Remifentanil Mylan Generics

Package leaflet: Information for the user

Remifentanil Mylan Generics 1 mg 2 mg 5 mg powder for concentrate for injectable solution or
infusion
Remifentanil
Generic medicine
Please read all of this leaflet carefully before you are given this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Remifentanil Mylan Generics is and what it is used for
2. What you need to know before you are given Remifentanil Mylan Generics
3. How to use Remifentanil Mylan Generics
4. Possible side effects
5. How to store Remifentanil Mylan Generics
6. Contents of the pack and other information

1. What Remifentanil Mylan Generics is and what it is used for

Remifentanil is an anaesthetic belonging to a group of medicines called opioids (substances that have effects in the body similar to morphine).
This medicine is used:

• to help you sleep before an operation,
• to keep you asleep and prevent you from feeling pain during an operation,
• to relieve pain while you are being treated in an Intensive Care Unit.

2. What you should know before being administered Remifentanil Mylan Generics

Do not take Remifentanil Mylan Generics:

• if you are allergic (hypersensitive) to remifentanil or to any of the other ingredients of this medicine listed in section 6,
• if you are allergic (hypersensitive) to drugs similar to fentanyl (analgesics similar to fentanyl belonging to the class of medicines known as opioids),
• if used as the sole medicine for anesthesia induction. Since the formulation contains glycine, Remifentanil must not be administered for epidural or intrathecal use (injections into the area around the spinal column or into the spinal fluid).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before being administered Remifentanil Mylan Generics if:

• you are allergic (hypersensitive) to any other opioid medicines, such as morphine or codeine,
• you have had any respiratory disorders (breathing problems),
• you suffer from severe heart conditions (heart failure),
• you have been diagnosed with low blood pressure (hypotension),
• you suffer from severe liver disorders (hepatic insufficiency),
• you feel weak or suffer from reduced blood volume (hypovolemia). Caution is also required if you are elderly.

During treatment with Remifentanil Mylan Generics:

• As with other morphine derivatives, the following may occur:
• respiratory disorders (breathing that is too shallow or slow),
• muscle rigidity. This effect depends on the dose and speed of administration. Therefore, when administered intravenously as a single slow dose (slow bolus injection), Remifentanil Mylan Generics must not be administered in less than 30 seconds,
• low blood pressure (hypotension) or slowed heart rate (bradycardia).

If any of these problems occur, your doctor will administer appropriate and specific treatment.
Your doctor will adjust the dose and rate of administration.
Before allowing you to leave the intensive care unit, your doctor will ensure that your general condition has sufficiently recovered.

• The effect of Remifentanil stops very rapidly. Within 5 to 10 minutes after stopping administration, there will no longer be any residual analgesic effect. During a surgical procedure known to be painful, upon awakening, or during use in an intensive care unit, analgesics must be administered before discontinuing Remifentanil. Sufficient time must be allowed to ensure that longer-acting analgesics become effective. These analgesics must be selected based on the type of surgery and the level of postoperative monitoring.

Other medicines and Remifentanil Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is because Remifentanil may interact with other medicines, causing undesirable effects.
In particular, inform your doctor or pharmacist if you are taking medicines for the heart or blood pressure, such as beta-blockers or calcium antagonists, or medicines that induce sleep, reduce anxiety, or relax muscles belonging to the group of medicines called benzodiazepines.
The concomitant use of Remifentanil Mylan Generics and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are available.
However, if your doctor prescribes Remifentanil Mylan Generics together with sedative medicines, your doctor must limit the dose and duration of concomitant treatment.
Inform your doctor about all sedative medicines you are taking and follow your doctor’s dosage recommendations carefully. It may be helpful to inform friends or relatives to watch for the signs and symptoms listed above. Contact your doctor if you experience any of these symptoms.
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Pregnancy and breastfeeding
Inform your doctor if you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding. This medicine should generally not be used during pregnancy unless otherwise indicated by your doctor.
You must not breastfeed within 24 hours following administration of Remifentanil.
There are insufficient data to recommend the use of remifentanil during labor and cesarean section.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You must not drive or operate machinery after being anesthetized with this medicine unless your doctor informs you that you may resume these activities.
It is advisable to be accompanied when returning home and to avoid consuming alcoholic beverages.
Athletes
Athletes should be informed that this medicine contains an active substance that may lead to a positive result in doping tests.

