Remifentanil 2 Mg Powder For Concentrate For Solution For Injection Or Infusion
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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
Read all of this leaflet carefully before you start having this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
In this leaflet:
1. What Remifentanil is and what it is used for
2. Before you are given Remifentanil
3. How you will be given Remifentanil
4. Possible side effects
5. How to store Remifentanil
6. Further information
Remifentanil contains the active ingredient remifentanil. This belongs to a group of medicines known as opioids. It has very quick onset and very short duration of action.
It is used to:
• stop you feeling pain before or while you are having an operation
• to relieve pain while you are under controlled mechanical ventilation in an Intensive Care Unit (for patients 18 years of age and over)
You must not receive Remifentanil:
• if you have ever had an allergic reaction to remifentanil, any of the other ingredients of Remifentanil (see list of ingredients in section 6) or other fentanyl analogues
• as injection into the spinal canal (intrathecal or epidural)
• as sole medicine to initiate anaesthesia
Using Remifentanil with food and drink
After having received Remifentanil you should not drink alcohol until fully recovered.
Pregnancy and breast-feeding
Remifentanil should not be given to pregnant women unless medically justified.
Remifentanil is not recommended during labour or a caesarean section.
You are advised to discontinue breast-feeding for 24 hours following administration of Remifentanil.
Talk to your doctor if you are pregnant, planning to become pregnant or are breast-feeding.
Your doctor will discuss the possible risks and benefits of being given Remifentanil if you are pregnant or breast-feeding.
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. You should not go home alone. It can be dangerous to drive, operate machinery, or work in dangerous situations too soon after having an operation.
Take special care with Remifentanil:
Before you receive Remifentanil, tell your doctor if you:
• have ever had any adverse reaction during an operation
• have ever had any allergic reactions or if you have been told that you are allergic to any opioid medicine used during an operation (e.g. fentanyl), or to any medicines used during an operation
• have or have ever had any of the following medical conditions
- slow heart beat
- low blood pressure
- chest or breathing problems
- impaired liver function
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.
If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before you are given Remifentanil.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines as well.
This is because Remifentanil can interact with other medicines to cause side effects.
In particular tell your doctor or pharmacist if you are taking:
• medicines for your heart or blood pressure, such as beta-blockers or calcium channel blockers
• Sedative medicines, such as benzodiazepines
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
Elderly patients are more sensitive to suffer from cardiac or circulatory disturbances. The initial dose of Remifentanil should be appropriately reduced in elderly patients.
How your injection is given Remifentanil must only be given under carefully controlled conditions and emergency equipment has to be available. Remifentanil will be given to you 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 can be given:
• as a single injection into your vein (it should not be given over less than 30 seconds).
• as a continuous infusion into your vein (the drug is given to you slowly over a longer period of time).
Remifentanil must not be given into your spinal canal.
The way you are given the drug and the dose you receive will depend on many factors such as:
• the operation you are going to have
• how much pain you are likely to be in
• your body weight
• your age
• other medicines you are given
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The following information is intended for medical or healthcare professionals only
PREPARATION GUIDE for Remifentanil 1 mg Powder Concentrate for Solution for Injection or Infusion Remifentanil 2 mg Powder Concentrate for Solution for Injection or Infusion Remifentanil 5 mg Powder 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 micrograms/ml (50 micrograms/ml is the recommended dilution for adults and 20 to 25 micrograms/ml for paediatric patients aged 1 year and over) with one of the following IV fluids listed on the next page. For target controlled infusion (TCI) the recommended dilution of Remifentanil is 20 to 50 micrograms/ml.
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The dose varies from patient to patient. Dosage in adults
Most patients respond to infusion rates between 0.1 and 2 microgram per kg body weight per minute.
Dosage in elderly
If used for an operation under general anesthesia, the initial dose of Remifentanil should be appropriately reduced in elderly patients.
Dosage in children (1 to 12 years of age)
For most children, infusion rates between 0.05 and 1.3 microgram per kg body weight per minute are sufficient to maintain sleep during an operation. The doses can be altered by the doctor and may be as high as 3 microgram per kg body weight per minute.
There is little experience of use of Remifentanil to treat children in intensive care units.
Remifentanil is not recommended for children under 1 year old.
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 or if you miss a dose of Remifentanil
Since Remifentanil will usually be given to you by a doctor or nurse under carefully controlled conditions, it is unlikely that you will be given too much or that you will miss a dose.
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.
