Vancomicin-mip 500

Leaflet accompanying the packaging: patient information

Vancomycin–MIP 500, 500 mg, powder for solution for infusion and oral solution

Oral

Vancomycin–MIP 1000, 1 g, powder for solution for infusion and oral solution

Vancomycin

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Vancomycin-MIP and what is it used for

Vancomycin is an antibiotic belonging to the class of glycopeptide antibiotics. The action of vancomycin involves killing certain bacteria that cause infections. Vancomycin in powder form is used to prepare a solution for infusion or oral solution.

Indications for use

Intravenous administration Vancomycin is used in all age groups in the form of an infusion (drip) to treat the following severe infections:

• skin and subcutaneous tissue infections;
• bone and joint infections;
• lung infections, known as pneumonia;
• infections of the inner lining of the heart (endocarditis);
• blood infections related to the above-mentioned infections. Oral administration Vancomycin may be given orally to adults and children to treat infection of the mucous membrane of the small and large intestine associated with damage to the mucous membrane (pseudomembranous colitis) caused by Clostridium difficilebacteria.

2. Important information before using Vancomycin-MIP

When not to use Vancomycin-MIP

• if the patient is allergic to vancomycin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

After injecting vancomycin into the eye, severe side effects have occurred, which can lead to loss of vision. Before starting treatment with Vancomycin-MIP, the patient should discuss this 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 infusion to treat diarrhea associated with Clostridium difficileinfection, instead of oral administration.
• the patient has ever had a severe skin rash or skin peeling, blisters, and (or) ulcers of the mouth 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 see their doctor immediately. During treatment with Vancomycin-MIP, the patient should discuss this with their doctor, hospital pharmacist, or nurse if:
• the patient is receiving long-term vancomycin treatment (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, they 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 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 the occurrence of skin redness (flushing) and allergic reactions. Additionally, concurrent use with other medicines, such as aminoglycoside antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen), or amphotericin B (an antifungal medicine), may increase the risk of kidney damage, and more frequent blood tests and kidney function tests may be necessary.

Vancomycin-MIP and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking, or have recently taken, and about any medicines they plan to take. Special caution is required if the patient is taking other medicines that may interact with vancomycin, such as:

• nephrotoxic (kidney-damaging) medicines (e.g., piperacillin with tazobactam) and ototoxic (hearing-damaging) medicines - may enhance each other's side effects; special caution is required when using aminoglycosides concurrently with vancomycin or immediately after it;
• anesthetics - may increase the risk of blood pressure drop, skin redness, flushing, hives, and itching (see section 4. Possible side effects);
• muscle relaxants - vancomycin may enhance and prolong the effects of muscle relaxants used during surgery, e.g., succinylcholine (neuromuscular blockade).

Use in elderly patients

The natural decline in glomerular filtration rate that occurs with age may lead to increased vancomycin levels in the blood if the dose is not properly adjusted (see "Dosing in patients with renal impairment").

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. There is insufficient observation on the use of vancomycin during pregnancy and breastfeeding in humans. Vancomycin can be given to pregnant women only when the benefit to the mother outweighs the potential risk to the fetus. Animal studies have not shown any effect of the medicine on the occurrence of developmental abnormalities. Vancomycin passes into human milk, and therefore, breastfeeding should be discontinued during treatment with this medicine, as the child may experience side effects.

Driving and using machines

There are no data available.

3. How to use Vancomycin-MIP

The patient will receive Vancomycin-MIP administered by medical staff during their hospital stay. The doctor will decide what dose of the medicine 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 medicines 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 kg of body weight. This dose is usually given every 8 to 12 hours. In some cases, the doctor may decide to use a starting dose of 30 mg per kg of body weight. The maximum daily dose should not exceed 2 g.

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 kg of body weight. This dose is usually given every 6 hours.
Preterm and full-term newborns (from 0 to 27 days of post-conceptional age)
The dose will be calculated based on post-conceptional age [the time from the first day of the last menstrual period to birth (gestational age) plus the time from birth (postnatal age)].

Oral administration

Adults and adolescents (12 to 18 years old)

The recommended dose is 125 mg every 6 hours. In some cases, the doctor may decide to use a higher daily dose, up to 500 mg every 6 hours. The maximum daily dose should not exceed 2 g.
If the patient has had other disorders (mucous membrane 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 kg of body weight. This dose is usually given every 6 hours. The maximum daily dose should not exceed 2 g.

