Vancomicin Kabi

Leaflet accompanying the packaging: information for the user

Vancomycin Kabi, 500 mg, powder for concentrate for solution for infusion

Vancomycin Kabi, 1000 mg, powder for concentrate for solution for infusion

Vancomycin hydrochloride

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• 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 Kabi and what is it used for
• 2. Important information before using Vancomycin Kabi
• 3. How to use Vancomycin Kabi
• 4. Possible side effects
• 5. How to store Vancomycin Kabi
• 6. Contents of the packaging and other information

1. What is Vancomycin Kabi and what is it used for

Vancomycin Kabi is a medicine belonging to the class of glycopeptide antibiotics. The action of Vancomycin Kabi involves combating certain bacteria that cause infections. Vancomycin in powder form is used to prepare a solution for infusion or oral solution. Vancomycin is used in the form of an infusion (drip) in patients of all age groups for the treatment of the following severe infections:

• skin and subcutaneous tissue infections;
• bone and joint infections;
• pulmonary infections, known as pneumonia;
• infections of the inner lining of the heart (endocarditis) and prevention of endocarditis in patients at risk, undergoing major surgical procedures.

Vancomycin may be given orally to patients of all age groups for the treatment of infection of the small and large intestine mucosa associated with mucosal damage (pseudomembranous colitis) caused by the bacteria Clostridioidesdifficile.

2. Important information before using Vancomycin Kabi

When not to use Vancomycin Kabi

• If the patient is allergic (hypersensitive) to vancomycin.
• For intramuscular administration, due to the risk of tissue damage at the injection site.

Warnings and precautions

After injecting vancomycin into the eye, severe side effects have occurred, which can lead to vision loss. Before starting treatment with Vancomycin Kabi, consult a doctor, hospital pharmacist, or nurse if:

• the patient has previously experienced an allergic reaction to teicoplanin, as this may indicate that the patient is also allergic to vancomycin;
• the patient has hearing disorders, 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, instead of orally, for the treatment of diarrhea associated with Clostridioides difficileinfection;
• the patient has ever experienced severe skin rash or skin peeling and blisters and/or oral ulcers after receiving vancomycin.

During treatment with Vancomycin Kabi, consult a doctor, hospital pharmacist, or nurse if:

• the patient is being treated with 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 the end of vancomycin treatment, in which case they should immediately consult a doctor. This may be a symptom of colitis (pseudomembranous colitis), which can occur during antibiotic treatment.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported with vancomycin. If the patient notices any of the symptoms described in section 4, they should stop using vancomycin and immediately consult a doctor.

Children

Vancomycin will be used with special caution in premature infants and young infants, as their kidneys are not fully developed, which may 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 (a medicine used for fungal infections), may increase the risk of kidney damage, and more frequent blood tests and kidney function tests may be necessary.

Vancomycin Kabi and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. The following medicines may interact with Vancomycin Kabi:

• medicines used to prevent pain during surgery (anesthetics);
• muscle relaxants;
• medicines used for bacterial infections (e.g., polymyxin B, piperacillin/tazobactam, colistin, bacitracin, aminoglycosides);
• a medicine used for fungal infections (amphotericin B);
• an antitubercular medicine (viomycin);
• an anticancer medicine (cisplatin);
• strong diuretics (strong medicines that stimulate urine production), such as furosemide.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine. Vancomycin should be used during pregnancy and breastfeeding only if it is absolutely necessary. The doctor may recommend stopping breastfeeding.

Driving and using machines

Vancomycin does not affect or has a negligible effect on the ability to drive and use machines.

3. How to use Vancomycin Kabi

Vancomycin Kabi will be administered to the patient 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;
• the patient's 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 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 30 mg per kilogram of body weight. The maximum daily dose should not exceed 2 grams.

Children from the first month of life and children under 12 years

The dose will be calculated 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 the post-conceptual 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 of advanced age, pregnant women, and patients with kidney function disorders, a different dose may be necessary.

Oral administration

Adults and adolescents (12 to 18 years)

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 grams. If the patient has had other disorders (mucosal infection), a different dose and duration of treatment may be necessary.

Newborns, infants, and children under 12 years

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 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. For the treatment of gastrointestinal disorders (pseudomembranous colitis), the medicine must be administered as an oral solution (the patient will take the medicine orally).

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 undergo blood tests and urine analysis, and may also have a hearing test to check for potential side effects.

Using a higher dose of Vancomycin Kabi than recommended

Since the medicine will be administered to the patient in the hospital, it is unlikely that the patient will receive too much or too little of the medicine. Nevertheless, if the patient has any doubts, they should inform their doctor or nurse. In case of any further doubts about the use of this medicine, consult a doctor or nurse.

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 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, oral ulcers, 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 body temperature, 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).

