Edicin

Warnings and precautions

After injecting vancomycin into the eye, severe side effects have occurred, which can lead to vision loss. Before starting Edicin, discuss with your doctor, hospital pharmacist, or nurse if: the patient has previously had an allergic reaction to teicoplanin, as this may indicate that the patient is also allergic to vancomycin; the patient has hearing impairment, especially if they are elderly (hearing tests may be necessary during treatment); the patient has kidney function disorders (blood tests and liver and kidney function tests may be necessary during treatment); the patient is receiving vancomycin by infusion to treat diarrhea associated with Clostridium difficileinfection, instead of oral administration; the patient has ever experienced a severe skin rash or skin peeling after receiving vancomycin. Severe skin reactions have occurred with vancomycin treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If the patient notices any of the symptoms described in section 4, they should stop using vancomycin and consult a doctor immediately. During Edicin treatment, discuss with your doctor, hospital pharmacist, or nurse if: the patient is receiving vancomycin for a long time (blood tests and liver and kidney function tests may be necessary during treatment); the patient experiences any skin reaction during treatment; the patient experiences severe or prolonged diarrhea during or after vancomycin treatment; in such a case, consult a doctor immediately. This may be a sign of colitis (pseudomembranous colitis), which can occur during antibiotic treatment.

Children

Vancomycin will be used with special caution in premature infants and young infants, as their kidneys are not fully developed, which can lead to vancomycin accumulation in the blood. In this age group, blood tests may be necessary to monitor vancomycin levels in the blood. Concurrent administration of vancomycin and anesthetics in children is associated with skin redness (flushing) and allergic reactions. Additionally, concurrent use with other medications, such as aminoglycoside antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen), or amphotericin B (an antifungal medication), may increase the risk of kidney damage, and therefore, more frequent blood tests and kidney function tests may be necessary.

Edicin and other medications

Tell your doctor, pharmacist, or nurse about all medications the patient is currently taking or has recently taken, as well as any medications the patient plans to take. Be cautious if the patient is taking other medications that may interact with vancomycin, such as: Concurrent use of vancomycin and anesthetics may cause low blood pressure, shortness of breath, skin redness, hives, and itching; it may also cause a severe reaction resembling an allergic reaction. The frequency of these disorders is lower when vancomycin is administered by slow intravenous infusion before anesthesia. When using medications that can damage hearing, nerves, and/or kidneys (especially those such as ethacrynic acid, aminoglycoside antibiotics, amphotericin B, bacitracin, polymyxin B, piperacillin/tazobactam, colistin, or viomycin), the doctor will closely monitor the patient's condition. When using vancomycin and muscle relaxants, the doctor will exercise special caution.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult a doctor before using this medication. Vancomycin can be used during pregnancy only if absolutely necessary, when the doctor believes the benefits of treatment outweigh the risks. The doctor will recommend monitoring vancomycin levels in the blood to minimize the risk of toxic effects on the fetus. Vancomycin passes into breast milk, and therefore, it can be used during breastfeeding only if other antibiotics have been ineffective. If the mother's treatment with vancomycin is absolutely necessary, the doctor will closely monitor the infant's condition or recommend stopping breastfeeding. There are no fertility studies.

Driving and using machines

Edicin has a negligible effect on the ability to drive and use machines.

3. How to use Edicin

The patient will receive Edicin administered by medical staff during their hospital stay. The doctor will decide what dose of the medication the patient should receive each day and how long the treatment should last.

Dosage

The administered dose will depend on:

• the patient's age,
• the patient's body weight,
• the type of infection,
• kidney function,
• the patient's hearing,
• any other medications the patient is taking.

Intravenous administration

Adults and adolescents (12 years and older)

The dosage will be determined based on the patient's body weight. The usual dose used in infusion is 15 to 20 mg per kilogram of body weight. This dose is usually administered every 8 to 12 hours. In some cases, the doctor may decide to use an initial dose of up to 30 mg per kilogram of body weight. The maximum dose of vancomycin should not exceed 2 grams per dose.

Use in children

Children from the first month of life and children under 12 years of age The dosage will be determined based on the patient's body weight. The usual dose used in infusion is 10 to 15 mg per kilogram of body weight. This dose is usually administered every 6 hours. Premature infants and full-term newborns (from 0 to 27 days) The dose will be calculated based on gestational age [the time from the first day of the last menstrual period to birth (gestational age) plus the time from birth (postnatal age)].

