Noralin
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
NORALIN
Solution for intravenous infusion 3 mg/50 mL, 5 mg/50 mL, 6 mg/50 mL & 10 mg/50 mL
Noradrenaline (norepinephrine) (as acid tartrate monohydrate)
Consumer Medicine Information
What is in this leaflet
Please read this leaflet carefully before you are given Noralin.
This leaflet answers some common questions about Noralin. It does not contain all the available information. The most up-to-date Consumer Medicine Information can be downloaded from www.ebs.tga.gov.au.
Reading this leaflet does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of giving you Noralin against the benefits this medicine is expected to have for you.
If you have any concerns about being given this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may want to read it again.
What Noralin is used for
Noralin contains noradrenaline (norepinephrine) acid tartrate monohydrate. It belongs to a group of medicines called sympathomimetic amines. It works by making the heartbeat more forcefully and constricting blood vessels. This results in a higher blood pressure and greater blood flow to the heart and other organs of the body.
Noralin is given in emergency situations as a result of medical conditions which cause a dramatic drop in blood pressure. Such situations/conditions could be:
associated with surgical procedures
infections caused by poliovirus
a heart attack
infection in the blood
severe reaction to a medicine
severe reaction to a blood transfusion
allergic reactions.
Noralin is used to restore blood pressure back to normal. It is given only by a doctor or nurse, usually in hospital.
Your doctor may have prescribed this medicine for another reason.
Ask your doctor if you have any questions about why it has been prescribed for you.
Noralin is only available with a doctor’s prescription.
There is no evidence that Noralin is addictive.
Before you are given Noralin
Noralin is not suitable for everyone.
When you must not be given it
You must not be given Noralin if you have:
low blood pressure due to low blood volume
blood clots in certain vessels.
If given in these cases, it can further reduce blood supply to important organs.
You must not be given Noralin if you are allergic to any medicine containing noradrenaline (norepinephrine), or any other similar medicines such as adrenaline, phenylephrine, pseudoephedrine, or any of the ingredients listed at the end of this leaflet.
You must not be given Noralin if you are also given general anaesthesia such as cyclopropane and halothane.
Noralin must not be used after the expiry date printed on the pack, or if the packaging is torn or shows signs of tampering. The solution must be clear before use.
If you are not sure whether you should be given this medicine, talk to your doctor.
Before you are given it
Tell your doctor or pharmacist if you have allergies to any other medicines, or any other substances, such as foods, preservatives or dyes.
Tell your doctor if you have or have had an overactive thyroid gland.
Tell your doctor or pharmacist if you are pregnant or breastfeeding.
Noralin may be given to pregnant women and women who are breastfeeding, but your doctor must be told if you are pregnant or breastfeeding. Your doctor will discuss the possible risks and benefits of you being given Noralin during pregnancy and breastfeeding.
Tell your doctor or pharmacist if you are over 65 years old
Elderly persons may be more sensitive to the effects of the medicine.
If you have not told your doctor about any of the above, tell them before you are given Noralin.
Tell your doctor if you have any medical conditions before being given Noralin.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Noralin may interfere with each other. These include:
antidepressants including moclobemide, imipramine and amitriptyline.
The above medicines may be affected by Noralin, or may affect how well it works. You may need different amounts of Noralin, or you may need to use different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while being given Noralin.
How Noralin is given
How it will be given
Noralin is ready-to use solution and should NOT be diluted. It will be given by slow intravenous infusion into a large vein. This medicine must only be given by a doctor or a nurse.
How much will be given
Your doctor will decide how many infusions you need, and how often you should receive them. The need for more doses will depend on how the medicine is affecting your blood pressure.
How long it will be given for
This medicine will be given until blood pressure and blood circulation to all organs is back to normal and remains normal even when the medicine is no longer given.
While you are being given Noralin
Things you must do
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are being given Noralin. Likewise, tell any other doctors, dentists and pharmacists who are treating you that you are being given this medicine.
