Active ingredient
- remifentanil hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL39699/0096, PL39699/0095, PL39699/0097.
Ultiva Injection
Package Leaflet: Information for the patient
Ultiva for Injection 1 mg
Ultiva for Injection 2 mg
Ultiva for Injection 5 mg
remifentanil hydrochloride
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
What is in this leaflet:
1 What Ultiva is and what it is used for
2 What you need to know before you are given Ultiva
3 How Ultiva is given
4 Possible side effects
5 How to store Ultiva
6 Contents of the pack and other information
1 What Ultiva is and what it is used for
Ultiva contains a medicine called remifentanil. This belongs to a group of medicines known as opioids.
Ultiva is used together with other medicines called anaesthetics
2 What you need to know before you are given Ultiva
Do not have Ultiva if:
If you are not sure if any of the above apply to you, talk to your doctor, pharmacist or nurse before you are given Ultiva.
Warnings and precautions
Check with your doctor or pharmacist before you are given Ultiva if:
If you are not sure if any of the above apply to you, talk to your doctor, pharmacist or nurse before you are given Ultiva.
Other medicines and Ultiva
Please tell your doctor or pharmacist if you are taking or have recently taken or might take other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Ultiva can work with other medicines to cause side effects.
In particular tell your doctor or pharmacist if you are taking:
Concomitant use of Ultiva and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
However if your doctor does prescribe Ultiva together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.
Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Driving and using machines
If you are only staying in hospital for the day, your doctor will tell you how long to wait before leaving the hospital or driving a car. It can be dangerous to drive too soon after having an operation.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
3 How Ultiva is given
How your injection is given
You will never be expected to give yourself this medicine. It will always be given to you by a person who is qualified to do so.
Ultiva can be given:
The way you are given the drug and the dose you receive will depend on:
The dose varies from one patient to another.
If you are given too much
The effects of Ultiva are carefully monitored throughout your operation and in intensive care, and appropriate action will be taken promptly if you receive too much.
After your operation
Tell your doctor or nurse if you are in pain. If you are in pain after your procedure, they will be able to give you other painkillers.
4 Possible side effects
Like all medicines, Ultiva can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.
Some people can be allergic to Ultiva. You must tell your doctor or nurse immediately if you have:
Rare (may affect up to 1 in 1,000 people)
Tell your doctor as soon as possible if you notice any of the following:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Not known (frequency cannot be estimated from the available data)
Other side effects that can happen when you wake up after having an anaesthetic include:
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Other side effects which occurred particularly upon abrupt cessation of Ultiva after prolonged administration of more than 3 days
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5 How to store Ultiva
6 Contents of the pack and other information
What Ultiva contains
The active substance is remifentanil hydrochloride.
The other ingredients are glycine and hydrochloric acid (for pH adjustment).
What Ultiva looks like and contents of the pack
Ultiva for injection is a sterile, non-pyrogenic, preservative-free, white to off-white, lyophilised powder and is available in the following strengths:
The powder will be mixed with an appropriate fluid before being injected. When mixed to form a solution, Ultiva is clear and colourless.
Each strength of Ultiva is supplied in cartons containing 5 vials.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturer:
or
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name Ultiva for injection 1 mg
Ultiva for injection 2 mg
Ultiva for injection 5 mg
Reference number PL 39699/0095
PL 39699/0096
PL 39699/0097
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in February 2021.
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