Prospecto: information for the user

Sufentanilo Altan 5 micrograms/ml, injectable solution EFG

Sufentanilo Altan contains as active ingredient sufentanilo, which constitutes a potent analgesic (relieves pain).

Sufentanilo Altan is used in general anesthesia, resuscitation and regional anesthesia.

Adults

In regional anesthesia, Sufentanilo Altan injectable solution (IV or epidural route) is injected via epidural route. This technique is used in so-called painless deliveries, in general surgery or for postoperative pain.

Children

• By intravenous route, Sufentanilo Altan injectable solution (IV or epidural route) is indicated as an analgesic agent in the induction and/or maintenance of balanced general anesthesia in children over one month old.
• By epidural route, Sufentanilo Altan injectable solution (IV or epidural route) is indicated for the treatment of pain after general, thoracic or orthopedic surgery in children over one year old.

No use Sufentanilo Altan:

• If you are allergic (hypersensitive) to sufentanil citrate or to morphine derivatives, or to any of the other components of Sufentanilo Altan mentioned in section 6.
• If you are allergic to morphine-derived medications.
• In association with:

• Determined opioid medications (nalbufina, buprenorphine), naltrexone (medication used for withdrawal or prevention of relapse of drug addiction) or nalmefene (medication used in certain cases of alcohol dependence) (see section “Other medications and Sufentanilo Altan).

• The epidural administration may be contraindicated in some treatments such as anticoagulant treatment (medications that decrease blood coagulation), general or localized infection at the injection site and/or significant hemorrhage (blood loss).

Consult your doctor or pharmacist in case of doubt.

Warnings and precautions

Be especially careful with Sufentanilo Altan injectable solution (IV or epidural):

• As with other morphine-type analgesics (pain medications), the use of Sufentanilo Altan injectable solution (IV or epidural) may be accompanied by respiratory depression (acute respiratory insufficiency) that may persist for some time after surgery.
• Consequently, you will be under medical surveillance for a period after surgery.
• If you experience significant drowsiness or respiratory problems after surgery, inform your doctor or healthcare staff immediately.
• When using Sufentanilo Altan injectable solution (IV or epidural) for prolonged sedation, you will receive respiratory assistance.
• Generally, this medication cannot be administered if you are taking alcoholic beverages, medications containing alcohol, crizotinib or idelalisib (cancer medications), or oxibate sodium (see section “Other medications and Sufentanilo Altan injectable solution).
• Inform your doctor if you or a family member has a history of mental illness (such as depression), alcoholism, or addiction, as the risk of sufentanil dependence may increase depending on the dose and duration of treatment.
• The use (even at therapeutic doses) may lead to physical dependence, as it can cause withdrawal symptoms and the reappearance of problems if you stop this medication abruptly.
• Inform your doctor if you are pregnant, think you may be pregnant, or are breastfeeding (for more information, see the section “Pregnancy”)
• Inform your doctor or pharmacist if you experience increased sensitivity to pain, despite taking increasing doses (hyperalgesia). Your doctor will decide if you need to adjust the dose or if you should stop taking this medication.

Inform your anesthesiologist if you experience:

• Low blood pressure, hypovolemia, or heart failure
• Cerebral blood flow problems
• Chronic respiratory disease
• Liver or kidney problems
• Thyroid hormone deficiency

Consult your doctor in case of doubt.

Children and adolescents

Due to the risk of overdose or underdose, the use of Sufentanilo Altan by intravenous route is not recommended during the neonatal period.

The use of Sufentanilo Altan by epidural route is not recommended in children under one year.

Other medications and Sufentanilo Altan

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription, homeopathic, herbal, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

This medication cannot be administeredin any casewith certain opioids (nalbufina, buprenorphine), with naltrexone (medication used for withdrawal or prevention of relapse), or with nalmefene (a medication used in certain cases of alcohol dependence).

