Sufentanil hameln

Leaflet accompanying the packaging: information for the user

Sufentanil hameln, 5 micrograms/ml, solution for injection/infusion

Sufentanil hameln, 50 micrograms/ml, solution for injection/infusion

Sufentanil

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet

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

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

Sufentanil hameln belongs to a group of medicines called opioid anesthetics, which relieve or prevent pain during or after anesthesia. Sufentanil hameln is administered intravenously during and after major surgical procedures with assisted ventilation.

Sufentanil hameln administered intravenously is used:

Adults

• to prevent pain during the induction and maintenance of general anesthesia in combination with other anesthetic medicines
• as an anesthetic for the induction and maintenance of anesthesia during major operations. Children Sufentanil administered intravenously is indicated as an analgesic during the induction and (or) maintenance of general anesthesia in children over 1 month of age.

Sufentanil hameln administered epidurally (outside the dura mater) is used:

Adults:

• to prevent pain after surgical procedures and after cesarean section
• to treat pain during labor and vaginal delivery. Children Sufentanil administered epidurally is indicated in children over 1 year of age for the treatment of postoperative pain after general surgery, thoracic surgery, or orthopedic procedures.

2. Important information before using Sufentanil hameln

When not to use Sufentanil hameln

• - intravenously:
• if the patient is allergicto sufentanil or to other medicines similar to morphine or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has diseases that cause breathing difficulties, such as asthma or chronic bronchitis,
• if the patient is taking any of the antidepressant medicines known as monoamine oxidase inhibitors (MAOIs). MAOI treatment should be discontinued 2 weeks before surgery,
• if the patient suffers from a liver enzyme disease called acute porphyria,
• if the patient is taking or has recently taken other strong painkillers, such as nalbuphine, buprenorphine, pentazocine,
• if the patient is in labor or before the umbilical cord is clamped during a cesarean section.
• - epidurally (outside the dura mater):
• if the patient has severe bleeding or shock,
• if the patient has a severe infection,
• if the patient has impaired wound healing,
• if the patient has an infection at the injection site,
• if the patient has changes in blood cell count or is being treated with medicines that inhibit blood clotting (anticoagulants).

Warnings and precautions

Before starting treatment with Sufentanil hameln, discuss it with your doctor or pharmacist if:

• the patient has abnormally slow intestinal motility
• the patient has gallbladder or pancreas disease
• the patient or any of their relatives have ever abused alcohol, prescription drugs, or narcotics ("addiction")
• the patient smokes
• the patient has ever had mood problems (depression, anxiety, or personality disorder) or has been treated by a psychiatrist for other mental illnesses This medicine contains sufentanil, which is an opioid medicine. Repeated use of opioid painkillers can lead to the medicine becoming less effective (the patient becomes accustomed to it). This can also lead to dependence and abuse of the medicine, which can result in life-threatening overdose. If the patient is concerned about the possibility of becoming dependent on Sufentanil hameln, it is essential to consult a doctor.
• Sufentanil hameln should only be used by trained anesthesiologists in hospitals or other facilities equipped with assisted ventilation and postoperative monitoring equipment.
• As with all strong painkillers of this type, dose-dependent respiratory depression may occur. This can last until the recovery period or recur during this time. Therefore, it is essential to carefully monitor patients postoperatively.
• Sufentanil hameln may cause sleep disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms of these disorders may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty staying asleep, or excessive daytime sleepiness. If these symptoms are observed, the patient should consult a doctor. The doctor may consider reducing the dose.
• Sufentanil hameln should be used with caution in patients with lung, liver, kidney, or thyroid disease, as well as in patients with alcoholism.
• Sufentanil hameln should be used with caution in patients with increased intracranial pressure or with head or brain injuries.
• In patients with decreased blood volume (hypotension), the administration of Sufentanil hameln may cause a decrease in blood pressure and a slowing of the heart rate.
• Involuntary muscle contractions may occur.

Consult a doctor when using Sufentanil hameln in the following cases:

• the patient experiences pain or increased sensitivity to pain (hyperalgesia) that does not respond to a higher dose of the prescribed medicine.

Newborns and (or) infants

• As with other opioids, newborns are sensitive to respiratory difficulties after sufentanil administration. Data on the behavior of infants after intravenous sufentanil administration are limited. Therefore, before using Sufentanil hameln in newborns and infants, the benefit-risk ratio should be carefully considered.
• Due to the risk of administering too high or too low a dose, intravenous use of Sufentanil hameln is not recommended in the neonatal period.
• The use of Sufentanil hameln in epidural anesthesia is not recommended in children under 1 year of age.