Method of administration

Intravenous infusion (drip) means that the medicine 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.
Oral administration method
If used to treat gastrointestinal disorders (pseudomembranous colitis), the medicine must be given in the form of an oral solution (the patient will take the medicine orally).
The contents of one vial of Vancomycin-MIP 500 should be dissolved in 10 ml of water, and the contents of one vial of Vancomycin-MIP 1000 should be dissolved in 20 ml of water. Single doses can be drawn (e.g., 2.5 ml = 125 mg of vancomycin) and given to the patient to drink in a slightly diluted form or introduced through a gastric tube. A flavor enhancer, such as a commonly used syrup, can be added to the prepared solution.
Intravenous administration method
Detailed instructions are provided at the end of the leaflet, in the section "Information intended for healthcare professionals only".
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 possible side effects.

Using a higher dose of Vancomycin-MIP than recommended

Treatment used in case of overdose:

• a specific antidote is not known;
• high levels of vancomycin in the blood can be effectively reduced using hemodialysis with polysulfone membranes, as well as hemofiltration or hemoperfusion with polysulfone resins;
• in case of overdose, symptomatic treatment and maintenance of kidney function are necessary. If a higher dose of the medicine is taken, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Vancomycin-MIP

The patient should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• red, flat, target-like or circular spots on the torso, often with blisters in the center, skin peeling, ulcers of the mouth, throat, nose, genitals, and eyes. 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, usually at the beginning of treatment (acute generalized exanthematous pustulosis).

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.
Vancomycin absorption from the gastrointestinal tract is negligible. However, if the patient has an inflammatory gastrointestinal disease, and especially if they also have kidney problems, side effects may occur that are similar to those that occur after intravenous vancomycin administration (drip).

Common side effects (may affect up to 1 in 10 people):

• Low blood pressure,
• Shortness of breath, wheezing (a high-pitched sound caused by obstruction of the airway),
• Rash and inflammation of the mucous membrane of the mouth, itching, itchy rash, hives,
• Kidney problems, usually detected in blood tests,
• Redness of the upper body and face, vein inflammation.

Uncommon side effects (may affect up to 1 in 100 people):

• Temporary or permanent hearing loss

Rare side effects (may affect up to 1 in 1,000 people)

• Decreased number of white blood cells, red blood cells, and platelets (blood cells responsible for blood clotting), increased number of certain white blood cells in the blood,
• Balance disorders, ringing in the ears, dizziness,
• Vasculitis (inflammation of blood vessels),
• Nausea (nausea),
• Kidney inflammation and kidney failure,
• Chest and back muscle pain,
• Fever, chills.

Very rare side effects (may affect up to 1 in 10,000 people)

• Sudden onset of a 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 estimated from the 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 tests,
• Rash with blisters and fever.

Reporting side effects

If side effects occur, including any possible side effects not listed in this leaflet, the patient should inform their doctor or hospital pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 this medicine.

5. How to store Vancomycin-MIP

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Expiry date". The expiry date refers to the last day of the month.
Store in a temperature below 25°C, protected from light.
Shelf life of the oral solution
The prepared oral solution can be stored for 96 hours at a temperature of 2°C-8°C.
Shelf life of the infusion solution
The prepared infusion solution remains stable for 24 hours in the refrigerator, i.e., at a temperature of 2°C-8°C. The infusion solution is best used immediately after preparation.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Vancomycin-MIP contains

• The active substance of the medicine is vancomycin. Vancomycin-MIP 500: 1 vial contains 500 mg of vancomycin (in the form of 510 mg of vancomycin hydrochloride), which corresponds to 500,000 IU of vancomycin. Vancomycin-MIP 1000: 1 vial contains 1 g of vancomycin (in the form of 1020 mg of vancomycin hydrochloride), which corresponds to 1,000,000 IU of vancomycin. The medicine does not contain any other ingredients.

What Vancomycin-MIP looks like and contents of the packaging

Depending on the crystal structure of the active substance, the lyophilizate may have a color ranging from white to slightly pink or even brown.
Vancomycin-MIP 500: vials made of colorless glass, sealed with a stopper and aluminum cap, in a cardboard box containing 1 vial or 5 vials.
Vancomycin-MIP 1000: vials made of colorless glass, sealed with a stopper and aluminum cap, in a cardboard box containing 1 vial or 5 vials.
Not all pack sizes may be marketed.

