Vancomicin Aptapharma

Leaflet attached to the packaging: patient information

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

Vancomycin AptaPharma, 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, pharmacist, or nurse.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

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

Vancomycin is an antibiotic belonging to the class of antibiotics called "glycopeptides". The action of vancomycin is to kill certain bacteria that cause infections. Vancomycin is used in all age groups by infusion to treat the following severe infections: skin and subcutaneous tissue infections; bone and joint infections; lung infections known as "pneumonia"; hospital-acquired pneumonia, including ventilator-associated pneumonia; infections of the inner lining of the heart (endocarditis) and prevention of endocarditis in patients undergoing major surgical procedures. 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 bacteria Clostridium difficile. Vancomycin in powder form is used to prepare a solution for infusion or oral solution.

2. Important information before using Vancomycin AptaPharma

When not to use Vancomycin AptaPharma

if the patient is allergic to vancomycin; intramuscularly due to the risk of necrosis at the injection site.

Warnings and precautions

Before starting treatment with Vancomycin AptaPharma, the patient should discuss with their doctor, hospital pharmacist, or nurse if: they have ever had a severe skin rash or skin peeling, blisters, and/or ulcers after receiving vancomycin; they have had an allergic reaction to teicoplanin in the past, as this may mean they are also allergic to vancomycin; they have hearing problems, especially if they are elderly (hearing tests may be necessary during treatment); they have kidney problems (blood tests and liver and kidney function tests may be necessary during treatment); they are receiving vancomycin by infusion to treat diarrhea associated with Clostridium difficileinfection, rather than oral administration.

• if the patient has had a severe skin rash or skin peeling, blisters, and/or ulcers after receiving vancomycin;
• if the patient has had an allergic reaction to teicoplanin in the past, as this may mean they are also allergic to vancomycin;

There have been reports of severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) in association with vancomycin treatment. If the patient notices any of the symptoms described in section 4, they must stop using vancomycin and consult their doctor immediately. During treatment with vancomycin, the patient should discuss with their doctor, hospital pharmacist, or nurse if: they are receiving vancomycin for a long time (blood tests and liver and kidney function tests may be necessary during treatment); they are over 65 years old (the doctor may need to adjust the dose); they have a skin reaction; they have 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. After injecting vancomycin into the eye, severe adverse reactions have occurred, which can lead to vision loss.

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.

Vancomycin AptaPharma and other medicines

The patient should tell their doctor, pharmacist, or nurse about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Additionally, they should not take new medicines without consulting their doctor. The following medicines may interact with vancomycin if taken at the same time, such as medicines used to treat: bacterial infections(streptomycin, neomycin, gentamicin, kanamycin, amikacin, bacitracin, tobramycin, polymyxin B, colistin), tuberculosis(viomycin), fungal infections(amphotericin B), cancer(cisplatin), and muscle relaxants during anesthesia, anesthetics(if the patient is to undergo general anesthesia), proton pump inhibitors, gastrointestinal motility inhibitors(medicines used to relieve diarrhea symptoms), diuretics(medicines used to treat water retention), and non-steroidal anti-inflammatory drugs(medicines used to treat inflammation, mild to moderate pain, and fever).

• bacterial infections(streptomycin, neomycin, gentamicin, kanamycin, amikacin, bacitracin, tobramycin, polymyxin B, colistin),
• tuberculosis(viomycin),
• fungal infections(amphotericin B),
• cancer(cisplatin), and
• muscle relaxants during anesthesia,
• anesthetics(if the patient is to undergo general anesthesia),
• proton pump inhibitors,
• gastrointestinal motility inhibitors(medicines used to relieve diarrhea symptoms),
• diuretics(medicines used to treat water retention), and
• non-steroidal anti-inflammatory drugs(medicines used to treat inflammation, mild to moderate pain, and fever).

If vancomycin is given at the same time as other medicines, the doctor may order blood tests to adjust the dose. Concurrent administration of vancomycin and anesthetics in children is associated with the occurrence of skin redness (flushing) and allergic reactions. Similarly, concurrent use with other medicines, such as aminoglycoside antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen), or amphotericin B (an antifungal medicine) or piperacillin/tazobactam (in the case of parenteral preparations) may increase the risk of kidney damage, and therefore, more frequent blood tests and kidney function tests may be necessary.

Pregnancy and breastfeeding

Pregnancy If the patient is pregnant, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor before using this medicine. Vancomycin AptaPharma can be given during pregnancy and breastfeeding only if absolutely necessary. The doctor will decide whether the patient needs to take Vancomycin AptaPharma. Breastfeeding The patient should tell their doctor if they are breastfeeding, as Vancomycin AptaPharma passes into breast milk. The doctor will decide whether vancomycin is really necessary or whether the patient should stop breastfeeding.

