REMIFENTANIL 1 mg Koncentrat Do Sporządzania Roztworu Infuzyjnego

Treść ulotki

1. Remifentanil
   1. What is Remifentanil Mylan generics 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. Package Contents and Other Information

Remifentanil Mylan Generics 1 mg 2 mg 5 mgpowder for concentrate for injectable solution or
infusion

Remifentanil

Generic medicine
Read this leaflet carefully before you are given this medicine as 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 any side effects occur, including those not listed in this leaflet, ask 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 Remifentanil Mylan Generics is given to you
• 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 is Remifentanil Mylan generics and what it is used for

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

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

2. What you need to know before you are given Remifentanil Mylan Generics

Do not take Remifentanil Mylan Generics:

• if you are allergic (hypersensitive) to remifentanil or any of the other ingredients of this medicine listed in section 6,
• if you are allergic (hypersensitive) to drugs similar to fentanyl (pain relievers, which are similar to fentanyl and are related to the class of drugs known as opioids).
• if it is being used as the sole medicine for induction of anesthesia. Since the formulation contains glycine, Remifentanil should not be administered for epidural and intrathecal use (injections into the area around the spinal cord or into the spinal fluid).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Remifentanil Mylan

Genericsif :

• you are allergic (hypersensitive) to any other opioid medicine, such as morphine or codeine
• you have had any respiratory problems (breathing difficulties),
• you suffer from severe heart disorders (heart failure),
• you have been told you have low blood pressure (hypotension),
• you suffer from severe liver disorders (hepatic insufficiency),
• you feel weak or suffer from a decrease in blood volume (hypovolemia). Caution is also necessary if you are elderly.

During therapy with Remifentanil Mylan Generics:

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

If these problems occur, your doctor will give you appropriate and specific treatment. The doctor will adjust the dose you are given and the rate of administration. Before allowing you to leave intensive care, the doctor will ensure that your general condition is satisfactory again.

• The action of Remifentanil stops very quickly. Within a period of 5 to 10 minutes after the administration is stopped, there will be no residual analgesic effect. During a surgical procedure known to be painful, on awakening or during use in Intensive Care Units, before stopping the administration of Remifentanil, analgesics must be administered. Sufficient time must be allowed to ensure that longer-acting analgesics are effective. These analgesics should be selected according to the type of surgical procedure and the level of post-operative monitoring.

Other medicines and Remifentanil Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This is because Remifentanil can interact with other medicines, causing unwanted effects.
In particular, tell 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 concurrent use of Remifentanil Mylan Generics and sedative medicines such as benzodiazepines or drugs related to them increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concurrent use should only be considered when other treatment options are not possible.
However, if your doctor prescribes Remifentanil Mylan Generics together with sedative medicines, the dose and duration of concomitant treatment must be limited by the doctor.
Tell your doctor about all the sedative medicines you are taking and carefully follow your doctor's recommendations on dosage. It may be helpful to inform friends or family to pay attention to the signs and symptoms listed above. Contact your doctor if you experience these symptoms.
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Pregnancy and breastfeeding
Tell your doctor if you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding. This medicine should generally not be used during pregnancy unless otherwise indicated by your doctor.
You should not breastfeed within 24 hours of receiving Remifentanil.
There is insufficient data to recommend the use of remifentanil during labor and cesarean delivery.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
You must not drive or operate machinery after being given anesthesia using this medicine unless your doctor tells you that you can resume these activities.
It is advisable to be accompanied on your return home and to avoid consuming alcoholic beverages.

Athletes
Athletes must be informed that this medicine contains an active ingredient that can cause a positive result in doping tests.

3. How to use Remifentanil Mylan Generics

You are not expected to take this medicine on your own. It will always be administered to you by
qualified medical personnel and under well-controlled conditions.
Dosage
The dose that will be administered to you will depend on:

• the type of surgery you will undergo,
• how much pain relief you will need.

The dose varies from patient to patient.
It depends on your age, body mass index and general health conditions.
The doctor will decide what the right dose is for you. He/she may adjust this dose depending on the effects
obtained during anesthesia.

Method of administration
The medicine will be administered to you intravenously.
Remifentanil can be administered:

• as a single intravenous injection (bolus injection),
• as a continuous intravenous infusion. This happens when the drug is administered slowly over a long period of time.

Special precautions will be taken to avoid any accidental administration, particularly
at the end of anesthesia.

Duration of treatment
The doctor will decide the duration of therapy most suitable for you and the type of surgery you will undergo.
The use of Remifentanil in critically ill 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:
The doctor will promptly intervene with appropriate actions.

