FENTANYL AMELN 50 MCG/ML Инъекционный раствор

Содержание инструкции

1. What is Fentanyl-hameln and what is it used for
2. What you need to know before you take Fentanyl-hameln
3. How to use Fentanyl-hameln
4. Possible side effects
5. How to store Fentanyl-hameln
6. Contents of the pack and other information

Fentanyl-hameln 50 micrograms/ml injectable solution
fentanyl
Generic Medicine

Read this leaflet carefully before you start to use this medicinebecause 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.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

The full name of the medicine is Fentanyl-hameln; it will be referred to as Fentanyl throughout this leaflet.

Contents of this leaflet:

• 1. What Fentanyl-hameln is and what it is used for
• 2. What you need to know before you use Fentanyl-hameln
• 3. How to use Fentanyl-hameln
• 4. Possible side effects
• 5. How to store Fentanyl-hameln
• 6. Contents of the pack and other information

1. What is Fentanyl-hameln and what is it used for

Fentanyl belongs to a group of strong painkillers called opioids.
At low doses Fentanyl is used to control pain during short-duration surgical procedures.
In addition to providing an analgesic action, high doses of Fentanyl are used
to lower the natural respiratory rate in case the patient is artificially ventilated.
During major surgical procedures Fentanyl is used in association
with a sedative called a neuroleptic, to put the patient to sleep.

2. What you need to know before you take Fentanyl-hameln

Fentanyl must NOT be administered to you- hameln if:

• you are allergicto fentanyl, to other medicines similar to morphine or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction can manifest as a skin rash, itching, swelling of the face or lips or shortness of breath.
• you suffer from a disease that causes difficulty breathing, e.g. asthma or chronic bronchitis. Make sure to talk to your doctor before surgery.
• you are taking or have recently taken an antidepressant from the monoamine oxidase inhibitor (MAOI) family - see also Other medicines and Fentanyl- hamelnfurther on regarding serotonin syndrome and the use of fentanyl with MAOIs and with serotonergic drugs such as SSRIs and SNRIs.
• you suffer from increased intracranial pressure or have a brain or skull injury.
• you suffer from low blood pressure or reduced blood volume.
• you suffer from myasthenia gravis, a disease that causes fatigue and muscle weakness.

Warnings and precautions

• Fentanyl-hameln must be used exclusively by an experienced anesthesiologist within a hospital or in other places equipped with intubation and assisted ventilation facilities.
• As with all strong painkillers of this type, good pain relief is associated with a lowering of the respiratory rate which can last until recovery or re-emergence at this stage. The effect may be prolonged especially in the elderly. In newborns this effect occurs even after small doses. Your breathing will be carefully monitored until it returns to normal. The doctor will have special tools and medicines to treat any involuntary lowering of the respiratory rate.
• Patients with epilepsy, thyroid, heart, lung, intestinal, liver and kidney diseases and those with a history of alcoholism will have a dose tailored to their particular needs and their response to therapy will be carefully monitored.
• Continued use or abuse of this type of drug may reduce its effectiveness and consequently require a higher dose.
• There is a possibility that newborns may develop a withdrawal syndrome after more than 5 days of therapy or from a certain total dose onwards. See section “Pregnancy and breastfeeding” below.
• Rapid injections of Fentanyl-hameln must be avoided.
• Fentanyl can cause low blood pressure, especially if you have low blood volume.
• Fentanyl can lead to gallbladder spasms

Talk to your doctor before using Fentanyl-hameln:

• If you or someone in your family has ever abused or been dependent on alcohol, prescription drugs or illegal substances (“addiction”).
• If you are a smoker.
• If you have ever had problems with your mood (depression, anxiety or a personality disorder) or have ever received treatment from a psychiatrist for another mental illness.
• If you are pregnant, may become pregnant or are breastfeeding. For further information, see section “Pregnancy and breastfeeding” below.
• If you have pain or increased sensitivity to pain (hyperalgesia) that does not respond to a higher dose of the medicine, as prescribed by the doctor. The doctor will decide whether to change the dose or stop using this medicine.