Driving and using machines

Vancomycin AptaPharma has no influence or negligible influence on the ability to drive and use machines.

3. How to use Vancomycin AptaPharma

The patient will receive Vancomycin AptaPharma administered by medical staff during their hospital stay. The doctor will decide what dose of the medicine the patient needs to receive each day and how long the treatment should last.

Dosage

The administered dose will depend on: the patient's age, the patient's weight, the infection the patient has, the patient's kidney function, the patient's hearing, and all other medicines the patient is taking.

• the patient's age,
• the patient's weight,
• the infection the patient has,
• the patient's kidney function,
• the patient's hearing,
• all 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 weight. The usual dose used in infusion is 15 to 20 mg per kilogram of body weight. This dose is usually given every 8 to 12 hours. In some cases, the doctor may decide to use a loading dose of up to 30 mg per kilogram of body weight. The maximum daily dose should not exceed 2 g.

Use in children

Children from the first month and children under 12 yearsThe dosage will be determined based on the patient's weight. The usual dose used in infusion is 10 to 15 mg per kilogram of body weight. This dose is usually given every 6 hours. Preterm 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 mother's last menstrual period to birth (gestational age) plus the time from birth (postnatal age)]. In elderly patients, obese patients, pregnant women, and patients with kidney problems, including those on dialysis, a different dose may be necessary.

Duration of treatment

The duration of treatment depends on the type of infection the patient has and may last from 1 to 6 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 look for signs of possible side effects.

Oral administration

Adults and adolescents (from 12 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 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 The recommended dose is 10 mg per kilogram 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 means that the medicine flows from a bottle or infusion bag through a tube into one of the patient's blood vessels. 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 medicine must be given 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 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 look for signs of possible side effects.

Using a higher dose of Vancomycin AptaPharma than recommended

Since the medicine will be administered to the patient during their hospital stay, it is unlikely that vancomycin will be given in excess. If there are any doubts, the patient should immediately tell their doctor or nurse. If there are any further doubts about using this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine 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 consult their doctor immediately:

• red, flat, target-like or round 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 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 absorption 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 problems, adverse reactions may occur that are the same as those that occur after vancomycin infusion.

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

• 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, itching rash, hives
• kidney problems 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):

• decrease in the number of white blood cells, red blood cells, and platelets (blood cells responsible for blood clotting)
• increase in the number of a certain type of white blood cells 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 affect up to 1 in 10,000 people):

• sudden onset of severe allergic skin reaction, including skin peeling or blistering. This may be accompanied by high fever and joint pain.
• cardiac arrest
• inflammation of the intestine 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, on the neck, in the 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 side effects not listed in this leaflet, the patient should tell 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 collected on the safety of the medicine.

5. How to store Vancomycin AptaPharma

Before reconstitution: Store in a temperature below 25°C. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date (EXP) stated on the label and carton. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment. The stability of the solution after reconstitution and subsequent dilution is stated below in the information for healthcare professionals.

6. Contents of the packaging and other information

What Vancomycin AptaPharma contains

The active substance of the medicine is vancomycin (as hydrochloride). Vancomycin AptaPharma 500 mg Each vial contains 500 mg of vancomycin, equivalent to 500,000 IU. Vancomycin AptaPharma 1000 mg Each vial contains 1000 mg of vancomycin, equivalent to 1,000,000 IU.

What Vancomycin AptaPharma looks like and contents of the pack

Vancomycin AptaPharma, 500 mg: The powder is in a 10 mL vial made of clear, colorless Type I glass, with a chlorobutyl rubber stopper and a white aluminum-polypropylene cap, with a self-adhesive identification label. Vancomycin AptaPharma, 1000 mg: The powder is in a 20 mL vial made of clear, colorless Type I glass, with a chlorobutyl rubber stopper and a blue aluminum-polypropylene cap, with a self-adhesive identification label. The carton contains 10 vials. Vancomycin AptaPharma, 500 mg Each vial contains vancomycin hydrochloride, equivalent to 500 mg of vancomycin. After reconstitution with 10 mL of water for injection, a solution with a concentration of 50 mg/mL is obtained, and after further dilution, a solution with a concentration of 5 mg/mL is obtained. Vancomycin AptaPharma, 1000 mg Each vial contains vancomycin hydrochloride, equivalent to 1000 mg of vancomycin. After reconstitution with 20 mL of water for injection, a solution with a concentration of 50 mg/mL is obtained, and after further dilution, a solution with a concentration of 5 mg/mL is obtained.

