SUFENTANIL AMELN 50 MCG/ML Инъекционный раствор

Содержание инструкции

1. Sufentanil hameln 50 micrograms/ml injectable solution or for infusion
   1. What is Sufentanil hameln and what is it used for
2. Sufentanil for epidural administration is indicated in children over 1 year of age for
   1. What you need to know before you use Sufentanil hameln
   2. How to use Sufentanil hameln
   3. Possible side effects
   4. How to store Sufentanil hameln
   5. Package contents and other information

Sufentanil hameln 50 micrograms/ml injectable solution or for infusion

Sufentanil
Generic medicine

Read this leaflet carefully before using 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, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What is Sufentanil hameln and what is it used for

Sufentanil hameln belongs to a group of medicines defined as opioid anesthetics which
relieve or prevent pain during or after general anesthesia. Sufentanil hameln is
administered intravenously during and after major surgical procedures requiring
mechanical ventilation.

Sufentanil hameln administered intravenously is used in/in:
Adults

• to prevent pain during the induction and maintenance of anesthesia in combination with other anesthetic medicines
• as a medicine to induce and maintain anesthesia during major surgical procedures Children Sufentanil intravenously is indicated as an analgesic during the induction and/or maintenance of balanced general anesthesia in children over 1 month of age.

Sufentanil hameln administered epidurally is used in/in:
Adults

• to prevent pain after surgery and cesarean section
• for the treatment of pain during labor and delivery

Children:

Sufentanil for epidural administration is indicated in children over 1 year of age for

post-operative pain control following general surgery, thoracic surgery
or orthopedic procedures.

2. What you need to know before you use Sufentanil hameln

Do not useSufentanil hameln

• by intravenous route if:
• you are allergicto Sufentanil, to other drugs similar to morphine or to any of the other ingredients of this medicine (listed in section 6).
• you suffer from any disease that causes difficulty breathing, such as asthma or chronic bronchitis.
• you are taking antidepressant medications known as monoamine oxidase inhibitors (MAOIs). MAOI therapy must be stopped 2 weeks before surgery.
• you suffer from a liver disease known as acute hepatic porphyria.
• you are taking or have recently taken other potent painkillers such as nalbuphine, buprenorphine, pentazocine.
• you are in labor or before clamping the umbilical cord during a cesarean section.
• by epidural route if:
• you suffer from severe bleeding or shock
• you suffer from a serious infection
• you suffer from impaired wound healing
• infection at the injection site
• you have abnormalities in the number of blood cells or if you are taking other medications that prevent blood clotting (anticoagulant drugs)

Warnings and precautions
Talk to your doctor or pharmacist before using Sufentanil hameln if:

• you have unusually slow bowel movements
• you have a disease of the gallbladder or pancreas
• you or a family member has ever suffered from alcohol, prescription drug or illegal substance abuse (“dependence”)
• you are a smoker
• you have ever had mood problems (depression, anxiety or a personality disorder) or have been treated by a psychiatrist for other mental illnesses. This medicine contains sufentanil, which is an opioid medicine. Repeated use of opioid analgesics can reduce the effectiveness of the drug (you get used to it). It can also lead to dependence and abuse, which can cause a potentially fatal overdose. If you are afraid of developing a dependence on Sufentanil hameln, it is important to consult your doctor.
• Sufentanil hameln should only be administered by experienced anesthesiologists and in hospital or other facilities where there is equipment for mechanical ventilation and post-operative monitoring.
• As with all strong painkillers of this type, a dose-dependent decrease in respiratory rate may occur. This may last until the recovery phase or occur again during that period. For this reason, careful post-operative monitoring of patients is essential.
• Sufentanil hameln can cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings caused by shortness of breath, difficulty staying asleep, or excessive daytime sleepiness. If you or another person observe these symptoms, contact your doctor. The doctor may consider reducing the dose.
• Sufentanil hameln must be used with extreme caution in patients with lung, liver, kidney and thyroid diseases and in alcoholic patients.
• Sufentanil hameln should be administered with caution in patients with increased intracranial pressure and head trauma.
• In patients with reduced blood volume (hypotension), the administration of Sufentanil hameln can cause a decrease in blood pressure and slow down the heartbeat.
• Involuntary muscle contractions may occur.

Consult your doctor while using Sufentanil hameln if:

• you experience pain or increased sensitivity to pain (hyperalgesia), which does not respond to an increase in the dose of the medicine as prescribed by the doctor.