This medication cannot, in general,be administered if you are consuming alcoholic beverages, medications containing alcohol, crizotinib or idelalisib (cancer medications), or oxibate sodium (medication used to treat a certain type of sleep disorder).

You must inform your doctor if you are taking:

Medications containing:

· Erythromycin, clarithromycin, or telithromycin (antibiotics)

· Itraconazole, voriconazole, posaconazole, or ketoconazole (to treat fungal infections)

· Nelfinavir or ritonavir (used in the treatment of HIV infection)

· Strong analgesics or sedatives (for example, medications used to treat sleep disorders, medications used to reduce anxiety, medications for mental disorders, some medications for coughs), as you may need to reduce the dose of Sufentanilo Altan.

Similarly, if you are given a strong analgesic or another sedative after receiving Sufentanilo Altan during surgery, you may need to reduce the dose of the analgesic or sedative to reduce the risk of severe side effects, such as respiratory problems, shallow breathing, intense drowsiness, and decreased consciousness, coma, or death.

· Medications used to treat depression, such as monoamine oxidase inhibitors (MAOIs). These medications should not be taken within two weeks of administering Sufentanilo Altan, nor simultaneously.

· Medications used to treat depression, such as selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs). It is not recommended to take these medications at the same time as Sufentanilo Altan

Inform your doctor or pharmacist if you use, have recently used, or may use any other medication.

Use of Sufentanilo Altan with food and drinks:

To administer this medication, you should avoid consuming alcoholic beverages (see section “Warnings and precautions”).

Pregnancy and breastfeeding:

Inform your anesthesiologist if you are pregnant or breastfeeding.

Sufentanilo Altan should not be used during pregnancy, unless absolutely necessary.

When this medication is administered to women during pregnancy, there is a risk that the newborn may experience neonatal withdrawal syndrome and respiratory depression.

The administration of Sufentanilo Altan to breastfeeding women should be done with caution and with doses not exceeding 30 µg; it is recommended to wait 4 hours after administering sufentanil before breastfeeding. Breastfeeding is not recommended with higher doses.

Driving and using machines:

Sufentanilo Altan may decrease your alertness or ability to drive.

You should wait a reasonable period of time (at least 24 hours) between administering this medication and resuming driving or using machines.

Always consult your doctor.

The concomitant use of Sufentanilo Altan and sedatives such as benzodiazepines or related medications (which can alleviate anxiety and seizures, relax muscles, and promote sleep) increases the risk of drowsiness, difficulty breathing, depression, and coma, and is likely to cause death. Therefore, the concomitant use of these medications should only be considered in the absence of any other viable treatment option. However, if Sufentanilo Altan is prescribed simultaneously with benzodiazepines and/or related medications, your doctor should limit the dose and duration of these concomitant treatments. Inform your doctor about all the medications you are taking and follow their dosage recommendations strictly. It may be helpful to inform your friends or family members about the symptoms mentioned above. Contact your doctor if you notice these symptoms.

Important information about some of the components of Sufentanilo Altan

2 ml ampoules

This medication contains less than 23 mg of sodium per ampoule, which is essentially “sodium-free”.

10 ml ampoules:

Patients with low-sodium diets should note that this medication contains 35.40 mg (1.5 mmoles) of sodium per ampoule.

This medication will be administered exclusively by specially trained personnel in anesthesia-reanimation or emergency medicine, who are familiar with the use of anesthetics, or under their control, and in fully equipped locations for the control and assistance of respiratory and cardiovascular functions.

Posology

The dose, administered by a healthcare professional, will be determined based on:

• age,

• weight,

• general condition,

• type of anesthesia used.

Form of use and route of administration

This medication will be administered to you via intravenous ( in vein ) to relieve pain throughout the body during surgical interventions or, epidural ( in the lower back area ), to relieve pain in some parts of the body, for example during childbirth or after an intervention.