Sufentanil hameln and other medicines

Concomitant use of Sufentanil hameln and sedative medicines, such as benzodiazepines or related medicines, increases the risk of sedation, respiratory depression, coma, and can be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible. If Sufentanil hameln is prescribed with sedative medicines, the dose and duration of concomitant treatment should be limited by the doctor. The patient should inform the doctor about all sedative medicines being taken and strictly follow the prescribed dose. It may be helpful to inform friends or relatives to watch for the above symptoms and signs. If such symptoms occur, the patient should consult a doctor. Concomitant use of opioids and medicines used to treat epilepsy, neuralgia, or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose and respiratory depression, which can lead to life-threatening complications.

Inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

In particular, inform your doctor if you are taking any of the following medicines:

• antidepressant medicines known as monoamine oxidase inhibitors (MAOIs); these medicines should not be taken within 2 weeks before or concurrently with Sufentanil hameln;
• antidepressant medicines known as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). Concomitant use of these medicines with Sufentanil hameln is not recommended.

The effect, duration of action, and efficacy of sufentanil and other medicines may be enhanced or prolonged when taken concomitantly. Consult a doctor if you are taking any of the following medicines:

• strong painkillers, such as other opioids
• sedatives and anxiolytics, such as barbiturates or sedatives
• muscle relaxants (e.g., vecuronium, suxamethonium)
• narcotic medicines (e.g., thiopental, etomidate, nitrous oxide)
• antipsychotic medicines (neuroleptics)
• antibiotics for bacterial infections (erythromycin)
• medicines used to treat fungal infections (e.g., ketoconazole, itraconazole)
• medicines used to treat viral infections (e.g., ritonavir used to treat HIV-AIDS)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine. Sufentanil hameln should not be administered intravenously during labor, as it crosses the placenta and may affect the baby's respiratory function. Sufentanil passes into breast milk. A decision should be made to either discontinue breastfeeding or discontinue/avoid sufentanil treatment, taking into account the benefits of breastfeeding for the baby and the benefits of treatment for the woman. Breastfeeding can be resumed 24 hours after the last use of sufentanil. Sufentanil hameln may be administered epidurally during labor.

Driving and using machines

After administration of Sufentanil hameln, do not drive or operate machinery for the next 24 hours.

Sufentanil hameln contains sodium

Sufentanil hameln contains 3.54 mg of sodium (the main component of common salt) per milliliter of solution. This corresponds to 0.2% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Sufentanil hameln

Sufentanil hameln is administered by a trained doctor into a vein (intravenously) or into the space surrounding the spine (epidurally/outside the dura mater) before the start of surgery. This is intended to anesthetize the patient and prevent pain during and after surgery. During the use of Sufentanil hameln, specially trained healthcare personnel will closely monitor the patient and have emergency equipment available.

Use in children (over 1 month) and adolescents

• Intravenous administration Sufentanil hameln is slowly injected into a vein by an anesthesiologist. The dosage depends on the dosage of anesthetics administered concomitantly, the type and duration of the procedure, and will be determined by the anesthesiologist.

Use in children (over 1 year) and adolescents

• Epidural administration (outside the dura mater) 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 concomitant use of local anesthetics and the required duration of analgesic action. Pediatric patients should be monitored for signs of respiratory depression for at least 2 hours after epidural administration of Sufentanil hameln.

Dosage

The dose and duration of administration of Sufentanil hameln are determined by the doctor. The dosage depends on the patient's age, weight, and physical condition, the type of surgical procedure, and the level of anesthesia.

• The proposed dose should be carefully adjusted in patients with thyroid hormone deficiency (hypothyroidism), lung function disorders, obesity, and alcoholism. In these patients, prolonged monitoring of vital signs is recommended after surgery.
• To induce and maintain anesthesia, the doctor will carefully decide which dose is appropriate for the child.
• Patients with liver or kidney function disorders will require lower doses.
• Elderly and debilitated patients will require lower doses.

Using a higher than recommended dose or missing a dose of Sufentanil hameln

Since Sufentanil hameln is usually administered by a doctor in strictly controlled conditions, it is unlikely that the patient will receive too high a dose or miss a dose. In very rare cases, if the patient receives too high a dose of Sufentanil hameln, breathing difficulties may occur. In such a case, the doctor or another healthcare professional should be informed immediately so that the team of specialists can take prompt action. If you have any further doubts about the use of this medicine, consult a 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 breathing difficulties occur, inform a doctor or seek medical attention immediately. Very common side effects (occurring in more than 1 in 10 people):

• sedation,
• itching.

