EDICIN 500 mg Powder

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Edicin, 500 mg, Powder for Solution for Infusion
3. Edicin, 1 g, Powder for Solution for Infusion
   1. Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet:
4. What Edicin is and what it is used for
5. Important information before using Edicin
   1. When not to use Edicin
   2. Warnings and precautions
   3. Children
   4. Edicin and other medications
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
6. How to use Edicin
   1. Dosage
   2. Adults and adolescents (12 years and older)
   3. Use in children
   4. Adults and adolescents (12 years and older)
   5. Use in children
   6. Method of administration
7. Possible side effects
   1. 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
   2. If the patient notices any of the following symptoms, they should stop taking vancomycin and consult their doctor immediately:
   3. Reporting side effects
8. How to store Edicin
9. Contents of the pack and other information
   1. What Edicin contains
   2. What Edicin looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Information intended for healthcare professionals only
   6. Oral administration
   7. Overdose
   8. Other sources of information
   9. Medical advice/education

Package Leaflet: Information for the Patient

Edicin, 500 mg, Powder for Solution for Infusion

Edicin, 1 g, Powder for Solution for Infusion

Vancomycin

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

1. What Edicin is and what it is used for

Vancomycin is an antibiotic belonging to the class of glycopeptide antibiotics. Vancomycin works by killing certain bacteria that cause infections. Vancomycin in powder form is used to prepare a solution for infusion or oral solution. Vancomycin is used in all age groups in the form of an infusion (drip) to treat the following severe infections: skin and soft tissue infections; bone and joint infections; lung infections, known as pneumonia; infections of the inner lining of the heart (endocarditis) and prevention of bacterial endocarditis in patients at risk undergoing major surgical procedures; central nervous system infections; blood infections related to the above-mentioned infections. Vancomycin may be given orally to adults and children to treat infections of the lining of the small and large intestine associated with damage to the lining (pseudomembranous colitis), caused by bacteria Clostridium difficile.

2. Important information before using Edicin

When not to use Edicin

if the patient is allergic to vancomycin.

Warnings and precautions

After injecting vancomycin into the eye, severe side effects have occurred, which can lead to vision loss. Before starting treatment with Edicin, the patient should discuss with their 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 problems, especially if they are elderly (hearing tests may be necessary during treatment); the patient has kidney problems (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 had a severe skin rash or skin peeling after taking 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 taking vancomycin and consult their doctor immediately. During treatment with Edicin, the patient should discuss with their 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 cases, the patient should consult their doctor immediately. This may be a sign of colitis (pseudomembranous colitis), which can occur during antibiotic treatment.

Children

Vancomycin will be used with 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 the occurrence of 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

The patient should inform their doctor, pharmacist, or nurse about all medications they are currently taking or have recently taken, as well as any medications they plan to take. The patient should be cautious if they are taking other medications that may interact with vancomycin, such as: Concurrent use of vancomycin and anesthetics may cause hypotension, dyspnea, skin redness, urticaria, 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 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 their 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 dose administered 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)]. For patients who are elderly, pregnant, or have kidney problems (including those on dialysis), a different dose may be necessary. Oral administration

Adults and adolescents (12 years and older)

The recommended dose is 125 mg every 6 hours. In some cases, the doctor may decide to use a higher daily dose, up to a maximum of 500 mg every 6 hours. The maximum daily dose should not exceed 2 grams. If the patient has had other conditions (intestinal infection), a different dose and duration of treatment may be necessary.

Use in children

Newborns, infants, and children under 12 years of age The recommended dose is 10 mg per kilogram of body weight. This dose is usually administered every 6 hours. The maximum daily dose should not exceed 2 grams.

Method of administration

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 over 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 for several weeks. The duration of treatment may vary depending on the patient's response to treatment. During treatment, the patient may have blood tests and urine analysis, and may also have a hearing test to check for potential side effects. If the patient has any further doubts about using this medication, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience 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 attending physician.

If the patient notices any of the following symptoms, they should stop taking vancomycin and consult their doctor immediately:

• red, flat, target-like or round patches 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).

• widespread rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).
• red, peeling rash with bumps under the skin and blisters, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis, see section 2 "Warnings and precautions").

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

• decreased blood pressure
• shortness of breath, wheezing (high-pitched sound caused by obstruction of airflow in the upper airways)
• rash and inflammation of the mouth, itching, itchy rash, hives
• kidney problems 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):

• transient or permanent hearing loss

Rare side effects(may occur in up to 1 in 1,000 patients):

• decreased white blood cell count, red blood cell count, and platelet count (blood cells responsible for blood clotting)
• increased white blood cell count
• balance disorders, ringing in the ears, dizziness
• vasculitis
• nausea (nausea)
• 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 allergic skin 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 determined 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 any not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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. By reporting side effects, more information can be gathered on the safety of the medication.