If you believe you have been administered more Sufentanilo Altan than necessary

This medication will only be administered to you in a hospital by healthcare professionals, so it is unlikely that you will receive more Sufentanilo Altan than you should; however, if you believe you have been administered more Sufentanilo Altan than you should, inform your doctor immediately. In case of accidental overdose, call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount administered.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to use Sufentanilo Altan This medication will only be administered to you in a hospital by healthcare professionals, so it is unlikely that you will not receive the dose of Sufentanilo Altan you should; however, if you believe that this medication has been forgotten, inform your doctor immediately.

If you have any other questions about the use of this product, ask your doctor, pharmacist, or nurse.

Like other medications, Sufentanilo Altan may have adverse effects, although not all people may experience them.

Frequencies are defined as very common (≥ 1/10), common (≥1/100 to <1

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

• Sedation.
• Pruritus.

Common adverse effects(may affect 1 to 10 people in every 100)

• Neonatal tremors.
• Dizziness.
• Headache.
• Increased heart rate.
• Hypertension.
• Hypotension.
• Pallor.
• Blue discoloration of the skin (nails and lips) of the newborn.
• Vomiting.
• Nausea.
• Decoloration of the skin.
• Muscle contractions.
• Urinary retention.
• Urinary incontinence (involuntary loss of urine).
• Fever.

Uncommon adverse effects(may affect between 1 and 10 people in every 1,000)

• Common cold.
• Allergy.
• Apathy.
• Nervousness.
• Difficulty coordinating movements.
• Abnormal movements of the newborn.
• Involuntary and painful muscle contractions.
• Exaggerated reflexes.
• Increased muscle tone.
• Decreased motor activity of the newborn.
• Somnolence.
• Visual disturbances.
• Blue discoloration of the skin (nails and lips).
• Cardiac rhythm disorder.
• Slow heart rate.
• Irregular heart contractions.
• Abnormal electrocardiogram.
• Difficulty breathing.
• Decreased pulmonary ventilation.
• Voice alteration.
• Cough.
• Hiccup.
• Respiratory disorder.
• Allergic skin inflammation.
• Excessive sweating.
• Extensive skin rash (also in newborns).
• Dry skin.
• Lower back pain.
• Decreased muscle tone in the newborn.
• Muscle rigidity.
• Increased or decreased body temperature.
• Chills.
• Pain.
• Reaction at the injection site.
• Pain at the injection site.

Adverse effects of unknown frequency(cannot be estimated from available data)

• Allergic reactions.
• Coma.
• Convulsion.
• Involuntary muscle contractions.
• Pupil constriction.
• Cardiac arrest.
• Acute distress with a drop in blood pressure.
• Respiratory arrest.
• Apnea.
• Depressed respiration.
• Pulmonary edema.
• Brusque contraction of the laryngeal muscles.
• Redness of the skin.
• Muscle spasms.

Children and adolescents

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

If you consider any of the adverse effects to be severe or notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Notification of suspected adverse reactions

It is essential to report suspected adverse reactions to the medication after its authorization. This allows for continuous monitoring of the benefit-risk ratio of the medication. Healthcare professionals are invited to report suspected adverse reactions through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.

Keep this medication out of the sight and reach of children.

Before dilution:Store the ampoules in the original packaging protected from light.

After dilution:From a microbiological standpoint, the product must be used immediately.

Do not use Sufentanilo Altan after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your doctor how to dispose of the packaging and unused medications. This will help the environment.

Composition ofSufentanilo Altan

• The active principle is sufentanil (in the form of citrate).

Sufentanilo Altan 5 micrograms/ml:

Each ml of solution contains 5 micrograms of sufentanil in the form of sufentanil citrate. The other components are: Sodium chloride, sodium hydroxide (to adjust the pH), hydrochloric acid (to adjust the pH) and water for injection in sufficient quantity for 1 ml.

