Vancomycin Hikma

Package leaflet: Information for the patient

VANCOMICINA HIKMA 500 mg powder for concentrate for solution for infusion and for

oral solution
VANCOMICINA HIKMA 1000 mg powder for concentrate for solution for infusion and for
oral solution
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Vancomicina Hikma is and what it is used for
2. What you need to know before taking Vancomicina Hikma
3. How to take Vancomicina Hikma
4. Possible side effects
5. How to store Vancomicina Hikma
6. Contents of the pack and other information

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

Vancomycin is an antibiotic that belongs to a group of antibiotics called "glycopeptides".
Vancomycin works by killing certain bacteria that cause infections.
Vancomycin powder is converted into a solution for infusion or for oral solution.
Vancomycin Hikma is used in all age groups by infusion for the treatment of the following serious infections:

• Infections of the skin and underlying tissue.
• Infections of the bones and joints.
• Lung infection known as "pneumonia".
• Infection of the inner lining of the heart (endocarditis) and for prevention of endocarditis in patients at risk undergoing major surgical procedures.
• Infection of the central nervous system.
• Blood infection related to the above-mentioned infections.

Vancomycin is indicated for the treatment of serious infections caused by bacteria called methicillin-resistant staphylococci.
It is particularly indicated in patients who either cannot be treated with antibiotics called penicillins or cephalosporins, or who have not improved after their use, or in cases where the microorganisms causing the infection are sensitive to vancomycin and resistant to other antibiotics.
Your doctor may carry out tests to isolate and identify the bacterium responsible for the infection and to confirm that Vancomycin Hikma is effective against it.
Vancomycin is used orally in adults and children for the treatment of infections of the mucosa of the small and large intestine with mucosal damage (pseudomembranous colitis), caused by the bacterium Clostridium difficile.

2. What you must know before using Vancomycin Hikma

Do not use Vancomycin Hikma

• if you are allergic to vancomycin or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Serious adverse reactions have been reported which may lead to vision loss following
injection of vancomycin into the eyes.
Signs of allergic reaction to this medicine, including breathing difficulties and chest
pain, have been reported with vancomycin. Immediately stop using Vancomycin Hikma and contact your
doctor or emergency medical services immediately if you notice any of these signs.
Talk to your doctor, pharmacist, or nurse before using Vancomycin Hikma if:

• you have previously had an allergic reaction to the medicine teicoplanin, as this may mean you are also allergic to vancomycin;
• you have a hearing disorder, especially if you are elderly (you may require hearing tests during treatment). If you have hearing loss (hearing impairment), your doctor will not administer Vancomycin Hikma unless strictly necessary, considering a dose reduction. Deafness may be preceded by ringing in the ears (tinnitus). If you are elderly, you are more likely to experience hearing damage;
• you have kidney disease (you will need blood and kidney function tests during treatment);
• you are receiving vancomycin by infusion for the treatment of Clostridium difficile-associated diarrhoea rather than orally;
• you have ever developed a severe skin reaction, skin peeling, blisters, and/or mouth ulcers after taking vancomycin.

Serious skin reactions have been reported in association with vancomycin treatment, including
Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic
symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop using
vancomycin and seek immediate medical assistance if you notice any of the symptoms described in
section 4.
Talk to your doctor, hospital pharmacist, or nurse during treatment with vancomycin if:

• you have received vancomycin for a prolonged period (you may need liver and kidney blood tests during treatment);
• you are taking other medicines at the same time that may cause a reduction in white blood cells (neutropenia): your doctor will perform periodic checks, as cases of neutropenia have been observed in patients treated with vancomycin;
• you develop any skin reaction during treatment;
• you develop severe and persistent diarrhoea during or after using vancomycin, contact your doctor immediately. This could be a sign of inflammation of the intestine (pseudomembranous colitis), which may occur following antibiotic treatment.

