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Ionsys is a brand name for Fentanyl. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: IONSYS is indicated for the management of acute moderate to severe post-operative pain in adult patients.
Verbatim from this product's EMA label. Tap a section to expand.
IONSYS is restricted to hospital use only. Treatment should be initiated by and remain under the guidance of a physician experienced in the management of opioid therapy. 4). 1). IONSYS should only be activated by the patient. Each dose of IONSYS delivers 40 micrograms of fentanyl over a 10 minute period, to a maximum of 240 micrograms per hour (6 doses each of 10 minutes duration).
IONSYS will operate for 24 hours after the system is assembled or for 80 doses, whichever comes first, and then becomes inoperative. After 24 hours or 80 doses, a new system should be applied if necessary. Each new system should be placed on a new skin site.
2). Medicinal product no longer authorised 3 Patients should not wear more than one system at a time. Used systems should not be reapplied to a patient. IONSYS should be removed before the patient is discharged. Elderly patients As with all fentanyl products, the clearance of fentanyl may be reduced in elderly patients, with a consequent increase in half life.
No specific dose adjustment is required in elderly patients. 8). 4). Paediatric population The safety and efficacy of IONSYS in children and adolescents younger than 18 years of age has not been established. 8, but no recommendation on posology can be made.
Method of administration IONSYS is for transdermal use only. Precaution to be taken before manipulating or administering the product Gloves should be worn when manipulating IONSYS. To avoid oral ingestion of the fentanyl- containing hydrogel, which may cause life-threatening hypoventilation or death, the hydrogel must not touch the mouth or other mucosal areas.
Patients should not get IONSYS wet. Prolonged contact with water could affect system performance and cause the system to fall off. Preparation of application site IONSYS should be applied to intact, non-irritated and non-irradiated skin.
IONSYS should not be placed on abnormal skin sites, such as scars, burns, tattoos, etc. IONSYS should also not be placed on skin on which topical medicines have been applied. Hair at the application site should be clipped (not shaved) before system application.
IONSYS should not be applied to a previously used skin site. The application site should be wiped with a standard alcohol swab and the skin should be allowed to dry completely before IONSYS is applied. No soaps, oils, lotions, or any other agents that might irritate the skin or alter its absorption characteristics should be used to clean the application site.
Summary of the safety profile The most commonly reported adverse reactions were nausea, vomiting, and application site reactions such as erythema and pruritus. These were mostly of mild to moderate severity. The most serious adverse reactions reported were hypotension and apnoea and all patients should be closely monitored for these.
Tabulated list of adverse reactions The following adverse reactions have been reported with IONSYS during clinical studies and post marketing experience. All adverse reactions are listed by System Organ Class and frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); and rare (≥1/10,000 to <1/1,000).
System Organ Class Very Common Common Uncommon Rare Infections and infestations Rhinitis Blood and lymphatic system disorders Anaemia Metabolism and nutrition disorders Decreased appetite Hypocalcaemia Hypoglycaemia Hypokalaemia Psychiatric disorders Insomnia Abnormal dreams Agitation Anxiety Confusional state Hallucination Nervousness Depression Thinking abnormal thoughts Nervous system disorders Dizziness Headache Migraine Paraesthesia Somnolence Syncope Dysgeusia Hypoaesthesia Eye disorders Vision blurred Ear and labyrinth disorders Vertigo Cardiac disorders Tachycardia Bradychardia Vascular disorders Hypotension Hypertension Orthostatic hypotension, Vasodilitation Respiratory, thoracic and mediastinal disorders Hypoxia Apnoea Cough Dyspnoea Hiccups Hypoventilation Lung disorder Gastrointestinal disorders Nausea Vomiting Constipation Abdominal pain Dry mouth Dyspepsia Flatulence Ileus Abdominal distension Diarrhoea Eructation Skin and subcutaneous tissue disorders Pruritus Rash Hyperhidrosis Musculoskeletal and connective tissue Back pain Pain in extremity Hypertonia MyalgiaMedicinal product no longer authorised 10 System Organ Class Very Common Common Uncommon Rare disorders Renal and urinary disorders Urinary retention Oliguria Dysuria General disorders and administration site conditions Application site erythema Application site oedema Application site pruritus Application site reaction Application site vesicles Pyrexia Application site pain Application site dryness Application site papules Asthenia Chills Application site reaction Pain Chest pain Malaise Application site paraesthesia Injection site oedema Injection site pain Oedema Injury, poisoning and procedural complications Wound complication Surgical and medical procedures Gastrointestinal disorder therapy Paediatric population Data on IONSYS in paediatrics is limited to information from a single clinical trial.
Before any surgery, the healthcare professional should ensure that the patient has been properly informed on how to use IONSYS post-operatively. A potentially dangerous amount of fentanyl remains in the IONSYS system after use. Medicinal product no longer authorised 6 IONSYS should be removed before a magnetic resonance imaging (MRI) procedure, cardioversion, defibrillation, X-ray, CT scan or diathermy is undertaken.
Excessive sweating may reduce delivery of fentanyl. Respiratory depression IONSYS should only be activated by the patient, to avoid potential overdosing. 9). 5). Chronic pulmonary disease In patients with chronic obstructive pulmonary disease or patients with conditions pre-disposing them to hypoventilation, more severe adverse reactions may be experienced.
