Secufen 5 micrograms/ml solution for injection EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

SECUFEN 5 micrograms/ml, injectable solution EFG

Sufentanil (citrate)

Package leaflet contents:

1. What SECUFEN is and what it is used for
2. What you need to know before you are given SECUFEN
3. How SECUFEN is administered
4. Possible side effects
5. Storage of SECUFEN
6. Contents of the pack and other information

1. What SECUFEN 5 micrograms/ml, injectable solution EFG is and what it is used for

SECUFEN contains the active substance sufentanil, which is a potent analgesic (relieves pain).

SECUFEN is used in general anaesthesia, resuscitation, and regional anaesthesia.

Adults

In regional anaesthesia, SECUFEN (IV or epidural route) is administered by epidural injection. This technique is used in so-called painless childbirth, general surgery, or for postoperative pain relief.

Children

• By intravenous route, SECUFEN injectable solution (IV or epidural route) is indicated as an analgesic agent for the induction and/or maintenance of balanced general anaesthesia in children over one month of age.
• By epidural route, SECUFEN injectable solution (IV or epidural route) is indicated for the treatment of pain following general, thoracic, or orthopaedic surgery in children over one year of age.

2. What you need to know before SECUFEN 5 micrograms/ml, injectable solution EFG is administered to you

Do not use SECUFEN:

• If you are allergic (hypersensitive) to sufentanil citrate or morphine derivatives, or to any of the other components of SECUFEN listed in section 6.

• If you are allergic to morphine-derived medicines.

• In combination with:

• Certain opioid medicines (nalbuphine, buprenorphine), naltrexone (a medicine used for abstinence or prevention of relapse in drug addiction), or nalmefene (a medicine used in certain cases of alcohol dependence) (see section “Other medicines and SECUFEN”).

• Epidural administration may be contraindicated in certain conditions such as anticoagulant therapy (medicines that reduce blood clotting), generalized or localized infection at the injection site, and/or significant hemorrhage (blood loss).

Consult your doctor or pharmacist if you have any doubts.

Warnings and precautions

Exercise special caution with SECUFEN injectable solution (IV or epidural):

• As with other morphine-type analgesics (medicines to relieve pain), the use of SECUFEN injectable solution (IV or epidural) may be associated with respiratory depression (acute respiratory insufficiency), which may persist for some time after surgery.
• Therefore, you will remain under medical supervision for a period after surgery.
• If you experience significant drowsiness or breathing difficulties after surgery, inform your doctor or healthcare staff immediately.
• When SECUFEN injectable solution (IV or epidural) is used for prolonged sedation, you will receive respiratory support.
• Generally, this medicine should not be administered if you are consuming alcoholic beverages, medicines containing alcohol, crizotinib or idelalisib (anticancer medicines), or sodium oxybate (see section “Other medicines and SECUFEN 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 dependence on sufentanil may increase depending on the dose and duration of treatment.
• Use (even at therapeutic doses) may lead to physical dependence, as it may cause withdrawal symptoms and recurrence of your condition if this medicine is stopped abruptly.
• Inform your doctor if you are pregnant, think you may be pregnant, or are breastfeeding (for further information, see section “Pregnancy”).
• Inform your doctor or pharmacist if you experience increased sensitivity to pain despite increasing doses (hyperalgesia). Your doctor will decide whether your dose needs to be adjusted or if you should stop taking this medicine.

Inform your anaesthetist if you have:

• Low blood pressure, hypovolemia, or heart failure.
• Impaired blood flow to the brain.
• Any chronic respiratory disease.
• Liver or kidney problems.
• Hormonal deficiency of the thyroid gland.

Consult your doctor if you have any doubts.

Children and adolescents

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

The use of SECUFEN by epidural route is not recommended in children under one year of age.

Other medicines and SECUFEN

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

This medicine must not under any circumstances be administered together with certain opioids (nalbuphine, buprenorphine), naltrexone (a medicine used for abstinence or relapse prevention), or nalmefene (a medicine used in some cases of alcohol dependence).

This medicine generally cannot be administered if you are consuming alcoholic beverages, medicines containing alcohol, crizotinib or idelalisib (anticancer medicines), or sodium oxybate (a medicine used to treat a certain type of sleep disorder).

