intravenous infusion.
The single dose vial has a pH
range of 4.5 to 5.5.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SUPRAVENTRICULAR TACHYCARDIA
Esmolol Juno is indicated for the rapid control of ventricular rate in
patients with atrial fibrillation
or atrial flutter in perioperative, postoperative, or other emergent
circumstances where short term
control of ventricular rate with a short-acting agent is desirable.
Esmolol Juno is also indicated
in non compensatory sinus tachycardia where, in the physician's
judgement, the rapid heart rate
requires specific intervention. Esmolol Juno is not intended for use
in chronic settings where
transfer to another agent is anticipated or for treatment periods
greater than 24 hours duration.
4.2
DOSE AND METHOD OF ADMINISTRATION
_Note_: Parenteral drug products should be inspected visually prior to
administration. Any
solutions which contain visible particulate matter or are hazy or
discoloured should not be used.
Product is for single use in one patient only. Discard any residue.
100 MG/10 ML VIAL:
This dosage form is available as a prediluted product to provide a
ready-to-use 10 mg/mL
concentration recommended for esmolol hydrochloride intravenous
administration. It may be
used to administer the appropriate esmolol hydrochloride loading
dosage infusions by hand-
held syringe while the maintenance infusion is being prepared.
When using the 100 mg vial, a loading dose of 0.5 mg/kg for a 70 kg
patient w