In such patients, opioids may decrease respiratory drive and increase airway resistance. Head injuries and increased intracranial pressure Fentanyl should not be used in patients who may be particularly susceptible to the intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure, impaired consciousness, or coma.
Opioids may obscure the clinical course of patients with head injury. Fentanyl should be used with caution in patients with brain tumours or other significant space occupying lesions of the brain. Cardiac disease Fentanyl may produce bradycardia or hypotension and should, therefore, be administered with caution to patients with bradyarrhythmias or any significant cardiovascular disease.
Paralytic ileus IONSYS should be used with caution in patients with paralytic ileus. Abuse potential and dependence Fentanyl has a well-known abuse potential. Patients with a prior history of drug dependence/alcohol abuse are more at risk to develop dependence and abuse in opioid treatment.
Physicians should evaluate patients for a history of drug abuse and follow such patients closely. Tolerance, physical dependence, and psychological dependence may develop upon repeated administration of opioids. Iatrogenic addiction following opioid administration is rare.
1. Severe respiratory depression or cystic fibrosis.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fentanyl in European Union.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Medicinal product no longer authorised 4 Gloves should be worn during the assembly of IONSYS. The tray is opened by pulling back on the tray lid. The sachet containing the Drug Unit should be opened starting at the pre-cut notch, then by carefully tearing along the top of the sachet.
The Drug Unit should be removed from the sachet and the Controller should be snapped on by aligning the shape and firmly pressing the two parts together. When assembled, the digital display of the Controller will complete a short self-test during which there will be an audible beep, the red light will flash once, and the digital display will flash the number 88.
At the end of the self-test, the display will show the number 0 and a green light will flash at a slow rate to indicate IONSYS is ready for application. Application of IONSYS The clear plastic film covering the adhesive should be removed and discarded with care taken not to touch the hydrogels.
IONSYS should be pressed firmly in place for at least 15 seconds with the sticky side down on the skin of the chest or upper arm of the patient. Pressure should be applied with the fingers around the outer edges to ensure adhesion to the skin site.
If at any point during use the system loosens from the skin, a non-allergenic tape may be used to secure the edges to ensure complete contact with the skin. When applying tape, care should be taken not to tape over the light window, the digital display, or the dosing button.
The dosing button must not be pressed. 6. Dose delivery A recessed dosing button is located on the Controller of IONSYS. To initiate administration of a fentanyl dose, the patient should press and release the dosing button twice within 3 seconds.
IONSYS should only be activated by the patient. Upon successful dose initiation, IONSYS will emit a beep indicating the start of delivery. The green light will change from a slow flash rate to a rapid flash rate and the digital display will alternate between a rotating circle and the number of completed doses during the entire 10-minute dose delivery period.
The next dose cannot be initiated until the previous 10-minute delivery period is complete. Pressing the button during delivery of a dose will not result in additional fentanyl being administered. After the 10-minute dose has been completely delivered, the green light will return to a slow flash rate, the digital display will show the number of doses that have been […]
In this study 28 paediatric patients, 6 to 16 years old, were treated with IONSYS fentanyl 40 micrograms after experiencing inadequate analgesia with IONSYS fentanyl 25 micrograms. 7%) were each reported at a higher incidence in paediatric patients relative to adults.
In summary, the limited size of the overall paediatric exposure is insufficient to guide safe and effective dosing of IONSYS in patients younger than 18 years of age. Elderly population Elderly patients (≥ 65 years) made up 28% (499/1763) of the total controlled clinical trial exposure to IONSYS 40 micrograms, with approximately 10% (174/1763) of exposures being in patients ≥ 75 years.
No overall differences were observed in the safety of IONSYS fentanyl 40 micrograms in elderly patients (≥ 65 years including a subpopulation ≥ 75 years) and adult patients for all controlled studies. Thus, the adverse reaction profile does not suggest a meaningful difference in safety compared to patients younger than 65 years of age.
Obese patients In the controlled clinical trial population, the adverse reaction profile in patients with BMI > 40 (86/1436 or 6%) showed no meaningful difference relative to patients with BMI ≤ 40. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Medicinal product no longer authorised 11
Fentanyl can be abused in a manner similar to other opioid agonists. Abuse or intentional misuse of IONSYS may result in overdose and/or death. Hepatic disease Fentanyl is metabolised into inactive metabolites in the liver. Hepatic disease may delay elimination.
Patients with hepatic impairment should be observed carefully for signs of fentanyl toxicity. Renal diseaseMedicinal product no longer authorised 7 Less than 10% of administered fentanyl is excreted unchanged by the kidney. Unlike morphine, no active fentanyl metabolites are eliminated by the kidney.
Data obtained with intravenous fentanyl in patients with renal failure suggest that the volume of distribution of fentanyl may be changed by dialysis. This may affect serum concentrations. If patients with renal impairment receive IONSYS, they should be observed carefully for signs of fentanyl toxicity.
8). Obese patients The overall adverse reaction profile for morbidly obese patients (BMI > 40) does not suggest a meaningful difference in safety compared to patients with BMI ≤ 40. 8). Hearing impairment IONSYS should be used with caution in patients with hearing impairment who might not be able to hear the audible signals from the system.
Thoracic/chest and upper abdominal surgeries Only limited data are available in patients with thoracic/chest and upper abdominal surgeries. IONSYS should, therefore, be used with caution in these patients. e. patients with a severe systemic disease that is a constant threat to life).
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