3. How to use Remifentanil Mylan Generics

You are not expected to self-administer this medicine. It will always be given to you by qualified medical personnel under closely controlled conditions.
Dosage
The dose you will be given depends on:

• the type of procedure you are undergoing,
• the level of pain relief you will require.

The dose varies from patient to patient.
It depends on your age, body mass index, and general state of health.
Your doctor will decide the appropriate dose for you. This dose may be adjusted by your doctor depending on the effects observed during anaesthesia.
Method of administration
This medicine will be administered intravenously.
Remifentanil may be administered:

• as a single intravenous injection (bolus injection),
• as a continuous intravenous infusion. This occurs when the drug is administered slowly over a prolonged period.

Special precautions will be taken to prevent any accidental administration, particularly at the end of anaesthesia.
Duration of treatment
Your doctor will determine the most suitable duration of treatment for you, depending on the type of procedure you are undergoing.
The use of Remifentanil in intensive care patients undergoing mechanical ventilation is not recommended for treatment longer than 3 days.
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If you take more Remifentanil Mylan Generics than you should:
Your doctor will promptly intervene with appropriate measures.
If you stop treatment with Remifentanil Mylan Generics:
Like other morphine derivatives, this medicine may cause dependence.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Allergic reactions including acute hypersensitivity allergic reactions (anaphylaxis): are rare
(may affect up to 1 in 1,000 people) in individuals receiving Remifentanil Mylan Generics. Signs include:

• raised, itchy rash (urticaria)
• swelling of the face or mouth (angioedema) causing breathing difficulties
• collapse. If you experience any of these symptoms, seek medical advice urgently.

Very common side effects (may affect more than 1 in 10 people)

• muscle rigidity – See also section 2,
• low blood pressure (hypotension) – See also section 2,
• nausea, vomiting.

Common side effects (may affect up to 1 in 10 people)

• slowed heart rate (bradycardia) – See also section 2,
• post-operative increase in blood pressure (hypertension)
• breathing difficulties (breathing too shallowly or slowly) – See also section 2, pauses in breathing (apnea),
• itching,
• post-operative chills.

Uncommon side effects (may affect up to 1 in 100 people)

• lack of oxygen in the blood (hypoxia),
• constipation,
• post-operative pain.

Rare side effects (may affect up to 1 in 1,000 people)

• drowsiness (sedation) during recovery from general anaesthesia,
• cardiac pause / cardiac arrest, usually preceded by slowed heart rate (bradycardia), have been reported in patients treated with remifentanil in combination with other anaesthetic drugs.

Other side effects (frequency not known: cannot be estimated from available data)

• physical need for Remifentanil Mylan Generics (drug dependence) or need to increase doses to achieve the same effect (drug tolerance)
• seizures
• a type of irregular heartbeat (atrioventricular block).

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Other side effects that may occur particularly after abrupt discontinuation of Remifentanil Mylan
Generics following prolonged administration for more than 3 days

• increased heart rate (tachycardia)
• high blood pressure (hypertension)
• restlessness (agitation).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Remifentanil Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label.
The expiry date refers to the last day of that month.
Do not store above 25°C.
The in-use chemical and physical stability of the reconstituted solution has been demonstrated for 24 hours at 25°C.
The in-use chemical and physical stability of the diluted solution has been demonstrated for 4 hours at 25°C.
For microbiological reasons, the product should be used immediately. If not used immediately, the duration and conditions of storage under normal conditions of use are the responsibility of the user and should normally not exceed 24 hours at a temperature between 2°C and 8°C, unless dilution/reconstitution has been carried out under controlled and validated aseptic conditions.
Do not use Remifentanil Mylan Generics if you notice any signs of deterioration after reconstitution.

6. Package contents and other information

What Remifentanil Mylan Generics contains

• The active substance is: remifentanil. Each vial contains 1 mg, 2 mg or 5 mg of remifentanil (as hydrochloride).