Tell your doctor immediately if you develop a rash or other symptoms of an allergic reaction.
These symptoms may be:
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.
In case of overdose
If you are given too much
As Noralin is given to you in hospital under the supervision of your doctor, it is very unlikely that you will receive an overdose.
Symptoms of an overdose may include headache, dizziness, sensitivity to light, slow heartbeat, chest pain, sweating and pale skin, vomiting, or trouble breathing.
Immediately tell your doctor or nurse if you think that you or anyone else may have been given too much Noralin.
They have information on how to recognise and treat an overdose.
Side effects
Tell your doctor as soon as possible if you do not feel well while you are being given Noralin.
Like all medicines, Noralin may occasionally cause side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or nurse if you notice any of the following:
skin and tissue damage close to the site of injection
anxiety, sleeplessness, psychotic state, feeling of confusion, agitation, weakness and shaking
headache
signs of change in blood pressure such as dizziness
tingling or numbness in the feet
coldness, numbness or discolouration of your limbs
acute glaucoma
increased saliva
passing less urine than normal or no urine, pain when passing urine.
If any of the following happen, tell your doctor or a nurse immediately:
serious allergic reaction (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)
breathing difficulties
fast, slow or irregular heartbeat, chest pain, palpitations
severe high blood pressure (symptoms may include violent headaches, extreme light sensitivity, intense sweating, nausea, vomiting, pale skin, or pain behind the breastbone).
These are very serious side effects; you may need urgent medical attention.
If you are over 65 years of age, you may have an increased chance of getting side effects.
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed above may also occur in some patients.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
After being given Noralin
Storage
Noralin will be stored in the pharmacy or on the ward under the recommended storage conditions.
It must be kept in a cool dry place, protected from light, where the temperature stays below 25°C. Do not refrigerate or freeze.
Disposal
Any Noralin which has passed its expiry date, or is left in the container after use, will be disposed of in a safe manner by your doctor, nurse or pharmacist.
Product description
What it looks like
Noralin is a clear sterile solution for intravenous infusion.
It is available in 50 mL vials in the following strengths: 3 mg/50 mL, 5 mg/50 mL, 6 mg/50 mL and 10 mg/50 mL. A box contains 1 vial.
Each 3 mg/50 mL vial contains noradrenaline (norepinephrine) 0.06 mg in 1 mL, present as 0.12 mg of noradrenaline (norepinephrine) acid tartrate monohydrate in 1 mL.
Each 5 mg/50 mL vial contains noradrenaline (norepinephrine) 0.1 mg in 1 mL, present as 0.2 mg of noradrenaline (norepinephrine) acid tartrate monohydrate in 1 mL.
Each 6 mg/50 mL vial contains noradrenaline (norepinephrine) 0.12 mg in 1 mL, present as 0.24 mg of noradrenaline (norepinephrine) acid tartrate monohydrate in 1 mL.
Each 10/50 mL vial contains noradrenaline (norepinephrine) 0.2 mg in 1 mL, present as 0.4 mg of noradrenaline (norepinephrine) acid tartrate monohydrate in 1 mL.
Not all presentations may be available.
Ingredients
Active ingredient:
noradrenaline (norepinephrine)
Inactive ingredients:
sodium chloride
hydrochloric acid
water for injections.
Noralin is sulfite free and does not contain any preservatives.
Sponsor details
Boucher & Muir Pty Ltd
Level 9, 76 Berry Street
North Sydney NSW 2060
Distributed in New Zealand by:
BNM Group
39 Anzac Road
Browns Bay
Auckland 0753
3 mg/50 mL: AUST R 316838
5 mg/50 mL: AUST R 316839
6 mg/50 mL: AUST R 316840
10 mg/50 mL: AUST R 316841
Date of preparation
This leaflet was prepared on 17 April 2020.
Source: Read Full Article