The repeated long-term use of opioid painkillers can make the drug less effective
(you get used to it). It can also lead to dependence and abuse which can lead to a
life-threatening overdose. If you are afraid of becoming dependent on Fentanyl, it is
important to consult your doctor.
If treatment is stopped, withdrawal symptoms may occur. Inform your doctor or
nurse if you think this is happening to you (see also section 4. Possible
side effects).

Other medicines and Fentanyl-hameln
The concomitant use of Fentanyl-hameln and sedative medicines such as benzodiazepines or medicines
related to them increases the risk of drowsiness, difficulty breathing (respiratory
depression), coma and can be life-threatening. For this reason, concomitant use
should only be considered when other treatment options are not possible.
However, if your doctor prescribes Fentanyl 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
the doctor's dosage recommendations. It may be helpful to inform friends or relatives to pay
attention to the signs and symptoms listed above. Contact your doctor if you experience these symptoms.
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Tell your doctor if you are taking any of the following medicines:

• painkillers
• sleeping pills
• tranquilizers
• medicines for epilepsy
• diazepam
• thiopental
• midazolam
• droperidol
• cimetidine
• clonidine
• vecuronium
• atracurium
• baclofen
• etomidate
• nitrous oxide
• ritonavir
• medicines used to treat fungal infections (e.g. itraconazole, fluconazole, voriconazole)
• Some painkillers for nerve pain (gabapentin and pregabalin).

Serotonin syndrome
In particular, do not take this medicine and tell your doctor or pharmacist if you have taken
medicines for depression called "monoamine oxidase inhibitors (MAOIs) in the last
two weeks. If this applies to you, do not take Fentanyl-. It is also important that
you tell your doctor or pharmacist if you are taking other serotonergic drugs including
antidepressants such as "selective serotonin reuptake inhibitors" (SSRIs) or
"serotonin and norepinephrine reuptake inhibitors" (SNRIs). This is because these
drugs can increase the risk of serotonin syndrome, a potentially life-threatening condition. Symptoms of this condition may include agitation,
hallucinations, coma, rapid heart rate, changes in blood pressure, fever,
hyperreflexia, coordination problems, rigidity, nausea, vomiting and diarrhea.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor for advice before using this medicine.
It is advisable not to take the medicine during childbirth, as fentanyl crosses the placenta
and can affect the baby's breathing. If you receive Fentanyl during pregnancy, there is
a risk that the baby will develop neonatal drug withdrawal syndrome after
birth which may require treatment. However, if the doctor decides that it is necessary, there is
treatment available to eliminate any adverse effects that may
occur.
Fentanyl can pass into breast milk, so it is recommended not to breastfeed for at least
24 hours after treatment.

Driving and operating machinery
Do not drive or use any tools or machinery, as fentanyl can reduce your level of
reactivity and concentration for a considerable period after administration.
Ask your doctor when you can resume these activities
You must be driven home and must not drink alcohol.

Fentanyl-hameln contains sodium
This medicine contains 3.5 mg of sodium (the main component of table salt) per
millilitre of solution. This is equivalent to 0.2% of the recommended daily intake
of salt for an adult.
For athletes: the use of the drug without a therapeutic need constitutes doping
and may still result in a positive doping test.

3. How to use Fentanyl-hameln

Fentanyl-hameln will be injected into a vein by a doctor just before you enter the operating room.
It will make you fall asleep and prevent you from feeling pain during the operation. Fentanyl will be
administered to you only in an environment where your airways can be monitored and
will be administered by personnel who can monitor you.
The initial dose must be reduced in the case of elderly and debilitated patients. The doctor will decide
how much Fentanyl to administer to you. The dose will depend on age, body weight, physical
conditions, other medications taken concurrently, and also on the type of surgery and of
anesthesia.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you start to experience difficulty breathing, dizziness or symptoms of low blood pressure and
slowed heartbeat, tell your doctor immediately or seek medical attention.

