Pancuronium Ielfa

Package Leaflet: Information for the User

PANCURONIUM JELFA,

2 mg/ml, solution for injection

Pancuronium bromide

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

• Keep this leaflet, you may need to read it again.
• Ask your doctor, pharmacist or nurse if you have any further questions.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse.

Table of Contents of the Leaflet:

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

1. WHAT IS PANCURONIUM JELFA AND WHAT IS IT USED FOR

Pancuronium is a non-depolarizing muscle relaxant.

Indications

Pancuronium Jelfa is intended for use only in a hospital setting:

• to relax muscles during endotracheal intubation (endotracheal intubation involves inserting a flexible tube through the mouth or nose into the trachea to mechanically support breathing) and during general anesthesia;
• in patients connected to a ventilator and receiving controlled ventilation;
• to relieve symptoms of tetanus.

2. IMPORTANT INFORMATION BEFORE USING PANCURONIUM JELFA

When not to use Pancuronium Jelfa

• if the patient is allergic to pancuronium, bromine or any other component of this medicine (listed in section 6);
• absolutely do not use pancuronium in the absence of technical possibilities for intubation and controlled ventilation,
• do not use in premature infants and newborns.

Warnings and precautions

Pancuronium bromide is intended for hospital use and may only be used by qualified medical personnel, if equipment for controlled ventilation is available.
Tell your doctor if the patient has any of the following diseases:

• myasthenia (muscle weakness);
• myasthenic syndrome (Eaton-Lambert syndrome);
• neuromuscular disorders;
• Heine-Medin disease (inflammation of the spinal cord);
• malignant hypertension, especially hypertension associated with kidney disease;
• adrenal chromaffin tumor (tumor causing arterial hypertension);
• coronary artery disease (ischemic heart disease);
• severe electrolyte disturbances (e.g. decreased potassium and calcium ion levels in the blood; increased magnesium ion levels in the blood).

Use in elderly patients
In elderly patients, the dose of the medicine should be reduced.

Other medicines and Pancuronium Jelfa

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

Pregnancy and breastfeeding

In pregnancy and breastfeeding, or if you suspect you are pregnant, or if you plan to become pregnant, consult your doctor before using this medicine.
The medicine may only be used during pregnancy if the doctor considers it absolutely necessary.
Studies have shown that pancuronium bromide can be safely used before cesarean section.
It is not known whether pancuronium bromide passes into breast milk in amounts that could affect the breastfed baby. If the medicine needs to be used, breastfeeding should be discontinued. It can be resumed after the medicine has been eliminated from the body (after 24 hours from administration).

Driving and operating machinery

Pancuronium Jelfa significantly impairs psychophysical fitness. For at least 24 hours after administration of the medicine, there is an absolute ban on driving vehicles and operating machinery.

Pancuronium Jelfa contains benzyl alcohol

The medicine contains benzyl alcohol, so it is not intended for use in premature infants and newborns. In infants and children up to 3 years of age, the medicine may cause poisoning and allergic reactions.
The medicine contains 20.00 mg of benzyl alcohol in each 2 ml ampoule, which corresponds to 10.00 mg/ml.
Benzyl alcohol may cause allergic reactions.
Administration of benzyl alcohol to young children is associated with a risk of severe side effects, including respiratory disorders (so-called "gasping syndrome").
Do not give to newborns (up to 4 weeks of age) without a doctor's recommendation.
Do not give to young children (under 3 years of age) for more than a week without a doctor's or pharmacist's recommendation.
Pregnant or breastfeeding women should consult their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

