Vancomycin-mip 1000

Package leaflet: Information for the user

Vancomycin-MIP 500, 500 mg, powder for solution for infusion and oral solution
Vancomycin-MIP 1000, 1 g, powder for solution for infusion and oral solution
Vancomycin
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Vancomycin-MIP is and what it is used for

Vancomycin is an antibiotic belonging to the glycopeptide class of antibiotics.
Vancomycin works by killing certain bacteria that cause infections.
Vancomycin powder is used to prepare a solution for infusion or an oral solution.

Indications for use

Intravenous use
Vancomycin is used in all age groups by infusion (intravenous drip) for the treatment of the following serious infections:

• Skin and soft tissue infections;
• Bone and joint infections;
• Lung infection known as pneumonia;
• Infection of the inner lining of the heart (endocarditis);
• Bloodstream infections associated with the above-mentioned infections.

Oral use
Vancomycin may be administered orally in adults and children for the treatment of infection of the mucous membrane of the small and large intestine associated with mucosal damage (pseudomembranous colitis) caused by Clostridium difficile bacteria.

2. Important information before using Vancomycin-MIP

When not to use Vancomycin-MIP

• if the patient is allergic to vancomycin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Severe adverse reactions, potentially leading to loss of vision, have occurred after vancomycin has been injected into the eye.
Before starting treatment with Vancomycin-MIP, 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 they are elderly (hearing tests may be necessary during treatment).
• the patient has impaired kidney function (blood tests and monitoring of liver and kidney function may be required during treatment).
• the patient is receiving vancomycin by infusion for the treatment of diarrhoea associated with Clostridium 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 during vancomycin therapy. If the patient experiences any of the symptoms described in section 4, vancomycin should be discontinued immediately and medical advice sought without delay.

During treatment with Vancomycin-MIP, discuss with your doctor, hospital pharmacist or nurse if:

• the patient is receiving vancomycin for a prolonged period (blood tests and monitoring of liver and kidney function may be required during treatment).
• the patient develops any skin reaction during treatment.
• the patient develops severe or persistent diarrhoea during or after treatment with vancomycin; in such a case, immediate medical consultation is required. This may be a sign of intestinal inflammation (pseudomembranous colitis), which can occur during antibiotic therapy.

Allergic reactions, including difficulty in breathing and chest pain, have been reported in patients receiving Vancomycin-MIP. If the patient experiences any of these symptoms, administration of Vancomycin-MIP should be stopped immediately and the doctor or emergency medical services contacted without delay.

Children
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 necessary in this age group.
Concomitant administration of vancomycin and anaesthetic agents in children has been associated with skin flushing (erythema) and allergic reactions. Additionally, 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, therefore more frequent blood tests and kidney function monitoring may be required.

Vancomycin-MIP and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Particular caution is required if the patient is taking other medicines that may interact with vancomycin, such as:

• nephrotoxic (kidney-damaging) and ototoxic (hearing-damaging) medicines (e.g. piperacillin with tazobactam) – may mutually enhance adverse effects; particular caution is required when aminoglycosides are used concomitantly with or immediately after vancomycin;
• anaesthetic agents – may increase the risk of hypotension, skin flushing, erythema, urticaria and pruritus (see section 4. Possible adverse effects);
• muscle relaxants – vancomycin may potentiate and prolong the effects of medicines used during surgery to reduce muscle tone, such as succinylcholine (neuromuscular blockade).

Use in elderly patients
The natural age-related decline in glomerular filtration rate may lead to increased vancomycin plasma concentrations if the dose is not appropriately adjusted (see "Dosage in patients with renal impairment").

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
There are insufficient data on the use of vancomycin during pregnancy and breastfeeding in humans. Vancomycin should be administered to pregnant women only if the benefit to the mother outweighs the potential risk to the foetus.
Animal studies have not shown any teratogenic effects.
Vancomycin passes into human milk; therefore, breastfeeding should be discontinued during treatment to avoid adverse effects in the breastfed infant.

Driving and operating machinery
No data available.

3. How to use Vancomycin-MIP

The patient will receive Vancomycin-MIP administered by medical personnel during hospitalization.
The doctor will decide the daily dose of the medicine the patient should receive and how long the treatment should last.
Dosage
The dose administered will depend on:

• the patient's age,
• the patient's body weight,
• the type of infection,
• kidney function status,
• the patient's hearing status,
• any other medicines the patient is taking.