You must inform your doctor if you are taking:

Medicines containing:

• Erythromycin, clarithromycin, or telithromycin (antibiotics)
• Itraconazole, voriconazole, posaconazole, or ketoconazole (used to treat infections caused by microscopic fungi)
• Nelfinavir or ritonavir (used in the treatment of HIV infection)

· Strong analgesics or sedative medicines (e.g., medicines used to treat sleep disorders, medicines used to reduce anxiety, medicines for mental disorders, some cough medicines), as the dose of SECUFEN may need to be reduced.

Likewise, if you are given a strong analgesic or another sedative medicine after receiving SECUFEN during surgery, it may be necessary to reduce the dose of the analgesic or sedative medicine to reduce the risk of serious side effects such as breathing problems, slow breathing, shallow breathing, intense drowsiness, decreased consciousness, coma, or death.

· Medicines used to treat depression, such as monoamine oxidase inhibitors (MAOIs). These medicines should not be taken within two weeks prior to administration of SECUFEN, nor simultaneously.

· Medicines used in the treatment of depression, such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs). It is not recommended to take these medicines at the same time as SECUFEN.

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Use of SECUFEN with food and drinks:

To allow administration of this medicine, consumption of alcoholic beverages should be avoided (see section “Warnings and precautions”).

Pregnancy and breastfeeding:

Inform your anaesthetist if you are pregnant or breastfeeding.

SECUFEN should not be used during pregnancy unless strictly necessary.

When this medicine is administered to women during pregnancy, there is a risk that the newborn may develop neonatal abstinence syndrome and respiratory depression.

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

Driving and use of machines:

SECUFEN may reduce your level of alertness or ability to drive.

A reasonable amount of time (at least 24 hours) should elapse between administration of this medicine and resuming driving or operating machinery.

You should always consult your doctor.

The concomitant use of SECUFEN and sedative medicines such as benzodiazepines or related medicines (which may relieve anxiety and seizures, allow muscle relaxation, and promote sleep) increases the risk of drowsiness, breathing difficulties, depression, and coma, and may result in death. Therefore, concomitant use of these medicines should only be considered when no other viable treatment options are available. However, if SECUFEN is prescribed simultaneously with benzodiazepines and/or related medicines, your doctor must limit the dose and duration of these concomitant treatments. Inform your doctor about all medicines you are taking and strictly follow their dosage recommendations. It may be helpful to inform your friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you notice these symptoms.

Important information about some of the components of SECUFEN

2 ml vials

This medicine contains less than 23 mg of sodium per vial, i.e., essentially “sodium-free”.

10 ml vials:

Patients on low-sodium diets should be aware that this medicine contains 35.40 mg (1.5 mmol) of sodium per vial.

3. How SECUFEN is administered

This medicine will be administered exclusively by specially trained personnel in anaesthesia-resuscitation or emergency medicine, who are familiar with the use of anaesthetics, or under their supervision, and in facilities fully equipped for monitoring and supporting respiratory and cardiovascular functions.

Dosage

The dose, administered by a healthcare professional, will be determined according to your:

• age,
• weight,
• general condition,
• type of anaesthesia used.

Method of administration and route

This medicine will be administered intravenously (into a vein) to relieve pain throughout the body during surgical procedures, or epidurally (into the lower back area), to relieve pain in certain parts of the body, for example during childbirth or after surgery.

If you think you have been given more SECUFEN than you should have

This medicine will only be administered to you in a hospital setting by healthcare professionals, so it is unlikely that you will receive more SECUFEN than intended. However, if you think you have been given too much SECUFEN, inform your doctor immediately. In case of accidental overdose, call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount administered.

It is recommended to take the medicine’s packaging and leaflet to the healthcare professional.

If you have forgotten to be given SECUFEN

This medicine will only be administered to you in a hospital by healthcare professionals, so it is unlikely that you will miss the intended dose of SECUFEN. Nevertheless, if you think this medicine has been omitted, inform your doctor immediately.

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

4. Possible adverse effects

Like other medicines, SECUFEN may cause adverse effects, although not everyone experiences them.

Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), and not known (frequency cannot be estimated from the available clinical data).