Marketing authorization holder

MIP Pharma Polska Sp. z o.o.
ul. Orzechowa 5
80-175 Gdańsk
phone: 58 303 93 62
fax: 58 322 16 13
email: info@mip-pharma.pl

Manufacturer

Chephasaar, Chemisch-pharmazeutische Fabrik GmbH
Mühlstrasse 50
D-66386 St. Ingbert
Germany

Date of last revision of the leaflet:

Other sources of information

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
www.urpl.gov.pl

Medical advice and 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 a specific current illness.
Despite antibiotic treatment, some bacteria may survive or multiply. This phenomenon is called resistance; it makes antibiotic treatment ineffective in some cases. 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 medicine, the patient should:
• 1 - use antibiotics only when prescribed by a doctor.
• 2 - strictly follow the prescribed method of administration.
• 3 - not use antibiotics again without the doctor's recommendation, even to treat a similar illness.

Information intended for healthcare professionals only

The patient should read the current full information about the product contained in the Summary of Product Characteristics (SmPC) available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
Spectrum of antibacterial activity
Vancomycin is active against Gram-positive bacteria, such as staphylococci, streptococci, enterococci, pneumococci, and Clostridium. Gram-negative bacteria are resistant.
In some cases, an increasing number of resistance cases are observed, especially among enterococci; the occurrence of multi-drug resistant Enterococcus faeciumstrains is particularly concerning.
Cross-resistance with other glycopeptide antibiotics, such as teicoplanin, occurs.
Bacterial cultures should be taken to isolate and identify the causative microorganisms and determine their susceptibility to vancomycin.
Dosage
In appropriate cases, vancomycin should be used in combination with other antibacterial products.

Intravenous administration

The initial dose should be determined based on the total body weight. Subsequent dose adjustments should be based on serum levels, with the aim of achieving the target therapeutic level. When determining subsequent doses and intervals between them, kidney function should also be taken into account.
Patients 12 years and older
The recommended dose is 15 to 20 mg/kg every 8 to 12 hours (do not exceed 2 g per dose).
In critically ill patients, a loading dose of 25-30 mg/kg may be used to rapidly achieve the target minimum vancomycin level in the serum.
Infants from the first month of life and children under 12 years of age:
The recommended dose is 10 to 15 mg/kg every 6 hours (see section 4.4 of the SmPC).
Full-term newborns (from birth to 27 days of postnatal age) and preterm infants (from birth to the expected date of delivery plus 27 days)
To determine the dosing regimen for newborns, the patient should consult a doctor experienced in treating newborns. One possible dosing regimen for newborns is presented in the table below (see section 4.4 of the SmPC):

PMA: post-conceptional age [time from the first day of the last menstrual period to birth (gestational age) plus time from birth (postnatal age)].
Duration of treatment
The suggested duration of treatment is given 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 48-72 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.
Special patient groups
Elderly patients
Due to age-related kidney function impairment, lower maintenance doses may be necessary (see "Dosing in patients with renal impairment").

Oral administration

Patients 12 years and older
Treatment of Clostridium difficileinfection (CDI).
The recommended dose of vancomycin is 125 mg every 6 hours for 10 days in the case of the first episode of non-severe CDI. This dose may be increased to 500 mg every 6 hours for 10 days in the case of severe or complicated disease. The maximum daily dose should not exceed 2 g.
For patients with multiple recurrences, treatment of the current CDI episode with vancomycin 125 mg four times a day for 10 days, followed by a tapering dose to 125 mg per day or a pulsed regimen, i.e., 125-500 mg/day every 2-3 days for at least 3 weeks, may be considered.
Newborns, infants, and children under 12 years of age
The 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 according to the clinical course of the disease in each case. Whenever possible, the use of the suspected antibacterial agent should be discontinued. Adequate fluid and electrolyte supplementation should be ensured.

In the case of pregnant women, it may be necessary to significantly increase the doses to achieve therapeutic levels in the serum (see section 4.6 of the SmPC).
Obese patients
In obese patients, the initial dose should be adjusted individually based on the total body weight, as for patients with normal body weight.

