Patient Information Leaflet

Vancomycin SaneXcel, 500 mg, powder for solution for infusion concentrate
Vancomycin SaneXcel, 1 g, powder for solution for infusion concentrate
Vancomycin
Please read all of this leaflet carefully before using this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or nurse.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Leaflet contents:

What Vancomycin SaneXcel is and what it is used for
What you need to know before you use Vancomycin SaneXcel
How to use Vancomycin SaneXcel
Possible side effects
How to store Vancomycin SaneXcel
Contents of the pack and other information

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

Vancomycin SaneXcel is an antibiotic belonging to a class of antibiotics called glycopeptides. Vancomycin works by eliminating certain bacteria that cause infections.
Vancomycin SaneXcel is used to prepare an infusion solution.
Vancomycin is administered by infusion in all age groups for the treatment of the following serious infections:
Complicated skin and soft tissue infections.
Bone and joint infections.
Community-acquired pneumonia (CAP).
Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP).
Infection of the inner lining of the heart (endocarditis).

2. Important information before using Vancomycin SaneXcel

When not to use Vancomycin SaneXcel:
If the patient is allergic to vancomycin.
As an intramuscular injection due to the risk of necrosis (tissue damage) at the injection site.

Warnings and precautions
Before starting treatment with Vancomycin SaneXcel, discuss with your 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 elderly (hearing tests may be required during treatment).
The patient has impaired kidney function (blood and kidney function tests may be necessary during treatment).
The patient is receiving vancomycin by infusion to treat diarrhea associated with Clostridioides difficile infection, instead of oral administration.
The patient has ever experienced severe skin rash, skin peeling, blisters, and/or oral mucosal ulcers after receiving vancomycin.
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 therapy. If the patient notices any of the symptoms described in section 4, vancomycin should be discontinued immediately and medical advice should be sought without delay.
Severe adverse reactions, potentially leading to vision loss, have occurred after intravitreal injection of vancomycin.

During treatment with Vancomycin SaneXcel, discuss with your doctor, hospital pharmacist, or nurse if:
The patient is receiving vancomycin for a prolonged period (blood tests and liver and kidney function monitoring may be required during treatment).
The patient develops any skin reaction during treatment.
The patient develops severe or persistent diarrhea during or after completion of vancomycin treatment; in such a case, immediate medical consultation is necessary. This may be a sign of intestinal inflammation (pseudomembranous colitis), which can occur during antibiotic therapy.
Prolonged use of vancomycin may lead to overgrowth of resistant microorganisms.

Children under 12 years of age
Vancomycin should be used with particular caution in premature infants and young children, as their kidneys are not fully developed, which may lead to accumulation of vancomycin in the blood. Blood tests to monitor vancomycin blood levels may be required in this age group.
Concomitant administration of vancomycin and anesthetic agents has been associated with skin redness (flushing) and allergic reactions in children. Similarly, concomitant use with other drugs such as aminoglycoside antibiotics, nonsteroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen), amphotericin B (an antifungal agent), or piperacillin with tazobactam (when administered parenterally) may increase the risk of kidney damage; therefore, more frequent blood and kidney function tests may be necessary.

Elderly patients
The doctor may reduce maintenance doses.

Vancomycin SaneXcel and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
This is particularly important when taking or using any of the following medicines:
Medicinal products that inhibit intestinal peristalsis,
Proton pump inhibitors (medicines that reduce gastric acid secretion).
Particular caution is advised when taking/using other medicines, as some may interact with Vancomycin SaneXcel, for example, medicines used in the treatment of:
Bacterial infections (aminoglycosides, bacitracin, polymyxin B, colistin, piperacillin with tazobactam),
Tuberculosis (viomycin),
Fungal infections (amphotericin B),
Cancer (cisplatin),
Muscle relaxants,
Anesthetics,
Medicines that may cause neutropenia (decreased neutrophil count in blood) or agranulocytosis (decreased granulocyte count in blood),
Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen.
The doctor may monitor blood counts and adjust the dose if Vancomycin SaneXcel is administered concomitantly with these medicines.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning a pregnancy, she should consult her doctor before using this medicine.
The doctor will decide whether the patient can receive Vancomycin SaneXcel.

Driving and operating machinery
Vancomycin SaneXcel has no effect or has a negligible effect on the ability to drive vehicles or operate machinery. However, the patient should not drive or operate machinery if feeling unwell.

