Remifentanil 5mg Powder For Concentrate For Solution For Injection Or Infusion
Package leaflet: information for the user
Remifentanil 1mg, 2mg and 5mg Powder for Concentrate for Solution for Injection or Infusion
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.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• The full name of this medicine is Remifentanil 1mg, 2mg and 5mg Powder for Concentrate for Solution for Injection or Infusion but within the leaflet it will be referred to as Remifentanil.
What is in this leaflet: j What Remifentanil is and what it is used for
^ What you need to know before you use Remifentanil _3 How to use Remifentanil 5 Possible side effects
How to store Remifentanil Contents of the pack and other information
j What Remifentanil is and what it is used for
Remifentanil belongs to a group called opioids. 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).
^ What you need to know before you use Remifentanil
Do not use Remifentanil
• if you are allergic to remifentanil or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to other fentanyl derivates (such as alfentanil, fentanyl, sufentanil). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. You may know this from earlier experience.
• as injection into the spinal canal.
• as sole medicine to initiate anaesthesia.
Warnings and precautions
Talk to your doctor or pharmacist before using
Remifentanil. Tell your doctor if you:
• ever had any adverse reactions during an operation.
• ever had any allergic reactions or if you have been told that you are allergic to:
- any medicines used during an operation
- opioid medicines (e.g., morphine, fentanyl, pethidine, codeine) , see also section above "Do not use Remifentanil"
• suffer from impaired lung and/or liver function (you may be more sensitive to breathing difficulties).
• Elderly or weak patients (caused by decreased blood volume and/or low blood pressure) are more sensitive to suffer from cardiac or circulatory disturbances.
• As with other opioids remifentanil may produce dependency.
• Following anesthesia with Remifentanil you should leave for home only accompanied and you should not drink alcohol.
• Remifentanil should be administered only in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function, and by persons specifically trained in the use of anaesthetic medicines and the recognition and management of the expected adverse effects of potent opioids, including respiratory and cardiac resuscitation.
• In ventilated intensive care patients the use of Remifentanil for more than 3 days is not recommended.
• Due to the rapid offset of action of remifentanil, patients may emerge rapidly from anaesthesia and no residual opioid activity will be present within 5-10 minutes after the discontinuation of Remifentanil.
For those patients undergoing surgical procedures where post-operative pain
is anticipated, analgesics should be administered prior to discontinuation of Remifentanil.
• At the doses recommended muscle rigidity may occur. As with other opioids, the incidence of muscle rigidity is related to the dose and rate of administration. Therefore, bolus injections should be administered over not less than 30 seconds.
• Hypotension and bradycardia may be managed by reducing the rate of infusion of Remifentanil or the dose of concurrent anaesthetics or by using intravenous fluids, vasopressor or anticholinergic agents.
Children
Remifentanil is not recommended in neonates and infants (children under the age of one year).
There is little experience of use of Remifentanil to treat children in intensive care units.
Elderly
If used for an operation under general anaesthesia, the initial dose of Remifentanil should be appropriately reduced in elderly patients.
Other medicines and Remifentanil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Also including medicines obtained without a prescription.
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). These medicines may increase the effect of Remifentanil on your heart (lowering of your blood pressure and your heart beat).
- other sedative medicines, such as benzodiazepines. Your doctor or pharmacist will alter the dose of these medicines when you are being given Remifentanil.
It may still be all right for you to receive Remifentanil and your doctor will be able to decide what is suitable for you.
Remifentanil is not metabolized by plasmacholinesterase, therefore, interactions with medicines metabolized by this enzyme are not anticipated.
Remifentanil with alcohol
After having received Remifentanil you should not drink alcohol until fully recovered.
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 or pharmacist for advice before this medicine is given to you. Remifentanil should not be given to pregnant women unless medically justified. Remifentanil is not recommended during labour or a Caesarian section.
It is recommended that you stop breastfeeding for 24 hours after Remifentanil has been given to you.
Driving and using machines
This medicine is only used in hospitalised patients. If you are discharged early, after you have been given Remifentanil you must not drive, operate machinery, or work in dangerous situations. You should not go home alone.
Continued top of next column
Continued top of next column
Continued over page
AAAI0250
__________________________________________________________
The following information is intended for medical or healthcare professionals only:
Instructions on use/handling of Remifentanil 1mg, 2mg and 5mg Powder for Concentrate for Solution for Injection or Infusion
|
Presentation |
Volume of diluent to be added |
Concentration of the reconstituted solution |
|
Remifentanil 1mg |
1ml |
1mg/ml |
|
Remifentanil 2mg |
2ml |
1mg/ml |
|
Remifentanil 5mg |
5ml |
1mg/ml |
Continued top of next column AAAI0250
Remifentanil 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 1mg/ml.
Following reconstitution, the product has to be inspected visually (as far as supported by the vial) for solids, discoloration or damage to the vials. If such changes are detected, the solution has to be discarded. The finished solution is for single use only. Unused solution has to be discarded.
For manually-controlled infusion, Remifentanil should be administered following further dilution to a concentration of 20 to 250pg/ml (50pg/ml is the recommended dilution for adults and 20 to 25pg/ml for paediatric patients aged 1 year and over).
Continued top of next column
For target controlled infusion (TCI), Remifentanil should be administered following further dilution to a concentration of 20 to 50pg/ml.
Dilution should be adjusted to the technical equipment of the infusion system and the expected patient requirements.