The following side effects have been reported:
Very common (may affect more than 1 in 10 people):

• feeling unwell (nausea)
• feeling sick (vomiting)
• muscle stiffness (which may affect the chest muscles, possibly leading to breathing difficulties)

Common (may affect up to 1 in 10 people):

• feeling dizzy or “light-headed”
• excessive tiredness (sedation)
• vision problems
• agitation
• fast or slow heartbeat
• low or high blood pressure
• pain in the veins
• confusion after surgery
• skin rash
• temporary cessation of breathing (apnea)
• difficulty breathing or wheezing
• spasms of the throat or lung muscles

Uncommon (may affect up to 1 in 100 people):

• excessive feeling of happiness (euphoria)
• headache
• changes in blood pressure
• swelling and blood clot in a vein
• faster breathing than normal
• severe decrease in body temperature beyond normal
• shivering
• hiccups
• agitation after surgery

Not known (frequency cannot be estimated from available data):

• severe allergic reaction causing difficulty breathing or dizziness
• convulsions
• loss of consciousness
• muscle spasms
• cardiac arrest (The doctor has medicines to reverse this effect)
• severe difficulty breathing or wheezing
• hiccups
• Delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that do not exist, sleep disturbances, nightmares)
• a condition that causes a lack of oxygen in the blood which can cause headache, nausea, restlessness and a fast heartbeat (metahemoglobinemia)
• tolerance to the medicinal product may develop (reduced effectiveness of the medicine due to continued use)
• drug dependence may occur
• difficulty standing upright (vertigo)
• Horner’s syndrome (drooping upper eyelid or raising of the lower eyelid, impression that the eye is sunken, constriction of the pupils)
• loss of the pharyngeal reflex or the ability to swallow
• fluid accumulation in the lungs
• spasms of the gallbladder
• abnormal sweating
• difficulty urinating
• symptoms of withdrawal syndrome (may manifest with the onset of the following side effects: nausea, vomiting, diarrhea, anxiety, shivering, tremor and sweating)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the website:
http://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 Fentanyl-hameln

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 label and on the
packaging after the words Exp. The expiry date refers to the last day of that month.
Keep the vials/bottles in the outer packaging to protect the medicine from light.
Validity after dilution: The chemical and physical stability during use of the dilutions has been
demonstrated for 24 hours at 25°C. From a microbiological point of view, the dilutions must be
used immediately. If the medicine is not used immediately, the user is
responsible for the storage times during use and the pre-use conditions which generally should not
exceed 24 hours at 2-8 °C, unless the dilution has taken place in a
controlled and aseptic environment.
Do not use this medicine if you notice that the solution is not clear and colourless.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Fentanyl-hameln contains
The active substance is fentanyl (as citrate).
1 ml of injectable solution contains
fentanil citrate 78.5 mcg
equivalent to fentanyl 50 mcg.
1 vial of 2 ml of injectable solution contains
fentanil citrate 157 mcg
equivalent to fentanyl 100 mcg.
1 vial of 10 ml of injectable solution contains
fentanil citrate 785 mcg
equivalent to fentanyl 500 mcg.
1 vial of 50 ml of injectable solution contains
fentanil citrate 3925 mcg
equivalent to fentanyl 2500 mcg.
The other ingredients are water for injections, sodium chloride, hydrochloric acid or
sodium hydroxide (to adjust the pH)

Description of Fentanyl-hameln and contents of the pack
Fentanyl is a clear and colourless injectable solution.
Glass vials type I, transparent, of 2 ml or 10 ml
Boxes of 5 vials of 2 or 10 ml
Boxes of 10 vials of 2 or 10 ml
Glass vial type I, transparent, of 50 ml with bromobutyl rubber stopper
Boxes of 1 vial of 50 ml
Boxes of 5 vials of 50 ml
Boxes of 10 vials of 50 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder
hameln pharma gmbh
Inselstraße 1
31787 Hameln
Germany
Exclusive distributor for Italy: TillomedItalia S.r.l., viale Richard 1°, 20143,
Milan, Italy