After reconstitution, the solution contains 1 mg/mL of remifentanil (as hydrochloride), when prepared as recommended.

• The other components are: glycine and hydrochloric acid 37% (for pH adjustment).

Description of the appearance of Remifentanil Mylan Generics and contents of the pack
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Remifentanil Mylan Generics is a white to off-white powder for concentrate for solution for injection or infusion.
Carton containing 1, 5, 10, 20, 25 and 50 glass vials.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Mylan S.p.A., via Vittor Pisani 20 – 20124 Milano (Italy)
Manufacturers
Mylan S.A.S., 117 allée des Parcs – 69800 SAINT-PRIEST - France
Laboratorio reigjofré s.a., Gran Capitán – 10, 08970 Sant Joan Despi, Barcelona – Spain
Orificemedical AB, Aktergatan 2 and 4, SE-271 55 Ystad - Sweden
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The following information is intended for healthcare professionals only
Remifentanil Mylan Generics 1 mg, 2 mg, 5 mg powder for concentrate for solution for injection or
for infusion
Instructions for use and handling
This medicinal product must be reconstituted by adding 1 mL of injectable solution to obtain a reconstituted solution with a remifentanil concentration of approximately 1 mg/mL. After reconstitution, the solution must not be administered undiluted but must be further diluted.
For manually controlled infusions, Remifentanil Mylan Generics can be diluted to concentrations between 20 and 250 micrograms/mL (the recommended dilution is 50 micrograms/mL for adults and 20 to 25 micrograms/mL for children aged 1 year and older).
For administration via target-controlled infusion (TCI), the recommended dilution of Remifentanil Mylan Generics is between 20 and 50 micrograms/mL.
Reconstitution and dilution of Remifentanil Mylan Generics solution can be performed using one of the following injectable solutions:

• Water for injections,
• Glucose 50 mg/mL (5%) solution for injection,
• Glucose 50 mg/mL (5%) 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 dilution depends on the technical capacity of the infusion set and the patient's anticipated needs.
When administered through an intravenous line in use, this medicinal product is compatible with Ringer's Lactate solution for injections and Ringer's Lactate and Glucose 50 mg/mL (5%) solution for injections, as well as with propofol.
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Dosage
For information on dosage, refer to the Summary of Product Characteristics.
Depending on the indication, dosage recommendations are provided for adults and/or children (aged 1 to 12 years), with adjustments suggested for special patient populations.
Management of overdose
Due to its extremely short duration of action, the risk of adverse effects following an overdose is limited to the few minutes immediately after administration (upon discontinuation of treatment, return to baseline conditions occurs within a maximum of 10 minutes).
In case of suspected or confirmed overdose, the following protocol should be followed:

• Discontinue administration of the medicinal product,
• Ensure airway patency,
• Initiate artificial ventilation with oxygen,
• Assess hemodynamic stability. If respiratory depression is associated with muscle rigidity, administration of a neuromuscular blocking agent may be required to facilitate ventilation. Maintenance of vascular filling, administration of specific medications (vasopressors) to correct hypotension, and other supportive measures for vital functions may also be beneficial.

In cases of severe respiratory depression and muscle rigidity, an opioid antagonist such as naloxone may be administered intravenously. It is unlikely that the duration of respiratory depression due to overdose will exceed the duration of action of the antidote.
Stability and storage conditions
Remifentanil Mylan Generics contains no preservatives and is for single use only. Unused solution must be discarded.
Medicinal products must not be disposed of via wastewater or household waste.
Incompatibilities
Remifentanil Mylan Generics must only be reconstituted or diluted with the recommended injectable solutions.
It must not be reconstituted or mixed with Ringer's Lactate solution for injection or Ringer's Lactate and Glucose 50 mg/mL (5%) solution for injection.
This medicinal product must not be mixed or placed in the same infusion solution as propofol.
The use of this medicinal product is not recommended for infusion through the same infusion set used for blood, serum or plasma.
This medicinal product must not be mixed with other medicinal products prior to administration.
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