Remifentanil 5 Mg Powder For Concentrate For Solution For Injection Or Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
Remifentanil 1 mg powder for concentrate for solution for injection or infusion Remifentanil 2 mg powder for concentrate for solution for injection or infusion Remifentanil 5 mg powder for concentrate for solution for injection or infusion
Remifentanil
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist or nurse.
- If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Remifentanil is and what it is used for
2. What you need to know before you use Remifentanil
3. How to use Remifentanil
4. Possible side effects
5. How to store Remifentanil
6. Contents of the pack and other information
1. WHAT REMIFENTANIL IS AND WHAT IT IS USED FOR
Remifentanil belongs to a group of medicines known as opioids used for pain relief. It differs from other medicines in this group by its very quick onset and very short duration of action.
- Remifentanil may be used to stop you feeling pain before or while you are having an operation.
- Remifentanil may be used to relieve pain while you are under controlled mechanical ventilation in an Intensive Care Unit (for patients 18 years of age and over).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE REMIFENTANIL
Do not use Remifentanil
- if you are allergic (hypersensitive) to remifentanil or any of the other ingredients of this medicine (listed in Section 6)
- if you are allergic to fentanyl analogs
- as injection into the spinal canal
- as sole medicine to initiate anaesthesia.
If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before having Remifentanil.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before using Remifentanil.
When do you need to be extra careful with this drug?
• if you suffer from impaired lung and/or liver function (you may be more sensitive for breathing difficulties).
• if you are over 65 years of age, are weak, have a reduced blood volume and/or low blood pressure (you are then more susceptible to heart disorders).
Other medicines and Remifentanil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines. This is because Remifentanil can work with other medicines to cause side effects. This is especially important with the following medicines as they may interact with your Remifentanil:
• medicines for blood pressure or heart problems known as beta-blockers or calcium channel blockers.
Remifentanil with food and drink and alcohol
After having received Remifentanil you should not drink alcohol until fully recovered.
Pregnancy and breast-feeding
Talk to your doctor if you are pregnant, planning to get pregnant or breast-feeding. Your doctor will will weigh up the benefit to you of receiving this medicine while you are pregnant.
You should stop breast-feeding your baby for 24 hours after receiving this medicine. If you express any breat milk during this time discard the milk and do not give it to your baby.
Driving and using machines
This medicine is only used in hospitalized patients. 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.
3. HOW TO USE REMIFENTANIL
Remifentanil must only be given under carefully controlled conditions and emergency equipment has to be available. Remifentanil will be given by or under the supervision of an experienced doctor who is familiar with the use and action of the type of medicine.
You will never be expected to give yourself this medication. It will always be given to you by a person who is qualified to do so.
Remifentanil must be given only by a single injection or as a continuous infusion into your vein. This is where the drug is slowly given to you over a longer period of time.
The way you are given the drug and the dose you receive will depend on:
• the operation or treatment in the Intensive Care Unit,
• how much pain you suffer from.
Dosage
The dosage varies from patient to patient. There are no dose adjustments needed for patients with impaired kidney or liver function.
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, Remifentanil can cause side effects, although not everybody gets them.
Allergic reactions, including anaphylaxis. These are rare (may affect up to 1 in 1,000 people). Symptoms are:
• swelling of the face or mouth (angioedema) that cause breathing difficulties
• a lumpy skin rash or ‘hives’
• a collapse.
You must tell your doctor immediately if you have one of these symptoms:
Very common (may affect more than 1 in 10 people)
• muscle stiffness
• low blood pressure (hypotension)
• feeling sick (nausea) or being sick (vomiting).
Common (may affect up to 1 in 10 people)
slow heart beat (bradycardia)
• shallow breathing (respiratory depression)
• breathing stops (apnoea)
• itching.
Uncommon (may affect up to 1 in 100 people)
• oxygen deficiency (hypoxia)
• constipation.
Rare (may affect up to 1 in 1,000 people)
• slow heart beat (bradycardia) followed by a disorder in the conduction system of the heart leading to arrhythmias (asystole/heart block) in patients receiving remifentanil with one or more anaesthetic medicines.
Not known (frequency cannot be estimated from the available data)
• physical need for remifentanil (drug dependence) or the need for increasing doses in time to get the same effect (drug tolerance)
• seizures/convulsions
• a form of irregular heartbeat (atrioventricular block).
Other side effects that can happen when you wake up after having an operation include:
Common (may affect up to 1 in 10 people)
• shivering
• high blood pressure (hypertension).
