Remifentanil 2 Mg Powder For Concentrate For Solution For Injection Or Infusion
TEVA UK Ref: 231-30-89049-B LEA REMIFENTANIL A/S POW INJ TEVAH <GOD
Version: 1 05 August 2014
L L epo0 BLUJBLId
L \ epo0 BLUJBLId
REMIFENTANIL 1 mg, 2 mg and 5 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION OR INFUSION
PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you
start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4
IN THIS LEAFLET:
1. What Remifentanil Powder for Concentrate for Solution for Injection or Infusion is and what it is used for
2. Before you are given Remifentanil Powder for Concentrate for Solution for Injection or Infusion
3. How Remifentanil Powder for Concentrate for Solution for Injection or Infusion is given
4. Possible side effects
5. How to store Remifentanil Powder for Concentrate for Solution for Injection or Infusion
6. Further information
OWHAT REMIFENTANIL POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION OR INFUSION IS AND WHAT IT IS USED FOR
Remifentanil belongs to a group of general anaesthetics, known as opioids.
Remifentanil is used to help put you to sleep before an operation, to keep you asleep and stop you feeling pain during an operation. If you are 18 years of age or older, it is also used to stop you from feeling pain while you receive treatment in an Intensive Care Unit.
©BEFORE YOU ARE GIVEN
REMIFENTANIL POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION OR INFUSION
You will NOT be given Remifentanil
• if you are allergic (hypersensitive) to remifentanil or to other similar medicines or to any of the other ingredients of Remifentanil • as an injection into your spine • as the only medicine to put you to sleep.
Take special care with Remifentanil • If you are elderley, debilitated or hypovolaemic (if you are dehydrated or have lost a lot of blood), you may be more prone to the side effects that can affect the heart, when Remifentanil is used.
• If you have lung problems or severe liver problems, you may be slightly more sensitive to the breathing difficulties that Remifentanil can cause.
• If you are anticipated to be in pain after your surgical procedure, then another form of pain relief will be given to you before Remifentanil is discontinued. It will be specifically chosen for you, taking into account your surgical procedure and the level of post-operative care that you will need. If another opioid medicine is given to you, then your doctor will further consider the risk of breathing difficulties. You may experience the following once you have woken from your surgery: shivering, agitation, fast heart beat and/or dizziness. If so, tell your doctor immediately.
• Whilst you are in surgery, your doctor may insert a tube into the windpipe to ensure your airway remains clear. You will be closely _ ____________
monitored and will not feel any discomfort from the tube.
Tell your doctor if you experience:
Severe muscle stiffness when you first receive this medicine (see section 4, Possible side effects). Remifentanil may cause dependency.
Taking other medicines
Please tell your doctor or anaesthetist if you are taking or have recently taken any other medicines, including herbal medicines and other medicines obtained without a prescription. This is because they can affect how Remifentanil works inside you and may cause side-effects.
You must tell your doctor or anaesthetist if you are taking (or intend to take) other medicines, such as:
• medicines for heart conditions, such as beta-blockers (these include atenolol, metoprolol and bisoproplol) as these may increase the side effects of remifentanil which affect the heart (including low blood pressure and decreased heart rate)
• calcium channel blocking agents (these include amlodipine, diltiazem and nifedipine) as these may increase the side effects of remifentanil which affect the heart (including low blood pressure and decreased heart rate)
• inhalation or intravenous anaesthetics and benzodiazepines (e.g. diazepam): your doctor or pharmacist will alter the dose of these medicines when you are being given Remifentanil.
Taking 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 used during pregnancy unless clearly necessary. It is recommended that you stop breast-feeding for 24 hours after Remifentanil has been given to you.
If you are pregnant, or think that you might be pregnant, or if you are breast-feeding, then you must tell your doctor or anaesthetist. Remifentanil is not recommended during labour or a Caesarean section.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines This medicine may cause problems with your concentration, coordination, movement and alertness. If you are discharged from hospital on the same day as your operation, then do not drive or operate machinery. It can be dangerous to drive too soon after having an operation, therefore it is advised that you are accompanied when returning home.
Important information about some of the ingredients of Remifentanil This medicinal product contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially 'sodium-free'.