Common side effects (occurring in less than 1 in 10 people):

• increased blood pressure
• decreased blood pressure
• nausea
• vomiting
• rapid heartbeat
• pallor
• blue discoloration of the skin in newborns due to low oxygen levels in the blood
• skin discoloration
• muscle tremors
• urination problems
• fever
• headache
• dizziness
• involuntary muscle tremors in newborns

Uncommon side effects (occurring in less than 1 in 100 people):

• irregular heartbeat
• decreased muscle tone in newborns
• back pain
• hypersensitivity
• rhinitis
• apathy
• irritability
• disorders of voluntary muscle coordination
• prolonged muscle contractions causing twisting and repetitive movements
• hyperreflexia
• abnormal increase in muscle tone
• weakness of voluntary movements in newborns
• sleepiness
• vision disorders
• skin allergic reaction
• excessive sweating
• dry skin
• rash
• muscle spasms (intraoperative muscle movements)
• feeling of cold
• breathing difficulties
• bronchospasm
• low heart rate
• cough
• hiccups
• voice disorders
• blue discoloration of the skin due to low oxygen levels in the blood
• abnormal electrocardiogram
• muscle stiffness, including stiffness of the chest wall, which can lead to breathing difficulties
• reaction at the injection site or pain at the injection site
• increased or decreased body temperature
• rash in newborns

Frequency not known (cannot be estimated from the available data):

• pupil constriction
• breathing difficulties
• severe allergic reaction with rash, breathing difficulties, and shock
• overwhelming feeling of well-being (euphoria)
• involuntary movements
• cardiac arrest (the doctor has medicines that can reverse this effect)
• laryngospasm
• difficulty maintaining an upright position (dizziness)
• coma
• seizures
• respiratory arrest
• fluid in the lungs
• redness of the skin
• muscle spasms

Side effects in children and adolescents

It is expected that the frequency, type, and severity of side effects in children will be the same as in adults.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sufentanil hameln

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the label and carton after the expiry date (EXP). The expiry date refers to the last day of the month stated. Do not store above 25°C. Store the ampoules in the outer packaging to protect from light. The medicine should be used immediately after opening. Information on the storage period of the diluted solution can be found below in the section "Information intended for healthcare professionals only". Do not use this medicine if:

• the solution is not clear and free from particles
• the packaging is damaged.

The doctor or pharmacist is responsible for the proper storage, use, and disposal of Sufentanil hameln.

6. Contents of the packaging and other information

What Sufentanil hameln contains

• The active substance of the medicine is sufentanil.

Sufentanil hameln, 5 micrograms/ml:

1 ml of solution for injection contains 5 micrograms of sufentanil (which corresponds to 7.5 micrograms of sufentanil citrate). One 2 ml ampoule contains 10 micrograms of sufentanil (which corresponds to 15 micrograms of sufentanil citrate). One 10 ml ampoule contains 50 micrograms of sufentanil (which corresponds to 75 micrograms of sufentanil citrate).

Sufentanil hameln, 50 micrograms/ml:

1 ml of solution for injection contains 50 micrograms of sufentanil (which corresponds to 75 micrograms of sufentanil citrate). One 1 ml ampoule contains 50 micrograms of sufentanil (which corresponds to 75 micrograms of sufentanil citrate). One 5 ml ampoule contains 250 micrograms of sufentanil (which corresponds to 375 micrograms of sufentanil citrate). One 20 ml ampoule contains 1000 micrograms of sufentanil (which corresponds to 1500 micrograms of sufentanil citrate).

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

What Sufentanil hameln looks like and contents of the pack

Solution for injection/infusion Sufentanil hameln is a clear and colorless solution. Sufentanil hameln, 5 micrograms/ml, is available in colorless glass type I ampoules in a cardboard box. The pack contains 10 ampoules of 10 ml solution. Sufentanil hameln, 50 micrograms/ml, is available in colorless glass type I ampoules in a cardboard box. The pack contains 10 ampoules of 5 ml solution. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Sufentanil hameln, 5 micrograms/ml:

Marketing authorization holder:

hameln pharma gmbh Inselstraße 1 31787 Hameln Germany Tel.: +49 171 766 2789 Manufacturer/Importer 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 Sufentanil hameln, 50 micrograms/ml:

Marketing authorization holder

hameln pharma gmbh Inselstraße 1 31787 Hameln Germany Tel.: +49 171 766 2789 Manufacturer/Importer Siegfried Hameln GmbH Langes Feld 13 31789 Hameln Germany hameln rds s.r.o. Horná 36, 900 01 Modra Slovakia