Aspect of the product and content of the package

Sufentanilo Altan is an injectable solution that is presented in sterile ampoules of 2 ml and 10 ml. Each package contains 5 ampoules of 2 ml, 10 ampoules of 2 ml or 10 ampoules of 10 ml.

One ampoule of 2 ml contains 10 micrograms of sufentanil (citrate). One ampoule of 10 ml contains 50 micrograms of sufentanil (citrate).

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Altan Pharmaceuticals, S.A.

C/ Cólquide, 6 Portal 2, 1st Floor, Office F

Edificio Prisma

28230 Las Rozas (Madrid)- Spain

Responsible for manufacturing:

LABORATOIRE RENAUDIN

Z.A. Errobi

64250 ITXASSOU (France)

Date of the last review of this leafletMay 2024

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

This information is intended solely for doctors or healthcare professionals

Special warnings

At the beginning of your treatment, this medicine may induce muscle stiffness.

This stiffness can be prevented by taking the following measures:

• The injection should be slow enough when using sufentanil in low doses
• The administration of muscle relaxants immediately before the administration of this medicine prevents muscle stiffness

When used in obstetrics by intravenous route, sufentanil will be administered after clamping the umbilical cord to prevent any depressive effect on the neonate's breathing. Nevertheless, intravenous use is contraindicated during delivery or before clamping the umbilical cord.

Dosage and administration

This medicine will be administered exclusively by specialist anesthesiologists or under their control, and who have the necessary anesthesia-reanimation equipment.

Sufentanil is usually administered more frequently associated with other agents: intravenous anesthetics, volatile anesthetics, benzodiazepines.

Information for the person in charge of administering Sufentanilo Altaninjectable solution (IV or epidural):

The dosage varies according to the anesthesia technique, the patient's condition, and the ventilation control modalities.

Depending on the different indications, the mode of use, and the dosages are as follows:

Adults

Intravenous route

General balanced anesthesia:

Short or medium duration interventions (one or two hours): 0.1 to 2 micrograms/kg for induction associated with a hypnotic and/or a volatile anesthetic agent and a muscle relaxant

Additional doses of 10 to 25 micrograms of sufentanil can be administered for the maintenance of anesthesia, depending on the clinical signs of decreased analgesia and the tolerance of the initial dose

Major surgical interventions (more than 2 hours): the total dose will be calculated based on an administration of 1 microgram/kg/hour, to be adjusted according to the surgical intervention, the patient's condition, and the associated products. A bolus of 75% of the total dose can be administered for induction and maintenance can be ensured either by injections of 10 to 50 micrograms depending on the clinical signs of decreased analgesia or by continuous perfusion. Sufentanil can be associated with a hypnotic and/or a volatile anesthetic agent and a muscle relaxant. In case of bradycardia, a dose (to be determined) of an anticholinergic agent (atropine) can be used.

Anesthesia analgesia (cardiovascular surgery):

A dose of 8 to 20 micrograms/kg will be administered in bolus for induction in association with 100% oxygen and a compatible muscle relaxant with the patient's cardiovascular condition.

A supplementary bolus of 5 to 10 micrograms/kg should be administered before sternotomy. Maintenance should be ensured either by repeated doses of 25 to 50 micrograms administered according to the clinical signs of decreased analgesia and the patient's tolerance to the initial bolus, or by continuous perfusion.

Compared to other morphine derivatives used in these protocols, the dosages of associated medications such as volatile anesthetics, benzodiazepines, will generally need to be reduced.

The average total dose administered in cardiovascular surgery is 12 to 30 micrograms/kg, with a predictable extubation period of 12 to 18 hours.

However, the dosage should be adjusted according to other anesthetic agents used, as well as individual variations and extubation period.

Prolonged sedation in intensive care unit or reanimation of ventilated patients:

0.2 to 2 micrograms/kg/hour, depending on the degree of sedation required and the respective dosages of associated products.