Your doctor will avoid administering Vancomycin Hikma subcutaneously or intramuscularly because this may
cause pain, irritation, or death of cells (necrosis) at the injection site. Vancomycin Hikma
will be administered into a vein (intravenously), and your doctor will take particular
care to avoid leakage of the medicine from the vein (extravasation).
Despite these precautions, after intravenous administration of Vancomycin Hikma, inflammation and formation of blood clots in the veins (thrombophlebitis) are not uncommon, sometimes severe. The frequency and severity of these events can be reduced if the medicine is injected slowly intravenously in diluted form and by changing the injection site. If Vancomycin Hikma is administered rapidly intravenously (bolus administration within a few minutes), you may experience flushing, severe drop in blood pressure (hypotension), shock, and, rarely, cardiac arrest. To avoid these events, the medicine must be administered over a period of not less than 60 minutes, with monitoring of heart rate and blood pressure.
If you are undergoing anaesthesia, you may more frequently experience low blood pressure (hypotension), redness (erythema), urticaria, and itching. To reduce the likelihood of such events, Vancomycin Hikma should be administered slowly, 60 minutes before the use of the anaesthetic agent.

Children
Vancomycin Hikma will be used with particular caution in premature infants and newborns, as their
kidneys are not fully developed and may accumulate vancomycin in the blood. This
age group requires blood tests to monitor vancomycin blood levels.
Concomitant administration of vancomycin and anaesthetic agents has been associated with
skin redness (erythema) and allergic reactions in children. Similarly, concomitant 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 therefore more frequent blood and kidney function tests may be required.

Elderly
If you are elderly, your doctor will adjust the dose of Vancomycin Hikma, as due to the natural
age-related decline in kidney filtration capacity, the amount of medicine in the blood may
easily become elevated.

Other medicines and Vancomycin Hikma
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor will pay particular attention when administering vancomycin together with:

• other medicines with potential toxicity to the hearing and kidney systems, such as aminoglycosides, amphotericin B, bacitracin, cisplatin, colistin, polymyxin B, piperacillin/tazobactam, especially if you already have hearing loss (hearing impairment) and reduced kidney function (renal insufficiency) before starting treatment;
• anaesthetics, as skin reactions (cutaneous erythema, histamine-like flushing) and severe allergic reactions (anaphylactoid reactions) may occur.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Pregnancy
Use this medicine during pregnancy only if your doctor considers it strictly necessary.
Breastfeeding
Vancomycin passes into breast milk. If you are breastfeeding, your doctor will administer vancomycin
with caution.

Driving and using machines
No adverse effects on the ability to drive vehicles or operate machinery are known.

3. How to use Vancomycin Hikma

Vancomycin will be administered to you by medical staff while you are in hospital. Your doctor will decide how much of this medicine you should receive each day and how long your treatment will last.

Dosage
The dose administered will depend on:

• your age,
• your body weight,
• the type of infection you have,
• your kidney function status,
• your hearing ability,
• other medicines you are taking.

Intravenous administration
Adults and adolescents (from 12 years of age)
The dose will be calculated based on your body weight. The usual infusion dose is 15–20 mg per kg of body weight. It is generally administered every 8–12 hours. In some cases, your doctor may decide to administer an initial dose of up to 30 mg per kg of body weight. The maximum dose should not exceed 2 g per single dose.

Use in children
Children from one month up to less than 12 years of age
The dose will be calculated based on body weight. The usual infusion dose is 10–15 mg per kg of body weight. It is generally administered every 6 hours.

Premature infants and newborns (from 0 to 27 days of age)
Dosage will be calculated based on postmenstrual age [(time elapsed from the first day of the last menstrual period to birth (gestational age) plus time elapsed after birth (postnatal age))].

Elderly patients, pregnant women, and patients with kidney disease, including those on dialysis, may require a different dose.

Oral administration
For adults and adolescents (from 12 to 18 years of age)
The recommended dose is 125 mg every 6 hours. In some cases, your doctor may decide to prescribe a higher daily dose, up to 500 mg every 6 hours. The maximum daily dose should not exceed 2 g.
If you have previously experienced further episodes (mucosal infection), you may require a different dose and duration of therapy.

Use in children
Newborns, infants, and children under 12 years of age
The recommended dose is 10 mg per kg of body weight. It is generally administered every 6 hours. The maximum daily dose should not exceed 2 g.