5. How to store Edicin

The medication should be stored out of sight and reach of children. Do not use after the expiration date stated on the packaging after the words EXP. The expiration date refers to the last day of the specified month. Store at a temperature below 25°C. Store in the original packaging. Storage of solutions: see "Preparation of the solution for infusion" at the end of the leaflet, in the section intended for healthcare professionals. Medications should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. 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 any 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 information about this medication, please contact: 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 is administered intravenously or orally; it should not be administered as a rapid intravenous injection (bolus) or intramuscularly (see section 4.8 of the Summary of Product Characteristics). Intravenous administrationThe initial dose should be determined based on total body weight. Subsequent dose adjustments should be based on serum vancomycin concentrations, with the aim of achieving the target therapeutic concentration. When determining subsequent doses and intervals, kidney function should also be considered. The following dosing regimens are recommended: Patients 12 years and olderThe recommended dose is 15 to 20 mg/kg every 8 to 12 hours (do not exceed 2 grams per dose). In severe cases, an initial dose of 25-30 mg/kg may be used to rapidly achieve the target minimum vancomycin concentration in serum. Infants from the first month of life and children under 12 years of ageThe recommended intravenous dose is 10 to 15 mg/kg every 6 hours. Full-term newborns (from birth to 27 days of postnatal age) and premature infants (from birth to the expected date of delivery plus 27 days)To determine the dosing regimen for newborns, the patient should consult an expert, as the Schwartz formula does not apply to such patients. One possible vancomycin dosing regimen for newborns is presented in the table below (see SmPC section 4.4): PMA: post-conceptual age [time from the first day of the last menstrual period to birth (gestational age) plus time from birth (postnatal age)]. Duration of treatmentThe recommended duration of treatment is presented in the table below. In each case, the duration of treatment should be adjusted according to the type and severity of the infection and the individual clinical response. * Continue until it is no longer necessary to remove necrotic tissue, the patient's clinical condition improves, and the patient has not had a fever for 48 to 72 hours. ** In the case of prosthetic joint infections, longer cycles of oral suppressive therapy with appropriate antibiotics should be considered. *** The duration and need for combination therapy depend on the type of valve and microorganism. Patients with impaired renal functionIn adult and pediatric patients with impaired renal function, the initial dose should be determined based on serum vancomycin concentrations, rather than the planned dosing regimen, especially in patients with severe renal impairment or those undergoing renal replacement therapy, due to the many variables that affect vancomycin concentrations in such patients. In patients with mild or moderate renal impairment, the initial dose should not be reduced. In patients with severe renal impairment, it is preferable to extend the intervals between doses rather than administer smaller doses. The patient should properly evaluate concomitantly administered medications that may decrease vancomycin clearance and/or increase its adverse effects (see SmPC section 4.4). Vancomycin is poorly removed by intermittent hemodialysis. However, the use of high-flux filters 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 renal impairment (creatinine clearance below 20 ml/min) or those undergoing renal replacement therapy, the appropriate intervals between doses and the size of subsequent doses depend largely on the RRT method used and should be determined based on serum vancomycin concentrations and residual renal function (see SmPC 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. In critically ill patients with renal impairment, the initial loading dose (25 to 30 mg/kg) should not be reduced. Children and adolescentsDose adjustments in children aged 1 year and older 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, the patient should consult an expert, as the Schwartz formula does not apply to such patients. The approximate dosing recommendations for children and adolescents presented in the table below are subject to the same principles as the recommendations for adult patients.

* The appropriate intervals between doses and the size of subsequent doses depend largely on the RRT method used and should be determined based on serum vancomycin concentrations before administration 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 impaired liver functionThere is no need to adjust the dose in patients with liver failure. PregnancyIn pregnant women, it may be necessary to significantly increase the dose to achieve therapeutic vancomycin concentrations in serum (see SmPC section 4.6). Obese patientsIn obese patients, the initial dose should be adjusted individually based on total body weight, just like in patients with normal body weight.

Oral administration

Patients 12 years and olderTreatment of Clostridium difficile-associated infections (CDI) 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 grams. In patients with multiple recurrences, treatment of the current CDI episode 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 (125-500 mg/day every 2-3 days) for at least 3 weeks, may be considered. Newborns, infants, and children under 12 years of ageThe recommended dose of vancomycin is 10 mg/kg every 6 hours for 10 days. The maximum daily dose should not exceed 2 grams. The duration of treatment with vancomycin may need to be adjusted according to the clinical course of the disease in each case. Whenever possible, the patient should stop using the suspected causative antibiotic. The patient should be ensured adequate fluid and electrolyte replacement. Monitoring vancomycin serum concentrations The frequency of monitoring vancomycin serum concentrations should be adjusted individually according to 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, vancomycin concentrations should be determined before the start of the hemodialysis session. Monitoring vancomycin serum concentrations after oral administration should be performed in patients with inflammatory bowel disease (see SmPC section 4.4). The minimum therapeutic vancomycin concentration in 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 SmPC sections 4.4 and 5.1). In predicting individual dosing required 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 and to adjust doses based on TDM results (see SmPC section 5.1). Method of administration Intravenous administrationVancomycin is usually administered intravenously in the form of intermittent infusions; 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 over 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 SmPC section 4.4. Patients with limited fluid intake may receive a solution of 500 mg/50 ml (1000 mg/100 ml), but at this higher concentration, the risk of infusion-related adverse effects is increased. Continuous vancomycin infusion may be considered, e.g., in patients with unstable vancomycin clearance. Oral administrationThe contents of the vial can be used to prepare an oral solution. The oral solution is prepared by dissolving the contents of the vial (500 mg of 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 the solution for infusionEdicin 500 mg The contents of the vial should be dissolved in 10 ml of water for injection. Edicin 1 g The contents of the vial 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 method of administration. 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 This should only be used 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 to provide the prescribed daily dose in a drip infusion over 24 hours. Stability and storage of solutionsThe prepared solution can be stored for up to 24 hours at a temperature of 2°C to 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 verified. Mixing vancomycin with alkaline solutions should be avoided. Concurrent use and mixing of vancomycin solutions with chloramphenicol, corticosteroids, methicillin, heparin, aminophylline, cephalosporin antibiotics, and phenobarbital are not recommended.

Overdose

In case of overdose, effects due to high vancomycin serum concentrations (ototoxic and nephrotoxic effects) can be expected. Supportive treatment is recommended to maintain renal function. Vancomycin is poorly removed from the blood by hemodialysis or peritoneal dialysis. Limited benefit has been reported with 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 the 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.

To maintain the effectiveness of this medication, the patient should:

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