Pancuronium jelfa

Package leaflet: Information for the user

PANCURONIUM JELFA,
2 mg/ml, solution for injection
Pancuronii bromidum
Please read all of this leaflet carefully before the medicine is administered, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• Consult your doctor, pharmacist, or nurse if you have any further questions.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Table of contents of the leaflet:

1. What Pancuronium Jelfa is and what it is 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 Pancuronium Jelfa is and what it is used for

Pancuronium is a non-depolarizing skeletal muscle relaxant.
Indications
Pancuronium Jelfa is intended for use only in a hospital setting:

• for relaxation of skeletal muscles during endotracheal intubation (endotracheal intubation involves placement of a flexible tube through the mouth or nose into the trachea to provide mechanical ventilation) and during general anaesthesia;
• in patients connected to a ventilator and receiving controlled ventilation;
• for alleviation of symptoms of tetanus.

2. Information before using Pancuronium Jelfa

When not to use Pancuronium Jelfa

• if the patient is allergic to pancuronium, bromide, or any of the other ingredients of this medicine (listed in section 6);
• pancuronium must absolutely not be used when there are no technical possibilities to perform intubation and apply controlled ventilation;
• do not use in premature infants and newborns.

Warnings and precautions
Pancuronium bromide is intended for hospital use and may be administered only by qualified medical personnel when equipment enabling controlled ventilation is available.
Inform your doctor if the patient has any of the following conditions:

• myasthenia gravis (muscle weakness, fatigue);
• myasthenic syndrome (Eaton-Lambert syndrome);
• neuromuscular disorders;
• Heine-Medin disease (poliomyelitis);
• malignant hypertension, especially hypertension associated with kidney diseases;
• pheochromocytoma (a tumour causing high blood pressure);
• coronary artery disease (ischaemic heart disease);
• severe electrolyte disturbances (e.g. decreased blood potassium and calcium ion levels; increased blood magnesium ion levels).

Use in elderly patients
The dose of the medicine should be reduced in elderly patients.
Other medicines and Pancuronium Jelfa
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Pregnancy and breastfeeding
During pregnancy, breastfeeding, or if pregnancy is suspected, or if a woman plans to become pregnant, this medicine should only be used after consulting a doctor.
The medicine may be used during pregnancy only if the doctor considers it absolutely necessary.
Studies have shown that pancuronium bromide can be safely used before caesarean section.
It is not known whether pancuronium bromide passes into breast milk in amounts that could affect the nursing infant. If the medicine must be used, breastfeeding should be discontinued. Breastfeeding may be resumed only after the medicine has been eliminated from the body (after 24 hours following administration).
Driving and operating machinery
Pancuronium Jelfa significantly impairs psychophysical performance. Driving vehicles and operating machinery is strictly prohibited for at least 24 hours after administration of the medicine.
Pancuronium Jelfa contains benzyl alcohol
This medicine contains benzyl alcohol and therefore 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 the risk of serious adverse reactions, including respiratory disorders (so-called "gasping syndrome").
Do not administer to newborns (up to 4 weeks of age) without a doctor's instruction.
Do not administer to young children (under 3 years of age) for longer than one week without a doctor's or pharmacist's advice.
Pregnant or breastfeeding women should consult a doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult a doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Pancuronium Jelfa contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Pancuronium Jelfa