©HOW REMIFENTANIL POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION OR INFUSION IS GIVEN
Remifentanil will only be given to you in a setting where specially trained medical staff can monitor your heart and breathing.
A doctor or anaesthetist will be giving you this medicine, so it is unlikely that you will receive an incorrect dose. How you are given this medicine, and the doses that you receive, will vary amongst patients and will be decided by your doctor or anaesthetist. This will depend upon the type of operation you are having and how long you are required to be asleep.
• Remifentanil will be given to you via a separate injection/infusion from other medication.
• Remifentanil can be given to you as a single injection or as a slow, continuous infusion into your vein.
• Remifentanil must not be given to you as an injection into your spine
r-.
<n
T3
o
u
ru
E
ru
.C
Q_
• Remifentanil must only be given in combination with another medicine to help put you to sleep.
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 are given more Remifentanil than you should
As your doctor or anaesthetist will be monitoring your condition during the procedure it is unlikely that you will be given too much Remifentanil. If you do receive too much Remifentanil, the doctor will stop the therapy and treat the symptoms.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
T4 POSSIBLE SIDE EFFECTS
Like all medicines, Remifentanil can cause side effects, although not everybody gets them. Muscle stiffness may be experienced when Remifentanil is first given to you to make you sleepy. If the stiffness becomes severe, then your doctor will give you medicine to relax your muscles. If you experience muscle stiffness whilst Remifentanil is given to you as a pain relief, then your doctor will reduce the amount or stop using it. The muscle stiffness will subside within minutes of discontinuation of Remifentanil.
The following side effects have been reported at the approximate frequencies shown: Frequency:
Very common (affects more than 1 user in 10) Common (affects 1 to 10 users in 100) Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
Not known (frequency cannot be estimated from the available data).
Your nurse or doctor should be told immediately if you begin to experience any of the following: Very common:
• Muscle stiffness
• Fainting or dizziness (possibly symptoms of low blood pressure)
• Nausea and/or vomiting.
Common:
• Unusually slow heart beat
• Slowing or stopping of your breathing
• Itching
• Shivering (following an operation)
• Dizziness or "flush" feelings following an operation (possibly symptoms of high blood pressure).
Uncommon:
• Constipation
• Aches (following an operation)
• Feelings of agitation or confusion, a bluish colour to the skin and/or shortness of breath (possibly indicating a deficiency in the amount of oxygen reaching body tissues).
Rare:
• Absence/stopping of the heart beat
• Drowsiness (following an operation)
• Allergic reactions such as shortness of breath, skin rash found anywhere on the body, sudden wheeziness, or swelling to the face/tongue have been observed in patients taking remifentanil with one or more anaesthetics.
Not known:
• Dependency.
Reporting of side effects
Before you are discharged from the hospital's recovery area after your surgical procedure, your doctor will ensure that you are fully conscious and have no post-operative side-effects, such as breathing difficulties, unusual heart beats and/ or dizziness. If you do experience these side-effects, your doctor will treat them appropriately.
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.
0HOW TO STORE REMIFENTANIL POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION OR INFUSION
Keep out of the reach and sight of children.
Do not use Remifentanil after the expiry date which is stated on the vial and carton after EXP The expiry date refers to the last day of that month. Storage conditions
Before opening: This medicinal product does not require any special storage conditions. After reconstitution/dilution: This product can be stored for 24 hours at 25°C. However, 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. Storage times of diluted product are usually no longer than 24 hours at 2-8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions. Your doctor will ensure that your medicine is kept in the correct storage conditions.
For single use only. Any unused solution should be discarded.
Remifentanil will not be used if your doctor notices any visible signs of deterioration. Medicines should not be disposed of via wastewater or household waste. Your doctor will dispose of medicines that are no longer required. These measures will help to protect the environment.
further information
What Remifentanil Powder for Concentrate for Solution for Injection or Infusion contains
The active substance is remifentanil. One vial contains either 1 mg, 2 mg or 5 mg of remifentanil. The other ingredients are:
• glycine (E640)
• hydrocloric acid (E507)
• sodium hydroxide (E524).
What Remifentanil Powder for Concentrate for Solution for Injection or Infusion looks like and contents of the pack
Remifentanil 1 mg Powder for Concentrate for Solution for Injection or Infusion is a white to off-white or yellowish compact powder contained in a colourless glass vial closed with a rubber stopper and white cap. It is available in cartons of 1 and 5 vials.