Continued over page
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
• The medicine has been prescribed to treat a medical or dental problem and
• You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
• It was not affecting your ability to drive safely Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Remifentanil contains sodium
This medicinal product contains less than 1mmol sodium (23mg) per ml, i.e. essentially 'sodium- free'.
^ How to use Remifentanil
Remifentanil is always used by healthcare professionals and only in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function and by persons specifically trained in the use of anaesthetic medicines and the recognition and management of the expected adverse effects of potent opioids, including respiratory and cardiac resuscitation.
The recommended dosage is always determined by the doctor dependent on the patient's individual condition and his response to the drug.
Remifentanil is for intravenous use only and must not be administered by epidural or intrathecal injection.
Dilution should be adjusted to the technical equipment of the infusion system and the expected patient requirements.
Remifentanil should not be mixed with other therapeutic agents prior to administration and for intravenous use it should only be admixed with one of the following fluids:
• 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
Newborns and infants
There is no data available on administration to newborns and infants younger than 1 year.
Dosage in special patient groups
In obese or critically ill patients the initial dose will be appropriately reduced and enhanced due to the response.
In patients with impaired liver or kidney function and in patients undergoing neurosurgery a dose reduction will not be necessary.
If you receive more Remifentanil than you should
If you have received too much of Remifentanil or if it is suspected, that you may have received too much, appropriate action will be taken promptly by your healthcare specialist team.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Continued top of next column AAAI0250
Ste_______
^ Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:
Very common (may affect more than 1 in 10 people)
• muscle stiffness
• feeling sick (nausea)
• being sick (vomiting)
• low blood pressure (hypotension)
Common (may affect up to 1 in 10 people)
• slow heart beat (bradycardia)
• shallow breathing (respiratory depression)
• breathing stops (apnoea)
• itching
• shivering after the operation
• high blood pressure (hypertension) after the operation
Uncommon (may affect up to 1 in 100 people)
• constipation
• pain after the operation
• oxygen deficiency (hypoxia)
Rare (may affect up to 1 in 1,000 people)
• slow heart beat followed by heart block in patients receiving remifentanil with one or more anaesthetic medicines
• sleepiness (during recovering from the operation)
• severe allergic reactions including shock, circulatory failure and heart attack in patients receiving remifentanil with one or more anaesthetic medicines
Not known (frequency cannot be estimated from the available data)
• cough
As with other medicines of this class (opioids), long-term use of Remifentanil can lead to dependence (frequency cannot be estimated from the available data). Please ask your doctor for advice.
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 at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
^ How to store Remifentanil
Keep this medicine out of the sight and reach of children.
Do not use Remifentanil after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
1mg: Do not store above 25°C. Do not refrigerate or freeze. Keep the vial in the outer carton in order to protect from light.
2mg and 5mg: Do not store above 30°C. Do not refrigerate or freeze.
After reconstitution and dilution, 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.
Following dilution, the solution has to be inspected visually to ensure that it is clear, colourless and virtually free from solids, and that there is no damage to the vials. If such changes are detected, the solution has to be discarded.
Continued top of next column
The diluted solution is for single use only.
Any unused solution has to be discarded. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
What Remifentanil contains
The active substance is: remifentanil (as hydrochloride)
• 1 vial contains 1mg remifentanil (as remifentanil hydrochloride).
• 1 vial contains 2mg remifentanil (as remifentanil hydrochloride).
• 1 vial contains 5mg remifentanil (as remifentanil hydrochloride).
After reconstitution the solution contains 1mg/ml remifentanil (as hydrochloride), if prepared as recommended.
The other ingredients are: glycine; hydrochloric acid 37% (for pH adjustment); sodium hydroxide 17% (for pH adjustment)
What Remifentanil looks like and contents of the pack
Remifentanil 1mg, 2mg and 5mg is a lyophilized white to slightly yellow cake or powdery mass for concentrate for solution for injection/infusion.
Each carton of Remifentanil 1mg contains 5 vials of 3.5ml.
Each carton of Remifentanil 2mg contains 5 vials of 3.5ml.
Each carton of Remifentanil 5mg contains 5 vials of 8ml.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavfkurvegi 76-78 220 Hafnarfjordur Iceland
Manufacturer
Elaiapharm
2881 route des Cretes, BP 205 Valbonne, 06904 Sophia Antipolis Cedex France
This leaflet was last revised in February 2016
Actavis, Barnstaple, EX32 8NS, UK
For dilution, one of the following IV fluids listed
below should be used:
• Water for Injections
• Glucose 50mg/ml (5%) solution for Injection
• Glucose 50mg/ml (5%) and sodium chloride 9mg/ ml (0.9 %) solution for injection
• Sodium chloride 9mg/ml (0.9 %) solution for injection
• Sodium chloride 4.5mg/ml (0.45 %) solution for injection.
Remifentanil has been shown to be compatible with the following IV fluids when administered into a running IV catheter:
• Lactated Ringer's solution for injection
• Lactated Ringer's and Glucose 50mg/ml (5%) solution for injection.
Remifentanil has been shown to be compatible with propofol when administered into a running IV catheter.
Any unused product or waste material should be disposed of in accordance with local requirements.
For full prescribing information refer to the Summary of Product Characteristics.
Continued top of next column Continued top of next column
AAAI0250
^actavis
Actavis, Barnstaple, EX32 8NS, UK