Intravenous administration
Adults and adolescents (aged 12 years and older)
The dosage will be determined based on the patient's body weight. The usual dose administered by infusion is 15 to 20 mg per kg of body weight. This dose is usually given every 8 to 12 hours.
In some cases, the doctor may decide to use an initial dose of 30 mg per kg of body weight. The maximum dose should not exceed 2 g.
Use in children
Children from 1 month of age and children under 12 years of age
The dosage will be determined based on the patient's body weight. The usual dose administered by infusion is 10 to 15 mg per kg of body weight. This dose is usually given every 6 hours.
Preterm neonates and full-term newborns (from 0 to 27 days)
The dose will be calculated based on postconceptional age [the time elapsed from the first day of the mother's last menstrual period to delivery (gestational age) plus the time elapsed since birth (postnatal age)].
In elderly patients, pregnant women, and patients with impaired kidney function, a different dosage may be required.
Oral administration
Adults and adolescents (aged 12 to 18 years)
The recommended dose is 125 mg every 6 hours. In some cases, the doctor may decide to use a higher daily dose, up to a maximum of 500 mg every 6 hours. The maximum daily dose should not exceed 2 g.
If the patient has previously had other disorders (mucosal infection), a different dosage and duration of treatment may be necessary.
Use in children
Newborns, infants, and children under 12 years of age
The recommended dose is 10 mg per kg 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 (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 bloodstream, never into muscle.
Vancomycin will be administered intravenously over at least 60 minutes.
Method of oral administration
When used to treat gastrointestinal disorders (so-called pseudomembranous colitis), the medicine must be administered as an oral solution (the patient will take the medicine orally).
The contents of one vial of Vancomycin-MIP 500 should be dissolved in 10 ml of water, and the contents of one vial of Vancomycin-MIP 1000 should be dissolved in 20 ml of water. Single doses (e.g., 2.5 ml = 125 mg vancomycin) may be drawn up and administered orally to the patient in a small dilution or administered via a gastric tube. A taste-improving agent, such as commonly used syrups, may be added to the prepared solution before administration.
Intravenous administration method
Detailed instructions are provided at the end of this leaflet, under the section “Information intended exclusively for healthcare professionals.”
Treatment duration
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 treatment.
During treatment, the patient may undergo blood tests and urine analysis, and may also have hearing tests to monitor for symptoms of potential adverse effects.
Use of a higher than recommended dose of Vancomycin-MIP
Treatment in case of overdose:

• no specific antidote is known;
• high plasma concentrations of vancomycin can be effectively reduced by hemodialysis using polysulfone membranes, as well as by hemofiltration or hemoperfusion using polysulfone resins;
• in case of overdose, symptomatic treatment and maintenance of kidney function are required. If a higher dose of the medicine is taken, seek immediate medical advice from a doctor or pharmacist.

Missed dose of Vancomycin-MIP
Do not administer a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient notices any of the following symptoms, vancomycin should be discontinued immediately and medical advice should be sought without delay:

• Reddish, flat, target-like or circular skin lesions on the trunk, often with blisters in the center, skin peeling, and ulceration of 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, peeling rash with subcutaneous nodules and blisters, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis).
• Chest pain, which may indicate a potentially serious allergic reaction known as Kounis syndrome.

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 must be notified immediately.
Absorption of vancomycin from the gastrointestinal tract is negligible. However, if the patient has an inflammatory condition of the gastrointestinal tract, and especially if there are also kidney function disorders, adverse reactions may occur similar to those observed after intravenous infusion of vancomycin.

Common adverse reactions (may occur in up to 1 in 10 patients):

• Decreased blood pressure,
• Shortness of breath, wheezing (a high-pitched sound caused by obstruction in the upper airways),
• Rash and inflammation of the oral mucosa, itching, itchy rash, urticaria,
• Kidney function disorders, usually detectable in blood tests,
• Redness of the upper body and face, phlebitis,
• Increased liver enzyme activity.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• Transient or permanent hearing loss

Rare adverse reactions (may occur in up to 1 in 1,000 patients):

• Decreased number of white blood cells, red blood cells, and platelets (blood cells responsible for blood clotting), increased number of certain white blood cells in the blood,
• Balance disturbances, tinnitus, dizziness,
• Vasculitis,
• Nausea,
• Kidney inflammation and kidney failure,
• Chest and back muscle pain,
• Fever, chills.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):

• Sudden onset of severe allergic skin reaction involving skin peeling or blistering, which 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 output.
• Rash with swelling and pain behind the ears, neck, groin, under the chin, and in the armpits (swelling of lymph nodes), abnormal blood test results and liver function tests,
• Rash with blisters and fever,
• Excessive breakdown of red blood cells leading to fatigue and pale skin (hemolytic anemia).