If you stop taking Remifentanil Mylan Generics:
Like other morphine derivatives, this medicine can cause dependence.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• raised, itchy rash (urticaria)
• swelling of the face or mouth (angioedema) causing difficulty in breathing
• collapse. If any of these symptoms occur, seek urgent medical attention.

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

• muscle stiffness - 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)

• slowing of the heart rate (bradycardia) -See also section 2,
• post-operative increase in blood pressure (hypertension)
• breathing difficulties (too shallow or slow breathing) - See also section 2, pauses in breathing (apnea),
• itching,
• post-operative shivering.

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 1000 people)

• feeling sleepy (sedation) during recovery from general anesthesia,
• cardiac arrest /cardiac standstill, usually preceded by a slowing of the heart rate (bradycardia), have been reported in patients treated with remifentanil in combination with other anesthetic drugs.

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

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

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

• fast heartbeat (tachycardia)
• high blood pressure (hypertension)
• restlessness (agitation).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
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 which is stated on the package and the label.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
The chemical and physical stability of the reconstituted solution has been demonstrated for 24 hours at 25°C.
The chemical and physical stability of the diluted solution has been demonstrated for 4 hours at 25°C.
For microbiological reasons, the product must be used immediately. If it is not
used immediately, the storage times and conditions under the current conditions of
use are the responsibility of the user and should normally not exceed 24 hours at a
temperature between 2° and 8°C, unless the dilution/reconstitution has taken place in
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 ingredient is: remifentanil. Each vial contains 1 mg 2 mg 5 mg 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).

Description of the Appearance of Remifentanil Mylan Generics and Package Contents
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Remifentanil Mylan Generics is a white to off-white powder for concentrate for solution
for injection or for infusion.
Pack containing 1, 5, 10, 20, 25 and 50 glass vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A. via Vittor Pisani 20 – 20124 Milan (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 och 4, SE-271 55 Ystad - Sweden
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The following information is intended only for healthcare professionals
Remifentanil Mylan Generics 1 mg 2 mg 5 mgpowder for concentrate for solution for injection or
for infusion
Instructions for Use and Handling
This medicine 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 should not be administered as is, but must be further
diluted.
For infusions performed in a manually controlled mode, 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 in children aged 1 year or older).
For administration by means of 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 carried out
with one of the following solutions for injectable preparations:

• Water for injections,
• 50 mg/ml (5%) Glucose solution,
• 50 mg/ml (5%) Glucose solution and 9 mg/ml (0.9%) Sodium Chloride solution,
• 9 mg/ml (0.9%) Sodium Chloride solution,
• 4.5 mg/ml (0.45%) Sodium Chloride solution.

The dilution depends on the technical capacity of the infusion set and the patient's expected needs.
This medicine, when administered in an in-line intravenous catheter, is
compatible with Ringer Lactate solution for injectable preparations and Ringer Lactate and Glucose 50
mg/ml (5%) solution for injectable preparations, as well as with propofol.
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Dosage and Administration
For information on dosage, refer to the Summary of Product Characteristics.
Depending on the indications, dosage recommendations are provided for adults and/or children (aged
between 1 and 12 years) and adjustments are proposed for special patient populations.

Overdose Treatment
Given its very short duration of action, the risk of adverse effects caused by an
overdose is limited to the few minutes immediately after its administration (upon discontinuation of
treatment, return to baseline conditions requires a maximum of 10 minutes).
In case of suspected or confirmed overdose, the following protocol should be followed:

• stop administering the medicine,
• ensure airway patency,
• start artificial ventilation with oxygen,
• and assess hemodynamic stability. If respiratory depression is associated with muscle rigidity, a neuromuscular blocking drug may be needed to facilitate ventilation. Maintaining vascular filling, administering certain medications (vasopressors) to correct hypotension, and other measures to support vital functions may be helpful.

In case of severe respiratory depression and muscle rigidity, a morphine antidote, such as naloxone, may be administered intravenously. The duration
of respiratory depression secondary to an overdose is unlikely to exceed the duration of action of the antidote.

Shelf Life and Storage Conditions
Remifentanil Mylan Generics is preservative-free and for single use only. Dispose of unused
solution.
Medicines should not be disposed of via wastewater or household waste.

Incompatibilities
Remifentanil Mylan Generics must only be reconstituted or diluted with the recommended
solutions for injectable preparations.
It must not be reconstituted or mixed with Ringer Lactate solution for injection or Ringer Lactate and
Glucose 50 mg/ml (5%) solution for injection.
This medicine should not be mixed or placed in the same infusion solution with
propofol.
The medicine is not recommended for use in the same infusion set as blood, serum or plasma.
This medicine should not be mixed with other medicines before administration.
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