Vancomicin Polpharma

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, information on the immediate packaging in a foreign language.

Vancomycin Polpharma (Vancomycin Azevedos), 500 mg, powder for solution for infusion

Concentrate for infusion solution
Vancomycinum
Vancomycin Polpharma and Vancomicina Azevedos are different trade names for the same medicine.

You should carefully read the contents of the 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 a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Vancomycin Polpharma 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 concentrate 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 subcutaneous tissue infections;
• bone and joint infections;
• pulmonary 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 associated with the above-mentioned infections.

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.

2. Important information before using Vancomycin Polpharma

When not to use Vancomycin Polpharma

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 Polpharma, you should discuss this with your doctor, hospital pharmacist, or nurse if:

• the patient has previously had an allergic reaction to teicoplanin, as this may mean 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 see a doctor immediately. During treatment with Vancomycin Polpharma, you should discuss this with your doctor, hospital pharmacist, or nurse if:

• the patient is receiving vancomycin treatment for a long time (blood tests and liver and kidney function tests may be necessary during treatment);
• the patient develops any skin rash during treatment;
• the patient develops severe or prolonged diarrhea during or after vancomycin treatment; in such cases, they should consult a doctor immediately. This may be a sign of colitis (pseudomembranous colitis), which can occur during antibiotic treatment.

Children

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

Vancomycin Polpharma and other medicines

You should tell your doctor, pharmacist, or nurse about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. You should be especially careful if you are taking other medicines that may interact with vancomycin, such as:

• Concomitant 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.
• During concomitant use of medications that can damage hearing, nerves, and/or kidneys (such as: etacrynic acid, aminoglycoside antibiotics, amphotericin B, bacitracin, polymyxin B, piperacillin/tazobactam, colistin, viomycin, or cisplatin), the doctor will closely monitor the patient's condition.
• During concomitant use of vancomycin and muscle relaxants, the doctor will exercise special caution.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult a doctor before using this medicine. Vancomycin can be used during pregnancy only if absolutely necessary, when the doctor believes that the benefits of treatment outweigh the risks. The doctor will recommend monitoring vancomycin levels in the serum 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

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

3. How to use Vancomycin Polpharma

The patient will receive Vancomycin Polpharma 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 dose 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 a loading dose of up to 30 mg per kilogram of body weight. The maximum daily dose of vancomycin should not exceed 2 grams.

Use in children

Children from the first month of life and children under 12 years of age The dose 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 birth to 27 days of postnatal age) The dose will be calculated based on postmenstrual age [the time from the first day of the last menstrual period to birth (gestational age) plus the time from birth (postnatal age)].

Administration method

Intravenous infusion (drip) means that the 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. If used to treat gastrointestinal disorders (so-called pseudomembranous colitis), the medicine must be administered orally (the patient will take the medicine 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 possible side effects. If you have any further doubts about using this medicine, you should consult a 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

notify their attending physician.

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

• red, flat, target-like or round spots on the torso, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. The occurrence of these severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome and toxic epidermal necrolysis).
• widespread rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).
• red, peeling rash with nodules 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 an obstruction in the airway)
• rash and inflammation of the mouth mucosa, itching, itchy rash, urticaria
• kidney function disorders detected in blood tests
• redness of the upper body and face, vein inflammation

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

• transient or permanent hearing loss

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

• 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
• vasculitis
• nausea (vomiting)
• kidney inflammation and kidney failure
• chest and back muscle pain
• fever, chills

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

• sudden onset of severe 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 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 side effects not listed in this leaflet, you should tell your 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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Vancomycin Polpharma

• The medicine should be stored out of sight and reach of children.
• Do not use after the expiry date stated on the packaging after the words EXP. The expiry date refers to the last day of the month stated.
• Store at a temperature below 25°C.
• Store in the original packaging.
• Storage of solutions: see "Preparation of infusion solution" at the end of the leaflet, in the section intended for healthcare professionals.
• Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Polpharma contains

The active substance of the medicine is vancomycin in the form of vancomycin hydrochloride. Each vial contains 500 mg of vancomycin. Vancomycin Polpharma does not contain any other ingredients.

