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Ultiva

Remifentanil hydrochloride
Consumer Medicine Information
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Ultiva. It does not contain all the information that is known about Ultiva. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What Ultiva is used for

Ultiva is an anaesthetic used with other anaesthetic medicines, to produce and/or maintain heavy sleep during your operation. If you are a cardiac patient, it may also be used to help relieve any pain immediately following your operation.
Ultiva may also be used for patients in the Intensive Care Unit to maintain sedation and relieve pain.
Ultiva belongs to a group of medicines called opioids. It differs from other medicines in this group by its very quick onset and very short duration of action.
Your doctor may have prescribed Ultiva for another reason.
Ask your doctor if you have any questions about why Ultiva has been prescribed for you.
As with other opioids, Ultiva can be addictive. This is unlikely to happen when Ultiva is only used during your operation.

Before you are given Ultiva

When you must not receive Ultiva

You must not receive Ultiva if you have ever had an allergic reaction to remifentanil hydrochloride or any of the ingredients listed at the end of this leaflet.
You should not receive Ultiva if you are allergic (hypersensitive) to other pain-relieving medicines which are similar to fentanyl and which are related to the class of medicines known as opioids.
Symptoms of an allergic reaction may be mild or severe. They usually include some or all of the following:
wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash ("hives") or fainting.

Before you receive Ultiva

You must tell your doctor if:
you have had any adverse reactions during an operation.
you have had any type of allergic reaction (hypersensitivity) to any other opioid medicines (e.g., morphine, fentanyl, pethidine, codeine), or to any medicines used during an operation.
You probably have an increased chance of being allergic to Ultiva if you are allergic to other opioids.
you are allergic to any other medicines or any other substance, such as foods, dyes or preservatives.
you have or have ever had any of the following medical conditions:
slow heart beat
low blood pressure
chest or breathing problems.
you are pregnant, intend to become pregnant, are breast feeding or plan to breast feed.
Like most medicines, Ultiva is not recommended in pregnancy and breast-feeding. However, your doctor will discuss the possible risks and benefits of being given Ultiva if you are pregnant or breast-feeding.
If you have not told your doctor about any of the above, tell them before you are given Ultiva.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.
Tell your doctor if you have recently been taking medicines for blood pressure or heart problems (known as beta-blockers or calcium channel blockers).
Some medicines, such as benzodiazepines, may interfere with Ultiva. Your doctor or pharmacist will be able to tell you what to do when being given Ultiva with other medicines.

How Ultiva is given

Ultiva can be given into a vein in two ways:
as a slow injection, or
as a slow infusion.
Ultiva will be administered by an anaesthetist or other highly trained doctor. You will never be expected to give yourself this medication. The dosage will vary according to many factors such as your body weight and the type of operation you have.

While you are using Ultiva

Things to be careful of

If you are discharged early, following treatment with Ultiva or any other anaesthetic agents, do not drive or operate machinery.

Side-Effects

Check with your doctor as soon as possible if you have any problems after receiving Ultiva, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
Like other medicines, Ultiva can cause some side-effects.
The most commonly reported side-effects are:
slow breathing
breathlessness
slow heart beat
drop in blood pressure
increased blood pressure which may cause a headache or sensation of warmth/flushing.
muscle stiffness
shivering
nausea
vomiting
aches
Ask your doctor or pharmacist to answer any questions you may have.
This is not a complete list of all possible side-effects. Others may occur in some people and there may be some side-effects not yet known.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.
Ask your doctor or pharmacist if you don't understand anything in this list.
Do not be alarmed by this list of possible side-effects. You may not experience any of them.

Product description

What Ultiva looks like

Ultiva is supplied as 1mg, 2mg or 5mg of white to off-white powder in a clear, glass vial.

Ingredients

Ultiva contains the active ingredient remifentanil (as hydrochloride) 1mg, 2mg or 5mg per vial. Other ingredients are glycine and hydrochloric acid. The powder is dissolved in a suitable sterile liquid before use.
Ultiva does not contain gluten or lactose.

Manufacturer

Your Ultiva is supplied by:
 
GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street
Abbotsford, Victoria, 3067
Australia.

Further Information

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition. You may also be able to find general information about your disease and its treatment from books, for example in public libraries.
 
Do not throw this leaflet away.
You may need to read it again.
 
This leaflet was prepared on 20 March 2015
 
The information provided applies only to: Ultiva® for Injection.
 
Ultiva® is a registered trade mark of the GlaxoSmithKline group of companies.
 
Ultiva 1 mg: AUST R 58688
Ultiva 2 mg: AUST R 58689
Ultiva 5 mg: AUST R 58690
 
© 2015 GlaxoSmithKline
 
Version 3.0