ESMOLOL NORIDEM esmolol hydrochloride 100 mg/10 mL solution for injection ampoule

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

esmolol hydrochloride, Quantity: 10 mg/mL

から入手可能:

Interpharma Pty Ltd

医薬品形態:

Injection, solution

構図:

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

投与経路:

Intravenous

パッケージ内のユニット:

10 x 10 mL ampoule

処方タイプ:

(S4) Prescription Only Medicine

適応症:

Supraventricular Tachycardia - ESMOLOL NORIDEM 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 NORIDEM is also indicated in non-compensatory sinus tachycardia where, in the physician's judgement, the rapid heart rate requires specific intervention. ESMOLOL NORIDEM is not intended for use in chronic settings where transfer to another agent is anticipated or for treatment periods greater than 24 hours duration.

製品概要:

Visual Identification: colourless to light yellow solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

認証ステータス:

Registered

承認日:

2022-11-02

情報リーフレット

ESMOLOL NORIDEM CMI V 1.1 Sep 2022
Page
1
of
5
ESMOLOL NORIDEM
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 BEING GIVEN ESMOLOL NORIDEM
ESMOLOL NORIDEM contains the active ingredient Esmolol Hydrochloride.
ESMOLOL NORIDEM 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 being given ESMOLOL
NORIDEM? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN ESMOLOL NORIDEM?
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 am
given ESMOLOL NORIDEM? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ESMOLOL NORIDEM 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 IS ESMOLOL NORIDEM GIVEN?
•
ESMOLOL NORIDEM must only be given by a doctor or nurse.
It is given as a slow injection into a vein. More instructions can be
found in Section 4. How is ESMOLOL NORIDEM given? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN - ESMOLOL NORIDEM?
THINGS YOU
SHOULD DO
•
If you are about to be started on any new medicines, remind your
doctor or pharmacist that you have
recently been given ESMOLOL NORIDEM
•
Tell any other doctors or dentists, and pharmacists who treat you that
you have been given this
medicine
•
If you are going to have surgery, tell the surgeon or anaesthetist
that you have been given this
medicine.
•
If you plan to become pregnant, tell your doctor that you have been
given this medicine
•
If you are being treated for d

製品の特徴

ESMOLOL NORIDEM PI V 1.5 Nov 2022
Page 1
AUSTRALIAN PRODUCT INFORMATION – ESMOLOL NORIDEM
(ESMOLOL HYDROCHLORIDE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Esmolol hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ESMOLOL NORIDEM is supplied as 100 mg/10 mL ampoule.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ESMOLOL NORIDEM is a clear, colourless to light yellow, sterile,
nonpyrogenic solution for
intravenous infusion. The single dose ampoule has a pH range of 4.5 to
5.5.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Supraventricular Tachycardia - ESMOLOL NORIDEM 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 NORIDEM is also indicated in non-compensatory
sinus tachycardia
where, in the physician's judgement, the rapid heart rate requires
specific intervention. ESMOLOL
NORIDEM 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
D
OSE 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 discolored
should not be used. For single
use in one patient on one occasion only. Discard any residue.
ESMOLOL NORIDEM is available as a 100 mg/10 mL solution for injection
ampoule. Esmolol
hydrochloride powder for injection is available in another brand (for
maintenance infusion dosing
only). If using the esmolol hydrochloride powder of injection, refer
to the specific Product
Information for complete dosage and administration instructions.
100 MG/10 ML AMPOULE:
This dosage form is prediluted to provide a ready-to-use 10 mg/mL
concentration recommended for esmolol hydrochloride intravenous
administration. It may be use