3. HOW TO USE PANCURONIUM JELFA

Due to significant individual differences in response to the medicine, the doctor will determine the dosage individually.
The medicine may only be used by medical personnel.
The medicine is administered intravenously.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although they may not occur in everyone.
Heart disorders and vascular disorders:
Increased heart rate, increased blood pressure, and increased cardiac output. Additionally, ventricular arrhythmias and atrioventricular block (conduction disorders) may occur. Less frequently than with other muscle relaxants, reactions related to histamine release (sudden drop in blood pressure, bronchospasm, and accompanying shortness of breath) may occur.
Immune system disorders:
In rare cases, pancuronium may cause an anaphylactic reaction, characterized by a sudden drop in blood pressure, edema, arrhythmias, and bronchospasm.
More frequently than with other muscle relaxants, skin allergic reactions may occur.
Gastrointestinal disorders:
Excessive salivation.
Metabolic and nutritional disorders:
In newborns who received pancuronium bromide, the relative risk of hyperbilirubinemia (increased bilirubin levels in the blood) was 1.2, compared to newborns who did not receive the medicine.
General disorders and administration site conditions:
Local skin reactions and pain at the injection site may occur.
Musculoskeletal and connective tissue disorders: unknown frequency: muscle weakness.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the medicine.

5. HOW TO STORE PANCURONIUM JELFA

Store in a refrigerator (2°C - 8°C). Do not freeze.
The medicine should be stored out of sight and reach of children.
Before use, check the expiration date on the packaging and do not use the medicine after the expiration date on the label and carton.
The expiration date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Pancuronium Jelfa contains

The active substance of the medicine is pancuronium bromide.
1 ampoule of 2 ml contains 4 mg of pancuronium bromide.
The other ingredients are benzyl alcohol, sodium chloride, anhydrous sodium acetate, glacial acetic acid, and water for injection.

What Pancuronium Jelfa looks like and contents of the pack

Pancuronium Jelfa is a sterile, colorless solution.
The medicine is available in packs of 10 ampoules of 2 ml, with a green and red stripe, in a cardboard box.

Marketing Authorization Holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer:

Przedsiębiorstwo Farmaceutyczne Jelfa SA
ul. Wincentego Pola 21, 58-500 Jelenia Góra, Poland
Date of last update of the leaflet:
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The following information is intended for healthcare professionals only

Precautions

Before administering the medicine, ensure that the patient can be intubated, receive oxygen therapy, and have access to a ventilator. Avoid using pancuronium without prior sedation of the patient. Administration of a muscle relaxant to a fully conscious person may have adverse psychological consequences.
In patients with myasthenia, increased sensitivity to pancuronium bromide is observed, and a dose of 0.005 mg/kg body weight may cause 90% of full muscle relaxation.
In patients with coronary artery disease, administration of pancuronium bromide may cause myocardial ischemia and provoke angina pectoris.
Generally, pancuronium bromide is not recommended for use in patients with myasthenia and coronary artery disease. In the case of using the medicine in these patients, it is recommended to administer a test dose of 0.005 mg/kg body weight intravenously (bolus) and then, if necessary (in the case of good tolerance to the medicine), in the form of a slow intravenous infusion until the desired muscle relaxation is achieved.
There is no need to reduce the dose in patients with mild and moderate renal impairment. However, it should be remembered that the half-life of the medicine may be prolonged in these patients.
In the case of severe renal impairment (GFR <10 ml min), pancuronium bromide should be avoided.
In patients with liver and kidney disorders, caution should be exercised when determining the dose.
After opening the ampoule with the medicine, the contents should be used immediately and the unused solution discarded.

Interactions with other medicines

Concomitant use of pancuronium bromide and inhalation anesthetics such as halothane, isoflurane, and enflurane may enhance the blockade of the neuromuscular junction and require modification of the pancuronium bromide dose.
Opioid analgesics, by inhibiting the respiratory center, may contribute to respiratory failure after pancuronium bromide.
The muscle relaxant effect of pancuronium is enhanced and prolonged by: barbiturates, lithium salts, furosemide, etacrynic acid, amphotericin, tetracyclines, polymyxin B, lincomycin, clindamycin, capreomycin, colistin, aminoglycoside antibiotics, ajmaline, propranolol, procainamide, and quinidine.
Respiratory acidosis, hypokalemia, hypermagnesemia, and hypercalcemia enhance the effect of muscle relaxants.
Beta-blockers prolong the effect of pancuronium.
Corticosteroids reduce the effect of pancuronium. However, after long-term use, when they cause hypokalemia, they may potentiate the blockade of the neuromuscular junction.
Lithium salts enhance and prolong the effect of pancuronium.
Patients treated with lithium salts are advised to stop taking them at least 24 hours before general anesthesia with pancuronium.
In the case of long-term carbamazepine use, the metabolism of pancuronium may be accelerated, and the effective duration of muscle relaxation may be significantly shortened.
Patients taking phenytoin may be less susceptible to the occurrence of neuromuscular blockade, the muscle relaxant effect of pancuronium bromide occurs later and lasts shorter, and standard doses may not cause full muscle relaxation.
Lowering the patient's body temperature also weakens the effect of pancuronium bromide.
Enhancement of the effect of cardiac glycosides by pancuronium may cause arrhythmias.
Edrophonium, neostigmine, and other acetylcholinesterase inhibitors reverse the muscle relaxant effect of pancuronium.
Combining pancuronium in the same syringe with other solutions may cause precipitation.