Epidural route

General surgery (thoracic, urological, orthopedic):

Initial doses of 0.75 micrograms/kg, diluted in 10 ml, allow for analgesia of 4 to 8 hours. Additional bolus doses of 25 to 50 micrograms can be administered according to the clinical signs of decreased analgesia.

Obstetrics:

Doses of 15 to 20 micrograms in bolus, diluted in 10 ml, associated with a local anesthetic such as bupivacaine (0.125%-0.25%). It is recommended not to exceed a total dose of 30 micrograms of sufentanil.

Post-cesarean analgesia:

Doses of 25 micrograms in bolus, diluted in 10 ml, associated with a local anesthetic such as bupivacaine (0.125%-0.25%). It is recommended not to exceed a total dose of 30 micrograms of sufentanil.

Postoperative analgesia:

Doses of 0.75 micrograms/kg, diluted in 10 ml, in single or repeated doses according to the clinical signs of decreased analgesia (25 to 50 micrograms), or in perfusion at a rate of 0.2 to 0.3 micrograms/kg/hour.

Special populations

Like other opioids, a reduction in dose is recommended in elderly, debilitated, or ASA class III/IV patients.

Pediatric population

Intravenous administration

Due to the great variability of pharmacokinetic parameters in neonates, no posological recommendations can be given (see sections 4.4 and 5.2).

Children over one month

Regardless of the dose, premedication with an anticholinergic such as atropine is recommended, unless contraindicated.

Induction of anesthesia

Sufentanilo Altan can be administered in slow bolus over at least 30 seconds at doses of 0.2 to 0.5 micrograms/kg, in combination with another anesthetic agent for induction. In case of major surgery (e.g. cardiac surgery), doses of up to 1 microgram/kg can be administered.

Maintenance of anesthesia in ventilated patients

In general balanced anesthesia, the dose depends on the dose of associated anesthetic agents and the type and duration of surgery. An initial dose of 0.3 to 2 micrograms/kg administered in slow bolus over at least 30 seconds can be followed by additional boluses of 0.1 to 1 microgram/kg as needed, up to a total dose of 5 micrograms/kg during cardiac surgery.

Epidural route

Sufentanilo Altan should only be administered by epidural route in children by anesthesiologists specifically trained in pediatric epidural anesthesia and in the management of opioid-induced respiratory depression. The necessary reanimation equipment, including intubation equipment and antinarcotics, should be readily available.

After epidural administration of Sufentanilo Altan in children, respiratory depression signs should be monitored for at least 2 hours.

The use of Sufentanilo Altan by epidural route in children has only been documented in a small number of cases.

Children under one year

The safety and efficacy of Sufentanilo Altan in children under one year have not been established (see sections 4.4 and 5.1).

The available data in children over 3 months are described in section 5.1, but no recommendations can be given.

No data are available for neonates and infants under 3 months.

Children over one year

A single dose of 0.25 to 0.75 micrograms/kg administered during surgery provides analgesic effect for 1 to 12 hours. The duration of analgesic effect depends on the type of surgical intervention and the concomitant use of an epidural local anesthetic of the amide type.

METHOD OF USE

If necessary, Sufentanilo Altan, injectable solution (IV or epidural) can be mixed with saline or glucose solutions. These dilutions are compatible with plastic bags for perfusion. The dilutions should be used within 24 hours of preparation.

Instructions for opening the ampoules

Protective gloves should be used to open the ampoules.

1. Hold the ampoule between the index and middle fingers, leaving the tip of the ampoule protruding.

2. With the other hand, hold the top of the ampoule with the index finger against the neck of the ampoule and the thumb over the color point, parallel to the (the) color ring(s).

3. Keeping the thumb in place, break the top of the ampoule with a dry movement while holding the body of the ampoule firmly in the hand.

Any accidental exposure of the skin should be rinsed with clean water. Avoid using soap, alcohol, or any other detergent that may cause chemical or physical skin abrasion.