Manufacturer:
Siegfried Hameln GmbH
Langes Feld 13
31789 Hameln
Germany
hameln rds s.r.o.
Horná 36, 900 01 Modra
Slovakia
HBM Pharma s.r.o.
Sklabinská 30, 03680 Martin
Slovakia

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
AT: Fentanyl-hameln 50 Microgram/ml Injection solution
DK: Fentanyl ”Hameln”, injection fluid, solution
FI: Fentanyl Hameln 50 mcg/ml injection, solution
DE: Fentanyl-hameln 50 Microgram/ml Injection solution
IT: Fentanyl-hameln
LU: Fentanyl Hameln 50 Microgram/ml Injection solution
NL: Fentanyl hameln 50 microgram/ml, solution for injection
NO: Fentanyl Hameln 50 mcg/ml injection fluid, solution
 -----------------------------------------------------------------------------------------------------------------------

The following information is intended exclusively for physicians or healthcare professionals:
PREPARATION INSTRUCTIONS FOR:
Fentanyl-hameln 50 micrograms/ml injectable solution
This is a summary of information relating to the preparation, storage and
administration of Fentanyl-hameln 50 micrograms/ml injectable solution.
It is important that you read the entire content of the leaflet before preparing this medicinal product.

Nature and contents of container
5 (10) colorless type I glass vials containing 2 or 10 ml of solution.
1 (5, 10) colorless type I glass vials containing 50 ml of solution, with bromobutyl rubber stopper.
Not all pack sizes may be marketed.

Incompatibilities
This medicinal product must not be mixed with other products except those mentioned below.
Check the compatibility of fentanyl before administration, if it is to be mixed with
other drugs.
Fentanyl citrate has been shown to be physiologically incompatible with sodium pentobarbital,
sodium methohexital, sodium thiopental and nafcillin.

Dilution
The product can be used diluted or undiluted. Dilution ranges tested with 0.9% sodium chloride solution and 5% glucose solution are 1:1 and 1:25. The maximum dilution should therefore not exceed 1 part of Fentanyl-hameln with 25 parts of 0.9% sodium chloride solution and with
5% glucose solution.

Storage
Store the vials/vials in the carton to protect from light.

Dosage and method of administration

Dosage
Fentanyl-hameln must only be administered in an environment where the airways can
be controlled and must be administered by personnel who can control them.
The dosage of Fentanyl-hameln must be adjusted individually according to age, weight,
physical conditions, underlying pathological condition, concomitant medication, as well as the type
of surgery and the type of anesthesia.

Adults
The usual therapeutic regimen in adults for intravenous injection is as follows:
Initial dose Supplementary dose
Spontaneous
breathing
50-200* micrograms 50 micrograms
Assisted
ventilation
300-3,500 micrograms
(up to 50 micrograms/kg)
100-200 micrograms
*Doses greater than 200 micrograms lead to the development of significant respiratory depression and
should therefore be used exclusively in anesthesia.
Fentanyl-hameln 50 micrograms/ml injection solution can also be administered as an infusion.
In ventilated patients, a loading dose of 1 microgram/kg/minute for the first 10 minutes is followed by an infusion of approximately 0.1 micrograms/kg/minute.
Alternatively, the loading dose can be administered as a bolus. Infusion rates should be
titrated according to the individual patient's response, and rates of up to
3 micrograms/kg/minute have been used in cardiac surgery. The infusion should be stopped approximately 40 minutes before the end
of surgery, unless artificial ventilation needs to be continued postoperatively.
For patients breathing spontaneously, lower infusion rates of
0.05-0.08 micrograms/kg/minute are required.