Vancomycin may cause allergic reactions, although severe allergic reactions (anaphylactic shock) are rare. The patient should immediately inform their doctor if they experience:

sudden wheezing, difficulty breathing, redness of the upper body, rash, or itching.
The absorption of vancomycin from the gastrointestinal tract is negligible. However, if the patient has an inflammatory condition of the gastrointestinal tract, and especially if they also have kidney function disorders, side effects may occur that are similar to those that occur after vancomycin infusion (drip).

The following side effects have been reported:

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

• low blood pressure;
• shortness of breath, loud breathing (high-pitched sound caused by an obstruction in the airway);
• rash and oral mucositis, itching, itching rash, hives;
• kidney problems, which can be detected by 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):

• decrease in the number of white blood cells, red blood cells, and platelets (blood cells responsible for blood clotting);
• increase in the number of certain white blood cells in the blood;
• balance disorders, ringing in the ears, dizziness;
• vein inflammation;
• nausea (nausea);
• kidney inflammation and kidney failure;
• chest pain and back muscle pain;
• fever, chills.

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

• severe skin allergic reaction, such as scaly or blistered skin, which may be associated with high fever and joint pain;
• heart attack (sudden cardiac arrest);
• inflammation of the intestines, causing abdominal pain and diarrhea, possibly with blood.

Frequency not known (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;
• rash with blisters and fever.

Reporting side effects

If side effects occur, including any not listed in the leaflet, the patient should inform their doctor, hospital 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. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Vancomycin Kabi

Medical staff will be responsible for storing the medicine. 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 and vial after "EXP". The expiry date refers to the last day of the month stated. Store the powder in the original packaging. Store below 25°C. Store the vial in the outer packaging to protect from light. The solution for infusion should be used immediately after preparation. If not used immediately, the solution should be stored in a refrigerator (2-8°C) and used within the recommended period. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Vancomycin Kabi contains

• The active substance of the medicine is vancomycin.

Vancomycin Kabi, 500 mg, powder for concentrate for solution for infusion Each vial contains 500 mg of vancomycin hydrochloride, equivalent to 500,000 IU of vancomycin. Vancomycin Kabi, 1000 mg, powder for concentrate for solution for infusion Each vial contains 1000 mg of vancomycin hydrochloride, equivalent to 1,000,000 IU of vancomycin.

What Vancomycin Kabi looks like and contents of the pack

Vancomycin Kabi, 500 mg, powder for concentrate for solution for infusion

• White to cream-colored powder in a clear glass vial (type I) with a chlorobutyl rubber stopper (type I) coated with silicon and a gray flip-off cap made of aluminum/PP.
• Pack sizes: 1 vial, 10 vials.

Vancomycin Kabi, 1000 mg, powder for concentrate for solution for infusion

• White to cream-colored powder in a clear glass vial (type I) with a chlorobutyl rubber stopper (type I) coated with silicon and a green flip-off cap made of aluminum/PP.
• Pack sizes: 1 vial, 10 vials.

The medicine is in the form of a powder that must be dissolved and diluted before administration to the patient.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw

Manufacturer

Xellia Pharmaceuticals ApS, Dalslandsgade 11, 2300 Copenhagen S, Denmark For more detailed information, please contact the marketing authorization holder: Fresenius Kabi Polska Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw, tel. +48 22 345 67 89

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium Vancomycine Fresenius Kabi 500 mg powder for concentrate for solution for infusion Vancomycine Fresenius Kabi 1000 mg powder for concentrate for solution for infusion Bulgaria Ванкомицин Каби 500 mg прах за концентрат за инфузионен разтвор Ванкомицин Каби 1000 mg прах за концентрат за инфузионен разтвор Czech Republic Vancomycin Kabi Denmark Vancomycin Fresenius Kabi Estonia Vancomycin Kabi 500 mg Vancomycin Kabi 1000 mg Greece Vancomycin/Kabi 500 mg κόνις για πυκνό σκεύασμα για παρασκευή διαλύματος προς έγχυση Vancomycin/Kabi 1000 mg κόνις για πυκνό σκεύασμα για παρασκευή διαλύματος προς έγχυση Netherlands Vancomycine Fresenius Kabi 500 mg poeder voor concentraat voor oplossing voor infusie Vancomycine Fresenius Kabi 1000 mg poeder voor concentraat voor oplossing voor infusie Ireland Vancomycin 500 mg powder for concentrate for solution for infusion Vancomycin 1000 mg powder for concentrate for solution for infusion Iceland Vancomycin Fresenius Kabi Lithuania Vancomycin Kabi 500 mg milteliai infuzinio tirpalo koncentratui Vancomycin Kabi 1000 mg milteliai infuzinio tirpalo koncentratui Luxembourg Vancomycin Kabi 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung oder einer Lösung zum Einnehmen Vancomycin Kabi 1000 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung oder einer Lösung zum Einnehmen Latvia Vancomycin Kabi 500 mg pulveris infūziju šķīduma koncentrāta pagatavošanai Vancomycin Kabi 1000 mg pulveris infūziju šķīduma koncentrāta pagatavošanai Germany Vancomycin Kabi 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung oder einer Lösung zum Einnehmen Vancomycin Kabi 1000 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung oder einer Lösung zum Einnehmen Norway Vancomycin Fresenius Kabi 500 mg pulver til konsentrat til infusjonsvæske, oppløsning Vancomycin Fresenius Kabi 1000 mg pulver til konsentrat til infusjonsvæske, oppløsning Poland Vancomycin Kabi Portugal Vancomicina Kabi Romania Vancomicina Kabi 500 mg pulbere pentru concentrat pentru soluție perfuzabilă Vancomicina Kabi 1000 mg pulbere pentru concentrat pentru soluție perfuzabilă Slovenia Vankomicin Kabi 500 mg prašek za koncentrat za raztopino za infundiranje Vankomicin Kabi 1000 mg prašek za koncentrat za raztopino za infundiranje Slovakia Vancomycin Kabi 500 mg Vancomycin Kabi 1000 mg Hungary Vancomycin Kabi 500 mg por oldatos infúzióhoz való koncentrátumhoz Vancomycin Kabi 1000 mg por oldatos infúzióhoz való koncentrátumhoz United Kingdom Vancomycin 500 mg powder for concentrate for solution for infusion Vancomycin 1000 mg powder for concentrate for solution for infusion Date of last revision of the leaflet: 25.05.2021