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

• Sedation
• Pruritus

Common adverse effects (may affect between 1 and 10 people in 100)

• Tremors in the newborn
• Dizziness
• Headache
• Increased heart rate
• Hypertension
• Hypotension
• Pallor
• Bluish discoloration of the skin (nails and lips) in the newborn
• Vomiting
• Nausea
• Skin discoloration
• Muscle contractions
• Urinary retention
• Urinary incontinence (involuntary loss of urine)
• Fever

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

• Cold-like symptoms
• Allergy
• Apathy
• Nervousness
• Difficulty coordinating movements
• Abnormal movements in the newborn
• Involuntary and painful muscle contractions
• Exaggerated reflexes
• Increased muscle tone
• Decreased motor activity in the newborn
• Somnolence
• Vision disorders
• Bluish discoloration of the skin (nails and lips)
• Heart rhythm disorder
• Slow heart rate
• Irregularities in heart contractions
• Abnormal electrocardiogram
• Breathing difficulty
• Reduced pulmonary ventilation
• Voice alteration
• Cough
• Hiccups
• Respiratory disorder
• Allergic skin inflammation
• Excessive sweating
• Extensive skin rash (also in newborns)
• Dry skin
• Low back pain
• Reduced muscle tone in the newborn
• Muscle rigidity
• Increase or decrease in body temperature
• Chills
• Pain
• Reaction at the injection site
• Pain at the injection site

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

• Allergic reactions
• Coma
• Convulsion
• Involuntary muscle contractions
• Pupillary constriction
• Cardiac arrest
• Acute malaise with drop in blood pressure
• Respiratory arrest
• Apnea
• Respiratory depression
• Pulmonary edema
• Sudden contraction of the laryngeal muscles
• Skin redness
• Muscle spasms

Children and adolescents

The frequency, type, and severity of adverse effects are expected to be the same as in adults.

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

Reporting suspected adverse reactions

It is important to report suspected adverse reactions to the medicine after authorization. This allows continued monitoring of the benefit-risk balance of the medicine. Healthcare professionals are encouraged to report suspected adverse reactions via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

5. Storage of SECUFEN

Keep this medicine 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 should be used immediately.

Do not use SECUFEN after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your doctor how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of SECUFEN

• The active substance is sufentanil (as citrate).

SECUFEN 5 micrograms/ml:

Each ml of solution contains 5 micrograms of sufentanil as sufentanil citrate. The other components are: sodium chloride, sodium hydroxide (to adjust pH), hydrochloric acid (to adjust pH), and water for injectable preparations, sufficient to make 1 ml.

Appearance of the product and contents of the container

SECUFEN is an injectable solution supplied in sterile 2 ml and 10 ml ampoules. Each pack contains either 5 ampoules of 2 ml, 10 ampoules of 2 ml, or 10 ampoules of 10 ml.

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

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Altan Pharmaceuticals, S.A.

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

Edificio Prisma

28230 Las Rozas (Madrid) - Spain

Manufacturer:

LABORATOIRE RENAUDIN

Z.A. Errobi

64250 ITXASSOU (France)

Date of latest revision of this package leaflet: May 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es

This information is intended exclusively for physicians or healthcare professionals

Special warnings

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

This rigidity can be prevented by taking the following measures:

• The injection should be sufficiently slow when using low doses of sufentanil
• Administration of muscle relaxants immediately before this medicine prevents muscle rigidity

When used in obstetrics by intravenous route, sufentanil should be administered after clamping of the umbilical cord to prevent any respiratory depressant effect on the neonate. However, intravenous use is contraindicated during labor or before clamping of the umbilical cord.

Dosage and method of administration

This medicine must be administered exclusively by specialist anaesthesiologists or emergency medicine physicians familiar with the use of anaesthetics, or under their supervision, and who have access to appropriate anaesthesia and resuscitation equipment.

Sufentanil is usually administered in combination with other agents: intravenous anaesthetics, volatile anaesthetics, benzodiazepines.

Information intended for the person responsible for administering SECUFEN injectable solution (IV or epidural route):

Dosage varies according to the anaesthetic technique, the patient's condition, and ventilation control methods.

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

Adults

Intravenous route

Balanced general anaesthesia:

Short or medium duration procedures (one to two hours): 0.1 to 2 micrograms/kg for induction, in combination with a hypnotic and/or a volatile anaesthetic agent and a muscle relaxant.

Doses of 10 to 25 micrograms of sufentanil may be administered for maintenance of anaesthesia, depending on clinical signs of reduced analgesia and tolerance to the initial dose.