Method of administration
Intravenous infusion means that the medicine flows from an infusion bottle or bag through a tube into one of your blood vessels and into your body. Your doctor or nurse will always administer vancomycin intravenously, never into muscle.

Vancomycin will be administered into the vein over at least 60 minutes.

If administered for the treatment of gastrointestinal disorders (so-called pseudomembranous colitis), the medicine must be given as an oral solution (you will take the medicine by mouth).
In these cases, the contents of the vial should be diluted in approximately 50 ml of water. To improve taste, sweet syrups may be added to the solution.

Vancomycin Hikma will be given to you either as an oral solution to drink or administered via a tube inserted through the nose into the stomach (nasogastric tube).

Duration of treatment
The duration of treatment depends on the type of infection and may last several weeks.
The length of therapy may vary for each patient depending on individual response to treatment.

During treatment, you may need to undergo blood tests; you may also be asked to provide urine samples and have hearing tests to monitor for possible adverse effects.

If you take more Vancomycin Hikma than you should
In case of accidental ingestion or overdose of Vancomycin Hikma, contact your doctor immediately or go to the nearest hospital.

If you have any doubts about how to use this medicine, consult your 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, although severe allergic reactions (anaphylactic shock) are rare. Inform your doctor immediately if you experience sudden wheezing, difficulty breathing, redness of the upper body, rash or itching.
Stop taking vancomycin and inform your doctor or nurse immediately if you experience any of the following symptoms:

• Flat, reddish spots, target-shaped or circular, on the trunk, often with central blisters, skin peeling, mouth ulcers, or ulcers in the throat, nose, genitals and eyes. These serious 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 syndrome or drug hypersensitivity syndrome).
• Widespread, red, scaly rash with subcutaneous bumps and blisters accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis).
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Absorption of vancomycin from the gastrointestinal tract is negligible. However, if you have an inflammatory disease of the digestive tract, especially if you also have kidney disease, side effects may occur that are typically seen when vancomycin is administered by infusion.
Common side effects (may affect up to 1 in 10 people):

• Decreased blood pressure
• Shortness of breath, noisy breathing (a high-pitched sound caused by obstruction of airflow in the upper airways)
• Inflammation and rash inside the mouth, itching, itchy rash, hives
• Kidney problems, which may mainly be detected in blood tests
• Redness of the upper body and face, inflammation of a vein
• Increased liver enzymes

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 white blood cells, red blood cells and platelets (blood cells responsible for clotting); increase in certain white blood cells in the blood
• Loss of balance, ringing in the ears, dizziness
• Inflammation of blood vessels
• Nausea (feeling of disgust)
• Inflammation of the kidneys 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 reaction with blistering or skin peeling. This may be associated with high fever and joint pain
• Cardiac arrest
• Inflammation of the intestine causing abdominal pain and diarrhoea, which may contain blood

Frequency not known (frequency cannot be estimated from the available data):

• Vomiting, diarrhoea
• Confusion, dizziness, loss of energy, swelling, fluid retention, reduced urine output
• Rash with swelling or pain behind the ears, in the neck, groin, under the chin and armpits (swollen lymph nodes), abnormal liver function and blood tests
• Rash with blisters and fever
• Excessive breakdown of red blood cells causing fatigue and pale skin (haemolytic anaemia)

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor, hospital pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vancomycin Hikma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after "Exp.". The expiry date refers to the last day of that month.
The stability of the reconstituted solution and of the product after dilution is reported in the information for healthcare professionals.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Vancomycin Hikma contains
Vancomycin Hikma 500 mg powder for concentrate for solution for infusion and for oral solution
The active substance is vancomycin hydrochloride equivalent to 500 mg of vancomycin.
Each vial contains 500 mg of vancomycin (as hydrochloride) equivalent to 500,000 IU of
vancomycin.
Vancomycin Hikma 1000 mg powder for concentrate for solution for infusion and for oral solution
The active substance is vancomycin hydrochloride equivalent to 1 g of vancomycin.
Each vial contains 1000 mg of vancomycin (as hydrochloride) equivalent to 1,000,000 IU of
vancomycin.