After your operation
Tell your doctor or nurse if you are in pain after your procedure; they will be able to give you other pain relievers.
If you have any further questions on the use of this product, ask your doctor or pharmacist or nurse.
Possible side effects on stopping treatment
If Remifentanil is stopped suddenly, particularly after prolonged administration for more than 3 days, some people may feel a faster heart beat (tachycardia), have high blood pressure (hypertension) or feel restless or agitated.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist or nurse.
Keep out of the reach and sight of children.
Do not use Remifentanil after the expiry date which is stated on the carton and the vials after EXP. The expiry date refers to the last day of that month.
Store below 25°C.
Keep vial in the outer carton in order to protect from light.
Do not use Remifentanil if you notice the solution is not clear and free of particles or if the container is damaged.
Any unused product or waste should be disposed of in accordance with local requirements.
Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Like all medicines, Remifentanil can cause side effects, although not everybody gets them.
You must tell your doctor or nurse immediately if you have:
• sudden wheeziness and chest pain or chest tightness
• swelling of your eyelids, face, lips, mouth or tongue or throat
• a lumpy skin rash or ‘hives’ anywhere on the body (urticaria)
These are symptoms of a serious allergic reaction that occurs very rarely and must be treated immediately.
The following side effects have been reported:
Very common side effects (affects more than 1 user in 10):
• low blood pressure (hypotension) which may cause dizziness, tiredness or fainting
• feeling sick (nausea)
• being sick (vomiting)
• muscle stiffness.
Common side effects (affects 1 to 10 users in 100):
• shivering after the operation
• slow heart beat
• high blood pressure after the operation
• breathing problems (shallow breathing, breathlessness)
• itching.
Uncommon side effects (affects 1 to 10 users in 1,000):
• oxygen deficiency (hypoxia) which may cause confusion or loss of coordination
• constipation
• pain after the operation
Rare side effects (affects 1 to 10 users in 10,000):
• sleepiness (during recovery from the operation)
• slow heart beat followed by heart block in patients receiving Remifentanil with one or more anaesthetic medicines
• severe allergic reactions including shock, circulatory failure and heart attack in patients receiving Remifentanil with one or more anaesthetic medicines
Unknown frequency
• drug dependence
• uncontrollable muscle contractions
• loss of consciousness due to heart block
• drug tolerance
What Remifentanil contains
• The active substance is remifentanil.
Remifentanil 1 mg Powder for Concentrate for Solution for Injection or Infusion 1 vial contains 1 mg remifentanil (as hydrochloride). When reconstituted, each ml contains 1 mg of remifentanil (1 mg in 1 ml).
Remifentanil 2 mg Powder for Concentrate for Solution for Injection or Infusion 1 vial contains 2 mg remifentanil (as hydrochloride). When reconstituted, each ml contains 1 mg of remifentanil (2 mg in 2 ml).
Remifentanil 5 mg Powder for Concentrate for Solution for Injection or Infusion 1 vial contains 5 mg remifentanil (as hydrochloride). When reconstituted, each ml contains 1 mg of remifentanil (5 mg in 5 ml).
• The other ingredients are Glycine and Hydrochloric acid (for pH-adjustment)
What Remifentanil looks like and contents of the pack
Remifentanil 1 mg Powder for Concentrate for Solution for Injection or Infusion is a white to almost white powder for concentrate for solution for injection or infusion packaged in glass vials and available in pack sizes of 1 x 4 ml vial and 5 x 4 ml vials.
Not all pack sizes may be marketed.
Remifentanil 2 mg Powder for Concentrate for Solution for Injection or Infusion is a white to almost white powder for concentrate for solution for injection or infusion packaged in glass vials and available in pack sizes of 1 x 4 ml vial and 5 x 4 ml vials.
Not all pack sizes may be marketed.
Remifentanil 5 mg Powder for Concentrate for Solution for Injection or Infusion is a white to almost white powder for concentrate for solution for injection or infusion packaged in glass vials and available in pack sizes of 1 x 13 ml vial and 5 x 13 ml vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia. Or Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,39179 Barleben, Germany.
This leaflet was last approved in 06/2014.
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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:
• sterilised Water for Injections
• Glucose 50 mg/ml (5 %) solution for injection
• Glucose 50 mg/ml (5 %) sol. for injection and sodium chloride 9 mg/ml (0.9 %) sol. 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
Store below 25°C. Keep vial in the outer carton in order to protect from light.
For storage condition of the reconstituted/diluted medicinal product, see section on the previous page under “Further Dilution”.
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