3. How to use Vancomycin SaneXcel

The patient will receive Vancomycin SaneXcel administered by medical personnel exclusively
during hospitalization. The physician will decide the daily dose the patient should receive and
how long the treatment should last.
Dosage
The dose given to the patient will depend on:
the patient's age,
the patient's body weight,
the type of infection,
renal function status,
the patient's hearing status,
any other medications the patient is taking.
Adults and adolescents (aged 12 years and older)
Dosage will be determined according to the patient's body weight. The usual intravenous infusion dose is 15 to 20 mg per kilogram of body weight. This dose is usually administered every 8 to 12 hours. In certain cases, the physician may decide to use an initial dose of up to 30 mg per kilogram of body weight.
The maximum daily dose should not exceed 2 g.
Use in children
Infants and children from 1 month of age up to less than 12 years
Dosage will be determined according to the patient's body weight. The usual intravenous infusion dose is 10 to 15 mg per kilogram of body weight. This dose is usually administered every 6 hours.
Preterm infants and full-term newborns (from 0 to 27 days)
The dose will be calculated based on postmenstrual age [the time elapsed from the first day of the mother's last menstrual period to delivery (gestational age) plus the time elapsed since the child's birth (postnatal age)].
Special patient groups
In elderly patients, pregnant women, and patients with impaired renal function, including dialyzed patients, adjustment of the dose may be necessary. The physician will decide on the appropriate dosage adjustment.
Method of administration
For intravenous use after reconstitution and dilution.
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 physician or nurse will always administer vancomycin intravenously, never intramuscularly.
Vancomycin will be administered intravenously over at least 60 minutes.
Duration of treatment
The duration of treatment depends on the type of infection present in the patient and may last several weeks.
The duration of treatment may vary depending on the individual patient's response to therapy.
During treatment, blood tests and urine analyses may be performed, and hearing tests may be conducted to monitor for potential adverse effects.
Accidental overdose of Vancomycin SaneXcel
Since this medicine is administered to the patient during hospitalization, it is unlikely that the patient will receive an excessive dose of Vancomycin SaneXcel. In case of any doubt, consult the physician immediately.
Missed dose of Vancomycin SaneXcel
Since this medicine is administered to the patient during hospitalization, it is unlikely that the patient will miss a dose of Vancomycin SaneXcel. However, if the patient suspects that a dose has been missed, the physician should be informed immediately.
If you have any further questions regarding the use of this medicine, consult your physician or nurse.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Vancomycin may cause allergic reactions; however, severe allergic reactions (anaphylactic reactions) are rare. If the patient suddenly develops wheezing, difficulty breathing, redness of the upper body, rash, or itching, the attending physician should be notified immediately.
If the patient notices any of the following symptoms, vancomycin should be discontinued and medical help sought immediately:
Red, flat, target-like or circular spots on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genital organs, and eyes. 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis).
Absorption of vancomycin from the gastrointestinal tract is minimal. However, if the patient has gastrointestinal inflammation, and especially if kidney function is impaired, adverse reactions similar to those occurring after intravenous vancomycin infusion may develop.

Common adverse reactions (may occur in up to 1 in 10 people)
Decreased blood pressure
Shortness of breath, wheezing (a high-pitched sound caused by an obstruction in airflow in the upper respiratory tract)
Rash and inflammation of the oral mucosa, itching, itchy rash, urticaria
Kidney function disorders detected usually in blood tests
Redness of the upper body and face, phlebitis

Uncommon adverse reactions (may occur in up to 1 in 100 people)
Transient or permanent hearing loss

Rare adverse reactions (may occur in 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 types of white blood cells in the blood
Balance disturbances, tinnitus, dizziness
Vasculitis
Nausea
Kidney inflammation and kidney failure
Chest pain and back muscle pain
Fever, chills

Very rare adverse reactions (may occur in up to 1 in 10,000 people)
Sudden onset of severe allergic skin reaction involving skin peeling or blister formation. 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, edema, fluid retention, reduced urine output
Rash with swelling and pain behind the ears, neck, groin, under the chin, and under the arms (lymph node swelling), abnormal blood test results and liver function abnormalities
Rash with blisters and fever

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, hospital pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Vancomycin SaneXcel

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and label after EXP. The expiry date refers to the last day of the indicated month.
Unopened vials: No special storage conditions apply.
The stability of the reconstituted concentrate and diluted product is provided at the end of the leaflet in the section intended for healthcare professionals.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Vancomycin SaneXcel contains

The active substance is vancomycin (in the form of vancomycin hydrochloride).
The medicine does not contain any other ingredients.

Vancomycin SaneXcel, 500 mg, powder for preparation of concentrate for infusion solution
Each vial contains 500 mg vancomycin hydrochloride, equivalent to 500,000 IU vancomycin.
After reconstitution with 10 mL of water for injections, 1 mL of concentrate for preparation of solution contains 50 mg vancomycin.
Vancomycin SaneXcel, 1 g, powder for preparation of concentrate for infusion solution
Each vial contains 1 g vancomycin hydrochloride, equivalent to 1,000,000 IU vancomycin.
After reconstitution with 20 mL of water for injections, 1 mL of concentrate for preparation of solution contains 50 mg vancomycin.