Description of the appearance of Vancomycin Hikma and contents of the pack
The lyophilized powder ranges in color from white to light brown.

Vancomycin Hikma 500 mg powder for concentrate for solution for infusion and for oral solution
Powder for concentrate for solution for infusion and for oral solution
Carton containing 1 vial or 10 vials

Vancomycin Hikma 1000 mg powder for concentrate for solution for infusion and for oral solution
Powder for concentrate for solution for infusion and for oral solution
Carton containing 1 vial or 10 vials

Further information
Medical advice/information
Antibiotics are used to treat bacterial infections. They are ineffective against viral infections.
If your doctor has prescribed antibiotics, they are specifically intended for your current illness.
Despite antibiotic treatment, some bacteria may survive or multiply. This phenomenon is known as resistance: some antibiotic treatments become ineffective.
The misuse of antibiotics increases resistance. It may also help bacteria become resistant, thereby delaying treatment or reducing antibiotic effectiveness if you do not follow the appropriate:

• dosage
• schedule
• duration of treatment

Therefore, to maintain the effectiveness of this medicine:

1. Use antibiotics only when prescribed.
2. Follow the instructions strictly.
3. Do not reuse an antibiotic without a medical prescription, even if you wish to treat a similar illness.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Hikma Italia SpA
Viale Certosa, 10 – 27100 Pavia (PV), Italy

Manufacturer
Hikma Italia SpA
Viale Certosa, 10 – 27100 Pavia (PV), Italy

The following information is intended exclusively for physicians or healthcare professionals

CLINICAL INFORMATION
Dosage, method and timing of administration
Dosage and method of administration
Dosage
Where appropriate, vancomycin should be administered in combination with other antibacterial agents.

Intravenous administration
The initial dose should be based on total body weight. Subsequent dose adjustments should be based on serum concentrations to achieve established therapeutic levels. Renal function must be taken into account for subsequent doses and dosing intervals.

Patients aged 12 years and older
The recommended dose is 15–20 mg/kg of body weight every 8–12 hours (should not exceed 2 g per dose).
In severely ill patients, an initial dose of 25–30 mg/kg of body weight may be used to facilitate achieving the target trough serum concentration.

Infants and children from 1 month up to 12 years of age
The recommended dose is 10–15 mg/kg of body weight every 6 hours (see section 4.4 of the Summary of Product Characteristics).

Term neonates (from birth up to 27 days of age) and preterm neonates (from birth up to 27 days after the expected date of delivery)
To establish an appropriate dosing regimen for neonates, advice should be sought from a physician experienced in neonatal care. A possible vancomycin dosing regimen for neonates is shown in the following table (see section 4.4).

PMA: postmenstrual age [(time elapsed from the first day of the last menstrual cycle to birth
(gestational age) plus the time elapsed after birth (postnatal age))].
Perioperative prophylaxis of bacterial endocarditis in all age groups
The recommended dose is an initial dose of 15 mg/kg before anesthesia induction. Depending on the
duration of the procedure, a second dose of vancomycin may be required.
Duration of treatment
The recommended duration of treatment is shown in the table below. In any case, the duration of
treatment should be adjusted according to the type and severity of the infection and individual clinical response.

*Continue until no further debridement is required, the patient has clinically improved,
and the patient has been afebrile for 48–72 hours.
** In the case of prosthetic joint infections, longer durations of oral antibiotic suppressive therapy should be considered with the indicated antibiotics.
***The duration and need for combination therapy depend on the type of valve and the causative organism.

Special populations
Elderly
Lower maintenance doses may be required due to age-related reduction in renal function.

Renal impairment
In pediatric and adult patients with renal impairment, consideration should be given to administering an initial dose followed by monitoring of vancomycin serum trough levels, rather than using a fixed scheduled dosing regimen—particularly in patients with severe renal impairment or those undergoing renal replacement therapy (RRT)—due to the many variable factors that may affect vancomycin levels in these patients.

In patients with mild to moderate renal impairment, the initial dose should not be reduced. In patients with severe renal impairment, it is preferable to prolong the dosing interval rather than administer lower daily doses.

