Remifentanil 5mg Powder For Concentrate For Solution For Injection Or Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER
Remifentanil 5mg, powder for concentrate for solution for injection or infusion
remifentanil
Read all of this leaflet carefully before you are given this medicine.
- 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 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.
In this leaflet:
1. What Remifentanil is and what it is used for
2. Before you are given Remifentanil
3. How to use Remifentanil
4. Possible side effects
5. How to store Remifentanil
6. Further information
1. WHAT REMIFENTANIL IS AND WHAT IT IS USED FOR
Remifentanil is an anaesthetic belonging to a group of medicines called opioids (substances that have a morphine-like action in the body).
This medicinal product is used:
- to help put you to sleep before an operation,
- to keep you asleep and stop you feeling pain during an operation,
- to stop you feeling pain while you receive treatment in an Intensive Care Unit.
2. BEFORE YOU ARE GIVEN REMIFENTANIL You must not be given Remifentanil :
- if you are allergic (hypersensitive) to the remifentanil or any of the other ingredients,
- if you are allergic (hypersensitive) to any other opioid medicines, such as morphine,
- if it is used as the sole agent for induction of anaesthesia,
As glycine is present in the formulation, Remifentanil must not be given for epidural and intrathecal use (injection into the area around the spine or into the spinal fluid).
Take special care with Remifentanil
Before you are given Remifentanil, tell your doctor if you:
• have had any respiratory disorders (problems with your breathing), have severe heart disorders (heart failure),
have been told your blood pressure is low (hypotension), have severe liver disorders (hepatic failure),
• feel weakened or suffer from a decrease in blood volume (hypovolaemia). Caution will also be exercised if you are older.
While under treatment with Remifentanil:
• As with other morphine derivatives, you may experience:
- respiratory disorders (too shallow or too slow breathing),
- muscular rigidity. This effect depends on the dose and the administration speed. For this reason, when given as a single slow administration into your vein (slow bolus injection), Remifentanil Mylan should not be given to you in less than 30 seconds.
- low blood pressure (hypotension) or slowdown of heart rate (bradycardia).
If it happens, your doctor will administer an appropriate and specific treatment. He/she will adjust the dose you are being given and the administration speed.
Your doctor will make sure you have fully regained satisfactory general condition before allowing you to leave the recovery room.
• Remifentanil has a very rapid offset of action. No residual painkilling activity will be present within 5 to 10 minutes after stopping the administration. During surgery known to be painful, on waking or during use in an Intensive Care Unit, painkillers must be given before stopping the Remifentanil administration. Sufficient time must be allowed to ensure that the longer acting painkillers are effective. These painkillers must be chosen as a function of the type of surgery and the level of postoperative monitoring.
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 is because Remifentanil can work 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, or medicines to induce sleep, reduce anxiety or relax muscles belonging to the group of agents called benzodiazepines.
Pregnancy and breast-feeding
Inform your doctor if you are pregnant or planning to get pregnant or breast-feeding.
This medicine should generally not be used during pregnancy, unless otherwise indicated by your doctor.
You must not breast-feed for the 24 hours following the administration of Remifentanil.
There are insufficient data to recommend remifentanil for use during labour and caesarean section. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive or use machines following anaesthesia including this medicine until your doctor tells you that you may start these activities again.
It is advisable that you are accompanied when you return home and that you avoid consuming alcoholic beverages.
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:
o The medicine has been prescribed to treat a medical or dental problem and o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and o 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.
Athletes
Athletes should be warned that this medicine contains an active substance that may give a positive result in anti-doping tests.
3. HOW TO USE REMIFENTANIL
You will never be expected to give yourself this medicine. It will always be given to you by a qualified health professional and under carefully controlled conditions.
Dosage
The dose you receive will depend on:
- the operation you have,
- how much pain relief you need.
The dose varies from one patient to another.
It depends on your age, your body mass and your general condition.
Your doctor will decide on a dose which is right for you. He/she may adjust it depending on the effects obtained during the anaesthesia.
Method of administration
You will be given this medicine by intravenous route.
Remifentanil can be given:
- as a single injection into your vein (bolus injection),
- as a continuous infusion into your vein. This is where the drug is slowly given to you over a long period of time.
Special precautions will be taken to avoid any accidental administration in particular at the end of anaesthesia.
Duration of treatment
Your doctor will decide on duration of therapy which is appropriate for you and the operation you have.
The use of Remifentanil in mechanically ventilated intensive care patients is not recommended for a period of more than 3 days.
If you are given more Remifentanil than you should:
Your doctor will take appropriate actions promptly.
When you stop being given Remifentanil :
This medicine may produce a dependency, like other morphine derivatives.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Remifentanil can cause side effects, although not everybody gets them.
Very common side effects (affects more than 1 user in 10)
- muscle rigidity - Please also refer to section 2,
- low blood pressure (hypotension) - Please also refer to section 2,
- nausea, vomiting.
Common side effects (affects 1 to 10 users in 100)
- slow down of heart rate (bradycardia) - Please also refer to section 2,
- post-operative increase in blood pressure (hypertension)
- respiratory disorders (too shallow or too slow breathing) - Please also refer to section 2, breathing pause (apnoea),
- itching (pruritus),
- post-operative shivering.