Dosage

Pancuronium should be administered intravenously.
Adults
Depending on the depth of muscle relaxation desired and individual response to the medicine, the dose for adults is 0.04 to 0.1 mg/kg body weight.
To determine individual sensitivity to pancuronium bromide, it is recommended to administer 1 mg of the medicine intravenously before administering the optimal dose for the patient. Ptosis may indicate hypersensitivity to pancuronium bromide and the need to use a smaller dose.
The optimal dose to achieve muscle relaxation necessary for endotracheal intubation is usually 0.09 mg/kg body weight. Adequate relaxation usually occurs within 2-3 minutes. If necessary, additional doses of 0.01 to 0.06 mg/kg body weight can be administered every 30-40 minutes or depending on the return of neuromuscular junction function.
Administration of a test dose of 0.007 mg/kg body weight intravenously (bolus) and then, within 3 minutes, a dose of 0.063 mg/kg body weight, accelerates the onset of muscle relaxation and prolongs its duration.
Children and adolescents
The dose of pancuronium bromide used in children is the same as in adults, on a body weight basis, and is 0.04 to 0.1 mg/kg body weight.
In children and adolescents up to 17 years of age, the maximum dose is 0.1 mg/kg body weight.
Infants
When using in infants in the first few months of life, individual sensitivity to the medicine should be checked each time.
The initial dose in infants is usually 0.02 to 0.04 mg/kg body weight of pancuronium bromide in the form of a bolus, and the maintenance dose is 0.015 to 0.02 mg/kg body weight.
Elderly patients
In elderly patients, the effect of pancuronium bromide is longer, so it may be necessary to reduce the dose.
Obese patients
In obese patients, determining the dose based on body weight may lead to overdose. Therefore, in these patients, individual response to the medicine is particularly important.
Patients with liver and kidney disorders
In patients with liver and kidney disorders, caution should be exercised when determining the dose.
After opening the ampoule with the medicine, the contents should be used immediately and the unused solution discarded.

Use of a higher than recommended dose of Pancuronium Jelfa

Pancuronium belongs to the group of muscle relaxants, including respiratory muscles. Therefore, any effective dose may be a lethal dose in the event of inability to intubate the patient and provide controlled ventilation.
Chronic poisoning does not occur. The main symptoms of acute poisoning caused by intravenous administration of an excessive dose of the medicine are: prolonged respiratory depression and circulatory collapse.
Initially, patients may experience: ptosis, difficulty swallowing and speaking, and then, within 2-3 minutes, paralysis of the limbs, neck, intercostal muscles, and diaphragm.
Tachycardia, arrhythmias, vasodilation with venous stasis, and significant hypotension are often observed.
Treatment includes intubation of the patient and provision of controlled ventilation until spontaneous breathing returns. Blood pressure should also be monitored.
Specific treatment includes intravenous administration of one of the following:

• 1. 10 mg of edrophonium (1 ml of 1% solution). If necessary, this dose can be repeated up to a total dose of 30 mg;
• 2. neostigmine methylsulfate (1 to 2 ml of 1:2000 solution) intravenously, together with 1 mg of atropine. After each administration of these agents, the cannula and vein should be flushed with a sodium chloride solution.