Major surgical procedures (more than 2 hours): total dose should be calculated based on an administration rate of 1 microgram/kg/hour, adjusted according to the surgical procedure, patient status, and associated products. Up to 75% of the total dose may be administered as a bolus for induction, with maintenance provided either by repeated injections of 10 to 50 micrograms depending on clinical signs of reduced analgesia, or by continuous infusion. Sufentanil may be combined with a hypnotic and/or a volatile anaesthetic agent and a muscle relaxant. In case of bradycardia, an appropriate dose (to be determined) of an anticholinergic agent (atropine) may be used.

Analgesic anaesthesia (cardiovascular surgery):

An initial bolus dose of 8 to 20 micrograms/kg should be administered for induction, in combination with 100% oxygen and a muscle relaxant compatible with the patient's cardiovascular status.

An additional 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 signs of reduced analgesia and patient tolerance to the initial bolus, or by continuous infusion.

Compared to other morphine derivatives used in such protocols, doses of associated medications such as volatile anaesthetics and benzodiazepines should generally be reduced.

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

However, dosage should be adjusted according to other anaesthetic agents used, individual variations, and desired extubation time.

Prolonged sedation in intensive care or resuscitation units for ventilated patients:

0.2 to 2 micrograms/kg/hour, depending on the required level of sedation and the respective doses of any concomitant medications.

Epidural route

General surgery (thoracic, urological, orthopaedic):

Initial doses of 0.75 micrograms/kg, diluted in 10 ml, provide analgesia lasting 4 to 8 hours. Additional boluses of 25 to 50 micrograms may be administered depending on signs of reduced analgesia.

Obstetrics:

Bolus dose of 15 to 20 micrograms, diluted in a volume of 10 ml, in combination with a local anaesthetic such as bupivacaine (0.125%–0.25%). The total dose of sufentanil should not exceed 30 micrograms.

Post-cesarean analgesia:

Bolus dose of 25 micrograms, diluted in a volume of 10 ml, in combination with a local anaesthetic such as bupivacaine (0.125%–0.25%). The total dose of sufentanil should not exceed 30 micrograms.

Postoperative analgesia:

Bolus dose of 0.75 micrograms/kg, diluted in 10 ml, administered as a single or repeated dose depending on signs of reduced analgesia (25 to 50 micrograms), or by continuous infusion at a rate of 0.2 to 0.3 micrograms/kg/hour.

Special populations

As with other opioids, dose reduction is recommended in elderly, debilitated patients, or those with ASA class III/IV.

Paediatric population

Intravenous administration

Due to the high variability of pharmacokinetic parameters in neonates, no dosage recommendations can be provided (see sections 4.4 and 5.2).

Children over one month of age

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

Induction of anaesthesia

SECUFEN may be administered as a slow bolus over at least 30 seconds at doses of 0.2 to 0.5 micrograms/kg, in combination with another anaesthetic agent for induction. In major surgery (e.g., cardiac surgery), doses up to 1 microgram/kg may be administered.

Maintenance of anaesthesia in ventilated patients

In balanced general anaesthesia, the dose depends on the doses of associated anaesthetic agents and the type and duration of surgery. An initial dose of 0.3 to 2 micrograms/kg administered as a slow bolus over at least 30 seconds may 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

SECUFEN should only be administered epidurally in children by anaesthesiologists specially trained in paediatric epidural anaesthesia and in managing the respiratory depressant effects of opioids. Appropriate resuscitation equipment, including intubation equipment and opioid antagonists, must be readily available.

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

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

Children under one year of age

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

Available data in children over 3 months of age are described in section 5.1, but no recommendations can be made.

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

Children over one year of age

A single bolus dose of 0.25 to 0.75 micrograms/kg administered during surgery provides analgesic effect lasting 1 to 12 hours. The duration of analgesia depends on the type of surgical procedure and concomitant use of an epidural local amide-type anaesthetic.

METHOD OF USE

If necessary, SECUFEN injectable solution (IV or epidural route) may be mixed with saline or glucose solutions. These dilutions are compatible with plastic infusion bags. Diluted solutions should be used within 24 hours of preparation.

Instructions for opening ampoules

Protective gloves should be worn when opening ampoules.

1. Hold the ampoule between index finger and thumb, allowing the tip of the ampoule to protrude.

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

1. Keeping the thumb on the dot, break off the top of the ampoule with a sharp movement while firmly holding the body of the ampoule in the hand.

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