Newborns/Infants

• Newborns are susceptible to breathing difficulties after the administration of sufentanil, as is the case with other opioids. Only limited data are available for infants on the use of sufentanil by intravenous route. For this reason, the doctor will carefully weigh the risks and benefits before administering Sufentanil hameln to newborns and infants.
• Due to the risk of over- or underdosage, the use of Sufentanil hameln by intravenous route is not recommended during the neonatal period.
• The use of Sufentanil hameln by epidural route is not recommended in children under 1 year of age.

Doping warning in sport
For those who engage in sporting activities: the use of the drug without therapeutic necessity constitutes doping
and may still result in positive anti-doping tests and health risks.

Other medicines and Sufentanil hameln
The concomitant use of Sufentanil 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 be considered only when other treatment options are not
possible.
However, if the doctor prescribes Sufentanil hameln 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 regarding the dose. It may be helpful to inform friends or family members to
pay attention to the signs and symptoms listed above.
Contact your doctor if you experience these symptoms.
The concomitant use of opioids and drugs used to treat epilepsy, neuralgia or anxiety
(gabapentin and pregabalin) increases the risk of opioid overdose and respiratory depression,
and can be potentially fatal.
Tell your doctor if you are taking, have recently taken or may take any
other medicine. In particular, tell your doctor that you are taking one of these medicines:

• Medicines for the treatment of depression known as monoamine oxidase inhibitors (Monoamine Oxidase Inhibitors, MAOI). These medicines should not be taken in the 2 weeks before or in conjunction with the administration of Sufentanil hameln.
• Medicines for the treatment of depression known as selective serotonin reuptake inhibitors (Selective Serotonin Reuptake Inhibitors, SSRI) and serotonin-norepinephrine reuptake inhibitors (Serotonin- Norepinephrine Reuptake Inhibitors, SNRI). It is recommended not to use these medicines in conjunction with Sufentanil hameln.

The mechanism of action of sufentanil, the duration of action of sufentanil and the effect of sufentanil
and other medicines may increase if they are taken together.
Tell your doctor if you are taking one of the following medicines:

• strong pain relievers such as other opioids
• sedatives and anxiolytics such as barbiturates or tranquilizers
• muscle relaxants (e.g. vecuronium, suxamethonium)
• general anesthetics (e.g. thiopental, etomidate, nitrous oxide)
• neuroleptic drugs (antipsychotics)
• antibiotics for the treatment of bacterial infections (erythromycin)
• drugs used to treat fungal infections (e.g. ketoconazole, itraconazole)
• drugs used to treat viral infections (e.g. ritonavir for the treatment of HIV-AIDS)

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
Sufentanil hameln should not be administered intravenously during labor because
it crosses the placenta and can affect the baby's breathing.
Sufentanil passes into breast milk. You should decide whether to stop breastfeeding or
stop/abstain from therapy with sufentanil, taking into account the
benefit of breastfeeding for the baby and the benefit of therapy for the woman.
Breastfeeding can be resumed 24 hours after the last administration of sufentanil.
Sufentanil hameln can be administered by epidural route during labor.

Driving and operating machinery
After you have been given Sufentanil hameln, you should not drive vehicles or operate
machinery for the next 24 hours.

Sufentanil hamelncontains sodium
This medicine contains 3.54 mg of sodium (the main component of table salt) per
millilitre of solution. This corresponds to 0.2% of the recommended daily intake
of salt for an adult.

3. How to use Sufentanil hameln

Sufentanil hameln will be injected, before the start of the operation, by an experienced doctor into a
vein (intravenously) or into the space surrounding the spinal cord (epidurally). It will
help to put you to sleep and prevent you from feeling pain during and after the operation.
During treatment with Sufentanil hameln, you will be carefully monitored by specialized
healthcare personnel and emergency equipment will be available.

Use in children over one month of age and in adolescents
Intravenous administration
Sufentanil is injected slowly into a vein by an anesthesiologist. The dosage depends on the dose
of concomitant anesthetics, the type and duration of the surgical intervention and will be determined
by the anesthesiologist.

Use in children over 1 year of age and in adolescents
Epidural administration
Sufentanil hameln is slowly injected into the epidural space (part of the spine) by an
anesthesiologist experienced in pediatric anesthesia techniques. The dosage depends on the use
of local anesthetics and the required duration of analgesia.
Pediatric patients will be monitored for signs of slowed breathing for at least
2 hours after epidural administration of Sufentanil hameln.

Dosage
Your doctor will decide at what dosage and for how long Sufentanil
hameln should be administered to you.
The dosage depends on your age, body weight and physical condition, the type of
surgical procedure and the level of anesthesia.