Administration method

Intravenous infusion (drip) means that the medication flows from a bottle or infusion bag through a tube into one of the patient's veins. The doctor or nurse will always administer vancomycin into the blood, not into the muscle. Vancomycin will be administered into a vein for at least 60 minutes. If used to treat gastrointestinal disorders (pseudomembranous colitis), the medication must be administered orally (the patient will take the medication by mouth). Instructions for preparing the solution before administration can be found in "Information intended for healthcare professionals only" at the end of the leaflet. Duration of treatment The duration of treatment depends on the type of infection the patient has and may last several weeks. The duration of treatment may vary depending on the patient's response to treatment. During treatment, the patient may undergo blood tests and urine analysis, and may also have a hearing test to check for potential side effects. In case of any further doubts about using this medication, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, Edicin can cause side effects, although not everybody gets them.

Vancomycin may cause allergic reactions, but severe allergic reactions (anaphylactic reactions) are rare. If the patient suddenly experiences wheezing, difficulty breathing, redness of the upper body, rash, or itching, they should immediately

inform their doctor.

If the patient notices any of the following symptoms, they should stop using vancomycin and immediately

consult a doctor:

• red, flat, target-like or round spots on the torso, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. The occurrence of these severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome and toxic epidermal necrolysis).

Frequent side effects(may occur in up to 1 in 10 patients):

• low blood pressure
• shortness of breath, wheezing (high-pitched sound caused by obstruction of airflow in the upper airways)
• rash and inflammation of the mucous membrane of the mouth, itching, itchy rash, hives
• kidney function disorders detected in blood tests
• redness of the upper body and face, vein inflammation

Uncommon side effects(may occur in up to 1 in 100 patients):

• temporary or permanent hearing loss

Rare side effects(may occur in up to 1 in 1000 patients):

• decrease in white blood cell, red blood cell, and platelet count (blood cells responsible for blood clotting)
• increase in certain white blood cell count in the blood
• balance disorders, ringing in the ears, dizziness
• vein inflammation
• nausea (vomiting)
• kidney inflammation and kidney failure
• chest and back muscle pain
• fever, chills

Very rare side effects(may occur in up to 1 in 10,000 patients):

• sudden onset of severe skin allergic reaction, including skin peeling or blistering. This may be accompanied by high fever and joint pain.
• cardiac arrest
• intestinal inflammation causing abdominal pain and diarrhea, which may contain blood.

Frequency not known(frequency cannot be estimated from available data)

• vomiting, diarrhea
• confusion, drowsiness, lack of energy, swelling, fluid retention, decreased urine production
• rash with swelling and pain in the area behind the ears, neck, armpits, under the chin and under the arms (lymph node swelling), abnormal blood test results and liver function
• rash with blisters and fever

Reporting side effects

If side effects occur, including those not listed in this leaflet, inform the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. Reporting side effects will help gather more information on the safety of the medication.

5. How to store Edicin

Store the medication in a place out of sight and reach of children. Do not use after the expiry date stated on the packaging after the phrase EXP. The expiry date refers to the last day of the stated month. Store in a temperature below 25°C. Store in the original packaging. Storage of solutions: see "Preparation of infusion solution" at the end of the leaflet, in the section intended for healthcare professionals. Medications should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Edicin contains

The active substance of the medication is vancomycin. Each vial contains 500 mg or 1 g of vancomycin. Edicin does not contain other ingredients.

What Edicin looks like and contents of the pack

Edicin is a white or almost white lyophilized powder, placed in a vial made of transparent glass, with a rubber stopper and an aluminum cap, in a cardboard box. The packaging contains 1 or 10 vials.

Marketing authorization holder

Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d Verovškova 57 1526 Ljubljana, Slovenia For more detailed information about this medication, consult: Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warsaw tel. +48 22 209 70 00 Date of last revision of the leaflet:03/2025 (marketing authorization holder's logo)