What Vancomycin Polpharma looks like and what the packaging contains

Vancomycin Polpharma is a white or slightly brownish powder. A vial made of colorless glass type I, with a rubber stopper and an aluminum cap, in a cardboard box. The packaging contains 10 vials. For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Portugal, the country of export:

Laboratórios Azevedos – Indústria Farmacêutica, S.A. Estrada Nacional 117-2, Alfragide 2614-503 Amadora Portugal

Manufacturer:

Sofarimex – Indústria Química e Farmacêutica, S.A. Av. das Indústrias, Alto de Colaride 2735-213 Cacém Portugal

Parallel importer:

Zakłady Farmaceutyczne POLPHARMA S.A. ul. Pelplińska 19 83-200 Starogard Gdański

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa ul. Działkowa 56 02-234 Warszawa LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o. ul. Długosza 49 51-162 Wrocław

Marketing authorization number in Portugal, the country of export: 5623707

Parallel import authorization number: 292/24

Date of leaflet approval: 22.07.2024

(parallel importer's logo)
___________________________________________________________________________

Information intended for healthcare professionals only

The medicinal product should be administered by intravenous infusion or orally; it should not be administered by rapid intravenous injection (bolus) or intramuscularly. Intravenous administrationThe initial dose should be determined based on total body weight. Subsequent dose adjustments should be based on serum vancomycin levels, with the aim of achieving the target therapeutic concentration. When determining subsequent doses and intervals, kidney function should also be taken into account. 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 critically ill patients, a loading dose of 25-30 mg/kg may be used to facilitate rapid achievement of target vancomycin serum concentrations. Infants from the first month of life and children under 12 yearsThe recommended intravenous dose is 10 to 15 mg/kg every 6 hours. Newborns (from birth to 27 days of postnatal age) and premature infants (from birth to expected date of delivery plus 27 days)To determine the dosing regimen for newborns, you should consult a doctor experienced in treating newborns. One possible vancomycin dosing regimen for newborns is presented in the table below: PMA: postmenstrual 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 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. Patients with impaired renal functionIn adult and pediatric patients with impaired renal function, the initial dose should be based on the initial dose, and subsequent dose adjustments should be based on serum vancomycin levels, rather than the planned treatment schedule, especially in patients with severe renal impairment or those undergoing renal replacement therapy due to the many variables that affect vancomycin levels in such patients. Patients with hepatic impairmentNo dose adjustment is necessary in patients with hepatic impairment. PregnancyIn pregnant women, it may be necessary to significantly increase the doses to achieve therapeutic vancomycin serum concentrations. Obese patientsIn obese patients, the initial dose should be adjusted individually based on total body weight, as for patients with normal body weight. 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 lasting at least 60 minutes or at a maximum rate of 10 mg/min (longer period) in a sufficiently diluted solution (at least 100 ml per 500 mg). Patients with restricted fluid intake may receive a solution of 500 mg/50 ml, but at this higher concentration, the risk of infusion-related side effects is increased. Continuous infusion of vancomycin 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 infusion solutionThe contents of the vial should be dissolved in 10 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 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 Only use when multiple infusions are not possible. The vancomycin solution with a concentration of 50 mg/ml should be diluted in such a volume of 5% glucose solution or 0.9% sodium chloride solution that the patient receives the prescribed daily dose in a drip infusion over 24 hours. Stability and storage conditions of solutionsThe prepared solution can be stored for up to 24 hours at a temperature 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 established. Mixing vancomycin with alkaline solutions should be avoided. It is not recommended to use vancomycin solutions concurrently with chloramphenicol, corticosteroids, methicillin, heparin, aminophylline, cefalosporin antibiotics, and phenobarbital.

Overdose

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

Other sources of information

Medical advice/education

Antibiotics are used to treat bacterial infections. They are ineffective against viral infections. If a doctor has prescribed antibiotics, they are necessary to treat a specific, current illness. Despite antibiotic treatment, some bacteria may survive or multiply. This phenomenon is called resistance; it causes antibiotic treatment to be ineffective sometimes. 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, you should:

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