• The suggested dose should be carefully adjusted in patients with hypothyroidism (thyroid gland with insufficient activity), kidney damage, obesity and alcoholism. After surgery, it is recommended to monitor the vital signs of these patients for a prolonged period.
• For induction and maintenance of anesthesia, the doctor will carefully decide which dose is appropriate for your child.
• Patients with liver or kidney damage require lower doses.
• Elderly and debilitated patients require lower doses.

If you are given more Sufentanil hameln than you should or if you miss a dose
Since Sufentanil hameln is normally administered by a doctor in
carefully controlled conditions, it is unlikely that you will be given too much or that
a dose will be missed.
In the very rare case that you accidentally receive an overdose of Sufentanil hameln, you may
experience difficulty breathing. In this case, you should inform the doctor or medical personnel
immediately so that the team of specialists can act promptly.
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.
The most common side effects are sedation, itching, nausea and vomiting. If you have difficulty
breathing, tell your doctor immediately or seek medical attention.
Very common (may affect more than 1 in 10 people)

• sedation
• itching

Common (may affect up to 1 in 10 people)

• high blood pressure
• low blood pressure
• nausea
• vomiting
• fast heartbeat
• paleness
• bluish skin discoloration in the newborn due to low blood oxygen levels
• skin discoloration
• muscle contractions
• difficulty holding urine or urinating
• fever
• headache
• dizziness
• involuntary muscle contractions in the newborn

Uncommon (may affect up to 1 in 100 people)

• irregular heartbeat
• decreased muscle tone in the newborn
• lower back pain
• hypersensitivity
• rhinitis
• apathy
• nervousness
• lack of voluntary coordination of muscle movements
• sustained muscle contractions causing twisting and repetitive movements
• hyperactive reflexes
• abnormally increased muscle tension
• decreased voluntary movements in the newborn
• dizziness
• visual disturbances
• allergic skin reaction
• abnormal sweating
• dry skin
• rash
• muscle contractions (intraoperative muscle movements)
• chills
• difficulty breathing
• bronchospasm
• slow heartbeat
• cough
• hiccups
• altered voice
• bluish skin discoloration due to low blood oxygen levels
• abnormal electrocardiogram
• muscle rigidity including rigidity of the chest wall, possibly resulting in altered breathing
• reaction at the injection site or pain at the injection site
• increase or decrease in body temperature
• rash in the newborn

Not known (frequency cannot be estimated from available data)

• constriction of the pupils
• difficulty breathing
• severe allergic reactions including rash, difficulty breathing and shock
• uncontrollable feeling of well-being (euphoria)
• involuntary movements
• cardiac arrest (the doctor has medicines to reverse this effect.)
• spasms of the throat muscles
• difficulty staying upright (vertigo)
• coma
• convulsions
• respiratory arrest
• fluid in the lungs
• skin flushing
• muscle spasms

Side effects in children and adolescents
It is expected that the frequency, type and severity of adverse reactions in children are the same
as in adults.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 Sufentanil 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 the carton
after "EXP:". The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Keep the vials in the outer packaging to protect the medicine from light.
The product must be used immediately after opening. For the validity period of the
diluted solution see "Information for healthcare professionals" below
Do not use this medicine if you notice that the solution is not clear and free from particles, or if the
container is damaged.
Your doctor and pharmacist are responsible for the correct storage, use and disposal
of Sufentanil hameln.

6. Package contents and other information

What Sufentanil hameln contains

• The active ingredient is sufentanil

1 ml of solution contains 50 micrograms of sufentanil (equivalent to 75 micrograms of
sufentanil citrate).
Each vial with 1 ml of solution contains 50 micrograms of sufentanil (equivalent to
75 micrograms of sufentanil citrate).
Each vial with 5 ml of solution contains 250 micrograms of sufentanil (equivalent to
375 micrograms of sufentanil citrate).
Each vial with 20 ml of solution contains 1000 micrograms of sufentanil (equivalent to
1500 micrograms of sufentanil citrate).

• The other ingredients are water for injections, sodium chloride, citric acid monohydrate.