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, the patient should inform their doctor, hospital pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
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-MIP

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Expiry date". The expiry date refers to the last day of the specified month.
Store below 25°C and protect from light.

Stability of the oral solution
The prepared oral solution may be stored for 96 hours at a temperature of 2°C–8°C.

Stability of the infusion solution
The prepared infusion solution remains stable for 24 hours when stored in a refrigerator at 2°C–8°C. The infusion solution should preferably be used immediately after preparation.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Vancomycin-MIP contains

• The active substance is vancomycin. Vancomycin-MIP 500: 1 vial contains 500 mg of vancomycin (as 510 mg of vancomycin hydrochloride), equivalent to 500,000 IU of vancomycin. Vancomycin-MIP 1000: 1 vial contains 1 g of vancomycin (as 1020 mg of vancomycin hydrochloride), equivalent to 1,000,000 IU of vancomycin.

The medicine does not contain any other ingredients.
What Vancomycin-MIP looks like and contents of the pack
Depending on the crystalline structure of the active substance, the lyophilisate may range in colour from white to slightly pink or even brownish.
Vancomycin-MIP 500: vials made of colourless glass, closed with a stopper and aluminium cap, packed in a cardboard box containing 1 vial or 5 vials.
Vancomycin-MIP 1000: vials made of colourless glass, closed with a stopper and aluminium cap, packed in a cardboard box containing 1 vial or 5 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
MIP Pharma Polska Sp. z o.o.
ul. Orzechowa 5
80-175 Gdańsk
tel. 58 303 93 62
fax. 58 322 16 13
e-mail: [email protected]
Manufacturer
Chephasaar, Chemisch-pharmazeutische Fabrik GmbH
Mühlstrasse 50
66386 St. Ingbert
Germany
Other sources of information
Detailed information on this medicine is available on the website of URPL, WM and PB.
www.urpl.gov.pl
Medical advice and education
Antibiotics are used to treat bacterial infections. They are ineffective against viral infections.
If your doctor has prescribed antibiotics, they are necessary for treating a specific, current illness.
Despite antibiotic treatment, some bacteria may survive or continue to multiply. This phenomenon is known as resistance and may result in antibiotic treatment being ineffective.
Improper use of antibiotics promotes the development of resistance. Patients can also contribute to the emergence of resistance, thereby delaying recovery or reducing the effectiveness of antibiotic therapy, if they do not adhere to the correct:

• dosage,
• treatment schedule,
• duration of treatment. Therefore, to preserve 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 – not reuse antibiotics without a doctor's recommendation, even to treat a similar illness.

Information intended exclusively for medical professionals

Please refer to the current full product information available in the Summary of Product Characteristics (SmPC) on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL,WM and PB).
Antibacterial spectrum of activity
Vancomycin is active against Gram-positive bacteria such as staphylococci, streptococci, enterococci, pneumococci, and Clostridium. Gram-negative bacteria are resistant.
In some cases, an increasing number of resistance cases has been observed, especially among enterococci; particularly concerning is the occurrence of multidrug-resistant strains of Enterococcus faecium.
Cross-resistance occurs with other glycopeptide antibiotics such as teicoplanin.
Bacterial cultures should be obtained to isolate and identify causative microorganisms and to determine their susceptibility to vancomycin.
Dosage
In appropriate cases, vancomycin should be used in combination with other antibacterial agents.
Intravenous administration
The initial dose should be based on total body weight. Subsequent dose adjustments should be guided by serum concentrations with the aim of achieving the target therapeutic concentration. Renal function should also be considered when determining subsequent doses and dosing intervals.
Patients aged 12 years and older
The recommended dose is 15 to 20 mg/kg every 8 to 12 hours (a dose higher than 2 g per single dose should not be used).
In critically ill patients, a loading dose of 25–30 mg/kg may be administered to facilitate rapid achievement of the target minimum serum vancomycin concentration.
Neonates from one month of age and children under 12 years of age:
The recommended dose is 10 to 15 mg/kg every 6 hours (see section 4.4 of the SmPC).
Term newborns (from birth to 27 days postnatal age) and preterm infants (from birth to expected date of delivery plus 27 days)
To determine the dosing regimen for neonates, advice should be sought from a physician experienced in treating neonates. One possible vancomycin dosing regimen for neonates is presented in the table below (see section 4.4 of the SmPC):

PMA: post-conceptional age [time elapsed from the first day of the last menstrual period to birth (gestational age) plus time elapsed since birth (postnatal age)].
Duration of treatment
The 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 infection and the individual clinical response.