Information intended for healthcare professionals only

The medicinal product should be administered by intravenous infusion or orally. Do not administer by rapid intravenous injection (bolus) or intramuscularly (see Summary of Product Characteristics, section 4.8). Intravenous administrationThe initial dose should be determined based on total body weight. Subsequent dose adjustments should be based on trough serum vancomycin concentrations, with the goal of achieving the target therapeutic concentration. Recommendations for dosing are presented below. * Continue until it is no longer necessary to remove necrotic tissue, the patient's clinical condition improves, and the patient is no longer feverish for 48 to 72 hours. ** In the case of prosthetic joint infections, consider longer cycles of oral suppressive therapy with appropriate antibiotics. *** The duration and need for combination therapy depend on the type of valve and microorganism. Patients over 65 years of ageDue to age-related kidney function impairment, lower maintenance doses may be necessary. Patients with kidney function disordersIn adult and pediatric patients with kidney function disorders, consider the initial dose, and then determine the trough serum vancomycin concentration, rather than the planned dosing schedule, especially in patients with severe kidney function disorders or those undergoing renal replacement therapy, due to the many variables affecting vancomycin concentrations in such patients. In patients with mild or moderate kidney function disorders, do not reduce the initial dose. In patients with severe kidney function disorders, it is preferable to extend the dosing intervals rather than administer lower doses. Properly evaluate concomitantly administered medications that may decrease vancomycin clearance and/or increase its adverse effects (see Summary of Product Characteristics, section 4.4). Vancomycin is poorly removed by intermittent hemodialysis. However, the use of high-flux dialysis membranes or continuous renal replacement therapy (CRRT) increases vancomycin clearance, and therefore, supplemental doses are essentially necessary (usually after a hemodialysis session in the case of intermittent hemodialysis). Adult patientsDose adjustments in adult patients may be based on the estimated glomerular filtration rate (eGFR) using the following formula: Men: [weight (kg) x 140 - age (years)] / 72 x serum creatinine concentration (mg/dl) Women: 0.85 x the value calculated using the above formula The usual initial dose for adult patients is 15 to 20 mg/kg; this dose can be administered every 24 hours to patients with a creatinine clearance of 20 to 49 ml/min. In patients with severe kidney function disorders (creatinine clearance below 20 ml/min) or those undergoing renal replacement therapy, the appropriate dosing intervals and subsequent doses depend largely on the RRT method used and should be determined based on trough serum vancomycin concentrations and residual renal function (see Summary of Product Characteristics, section 4.4). Depending on the clinical situation, it may be necessary to withhold the next dose until the vancomycin concentration in the blood is determined. Children and adolescentsDose adjustments in children over 1 year of age and adolescents may be based on the estimated glomerular filtration rate (eGFR) using the modified Schwartz formula: eGFR (ml/min/1.73 m^2) = (height in cm x 0.413) / serum creatinine concentration (mg/dl) eGFR (ml/min/1.73 m^2) = (height in cm x 36.2 / serum creatinine concentration (μmol/l) For newborns and infants under 1 year of age, consult an expert, as the Schwartz formula does not apply to such patients. The recommended dosing guidelines for children and adolescents are subject to the same principles as those for adult patients.

* The appropriate dosing intervals and subsequent doses depend largely on the RRT method used and should be determined based on trough serum vancomycin concentrations and residual renal function. Depending on the clinical situation, it may be necessary to withhold the next dose until the vancomycin concentration in the blood is determined. Patients with liver function disordersThere is no need to adjust the dose in patients with liver failure. PregnancyIn pregnant women, it may be necessary to significantly increase the doses to achieve therapeutic vancomycin concentrations in the blood (see Summary of Product Characteristics, section 4.6). Obese patientsIn obese patients, the initial dose should be adjusted individually based on total body weight, as for patients with normal body weight.