Monitoring of vancomycin levels in the serum

The frequency of therapeutic monitoring (TDM) 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 once a week in stable patients with a visible response to treatment. In patients with normal kidney function, vancomycin levels in the serum should be determined on the second day of treatment, immediately before the next dose. In patients undergoing intermittent hemodialysis, vancomycin levels should be determined before the start of the hemodialysis session. Monitoring of vancomycin levels in the serum after oral administration should be performed in patients with inflammatory bowel disease (see section 4.4 of the SmPC). The minimum therapeutic level of vancomycin in the blood should be 10-20 mg/l, depending on the site of infection and the susceptibility of the pathogen. Clinical laboratories usually recommend a minimum level of 15-20 mg/l, ensuring better coverage of microorganisms classified as susceptible with an MIC ≥1 mg/l (see sections 4.4 and 5.1 of the SmPC). In predicting individual dosing required to achieve the appropriate AUC value, model-based methods may be useful. A model-based approach can be used when calculating the individual initial dose and when modifying doses based on TDM results (see section 5.1 of the SmPC).
Method of administration
Intravenous administration
Vancomycin is usually administered intravenously in the form of an intermittent infusion; the dosing recommendations provided in this section for the intravenous route refer to this method of administration.

The initial dose should be determined based on the total body weight. Subsequent dose adjustments should be based on serum levels, with the aim of achieving the target therapeutic level. When determining subsequent doses and intervals between them, kidney function should also be taken into account.
Patients 12 years and older
The recommended dose is 15 to 20 mg/kg every 8 to 12 hours (do not exceed 2 g per dose).
In critically ill patients, a loading dose of 25-30 mg/kg may be used to rapidly achieve the target minimum vancomycin level in the serum.
Infants from the first month of life and children under 12 years of age:
The recommended dose is 10 to 15 mg/kg every 6 hours (see section 4.4 of the SmPC).
Full-term newborns (from birth to 27 days of postnatal age) and preterm infants (from birth to the expected date of delivery plus 27 days)
To determine the dosing regimen for newborns, the patient should consult a doctor experienced in treating newborns. One possible dosing regimen for newborns is presented in the table below (see section 4.4 of the SmPC):

PMA: post-conceptional age [time from the first day of the last menstrual period to birth (gestational age) plus time from birth (postnatal age)].
Duration of treatment
The suggested duration of treatment is given 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 48-72 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.
Special patient groups
Elderly patients
Due to age-related kidney function impairment, lower maintenance doses may be necessary (see "Dosing in patients with renal impairment").
Patients with renal impairment
In adult and pediatric patients with renal impairment, the initial dose should be based on the estimated glomerular filtration rate (eGFR), and subsequent doses should be based on serum levels, rather than the planned dosing regimen, especially in patients with severe renal impairment or those undergoing renal replacement therapy (RRT), due to the many variables affecting vancomycin levels in these patients.
For 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 dosing intervals rather than administer lower doses.
The patient's concurrent medications that may decrease vancomycin clearance and (or) enhance its side effects should be carefully evaluated (see section 4.4 of the SmPC).
Vancomycin is poorly removed by intermittent hemodialysis. However, the use of high-flux dialysis membranes or continuous RRT increases vancomycin clearance, and supplemental doses are usually necessary (usually after a hemodialysis session, in the case of intermittent hemodialysis).
Adult patients
Dose 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.
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 dosing intervals and subsequent doses depend largely on the RRT method used and should be determined based on vancomycin serum levels and residual renal function (see section 4.4 of the SmPC). Depending on the clinical situation, it may be necessary to withhold the next dose until vancomycin levels are determined.
Children and adolescents
Dose adjustments in children and adolescents 1 year and older may be based on the estimated glomerular filtration rate (eGFR) using the modified Schwartz formula:
eGFR (ml/min/1.73 m2) = (height in cm x 0.413) / serum creatinine concentration (mg/dl)
eGFR (ml/min/1.73 m2) = (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 these patients.
Guidance on dosing in children and adolescents is provided in the table below, subject to the same rules as the recommendations for adult patients.
*The dosing intervals and subsequent doses depend largely on the RRT method used and should be determined based on vancomycin serum levels before administration and residual renal function. Depending on the clinical situation, it may be necessary to withhold the next dose until vancomycin levels are determined.
Patient with hepatic impairment:
No dose adjustment is necessary in patients with mild hepatic impairment.