Neuroleptoanalgesia and neuroleptoanesthesia
For neuroleptoanalgesia, adults usually require an initial dose of 50 - 100 micrograms
(0.7-1.4 micrograms/kg) of fentanyl injected slowly intravenously in association with a
neuroleptic (preferably droperidol). A second dose of

• 50 - 100 micrograms (0.7-1.4 micrograms/kg) of fentanyl can be administered, if necessary, 30 to 45 minutes after administration of the initial dose.

For neuroleptoanesthesia under assisted ventilation, adults usually require a
initial dose of 200 - 600 micrograms (2.8 - 8.4 micrograms/kg) of fentanyl injected slowly intravenously in association with a neuroleptic (preferably droperidol). The dose depends
on the duration and severity of the surgical procedure, as well as the drug used
to induce general anesthesia. For maintenance of anesthesia, additional doses of 50 - 100 micrograms (0.7-1.4 micrograms/kg) of fentanyl can be administered every 30 - 45 minutes. The
timing and doses of additional administrations should be adjusted according to
the course of the surgical procedure.

Treatment of pain in intensive care units
For use in the treatment of pain in ventilated patients in intensive care units, the dose of fentanyl
must be adjusted individually, depending on the course of the pain and concomitant medication.
Initial doses are usually in the range of

• 50 - 100 micrograms intravenously (0.7-1.4 micrograms/kg), but, if necessary, higher doses may be used. The initial dose is usually followed by repeated injections, up to a total of 25 - 125 micrograms of fentanyl per hour (0.35 – 1.8 micrograms/kg/hour).

Dosage in the paediatric population
For children aged between 12 and 17 years, the dosage regimen recommended for
adults should be followed.
For children aged between 2 and 11 years, the following usual dosage regimen is recommended:

Paediatric use
Analgesia during a surgical procedure, potentiation of anesthesia with spontaneous breathing:
Techniques involving analgesia in a child breathing spontaneously should only be
adopted as part of an anesthetic or sedation/analgesia technique practiced by experienced personnel in an environment where sudden thoracic rigidity requiring intubation or apnea requiring respiratory support can be managed.

Dosage in elderly and debilitated patients
As with other opioids, the initial dose should be reduced in elderly patients (over 65 years of age) and
debilitated patients. The effects of the initial dose should be taken into account to determine the additional doses.

Obese patients
Obese patients may be at risk of overdose if the dose is calculated based on body weight.
Obese patients should receive a dose calculated on the basis of estimated lean body mass.

Renal impairment
In patients with impaired renal function, a reduced dose of Fentanyl-hameln should be considered; these patients should be carefully monitored for signs of fentanyl toxicity.

Doses in patients undergoing chronic opioid therapy
In patients treated chronically with opioid drugs or with a known history of opioid abuse, a
higher dose of fentanyl may be necessary.

Doses in patients with other diseases
In patients with any of the following diseases, the dose should be titrated with great care:

• uncompensated hypothyroidism
• lung diseases, especially those causing reduced vital capacity
• alcohol abuse
• impaired liver function

Caution should also be exercised when administering Fentanyl-hameln to patients with
renal insufficiency, prostatic hypertrophy, porphyria and bradyarrhythmia.
In all these conditions, except in the case of alcohol abuse, it may be necessary to reduce the dose.
In the case of alcohol abuse, it may be necessary to reduce or increase the dose.
In these types of patients, a long period of postoperative monitoring is recommended.
Method and duration of administration
Administration by intravenous route as a bolus injection or by infusion.
For instructions on diluting the medicinal product before administration, see above.
To prevent bradycardia, it is recommended to administer a small intravenous dose of an
anticholinergic agent just before inducing anesthesia.
For intravenous injection, Fentanyl-hameln should be administered slowly over 1 - 2
minutes (see section 4.4. of the summary of product characteristics), if applicable, in
association with a neuroleptic (preferably droperidol).
In anesthesia, the duration of administration depends on the duration of the surgical procedure. In
the treatment of pain in intensive care unit patients, the doctor must define the duration of
administration based on the intensity and duration of the pain.

Marketing Authorisation Holder
hameln pharma gmbh
Inselstraße 1
31787 Hameln
Germany