Marketing authorization holder

Apta Medica Internacional d.o.o. Likozarjeva Ulica 6, 1000 Ljubljana, Slovenia

Manufacturer

Laboratorio Reig Jofré SA, Gran Capità, 10, 08970 Sant Joan Despí, Barcelona, Spain

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

Date of last revision of the leaflet:

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 a specific, current illness. Despite antibiotic treatment, some bacteria may survive or multiply. This phenomenon is called resistance; sometimes antibiotic treatment becomes ineffective. Improper use of antibiotics increases resistance. The patient may even facilitate the development of resistance and thus delay recovery or reduce the effectiveness of antibiotic therapy if they do not follow the proper: dosage, treatment schedule, and duration of treatment. Therefore, to maintain the effectiveness of this medicine, the patient should: not use antibiotics unless prescribed by a doctor; strictly follow the prescribed method of use; not use an antibiotic again without the doctor's recommendation, even to treat a similar illness.

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

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Information intended for healthcare professionals only

This information is part of the Summary of Product Characteristics, which is intended to assist in the administration of Vancomycin AptaPharma. When assessing the suitability of the medicine for a particular patient, the doctor should consult the Summary of Product Characteristics.

Intravenous administration

For intravenous infusion only. Do not administer intramuscularly. Preparation of the reconstituted solution The contents of each 500 mg vial should be dissolved in 10 mL of sterile water for injection. The contents of each 1000 mg vial should be dissolved in 20 mL of sterile water for injection. One mL of the reconstituted solution contains 50 mg of vancomycin. Appearance of the reconstituted solution After reconstitution, the solution is clear and colorless without particles. Preparation of the diluted solution for infusion The reconstituted solution containing 50 mg/mL of vancomycin should be further diluted. Suitable diluents are: 50 mg/mL (5%) glucose solution for injection, 9 mg/mL (0.9%) sodium chloride solution for injection, Ringer's solution with lactate, and Ringer's solution with acetate.

Intermittent infusion

The reconstituted solution containing 500 mg of vancomycin (50 mg/mL) should be initially diluted in at least 100 mL of diluent (to achieve 5 mg/mL). The reconstituted solution containing 1000 mg of vancomycin (50 mg/mL) should be initially diluted in at least 200 mL of diluent (to achieve 5 mg/mL). The concentration of vancomycin in the infusion solution should not exceed 5 mg/mL. The desired dose should be administered slowly intravenously at a rate not exceeding 10 mg/min over at least 60 minutes or longer.

Continuous infusion

This should only be used when intermittent infusion is not possible. Two to four 500 mg vials (1-2 g) or one to two 1000 mg vials (1-2 g) can be dissolved in an appropriate amount of the above-mentioned diluent and administered by drip, so that the prescribed daily dose is given to the patient over 24 hours.

Appearance of the diluted solution

After dilution, the solution is clear and colorless without particles. Before administration, the reconstituted and diluted solutions should be inspected for the presence of particles and discoloration. Only a clear and colorless solution without particles should be used.

Oral administration

In the case of oral administration, solutions containing 500 mg and 1000 mg of vancomycin can be diluted in 30 mL of water and given to the patient or administered through a nasogastric tube.

Shelf life

Shelf life of the reconstituted solution: The reconstituted solution with water for injection remains stable for 24 hours at a temperature of 2°C – 8°C. From a microbiological point of view, the solution should be used immediately. Shelf life of the diluted solution: The chemical and physical stability of the solution has been demonstrated: for 8 hours at 25°C, after reconstitution and further dilution with 9 mg/mL (0.9%) sodium chloride solution or 50 mg/mL (5%) glucose solution; for 4 days at 2°C - 8°C, after reconstitution and further dilution with Ringer's lactate or Ringer's acetate; for 14 days at 2°C - 8°C, after reconstitution and further dilution with 9 mg/mL (0.9%) sodium chloride solution or 50 mg/mL (5%) glucose solution. From a microbiological point of view, the product should be used immediately. Patients with renal impairment In adult patients and in children and adolescents with renal impairment, the initial dose should be based on the severity of the infection and the patient's renal function, and subsequent doses should be based on the lowest effective serum vancomycin concentration, rather than the planned treatment schedule, especially in patients with severe renal impairment or those undergoing renal replacement therapy (RRT), 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 dosing intervals rather than administer lower daily doses. The patient's concomitant medications that may decrease vancomycin clearance and/or increase the risk of adverse reactions (see section 4.4) should be properly evaluated. 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, supplementary doses are usually necessary (e.g., after a hemodialysis session in the case of intermittent hemodialysis). Vancomycin solutions have a low pH, which may cause chemical or physical instability when mixed with other substances. Mixing vancomycin with alkaline solutions should be avoided. This medicine should not be mixed with other infusion solutions except for 9 mg/mL (0.9%) sodium chloride solution, 50 mg/mL (5%) glucose solution, Ringer's lactate, or Ringer's acetate.