METARAMINOL JUNO metaraminol (as tartrate) 5 mg/10 mL solution for injection pre-filled syringe

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

metaraminol tartrate, Quantity: 9.488 mg (Equivalent: metaraminol, Qty 5 mg)

Dostupné z:

Juno Pharmaceuticals Pty Ltd

Forma lieku:

Injection, solution

Zloženie:

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

Spôsob podávania:

Intravenous

Počet v balení:

10

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

Prevention and treatment of the acute hypotensive state occurring with spinal anaesthesia,Adjunctive treatment of hypotension due to haemorrhage, reactions to medications, surgical complications, and shock associated with brain damage due to tumour or trauma. ,It may also be useful as an adjunct in the treatment of hypotension due to cardiogenic shock or septicaemia.

Prehľad produktov:

Visual Identification: A clear, colourless, pyrogen free and sterile solution for injection in a sterile polypropylene prefilled syringe; Container Type: Syringe; Container Material: PP; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizácia:

Registered

Dátum Autorizácia:

2019-03-07

Príbalový leták

Metaraminol Juno
1
METARAMINOL 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 METARAMINOL JUNO?
Metaraminol Juno contains the active ingredient metaraminol tartrate.
Metaraminol Juno is used to increase your blood
pressure which can drop during spinal anaesthesia or can drop as a
reaction to medications or surgical complications.
For more information, see Section 1. Why am I using Metaraminol Juno?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE METARAMINOL JUNO?
Do not use if you have ever had an allergic reaction to Metaraminol
Juno 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
Metaraminol Juno?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Metaraminol Juno 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 METARAMINOL JUNO?
•
Metaraminol Juno must only be given by a doctor or nurse.
•
Metaraminol Juno is administered in a hospital as an injection into a
vein or diluted before use and given with fluids into a
vein.
•
Your doctor will decide what dose of Metaraminol Juno you will receive
and how long you will receive it for. This depends
on your medical condition and other factors, such as your weight.
More instructions can be found in Section 4. How do I use Metaraminol
Juno?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING METARAMINOL JUNO?
THINGS YOU
SHOULD DO
•
Always follow your doctor's instructions carefully.
•
Your doctor or nurse will monitor your blood pressure.
•
Remind any doctor, dentist or pharmacist you visit that you are using
Metaraminol Juno.
DRIVING OR USING
MACHINES
•

Súhrn charakteristických

Australian Product Information
METARAMINOL JUNO SOLUTION FOR INJECTION
_ _
_ (METARAMINOL (AS TARTRATE)) _
_ _
PRODUCT INFORMATION
1 NAME OF THE MEDICINE
Metaraminol tartrate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Metaraminol tartrate is a white, crystalline powder, which is freely
soluble in water, slightly
soluble in alcohol, and practically insoluble in chloroform and in
ether.
Each mL of Metaraminol Juno solution for injection contains
metaraminol (as tartrate) 0.5 mg,
sodium chloride 9 mg, hydrochloric acid and water for injections to 1
mL.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Metaraminol (as tartrate) 5mg/10mL injection pre-filled syringe
Metaraminol (as tartrate) 2.5mg/5mL injection pre-filled syringe
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
•
Prevention and treatment of the acute hypotensive state occurring with
spinal anaesthesia
•
Adjunctive treatment of hypotension due to haemorrhage, reactions to
medications,
surgical complications, and shock associated with brain damage due to
tumour or trauma.
•
It may also be useful as an adjunct in the treatment of hypotension
due to cardiogenic shock
or septicaemia.
4.2 DOSE AND METHOD OF ADMINISTRATION
Metaraminol Juno injection is for intravenous administration only
(injection) and should be used
in one patient on one occasion only.
It contains no antimicrobial preservative. Unused solution should be
discarded.
Because the maximum effect is not immediately apparent, at least ten
minutes should elapse
before increasing the dosage. As the effect tapers off when the
vasopressor is discontinued,
the patient should be carefully observed so that therapy can be
reinitiated promptly if the blood
pressure falls too rapidly. Patients with coexistent shock and
acidosis may show a poor
response to vasopressors. Established methods of shock management,
such as blood or fluid
replacement when indicated, and other measures directed to the
specific cause of the shock
also should be used.
Australian Pro