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 a specific current illness. Despite the use of antibiotics, some bacteria may survive or multiply. This phenomenon is called resistance, which 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 medicine, 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 a doctor's recommendation, even to treat a similar illness.

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Information intended for healthcare professionals only:

Preparation

Concentrate

500 mg Dissolve the contents of the vial in 10 ml of sterile water for injection. 1000 mg Dissolve the contents of the vial in 20 ml of sterile water for injection.

Solution for infusion

500 mg Dilute the prepared concentrate (50 mg/ml) in at least 100 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, glucose 50 mg/ml (5%) solution for injection, sodium chloride 9 mg/ml (0.9%) in glucose 50 mg/ml (5%) solution for injection, or Ringer's solution with acetate for injection. 1000 mg Dilute the prepared concentrate (50 mg/ml) in at least 200 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, glucose 50 mg/ml (5%) solution for injection, sodium chloride 9 mg/ml (0.9%) in glucose 50 mg/ml (5%) solution for injection, or Ringer's solution with acetate for injection. The concentration of the prepared solution for infusion should not exceed 0.5% w/v (5 mg/ml). For patients with fluid restriction, a solution with a concentration of up to 10 mg/ml can be used; the use of such high concentrations may increase the risk of infusion-related side effects. Solutions obtained after dissolution and dilution should be inspected before administration for visible particles and discoloration. Only use a clear solution without visible particles.

Infusion

Administer the appropriate dose slowly by intravenous infusion over at least 60 minutes or at a rate not greater than 10 mg/min (whichever is longer), which corresponds to 2 ml/min for an infusion solution with a concentration of 5 mg/ml.

Solution for oral administration

A volume equivalent to 2.5 ml of the prepared concentrate contains 125 mg of vancomycin hydrochloride and should be diluted with 5 ml of water, i.e., 1 volume of the prepared concentrate should be diluted in 2 volumes of water. The diluted solution should be administered to the patient orally or through a nasogastric tube. A flavoring agent, such as a commonly used syrup, can be added to the prepared solution before administration.

Dosage

Intravenous administration

The initial dose is adjusted individually based on the patient's total body weight. The usual dose used is: Patients 12 years and older 15 to 20 mg/kg every 8 to 12 hours (do not exceed 2 grams per dose). Newborns from the first month of life and children under 12 years 10 to 15 mg/kg every 6 hours. Newborns (from birth to 27 days) and premature infants (from birth to the expected date of delivery plus 27 days) To determine the dosing schedule for newborns, consult a doctor experienced in treating newborns. One possible dosing schedule for vancomycin in newborns is presented in the table below: PMA: post-conceptual 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

Patients 12 years and older Treatment of Clostridioides difficileinfection (CDI): The recommended dose of vancomycin is 125 mg every 6 hours for 10 days for the first episode of non-severe Clostridioides difficileinfection. The dose can be increased to 500 mg every 6 hours for 10 days for severe or complicated infections. Do not exceed the maximum daily dose of 2 grams. Newborns, infants, and children under 12 years The recommended dose of vancomycin is 10 mg/kg every 6 hours for 10 days orally. Do not exceed the maximum daily dose of 2 grams.

Storage

Vancomycin Kabi, powder for concentrate for solution for infusion, should be stored below 25°C. Store the vial in the outer packaging to protect from light. Do not use Vancomycin Kabi, powder for concentrate for solution for infusion, after the expiry date stated on the carton. Prepared concentrate For intravenous administration: the prepared concentrate should be diluted immediately after preparation. For oral administration: the chemical and physical stability of the concentrate has been demonstrated for 96 hours at 2-8°C. Diluted medicine From a microbiological and physicochemical perspective, the medicine should be used immediately after dilution.