Due to significant individual differences in response to the drug, the dosage will be determined individually by the physician.
The drug may be administered only by medical personnel.
The drug is administered intravenously.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Cardiac and vascular disorders:
Increased heart rate, elevated arterial blood pressure, and increased cardiac minute volume. Additionally, ventricular arrhythmias and atrioventricular dissociation (conduction disturbances) may occur. Less frequently than with other muscle relaxants, reactions related to histamine release may occur (sudden drop in blood pressure, bronchospasm, and accompanying shortness of breath).
Immune system disorders:
In rare cases, pancuronium may cause an anaphylactic reaction, manifested by sudden drop in arterial blood pressure, development of vascular exudates (edema), cardiac arrhythmias, and bronchospasm.
Skin allergic reactions may occur more frequently than with other muscle relaxants.
Gastrointestinal disorders:
Excessive salivation.
Metabolism and nutrition disorders:
In newborns treated with pancuronium bromide, the relative risk of developing hyperbilirubinemia (increased blood bilirubin concentration) was 1.2 compared to newborns not treated with the drug.
General disorders and administration site conditions:
Local skin reactions and pain at the injection site are occasionally observed.
Musculoskeletal and connective tissue disorders:
Frequency not known: muscle weakness.
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide 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.
Keep the medicine out of sight and reach of children.
Before use, check the expiry date stated on the packaging and do not use this medicine
after the expiry date indicated on the label and carton.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Pancuronium Jelfa contains
The active substance is pancuronium bromide.
Each 2 ml ampoule contains 4 mg of pancuronium bromide.
The other ingredients are benzyl alcohol, sodium chloride, anhydrous sodium acetate, glacial acetic acid,
water for injections.

What Pancuronium Jelfa looks like and contents of the pack
Pancuronium Jelfa is a sterile, clear solution.
The available pack consists of 10 ampoules of 2 ml capacity, made of colourless glass with one green and one red stripe, placed in a cardboard box.

Marketing Authorisation 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

The following information is intended solely for medical personnel

Precautions
Prior to administration of the drug, ensure availability of equipment for intubation, oxygen therapy, and access to a ventilator. Pancuronium should not be administered without prior induction of anesthesia. Administration of a neuromuscular blocking agent to a fully conscious patient may lead to adverse psychological consequences.

Increased sensitivity to pancuronium bromide is observed in patients with myasthenia gravis, and even a dose of 0.005 mg/kg body weight may induce muscle relaxation equivalent to 90% of maximal effect.

In patients with coronary artery disease, administration of pancuronium bromide may provoke myocardial ischemia and angina pectoris.

Pancuronium bromide is generally not recommended for use in patients with myasthenia gravis or coronary artery disease. If use is necessary in these patients, a test dose of 0.005 mg/kg body weight should be administered intravenously (bolus), followed, if tolerated, by slow continuous infusion as needed to achieve the desired degree of muscle relaxation.

Dose reduction is not usually required in patients with mild to moderate renal impairment. However, the elimination half-life of the drug may be prolonged in these patients.

In patients with severe renal failure (GFR < 10 ml/min), administration of pancuronium bromide should be avoided.

In patients with hepatic insufficiency or biliary obstruction, a higher initial dose may be required to achieve adequate muscle relaxation. However, repeat dosing should not occur earlier than 120 minutes due to prolonged elimination half-life in such patients.

In patients with extensive burns, resistance to the effects of pancuronium bromide may occur, necessitating higher doses.

In patients with severe electrolyte disturbances—such as hypokalemia, hypocalcemia, hypermagnesemia, severe fluid and electrolyte imbalances, acid-base disturbances, or hypoproteinemia—the effect of pancuronium bromide may be enhanced and prolonged.

In patients with coronary artery disease, administration of pancuronium bromide may provoke myocardial ischemia and angina pectoris.

In patients with pheochromocytoma, administration of pancuronium bromide may cause significant arterial hypertension.

Interactions with other drugs
Concomitant use of pancuronium bromide with inhalational anesthetics such as halothane, isoflurane, or enflurane may potentiate neuromuscular blockade, necessitating adjustment of the pancuronium bromide dose.

Opioid analgesics may contribute to post-pancuronium respiratory failure due to respiratory center depression.

The muscle relaxant effect of pancuronium is enhanced and prolonged by: barbiturates, lithium salts, furosemide, ethacrynic acid, amphotericin, tetracyclines, polymyxin B, lincomycin, clindamycin, capreomycin, colistin, aminoglycoside antibiotics, ajmaline, propranolol, procainamide, and quinidine.

Respiratory acidosis, hypokalemia, hypermagnesemia, and hypercalcemia enhance the effects of neuromuscular blocking agents.