Remifentanil 2 mg Powder for Concentrate for Solution for Injection or Infusion is a white to off-white or yellowish compact powder contained in a colourless glass vial closed with a rubber stopper and grey cap. It is available in cartons of 1 and 5 vials.
Remifentanil 5 mg Powder for Concentrate for Solution for Injection or Infusion is a white to off-white or yellowish compact powder contained in a colourless glass vial closed with a rubber stopper and blue cap. It is available in cartons of 1 and 5 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder is TEVA UK Limited, Eastbourne, BN22 9AG.
Manufacturer is TEVA Pharmaceutical Works Private Limited Company, H-2100, Godollo, Hungary.
This leaflet was last revised July 2014.
PL 00289/1350-52 89049-B
Pharma code 17
Pharma code 17
PREPARATION GUIDE FOR USE WITH Remifentanil 1 mg, 2 mg and 5 mg Powder for Concentrate for Solution for Injection or Infusion (Please note this is a Prescriber Information Leaflet NOT the SPC. For full details regarding this product please refer to the SPC).
The following information is intended for medical or healthcare professionals only:
Incompatibilities
Remifentanil should not be admixed with Lactated Ringer's Injection or Lactated Ringer's and glucose 50 mg/ml (5%) solution for injection. Remifentanil should not be mixed with propofol in the same intravenous admixture solution. Remifentanil is compatible with propofol when administered in a running IV catheter.
Administration of Remifentanil into the same intravenous line with blood/serum/plasma is not recommended as non-specific esterase in blood products may lead to the hydrolysis of remifentanil to its inactive metabolite.
Remifentanil should not be mixed with other therapeutic agents prior to administration.
Special precautions for disposal and other handling Reconstitution:
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 1 mg/ml of remifentanil.
Shake until completely dissolved. The reconstituted solution should be clear, colourless and free of visible particles.
Further dilution:
After reconstitution, Remifentanil 1 mg, 2 mg or 5 mg 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 the 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 be used if the solution is clear and free from particles.
Ideally, intravenous infusions of remifentanil should be prepared at the time of administration.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.
|
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 |
“O
3"
QJ
3
£U
n
O
CL
0>
■-J
For tables showing guidelines for the infusion rate of Remifentanil for manually-controlled infusion and for tables providing the equivalent blood remifentanil concentration using a TCI approach for various manually-controlled infusion rates at steady state, please refer to the Summary of Product Characteristics (SPC) for Remifentanil.
Storage information
See section 5 'How to store Remifentanil'.
After first opening
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C after initial reconstitution with:
• 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
• Lactated Ringer's Injection
• Lactated Ringer's and glucose 50 mg/ml (5%) solution for injection.
Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C after further dilution with:
• 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.
Chemical and physical in-use stability has been demonstrated for 8 hours at 25°C after further dilution with:
• Lactated Ringer's Injection
• Lactated Ringer's and glucose 50 mg/ml (5%) solution for injection.
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 2-8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Any unused portion should be discarded.
Method of administration
Remifentanil is for intravenous use only and must not be administered by epidural or intrathecal injection.
Remifentanil should not be administered without further dilution after reconstitution of the lyophi-lised powder.
Continuous infusions of remifentanil must be administered by a calibrated infusion device into a fast flowing IV line or via a dedicated IV line. This infusion line should be connected at, or close to, the venous cannula, to minimise potential dead space. Care should be taken to avoid obstruction or disconnection of infusion lines and to adequately clear the lines to remove residual remifentanil after use. IV lines/infusion system should be removed after cessation of use to avoid inadvertent administration.
Remifentanil may be given by target-controlled infusion (TCI) with an approved infusion device incorporating the Minto pharmacokinetic model with covariates for age and lean body mass (LBM). Please refer to the Summary of Product Characteristics (SPC) of Remifentanil for specific manually- and target-controlled infusion guidance. Information and posologies can be found on the induction, maintenance and discontinuation of Remifentanil in adults, children and special care patients, such as elderly, renally-impaired, cardiac and intensive care patients.
3-29123050/A 89049-B
Pharma code 17