Description of the appearance of Sufentanil hameln and contents of the pack
Solution for injection or infusion
Sufentanil hameln is a clear and colourless solution.
Sufentanil hameln 50 micrograms/ml is supplied in colourless glass vials.
Original pack containing 5 vials of 1, 5 or 20 ml of solution.
Original pack containing 10 vials of 1 or 5 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
hameln pharma gmbh
Inselstraße 1
31787 Hameln
Germany

Manufacturer
Siegfried Hameln GmbH
Langes Feld 13
31789 Hameln
Germany
hameln rds s.r.o.
Horná 36, 900 01 Modra
Slovakia

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
AT Sufentanil-hameln 50 Mikrogramm/ml Injektions-/Infusionslösung
Sufentanil-hameln 5 Mikrogramm/ml Injektions-/Infusionslösung
BE Sufentanil hameln 5 microgram/ml , oplossing voor injectie/infusie
Sufentanil hameln 50 microgram/ml , oplossing voor injectie/infusie
CZ Sufentanil hameln (5 mikrogramů/ml injekční/infuzní roztok)
Sufentanil hameln (50 mikrogramů/ml injekční/infuzní roztok)
DK Sufentanil Hameln 5 mikrog/ml injektions-/infusionsvæske, opløsning
Sufentanil hameln 50 mikrog/ml injektions-/infusionsvæske, opløsning
DE Sufentanil-hameln 50 Mikrogramm/ml Injektions-/Infusionslösung
Sufentanil-hameln 5 Mikrogramm/ml Injektions-/Infusionslösung
FI Sufentanil hameln 50 mikrog/ml injektio-/infuusioneste, liuos
Sufentanil hameln 5 mikrog/ml injektio-/infuusioneste, liuos
HR Sufentanil hameln 5 mikrograma/ml otopina za injekciju/infuziju
Sufentanil hameln 50 mikrograma/ml otopina za injekciju/infuziju
HU Sufentanil hameln 5 mikrogramm/ml oldatos injekció/infúzió
Sufentanil hameln 50 mikrogramm/ml oldatos injekció/infúzió
IS Sufentanil hameln 5 míkrógrömm/ml stungulyf/innrennslislyf, lausn
Sufentanil hameln 50 míkrógrömm/ml stungulyf/innrennslislyf, lausn
IT Sufentanil hameln
NL Sufentanil-hameln 50 microgram/ml, oplossing voor injectie / infusie
Sufentanil-hameln 5 microgram/ml, oplossing voor injectie / infusie
NO Sufentanil hameln (5 mikrog/ml injeksjons-/infusjonsvæske, oppløsning)
Sufentanil hameln (50 mikrog/ml injeksjons-/infusjonsvæske, oppløsning)
PL Sufentanil hameln (5 mikrogramów/ml roztwór do wstrzykiwań/do infuzji)
Sufentanil hameln (50 mikrogramów/ml roztwór do wstrzykiwań/do infuzji)
PT Sufentanil-hameln 0,05 mg/ml solucão injectável ou para perfusão
Sufentanil-hameln 0,005 mg/ml solucão injectável ou para perfusão
SE Sufentanil hameln 5 mikrogram/ml injektions-/infusionsvätska, lösning
Sufentanil hameln 50 mikrogram/ml injektions-/infusionsvätska, lösning
SI Sufentanil hameln 5 mikrogramov/ml raztopina za injiciranje/infundiranje
Sufentanil hameln 50 mikrogramov/ml raztopina za injiciranje/infundiranje
SK Sufentanil hameln 5 mikrogramov/ml injekčný/infúzny roztok
Sufentanil hameln 50 mikrogramov/ml injekčný/infúzny roztok
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The following information is intended exclusively for physicians or healthcare professionals:
Sufentanil hameln 50 micrograms/ml solution for injection or infusion
Special precautions for use, handling and disposal
Sufentanil must only be administered by anaesthetists or other physicians experienced in its use and
effects, or under their supervision. Epidural administration must be
carried out by a physician with the necessary experience in the application of the epidural technique.
Before administration, it is necessary to ensure the correct position of the needle or
catheter.
Sufentanil citrate is physically incompatible with diazepam, lorazepam, sodium phenobarbital,
sodium phenytoin and sodium thiopental.
The product can be mixed with Ringer's lactate solution, with a 0.9% sodium chloride infusion solution or with 5% glucose solution. For epidural administration, the product can
be mixed with 0.9% NaCl solution and/or bupivacaine.
The chemical and physical stability of the dilutions is guaranteed for 72 hours at 20 – 25°C. From a
microbiological point of view, the product must be used immediately. If not used immediately, the
storage times and conditions are the direct responsibility of the user, and
normally should not exceed 24 hours at 2 – 8°C, unless the dilution has been prepared
under controlled and validated aseptic conditions.
Before administration, check the solution for the presence of particles or other signs of
deterioration and that the packaging is intact. The solution must be discarded when defects of this kind are observed.