* Continue until no further removal of necrotic tissue is required,
the patient's clinical condition has improved, and the patient has been afebrile for 48–72 hours.
** In the case of prosthetic joint infections, consider longer cycles of oral
suppressive antibiotic therapy with appropriate antibiotics for infected joint prostheses.
*** The duration and necessity of combination therapy depend on the type of prosthesis
and microorganism involved.

Special patient groups

Elderly patients
Due to age-related reduction in renal function, lower maintenance doses may be necessary.

Patients with renal impairment
In adult and pediatric patients with impaired renal function, consider administering an initial loading dose followed by serum vancomycin trough concentration monitoring, rather than adhering to a fixed dosing schedule, especially in patients with severe renal impairment or those undergoing renal replacement therapy (RRT), due to multiple variable factors affecting 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, prolonging the interval between doses is preferred over administering smaller doses.
Concomitant administration of other medicinal products that may reduce vancomycin clearance and/or increase its adverse effects should be carefully evaluated (see section 4.4 of SmPC).
Vancomycin is only minimally removed by intermittent hemodialysis. However, the use of high-permeability dialysis membranes or continuous renal replacement therapy (CRRT) increases vancomycin clearance, and supplemental doses are generally required (usually administered after the hemodialysis session in the case of intermittent hemodialysis).

Adult patients
Dose adjustments in adult patients may be based on estimated glomerular filtration rate (eGFR) calculated using the following formula:
Men: [Body weight (kg) × (140 − age in years)] / [72 × serum creatinine concentration (mg/dL)]
Women: 0.85 × value calculated using the above formula for men.
The usual initial dose for adult patients is 15 to 20 mg/kg; this dose may be administered every 24 hours to patients with creatinine clearance between 20 and 49 mL/min. In patients with severe renal impairment (creatinine clearance below 20 mL/min) or those undergoing renal replacement therapy, appropriate dosing intervals and dose sizes largely depend on the RRT method used and should be determined based on vancomycin serum trough concentrations and residual renal function (see section 4.4 of SmPC). Depending on the clinical situation, consideration may be given to withholding the next dose until vancomycin blood concentration is measured.
In critically ill patients with renal impairment, the initial loading dose should not be reduced.

Children and adolescents
Dose adjustments in pediatric and adolescent patients aged 1 year and older may be based on estimated glomerular filtration rate (eGFR) using the modified Schwartz formula:
eGFR (mL/min/1.73 m²) = (height in cm × 0.413) / serum creatinine concentration (mg/dL)
eGFR (mL/min/1.73 m²) = (height in cm × 36.2) / serum creatinine concentration (μmol/L)
For neonates and infants under 1 year of age, expert consultation is recommended, as the Schwartz formula is not applicable in these patients.
Guidance on dosing in children and adolescents provided in the table below follows the same principles as those for adult patients.