Particular consideration should be given to concomitant administration of medicinal products that may reduce vancomycin clearance and/or enhance its adverse effects (see section 4.4 of the Summary of Product Characteristics).

Vancomycin is poorly dialyzable by intermittent hemodialysis. However, the use of high-flux membranes and continuous renal replacement therapy (CRRT) increases vancomycin clearance and generally requires supplemental dosing (usually after the hemodialysis session in the case of intermittent hemodialysis).

Adults
Dose adjustments in adult patients may be based on estimated glomerular filtration rate (eGFR) using the following formula:
Men: [Weight (kg) × (140 – age in years)] / (72 × serum creatinine [mg/dL])
Women: 0.85 × the value calculated from the formula above.

The usual initial dose for adult patients is 15–20 mg/kg, which may be administered every 24 hours in patients with creatinine clearance between 20 and 49 mL/min. In patients with severe renal impairment (creatinine clearance < 20 mL/min) or those undergoing renal replacement therapy, the appropriate timing and dosage of subsequent doses largely depend on the type of RRT and should be based on serum vancomycin trough levels and residual renal function (see section 4.4 of the Summary of Product Characteristics).

Depending on the clinical situation, delaying the next dose to await vancomycin level results may be considered.

In critically ill patients with renal impairment, the initial loading dose (25–30 mg/kg) should not be reduced.

Pediatric population
Dose adjustments in pediatric patients aged 1 year and older may be based on estimated glomerular filtration rate (eGFR) using the revised Schwartz formula:
eGFR (mL/min/1.73 m²) = (height in cm × 0.413) / serum creatinine (mg/dL)
eGFR (mL/min/1.73 m²) = (height in cm × 36.2) / serum creatinine (μmol/L)

For neonates and infants under 1 year of age, expert consultation should be sought, as the Schwartz formula is not applicable to this population.

Guideline dose recommendations for the pediatric population are shown in the table below, following the same principles as for adult patients.

*The appropriate timing and amount of subsequent doses largely depends on the mode of RRT and should be based on serum vancomycin levels obtained prior to dosing and on residual renal function. Depending on the clinical situation, consideration may be given to delaying the next dose to await the results of vancomycin levels.

Hepatic impairment:
Dosage adjustment is not required in patients with hepatic impairment.

Pregnancy
Significantly increased doses may be required to achieve therapeutic serum concentrations in pregnant women (see Section 4.6 of the Summary of Product Characteristics).

Obese patients
In obese patients, the initial dose should be individually adjusted according to total body weight as in non-obese patients.

Oral administration
Patients aged 12 years and older
Treatment of Clostridium difficile infection (CDI):
The recommended dose of vancomycin is 125 mg every 6 hours for 10 days for the first episode of non-severe CDI. This dose may be increased to 500 mg every 6 hours for 10 days in cases of severe disease or with complications. The maximum daily dose should not exceed 2 g.

In patients with multiple recurrences, consideration may be given to treating the current episode of CDI with vancomycin 125 mg four times daily for 10 days, followed by a gradual tapering down to 125 mg daily or an intermittent regimen, i.e., 125–500 mg/day every 2–3 days for at least 3 weeks.

Neonates, infants and children under 12 years of age
The recommended dose of vancomycin is 10 mg/kg orally every 6 hours for 10 days. The maximum daily dose should not exceed 2 g.

The duration of vancomycin treatment may need to be adjusted according to the clinical course of individual patients. When possible, the antibacterial agent suspected of having caused the CDI should be discontinued. Adequate fluid and electrolyte replacement should be ensured.

Monitoring of serum vancomycin concentrations
The frequency of therapeutic drug monitoring (TDM) should be individualized based on clinical status and response to treatment, ranging from daily sampling which may be required in some hemodynamically unstable patients, to at least once weekly in stable patients showing a response to treatment. In patients with normal renal function, serum vancomycin concentration should be monitored on the second day of treatment, immediately before the next dose.

In patients undergoing intermittent dialysis, vancomycin levels should generally be obtained before the start of the hemodialysis session.

Serum vancomycin concentration monitoring should be performed after oral administration in patients with inflammatory intestinal disorders (see section 4.4 of the Summary of Product Characteristics).