What Vancomycin SaneXcel looks like and contents of the pack
Vancomycin SaneXcel, 500 mg, powder for preparation of concentrate for infusion solution
Sterile powder in the form of a whitish to light beige solid.
Vial made of colourless type I glass with a capacity of 12 mL, with a bromobutyl rubber stopper coated with silicone and an aluminium seal, and a purple plastic flip-off cap.
Vancomycin SaneXcel, 1 g, powder for preparation of concentrate for infusion solution
Sterile powder in the form of a whitish to light beige solid.
Vial made of colourless type I glass with a capacity of 20 mL, with a bromobutyl rubber stopper coated with silicone and an aluminium seal, and a green plastic flip-off cap.
Pack sizes: 10 vials.
Not all pack sizes may be marketed.
The medicine is in the form of a powder which must be dissolved before administration to the patient.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
J.J. Bishop Health a.s.
Rybná 682/14, Staré Město
110 00 Prague 1
Czech Republic
e-mail: [email protected]

Manufacturer:
Anfarm Hellas S.A.
61st Km National Road Athens Lamia
320 09 Schimatari
Greece

This medicine is authorised for sale in the European Economic Area under the following names:
Czech Republic: Vancomycin SaneXcel
Poland: Vancomycin SaneXcel
Slovakia: Vancomycin SaneXcel 500 mg
Vancomycin SaneXcel 1000 mg

Other sources of information
Medical advice/education
Antibiotics are used to treat bacterial infections. They are ineffective against viral infections.
If your doctor has prescribed antibiotics for you, they are necessary for treating your current specific illness.
Despite antibiotic treatment, some bacteria may survive or multiply. This phenomenon is known as resistance: sometimes antibiotic treatment becomes ineffective.
Improper use of antibiotics increases resistance. You may even contribute to the development of resistance and thereby delay recovery or reduce the effectiveness of antibiotic therapy if you do not follow the correct:
Dosing
Treatment schedule
Duration of treatment
Therefore, to preserve the effectiveness of this medicine, you should:

Use antibiotics only when prescribed by a doctor.
Strictly follow the prescribed method of use.
Do not reuse antibiotics without a doctor's recommendation, even to treat a similar illness.

The following information is intended exclusively for healthcare professionals:
IMPORTANT: For additional information, please refer to the Summary of Product Characteristics.
Preparation of infusion solution
Before use, the powder must be dissolved in water for injections. Further dilution with an appropriate infusion solution is required.
The reconstituted solution must be diluted with compatible solutions, see below.
All procedures must be carried out under aseptic conditions.
First, add 10 mL of water for injections to the 500 mg vial or 20 mL of water for injections to the 1 g vial. Reconstitution in this way will yield a solution with a concentration of 50 mg/mL. After reconstitution in water, a clear solution is obtained.
The prepared vancomycin concentrate may be stored for up to 24 hours at a temperature below 25°C or up to 14 days in a refrigerator (at 2°C to 8°C) without significant loss of efficacy.
Before administration to the patient, the concentrate must be further diluted:
Dissolve the reconstituted concentrate of Vancomycin SaneXcel 500 mg in 100 mL of diluent (to a concentration of 5 mg/mL).
Dissolve the reconstituted concentrate of Vancomycin SaneXcel 1 g in 200 mL of diluent (to a concentration of 5 mg/mL).
In patients where restricted volume administration is necessary, the final vancomycin concentration in the infusion solution may be increased up to 10 mg/mL.
Compatibility with infusion solutions:
The following solutions are suitable for preparing the infusion solution:
0.9% sodium chloride infusion solution,
5% glucose solution,
Ringer's lactate solution,
0.9% sodium chloride and 5% glucose solution,
0.3% sodium chloride and 3.3% glucose solution,
Ringer's lactate and 5% glucose solution.
The ready-to-use infusion solution may be stored for up to 24 hours at a temperature below 25°C or up to 96 hours in a refrigerator (at 2°C to 8°C) within concentration ranges of 2.5 mg/mL to 10 mg/mL.

Storage
Unopened vials: No special storage requirements.
Reconstituted concentrate: After reconstitution, chemical and physical stability of the concentrate has been demonstrated for up to 24 hours at temperatures below 25°C or up to 14 days in a refrigerator (at 2°C to 8°C).
Further dilution of solutions: After further dilution of the infusion solution, chemical and physical stability of the concentrate has been demonstrated for 24 hours at temperatures below 25°C or 96 hours in a refrigerator (at 2°C to 8°C). Detailed information on reconstitution is provided above under "Preparation of infusion solution".
This product does not contain preservatives.
From a microbiological point of view, the product should be used immediately. If not used immediately, the responsibility for storage conditions and duration prior to use lies with the user and should normally not exceed 24 hours at 2°C to 8°C, unless reconstitution and dilution were carried out under controlled, validated aseptic conditions.