Oral administration

Patients 12 years and older
Treatment of Clostridium difficileinfection (CDI).
The recommended dose of vancomycin is 125 mg every 6 hours for 10 days in the case of the first episode of non-severe CDI. This dose may be increased to 500 mg every 6 hours for 10 days in the case of severe or complicated disease. The maximum daily dose should not exceed 2 g.
Newborns, infants, and children under 12 years of age
The 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 according to the clinical course of the disease in each case. Whenever possible, the use of the suspected antibacterial agent should be discontinued. Adequate fluid and electrolyte supplementation should be ensured.

Monitoring of vancomycin levels in the serum should be performed in patients with inflammatory bowel disease (see section 4.4 of the SmPC). The minimum therapeutic level of vancomycin in the blood should be 10-20 mg/l, depending on the site of infection and the susceptibility of the pathogen. Clinical laboratories usually recommend a minimum level of 15-20 mg/l, ensuring better coverage of microorganisms classified as susceptible with an MIC ≥1 mg/l (see sections 4.4 and 5.1 of the SmPC).
Method of administration
Intravenous administration
Vancomycin is usually administered intravenously in the form of an intermittent infusion; the dosing recommendations provided in this section for the intravenous route refer to this method of administration.
The initial dose should be determined based on the total body weight. Subsequent dose adjustments should be based on serum levels, with the aim of achieving the target therapeutic level. When determining subsequent doses and intervals between them, kidney function should also be taken into account.
Patients 12 years and older
The recommended dose is 15 to 20 mg/kg every 8 to 12 hours (do not exceed 2 g per dose).
In critically ill patients, a loading dose of 25-30 mg/kg may be used to rapidly achieve the target minimum vancomycin level in the serum.
Infants from the first month of life and children under 12 years of age:
The recommended dose is 10 to 15 mg/kg every 6 hours (see section 4.4 of the SmPC).
Full-term newborns (from birth to 27 days of postnatal age) and preterm infants (from birth to the expected date of delivery plus 27 days)
To determine the dosing regimen for newborns, the patient should consult a doctor experienced in treating newborns. One possible dosing regimen for newborns is presented in the table below (see section 4.4 of the SmPC):

PMA: post-conceptional age [time from the first day of the last menstrual period to birth (gestational age) plus time from birth (postnatal age)].
Duration of treatment
The suggested duration of treatment is given 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 48-72 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.
Special patient groups
Elderly patients
Due to age-related kidney function impairment, lower maintenance doses may be necessary (see "Dosing in patients with renal impairment").
Patients with renal impairment
In adult and pediatric patients with renal impairment, the initial dose should be based on the estimated glomerular filtration rate (eGFR), and subsequent doses should be based on serum levels, rather than the planned dosing regimen, especially in patients with severe renal impairment or those undergoing renal replacement therapy (RRT), due to the many variables affecting vancomycin levels in these patients.
For 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 dosing intervals rather than administer lower doses.
The patient's concurrent medications that may decrease vancomycin clearance and (or) enhance its side effects should be carefully evaluated (see section 4.4 of the SmPC).
Vancomycin is poorly removed by intermittent hemodialysis. However, the use of high-flux dialysis membranes or continuous RRT increases vancomycin clearance, and supplemental doses are usually necessary (usually after a hemodialysis session, in the case of intermittent hemodialysis).
Adult patients
Dose 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.
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 dosing intervals and subsequent doses depend largely on the RRT method used and should be determined based on vancomycin serum levels and residual renal function (see section 4.4 of the SmPC). Depending on the clinical situation, it may be necessary to withhold the next dose until vancomycin levels are determined.
Children and adolescents
Dose adjustments in children and adolescents 1 year and older may be based on the estimated glomerular filtration rate (eGFR) using the modified Schwartz formula:
eGFR (ml/min/1.73 m2) = (height in cm x 0.413) / serum creatinine concentration (mg/dl)
eGFR (ml/min/1.73 m2) = (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 these patients.
Guidance on dosing in children and adolescents is provided in the table below, subject to the same rules as the recommendations for adult patients.
*The dosing intervals and subsequent doses depend largely on the RRT method used and should be determined based on vancomycin serum levels before administration and residual renal function. Depending on the clinical situation, it may be necessary to withhold the next dose until vancomycin levels are determined.
Patient with hepatic impairment:
No dose adjustment is necessary in patients with mild hepatic impairment.
Pregnancy:
In the case of pregnant women, it may be necessary to significantly increase the doses to achieve therapeutic levels in the serum (see section 4.6 of the SmPC).
Obese patients:
In obese patients, the initial dose should be adjusted individually based on the total body weight, as for patients with normal body weight.