Intravenous administration

Patients 12 years and olderTreatment of Clostridium difficile-associated diarrhea (CDAD) The recommended dose of vancomycin is 125 mg every 6 hours for 10 days. The dose may be increased to 500 mg every 6 hours for 10 days in cases of severe or complicated disease. The maximum daily dose should not exceed 2 g. For patients with multiple recurrences, consider treating the current episode of CDAD with vancomycin 125 mg four times a day for 10 days, followed by a gradual dose reduction to 125 mg per day or a pulsing regimen, i.e., 125-500 mg/day every 2-3 days for at least 3 weeks. Newborns, infants, and children under 12 yearsThe recommended dose of vancomycin is 10 mg/kg every 6 hours for 10 days. The maximum daily dose should not exceed 2 g. The duration of treatment with vancomycin may need to be adjusted based on the clinical course of the disease in each case. Whenever possible, discontinue the use of the suspected offending antibiotic. Ensure adequate fluid and electrolyte supplementation. Monitoring vancomycin blood levels The frequency of monitoring therapeutic drug levels should be individualized based on the clinical situation and response to treatment; the frequency of sampling may range from daily in some unstable hemodynamic patients to at least once a week in stable patients with a visible response to treatment. In patients undergoing intermittent hemodialysis, determine the vancomycin concentration before the start of the hemodialysis session. Monitoring vancomycin blood levels after oral administration should be performed in patients with inflammatory bowel disease (see Summary of Product Characteristics, section 4.4). The minimum therapeutic vancomycin concentration in the blood should be 10-20 mg/l, depending on the site of infection and pathogen susceptibility. Clinical laboratories usually recommend a minimum concentration of 15-20 mg/l, ensuring better coverage of microorganisms classified as susceptible with an MIC ≥1 mg/l (see Summary of Product Characteristics, sections 4.4 and 5.1). In predicting individualized dosing necessary to achieve the appropriate AUC value, model-based approaches may be useful. A model-based approach can be used to calculate the individual initial dose, as well as to modify doses based on TDM results (see Summary of Product Characteristics, section 5.1). Administration method Intravenous administrationVancomycin is usually administered by intravenous infusion; the dosing recommendations presented in this section for the intravenous route refer to this method of administration. Vancomycin should be administered only by slow intravenous infusion lasting at least 1 hour or at a maximum rate of 10 mg/min (longer period) in a sufficiently diluted solution (at least 100 ml per 500 mg or at least 200 ml per 1000 mg), see Summary of Product Characteristics, section 4.4. Patients with limited fluid intake may receive a solution of 500 mg/50 ml (1000 mg/100 ml), but with this higher concentration, the risk of infusion-related adverse effects is increased. Consider using continuous vancomycin infusion, e.g., in patients with unstable vancomycin clearance. Oral administrationThe vial contents can be used to prepare an oral solution. The oral solution is prepared by dissolving the vial contents (500 mg vancomycin) in 30 ml of water. The appropriate dose can be administered to the patient to drink or through a nasogastric tube. Syrup can be added to the solution to improve the taste. Preparation of infusion solutionEdicin 500 mg The vial contents should be dissolved in 10 ml of water for injection. Edicin 1 g The vial contents should be dissolved in 20 ml of water for injection. 1 ml of the resulting solution contains 50 mg of vancomycin. The solution can be further diluted depending on the administration method. Multiple infusions The prepared solution should be diluted in 100 ml or 200 ml of 5% glucose solution or 0.9% sodium chloride solution. The vancomycin concentration in the resulting solution should not exceed 5 mg/ml. The solution should be administered intravenously slowly, at a maximum rate of 10 mg/min, over at least 60 minutes. Continuous infusion Use only when multiple infusions are not possible. The vancomycin solution with a concentration of 50 mg/ml should be diluted in a sufficient volume of 5% glucose solution or 0.9% sodium chloride solution so that the patient receives the prescribed daily dose in a drip infusion over 24 hours. Stability and storage conditions of solutionsThe prepared solution can be stored for up to 24 hours at a temperature between 2°C and 8°C. For microbiological reasons, the prepared solution should be used immediately. Otherwise, the user is responsible for the storage time and conditions of the prepared solution. IncompatibilitiesThe solution has a low pH and may be physically or chemically unstable when mixed with other substances. Vancomycin solutions should not be mixed with other solutions, except those whose compatibility has been reliably established. Avoid mixing vancomycin with alkaline solutions. It is not recommended to use vancomycin solutions concurrently with or mix them with chloramphenicol, corticosteroids, methicillin, heparin, aminophylline, cephalosporin antibiotics, or phenobarbital.

Overdose

In case of overdose, effects due to high vancomycin concentrations in the blood (ototoxic and nephrotoxic effects) can be expected. Supportive treatment is recommended, maintaining renal function. Vancomycin is poorly removed from the blood by hemodialysis or peritoneal dialysis. Limited benefit has been reported from the use of hemofiltration using Amberlite XAD-4 resin.

Other sources of information

Medical advice/education

Antibiotics are used to treat bacterial infections. They are ineffective against viral infections. If a doctor has prescribed antibiotics for the patient, they are necessary to treat the current illness. Despite antibiotic treatment, some bacteria may survive or multiply. This phenomenon is called resistance; it can make antibiotic treatment ineffective. Improper use of antibiotics promotes the development of resistance. The patient can also facilitate the development of resistance and thus delay recovery or reduce the effectiveness of antibiotic therapy if they do not follow the proper:

• dosing,
• treatment schedule,
• duration of treatment.

Therefore, to maintain the effectiveness of this medication, you should:

• 1 - use antibiotics only when prescribed by a doctor
• 2 - strictly follow the prescribed administration method
• 3 - do not use an antibiotic again without a doctor's recommendation, even to treat a similar illness.