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria Sufentanil-hameln 50 Mikrogramm/ml Injektions-/Infusionslösung Sufentanil-hameln 5 Mikrogramm/ml Injektions-/Infusionslösung Belgium Sufentanil hameln 5 microgram/ml, oplossing voor injectie/infusie Sufentanil hameln 50 microgram/ml, oplossing voor injectie/infusie Czech Republic Sufentanil hameln (5 mikrogramů/ml injekční/infuzní roztok) Sufentanil hameln (50 mikrogramů/ml injekční/infuzní roztok) Denmark Sufentanil hameln 5 mikrog/ml injektions-/infusionsvæske, opløsning Sufentanil hameln 50 mikrog/ml injektions-/infusionsvæske, opløsning Germany Sufentanil-hameln 50 Mikrogramm/ml Injektions-/Infusionslösung Sufentanil-hameln 5 Mikrogramm/ml Injektions-/Infusionslösung Finland Sufentanil hameln 50 mikrog/ml injektio-/infuusioneste, liuos Sufentanil hameln 5 mikrog/ml injektio-/infuusioneste, liuos Croatia Sufentanil hameln 5 mikrograma/ml otopina za injekciju / infuziju Sufentanil hameln 50 mikrograma/ml otopina za injekciju / infuziju Hungary Sufentanil hameln 5 mikrogramm/ml oldatos injekció/infúzió Sufentanil hameln 50 mikrogramm/ml oldatos injekció/infúzió Iceland Sufentanil hameln 5 míkrógrömm/ml stungulyf/innrennslislyf, lausn Sufentanil hameln 50 míkrógrömm/ml stungulyf/innrennslislyf, lausn Italy Sufentanil hameln 50 microgrammi/ml, soluzione iniettabile o per infusione Netherlands Sufentanil-hameln 50 microgram/ml, oplossing voor injectie / infusie Sufentanil-hameln 5 microgram/ml, oplossing voor injectie/ infusie Norway Sufentanil hameln (5 mikrog/ml injeksjons-/infusjonsvæske, oppløsning) Sufentanil hameln (50 mikrog/ml injeksjons-/infusjonsvæske, oppløsning) Poland Sufentanil hameln Portugal Sufentanil-hameln 0,05 mg/ml solucão injectável ou para perfusão Sufentanil-hameln 0,005 mg/ml solucão injectável ou para perfusão Sweden Sufentanil hameln 5 mikrogram/ml injektions-/infusionsvätska, lösning Sufentanil hameln 50 mikrogram/ml injektions-/infusionsvätska, lösning Slovenia Sufentanil hameln 5 mikrogramov/ml raztopina za injiciranje/infundiranje Sufentanil hameln 50 mikrogramov/ml raztopina za injiciranje/infundiranje Slovakia Sufentanil hameln 5 mikrogramov/ml injekčný/infúzny roztok Sufentanil hameln 50 mikrogramov/ml injekčný/infúzny roztok

Date of last revision of the leaflet:

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Information intended for healthcare professionals only:

Sufentanil hameln, 5 micrograms/ml, solution for injection/infusion

Sufentanil hameln, 50 micrograms/ml, solution for injection/infusion

Instructions for preparation and disposal of the medicine Sufentanil should only be administered by anesthesiologists or other doctors who are familiar with the use and effects of the medicine, or under their supervision. Epidural administration must be performed only by a doctor with experience in epidural administration techniques. Before administration, the correct placement of the needle or catheter should be checked. Sufentanil citrate is physically incompatible with diazepam, lorazepam, sodium phenobarbital, phenytoin, and thiopental. The medicinal product can be mixed with Ringer's solution with lactate, 9 mg/ml (0.9%) sodium chloride solution, or 50 mg/ml (5%) glucose solution for infusion. In the case of epidural administration, the product can be mixed with 9 mg/ml (0.9%) sodium chloride solution and (or) bupivacaine solution. It has been shown that diluted solutions are chemically and physically stable for 72 hours at 20-25°C. From a microbiological point of view, diluted solutions should be used immediately. If the solution is not used immediately, the user is responsible for the storage conditions and storage time, which should not normally exceed 24 hours at 2 to 8°C, unless the dilution has taken place in controlled and validated aseptic conditions. Before administration, the contents of the ampoules should be carefully visually inspected for the presence of particles, damage to the container, or any visible signs of deterioration. If such defects are found, the solution should be discarded.