Uncommon side effects (affects 1 to 10 users in 1,000)
- lack of oxygen in the blood (hypoxia),
- constipation,
- post-operative aches.
Rareside effects (affects 1 to 10 users in 10,000)
- allergic reactions including acute hypersensitivity allergic reaction (anaphylaxis) have been reported in patients receiving remifentanil in conjunction with one or more anaesthetic agents.
- sleepy feeling (sedation) during recovery from general anaesthesia,
- cardiac pause/cardiac arrest, usually preceded by slowdown of heart rate (bradycardia), has been reported in patients receiving remifentanil in conjunction with other anaesthetic agents.
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.
5. HOW TO STORE REMIFENTANIL
Keep out of the reach and sight of children.
Do not use Remifentanil after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month.
Do not store above 25°C.
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours at 25° C.
Chemical and physical-in-use stability of the diluted solution has been demonstrated for 4 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 / dilution has taken place in controlled and validated aseptic conditions.
Do not use Remifentanil if you notice any sign of deterioration after reconstitution.
6. FURTHER INFORMATION
What Remifentanil contains
- The active substance is: Remifentanil.
Each vial contains 5mg of remifentanil (as hydrochloride).
After reconstitution the solution contains 1 mg/ml of remifentanil (as hydrochloride), if prepared as recommended.
- The other ingredients are:
Glycine and hydrochloric acid 37% (for pH adjustment).
What Remifentanil looks like and contents of the pack
Remifentanil is a white to off-white, powder for concentrate for solution for injection or infusion. Box of 1, 5, 10, 20, 25 or 50 glass vials.
Not all pack size may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, UK
Manufacturers
Laboratorio Reig Jofre S.A., C/Gran Capitan, 10, Sant Joan Despi, Barcelona, 08970, Spain
This leaflet was last approved in 7/2014.
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The following information is intended for medical or healthcare professionals only Remifentanil 5mg, powder for concentrate for solution for injection or infusion Instructions for use and handling
This medicine must be reconstituted by addition of 5 ml of solution for injection to obtain a reconstituted solution with a concentration of remifentanil of approximately 1 mg/ml. After reconstitution the solution must not be administered as is, but must be diluted further.
For infusions performed in manually-controlled mode, Remifentanil may be diluted at concentrations ranging from 20 to 250 micrograms/ml (the recommended dilution is of 50 micrograms/ml in adults and 20 to 25 micrograms/ml in children aged 1 year or older).
For administration by Target Controlled-Infusion, the recommended Remifentanil dilution is of 20 to 50 micrograms/ml.
The reconstitution and dilution of the Remifentanil solution may be performed with one of the following solutions for injection:
• water for injections,
• glucose 50 mg/ml (5 %) solution,
• glucose 50 mg/ml (5 %) and sodium chloride 9 mg/ml (0.9 %) solution,
• sodium chloride 9 mg/ml (0.9 %) solution,
• sodium chloride 4.5 mg/ml (0.45 %) solution.
The dilution is dependent upon the technical capability of the infusion device and the anticipated requirements of the patient.
This medicine is compatible with lactated Ringer’s solution for injection and lactated Ringer’s and glucose 50 mg/ml (5 %) solution for injection as well as with propofol when administered into a
running intravenous catheter.
Posology
Please refer to the Summary of Product Characteristics for information on the posology.
Depending on indications, dosage recommendations are given for adults and/or children (aged 1 to 12 years) and adjustment is proposed for special populations.
Treatment of overdosage
In view of its very short duration of action, the risk of undesirable effects due to an overdose is limited to the few minutes following its administration (after stopping the treatment, the return to initial condition requires at most 10 minutes).
In case of a confirmed or suspected overdose, the protocol to follow is the following:
- stop the administration of the medicine,
- ensure patency of the airway,
- start artificial ventilation with oxygen,
- and establish haemodynamic stability.
If the respiratory depression is associated with a muscular rigidity, the administration of a neuromuscular blocking agent may be required to facilitate ventilation.
Maintenance of vascular filling, the administration of certain medicines (vasopressors) to rectify hypotension and other vital function assistance measures may be useful.
In case of severe respiratory depression and muscular rigidity, a morphine antidote, such as naloxone may be administered by intravenous route. The duration of respiratory depression secondary to an overdose is unlikely to exceed the duration of the antidote.
Stability and storage conditions
Remifentanil is preservative free and intended for single use only. Discard any unused solution. Medicines should not be disposed of via wastewater or household waste.
Incompatibilities
Remifentanil must be reconstituted or diluted only with the recommended solutions for injection. It should not be reconstituted or mixed with lactated Ringer’s solution for injection or lactated Ringer’s and glucose 50 mg/ml (5 %) solution for injection.
This medicine should not be mixed with propofol or placed in the same solution for infusion.
It is not recommended to infuse this medicine in the same intravenous line as that used for blood, serum or plasma.
This medicine should not be mixed with other medicines before its administration.