*Appropriate intervals between doses and the size of subsequent doses largely depend on
the applied RRT method and should be established based on serum vancomycin concentrations
before administration and residual renal function. Depending on the clinical situation,
postponing the next dose until serum vancomycin concentration is measured may be considered.
Patients with hepatic impairment:
Dose adjustment is not necessary in patients with mild hepatic impairment.
Pregnancy
In pregnant women, significantly higher doses may be required to achieve therapeutic serum
concentrations (see section 4.6 of SmPC).
Obese patients
In obese patients, the initial dose should be individually adjusted according to total body weight,
similarly to patients with normal body weight.
Oral administration
Patients aged 12 years and older
Treatment of infections caused by Clostridium difficile (Clostridium difficile infection, CDI).
The recommended dose of vancomycin is 125 mg every 6 hours for 10 days in the case of a first
non-severe CDI episode. This dose may be increased to 500 mg every 6 hours for 10 days in cases
of severe or complicated disease. The maximum daily dose should not exceed 2 g.
In patients with multiple recurrences, treatment of the current CDI episode with vancomycin
125 mg four times daily for 10 days, followed by a gradual dose reduction down to 125 mg daily,
or a pulsed-dose regimen (i.e., 125–500 mg/day every 2–3 days for at least 3 weeks) may be considered.
Neonates, infants, and children under 12 years of age
The recommended dose of vancomycin is 10 mg/kg body weight every 6 hours for 10 days.
The maximum daily dose should not exceed 2 g.
Adjustment of vancomycin treatment duration according to the individual clinical course of the
disease may be necessary. Whenever possible, the antibacterial agent suspected of causing CDI
should be discontinued. Adequate fluid and electrolyte replacement should be ensured.
Monitoring serum vancomycin concentration
The frequency of therapeutic drug monitoring (TDM) should be individually adjusted according
to the clinical situation and response to treatment; sampling frequency may range from daily
in some hemodynamically unstable patients to once weekly in stable patients showing a clear
response to therapy. In patients with normal renal function, serum vancomycin concentration
should be measured on the second day of treatment, immediately before the next dose.
In patients undergoing intermittent hemodialysis, serum vancomycin concentration should be
measured before the start of a hemodialysis session.
Serum vancomycin concentration monitoring after oral administration should be performed in
patients with inflammatory bowel diseases (see section 4.4 of SmPC).
The minimum therapeutic blood concentration of vancomycin should be 10–20 mg/L, depending
on the site of infection and pathogen susceptibility. Clinical laboratories usually recommend a
minimum concentration of 15–20 mg/L, ensuring better coverage of organisms classified as
susceptible with an MIC ≥1 mg/L (see sections 4.4 and 5.1 of SmPC).
In predicting individual dosing required to achieve an appropriate AUC value, model-based
methods may be useful. Model-based approaches can be applied both in calculating the initial
individual dose and in modifying doses based on TDM results (see section 5.1 of SmPC).
Method of administration
Intravenous administration
Vancomycin is usually administered intravenously as an intermittent infusion; dosing
recommendations provided in this section for the intravenous route refer to this method of
administration.
Vancomycin should be administered exclusively by slow intravenous infusion lasting at least
one hour or at a maximum rate of 10 mg/min (longer duration), in a sufficiently diluted solution
(at least 100 mL per 500 mg, i.e., 200 mL per 1000 mg) (see section 4.4 of SmPC).
Patients with restricted fluid intake may receive a 500 mg/50 mL (1000 mg/100 mL) solution;
however, with such higher concentrations, the risk of infusion-related adverse reactions increases.
Preparation of the solution
Before use, the dry substance should be dissolved in water for injections. The resulting solution
should then be further diluted with compatible injection solutions (see section "Pharmaceutical
incompatibilities" below).
The contents of a Vancomycin–MIP 500 vial should be dissolved in 10 mL of water for injections,
then further diluted with other infusion solutions to a final volume of at least 100 mL.
The contents of a Vancomycin–MIP 1000 vial should be dissolved in 20 mL of water for infusion,
then further diluted with other infusion solutions to a final volume of at least 200 mL.
The powder should be dissolved in such a volume of solvent that the concentration of the infusion
solution does not exceed 5 mg/mL (i.e., 125 mg/25 mL or 250 mg/50 mL or 500 mg/100 mL or 1 g/200 mL).
Continuous vancomycin infusion may be considered, e.g., in patients with unstable vancomycin clearance.
Oral administration
The contents of one Vancomycin–MIP 500 vial should be dissolved in 10 mL of water.
The contents of one Vancomycin–MIP 1000 vial should be dissolved in 20 mL of water.
Single doses (e.g., 2.5 mL = 125 mg vancomycin) may be withdrawn from the prepared solution
and administered orally or via a gastric tube with minimal dilution. Flavoring agents, such as commonly used syrups, may be added to the solution.
Pharmaceutical incompatibilities
Vancomycin solutions have a low pH. Mixing them with other substances may lead to chemical
or physical instability. Each parenteral solution should be inspected visually for precipitation
or discoloration before administration. Cloudiness of the solution occurs when vancomycin
solution is mixed with the following substances:
aminophylline, barbiturates, benzylpenicillin, chloramphenicol sodium succinate, sodium
chlorothiazide, dexamethasone sodium phosphate 21-dihydrogen phosphate, sodium heparin,
hydrocortisone sodium succinate 21-hydrogen succinate, methicillin sodium, sodium bicarbonate,
sodium nitrofurantoin, sodium novobiocin, sodium phenytoin, sodium sulfadiazine,
diethanolamine sulfafurazole.
Compatibility with intravenous fluids
The following fluids may be used to prepare the infusion solution:

• water for injections;
• 5% glucose solution;
• 0.9% NaCl solution.
  Vancomycin solution should generally be administered separately unless its physicochemical compatibility with a given injection solution has been demonstrated.
  Combination therapy
  If combination therapy with vancomycin and other antibiotics or chemotherapeutic agents is used,
  these products should be administered separately.