Uncommon (may affect up to 1 in 100 people)
• pain.
Rare (may affect up to 1 in 1,000 people)
• feeling very calm or drowsy.
Other side effects that have occurred in particular after abrupt discontinuation of Remifentanil after prolonged administration of more than 3 days:
• increases in heart rate (tachycardia)
• high blood pressure (hypertension)
• feeling restless (agitation).
As with other medicines of this class (opioids), long-term use of Remifentanil can lead to dependence. Please ask your doctor for advise.
Reporting of side effects
If you get any side effects, talk to your doctor or 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 at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE REMIFENTANIL
Keep out of the sight and reach of children.
Do not use Remifentanil after the expiry date which is stated on the carton and label after “EXP.”. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not refrigerate or freeze.
Do not use Remifentanil if you notice the solution is not clear and free of particles or if the container is damaged.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Remifentanil contains
The active substance is remifentanil.
Each vial contains either 1 mg, 2 mg or 5 mg of remifentanil (as hydrochloride).
After reconstitution as directed each ml contains 1 mg remifentanil.
The other ingredients are glycine and hydrochloric acid.
What Remifentanil looks like and contents of the pack
Remifentanil is a white to off white or yellowish powder for concentrate for solution for injection or infusion. It is supplied in colourless glass vials.
Package size:
Remifentanil 1 mg powder for concentrate for solution for injection or infusion: 5 vials per pack Remifentanil 2 mg powder for concentrate for solution for injection or infusion: 5 vials per pack Remifentanil 5 mg powder for concentrate for solution for injection or infusion: 5 vials per pack
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Limited,
Ramsgate Road,
Sandwich,
Kent CT13 9NJ.
Manufacturer
Hameln pharmaceuticals GmbH,
Langes Feld 13,
31789 Hameln,
Germany.
This leaflet was last revised in 03/2015.
Ref: gxRN 4_0 UK
The following information is intended for medical or healthcare professionals only: PREPARATION GUIDE for
Remifentanil 1 mg powder for concentrate for solution for injection or infusion Remifentanil 2 mg powder for concentrate for solution for injection or infusion Remifentanil 5 mg powder for concentrate for solution for injection or infusion
It is important that you read the entire contents of this guide prior to the preparation of this medicinal product.
Remifentanil should not be administered without further dilution after reconstitution of the lyophilized powder.
Reconstitution
Remifentanil 1 mg / 2 mg / 5 mg should be prepared for intravenous use by adding the appropriate volume (as stated in the table below) of one of the below listed diluents to give a reconstituted solution with a concentration of approximately 1 mg/ml.
|
Presentation |
Volume of diluent to be added |
Concentration of the reconstituted solution |
|
Remifentanil 1 mg |
1 ml |
1 mg/ml |
|
Remifentanil 2 mg |
2 ml |
1 mg/ml |
|
Remifentanil 5 mg |
5 ml |
1 mg/ml |
Shake until completely dissolved. The reconstituted solution should be clear, colourless and free of visible particles.
Further Dilution
After reconstitution Remifentanil should not be administered without further dilution to concentrations of 20 to 250 pg/ml (50 pg/ml is the recommended dilution for adults and 20 to 25 pg/ml for paediatric patients aged 1 year and over) with one of the following IV fluids listed below.
For target controlled infusion (TCI) the recommended dilution of Remifentanil is 20 to 50 pg/ml.
The dilution is dependent upon the technical capability of the infusion device and the anticipated requirements of the patient.
One of the following solutions should be used for dilution:
Water for Injections
Glucose 50 mg/ml (5 %) solution for injection
Glucose 50 mg/ml (5 %) solution for injection and sodium chloride 9 mg/ml (0.9 %) solution for injection
Sodium chloride 9 mg/ml (0.9 %) solution for injection Sodium chloride 4.5 mg/ml (0.45 %) solution for injection.
The following intravenous fluids may also be used when administered into a running IV catheter: Lactated Ringer's Injection
Lactated Ringer's and glucose 50 mg/ml (5 %) solution for injection.
Remifentanil is compatible with propofol when administered into a running IV catheter.
No other diluents should be used.
The solution is to be inspected visually for particulate matter prior to administration. The solution should only be used if the solution is clear and free from particles.
Ideally, intravenous infusions of Remifentanil should be prepared at the time of administration. Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
The content of the vial is for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.
Special precautions for storage
Do not store above 25°C.
Do not refrigerate or freeze.
For storage condition of the reconstituted/diluted medicinal product, see section above under Further dilution.
Ref: gxRN 4_0 UK