Beta-adrenergic blockers prolong the action of pancuronium.

Glucocorticoids reduce the potency of pancuronium. However, with prolonged use, when hypokalemia develops, they may potentiate neuromuscular blockade.

Lithium salts enhance and prolong the effect of pancuronium.

Patients receiving lithium therapy should discontinue lithium at least 24 hours before general anesthesia involving pancuronium.

In patients receiving long-term carbamazepine therapy, pancuronium metabolism may be accelerated, resulting in significantly shortened duration of muscle relaxation.

Patients receiving phenytoin may be less responsive to neuromuscular blockade; the muscle relaxant effect of pancuronium bromide appears later and is shorter in duration, and standard doses may fail to produce complete relaxation.

Hypothermia also reduces the effect of pancuronium bromide.

Pancuronium may potentiate the effects of cardiac glycosides, potentially leading to arrhythmias.

Edrophonium, neostigmine, and other acetylcholinesterase inhibitors reverse the muscle relaxant effect of pancuronium.

Mixing pancuronium with other solutions in the same syringe may result in precipitation.

Dosage
Pancuronium should be administered intravenously.

Adults
Depending on the desired depth of muscle relaxation and individual response, the dose for adults ranges from 0.04 to 0.1 mg/kg body weight.

To assess individual sensitivity to pancuronium bromide, it is recommended to administer an initial intravenous test dose of 1 mg. Ptosis may indicate hypersensitivity to pancuronium bromide and the need for a reduced dose.

The optimal dose for tracheal intubation is usually 0.09 mg/kg body weight. Adequate relaxation typically occurs within 2–3 minutes. Additional doses of 0.01 to 0.06 mg/kg body weight may be administered every 30–40 minutes, or as neuromuscular function returns.

Administration of an initial intravenous bolus dose of 0.007 mg/kg body weight, followed 3 minutes later by 0.063 mg/kg body weight, accelerates the onset and prolongs the duration of muscle relaxation.

Children and adolescents
The dose of pancuronium bromide in children, when calculated per body weight, is the same as in adults: 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 used in infants during the first few months of life, individual sensitivity to the drug should be assessed each time.

The initial dose in infants is typically 0.02 to 0.04 mg/kg body weight of pancuronium bromide as a bolus, with maintenance doses of 0.015 to 0.02 mg/kg body weight.

Elderly patients
The effect of pancuronium bromide is prolonged in elderly patients; therefore, dose reduction may be advisable.

Obese patients
Dose calculation based on total body weight in obese patients may lead to overdosing. Therefore, careful assessment of individual response to the drug is particularly important in these patients.

Patients with hepatic or renal impairment
Caution is required when determining dosage in patients with hepatic or renal dysfunction.

After opening the ampoule, the solution should be used immediately, and any unused portion should be discarded.

Administration of a higher than recommended dose of Pancuronium Jelfa
Pancuronium is a neuromuscular blocking agent, including respiratory muscles. Therefore, any effective dose may be lethal if intubation and controlled ventilation are not possible.

Chronic intoxication does not occur. The main symptoms of acute overdose following intravenous administration of excessive doses are prolonged respiratory depression and circulatory collapse.

Initially, patients may exhibit ptosis, difficulty swallowing and speaking, followed within 2–3 minutes by paralysis of limb, neck, intercostal, and diaphragmatic muscles.

Tachycardia, cardiac arrhythmias, vasodilation with venous stasis, and significant hypotension are frequently observed.

Management includes intubation and controlled ventilation until spontaneous respiration returns, along with monitoring and support of arterial blood pressure.

Specific treatment includes intravenous administration of one of the following agents:

1. 10 mg edrophonium (1 ml of 1% solution). This dose may be repeated as needed up to a total of 30 mg;
2. Neostigmine methylsulfate (1 to 2 ml of 1:2000 solution) intravenously together with 1 mg atropine. After each administration, the cannula and vein should be flushed with sodium chloride solution.