The therapeutic trough serum level of vancomycin should normally be 10–20 mg/L, depending on the site of infection and pathogen susceptibility. Trough levels of 15–20 mg/L are generally recommended by clinical laboratories to better cover pathogens classified as susceptible with MIC ≥1 mg/L (see sections 4.4 and 5.1 of the Summary of Product Characteristics).

Model-based methods may be useful in predicting individual dose requirements to achieve adequate AUC.

Model-based approaches can be used both for calculating an individualized initial dose and for dose adjustments based on TDM results (see section 5.1 of the Summary of Product Characteristics).

Method of administration
Intravenous administration
Vancomycin for intravenous use is generally administered as an intermittent infusion, and the dosage recommendations provided in this section for intravenous route correspond to this type of administration.

Vancomycin should be administered only as a slow intravenous infusion lasting at least one hour or at a maximum rate of 10 mg/min (whichever is longer), and sufficiently diluted (at least 100 ml per 500 mg or at least 200 ml per 1000 mg) (see section 4.4 of the Summary of Product Characteristics).

Patients whose fluid intake must be restricted may also receive a solution of 500 mg/50 ml or 1000 mg/100 ml, although the risk of infusion-related adverse effects may be increased with these higher concentrations.

For information on solution preparation, see section 6.6 of the Summary of Product Characteristics.

Continuous infusion of vancomycin may be considered, e.g., in patients with unstable vancomycin clearance.

Oral administration
In this case, the contents of one vial (500 mg) may be diluted in approximately 50 ml of water and administered orally or via a nasogastric tube. To improve the taste of oral administration, sweet syrups may be added to the solution.

Instructions for use and handling
Preparation of the solution
At the time of use, add 10 ml of sterile water for injection to the 500 mg vial or 20 ml of sterile water for injection to the 1000 mg vial. The reconstituted vials will yield a solution of 50 mg/ml.

The reconstituted solution may be colorless or have a slight brownish-pink tint.

Further dilution of the solution is required. Read the following instructions:

1. Intermittent intravenous administration (preferred method). The solutions prepared as described above (containing 500 mg and 1000 mg of vancomycin) are added to 100 ml and 200 ml, respectively, of 0.9% sodium chloride or 5% glucose solution. The intravenous infusion is administered over at least 60 minutes (see "Undesirable effects") and repeated every 6 hours. Compatibility with other intravenous fluids: 5% dextrose solutions, 0.9% sodium chloride solutions, lactated Ringer's solution, lactated Ringer's and 5% dextrose solution, Normosol-M with 5% dextrose, Isolyte-E solution, Ringer acetate solution.

2. Continuous infusion administration (to be used only when intermittent administration is not feasible). Add the contents of the vials (1000–2000 mg), prepared as described above, to the volume of 0.9% sodium chloride or 5% glucose solution required to allow slow intravenous infusion over 24 hours.

Oral administration
The contents of one vial (500 mg) may be diluted in approximately 50 ml of water and administered orally or via a nasogastric tube.

Vancomycin solution has a low pH and may cause physical instability of other compounds.

Prior to administration, parenterally administered drugs should be checked for any specific problems and/or color changes whenever the solution or container permits.

From a microbiological standpoint, the product should be used immediately after reconstitution/dilution. If not used immediately, the conditions and duration of storage prior to use are the responsibility of the user; normally, the storage period should not exceed 24 hours, and the product should be stored between +2 °C and +8 °C, unless reconstitution/dilution has been carried out under controlled and validated aseptic conditions.

Chemical and physical stability of the medicinal product after reconstitution has been demonstrated for 4 days between +2 °C and +8 °C and for 2 days when stored between 20 °C and 25 °C.

O verdosage
Maintenance of glomerular filtration is recommended as supportive measure. Vancomycin is poorly removed by dialysis.

Increased vancomycin clearance has been achieved by hemofiltration and hemoperfusion with polysulfonic resins. In managing overdose, consider the possibility of multiple drug overdose, drug interactions, or unusual pharmacokinetics in the patient.

Disposal
Vials are for single use only. Unused medicines must be discarded.
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.