PATIENT INFORMATION LEAFLET

Vancomycin MIP 500 mg, powder for solution for infusion EFG

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Vancomicina MIP is an antibiotic that belongs to the group of "glucopéptidos" and works by eliminating certain bacteria that cause infections.

Vancomycin powder is converted into a solution for infusion.

Vancomycin is used in all age groups via intravenous infusion for the treatment of the following severe infections:

-Skin and tissue infections beneath the skin.

-Bone and joint infections.

-A lung infection called "pneumonia".

-Endocarditis, an infection of the heart's inner lining, and to prevent endocarditis in patients at risk undergoing major surgical procedures.

-Blood infection associated with the aforementioned infections.

Do not use Vancomicina MIP

• if you are allergic to vancomycin or any of the other components of this medication (listed in section 6).

Warnings and precautions

Severe side effects that may cause loss of vision have been reported after injection of vancomycin into the eyes.

Speak with your doctor or hospital pharmacist or nurse before using this medicationif:

• You have had an allergic reaction to teicoplanin, as this may also mean you are allergic to vancomycin.
• You have a hearing problem, especially if you are an older person (you may need hearing tests during treatment).
• You have kidney problems (so you will need blood tests and kidney function tests during treatment).
• You are being given vancomycin by infusion for the treatment of diarrhea associated with Clostridium difficile infection instead of oral administration.
• You have ever developed severe skin rash or skin peeling, blisters, and/or mouth sores after taking vancomycin.

Speak with your doctor or hospital pharmacist or nurse during treatment with Vancomicina MIP if

-You are being given vancomycin for a long time (you may need blood tests, a liver function test, or kidney function test during treatment).

-You develop any skin reaction during treatment.

-Consult your doctor immediately if you develop severe or chronic diarrhea during or after using vancomycin. This may be a sign of intestinal inflammation (pseudomembranous colitis) that can occur after antibiotic treatment.

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 in association with vancomycin treatment. Stop using vancomycin and seek medical attention immediately if you notice any of the symptoms described in section 4.

Children

Vancomycin is used with special care in premature babies and small babies, as their kidneys are not fully developed and may accumulate vancomycin in the blood. To control vancomycin levels in the blood, blood tests are performed for this age group.

The simultaneous administration of vancomycin and anesthetics has been associated with skin redness (erythema) and allergic reactions in children. Similarly, the use of other medications such as aminoglycoside antibiotics, nonsteroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) or amphotericin B (a medication for fungal infections) may increase the risk of kidney damage and therefore more frequent kidney and blood tests will be necessary.

Use of Vancomicina MIP with other medications

Inform your doctor or hospital pharmacist if you are taking, have taken recently, or may need to take any other medication.

• Medications potentially harmful to the kidneys and ears:If you take vancomycin at the same time as other medications potentially harmful to the kidneys and ears (for example, some aminoglycoside antibiotic, piperacillin/tazobactam), this harmful effect may be increased. In this case, comprehensive and regular checks of renal and auditory functions are necessary.
• Anesthetics:The use of anesthetics increases the risk of experiencing certain side effects associated with vancomycin, such as low blood pressure, skin redness, urticaria, and itching.
• Muscle relaxants:If you use muscle relaxants (such as succinylcholine) at the same time, the effects may be intensified or prolonged.

Pregnancy, breastfeeding, and fertility

Consult your doctor or hospital pharmacist before taking any medication.

Vancomycin crosses the placenta and there is a risk of toxicity to the fetus's ears and kidneys. Therefore, if you are pregnant, your doctor should administer vancomycin only if it is clearly necessary and after a careful study of the benefits and risks.

Vancomycin passes into breast milk. Since the baby may be affected by this medication, it should only be used during breastfeeding if other antibiotics have not been effective. Consult with your doctor about the possibility of stopping breastfeeding.

Driving and operating machinery

Vancomicina MIP does not affect or insignificantly affects the ability to drive and operate machinery.

The medical staff will administer vancomycin during your hospital stay. Your doctor will decide the amount of medication you should receive each day and how long the treatment will last.

Dosage

The administered dose will depend on:

-your age,

-your weight,

-the infection you have,

-kidney function,

-your hearing ability,

-any other medication you are taking.

Intravenous administration

Adults and adolescents (12 years and older)

The dose will be calculated according to your body weight. The usual infusion dose is 15 to 20 mg per kilogram of body weight. It is usually administered every 8 to 12 hours. In some cases, your doctor may decide to give 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

Children aged 1 month to less than 12 years

The dose will be calculated according to your body weight. The usual infusion dose is 10 to 15 mg per kilogram of body weight. It is usually administered every 6 hours.

Preterm and full-term newborns (0 to 27 days)

The dose will be calculated according to the postmenstrual age (time elapsed between the first day of the last menstrual period and birth (gestational age) plus the time elapsed after birth (postnatal age).

Patients with advanced age, pregnant women, and patients with kidney disorders, including those on dialysis, may require a different dose.

Administration form

Intravenous infusion means that the medication flows from a perfusion bottle or bag through a tube into one of your blood vessels and into your body. Your doctor or nurse will always administer vancomycin into the blood and not into the muscle.

Vancomycin is administered in the vein for at least 60 minutes.

Treatment duration

The treatment duration depends on the infection and may last several weeks.

The treatment duration may be different depending on the individual response to treatment for each patient.

During treatment, blood samples, urine samples, and possibly hearing tests will be taken to look for signs of possible side effects.

If you use more Vancomicina MIP than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Vancomicina MIP

You should not apply a double dose to compensate for missed doses. Only one missed dose can be administered before the next scheduled dose if the interval between the two administrations is quite wide.

In case of interruption or premature suspension of treatment with Vancomicina MIP

Low doses, irregular administration, or premature suspension of treatment may compromise the outcome or cause relapses with a more complicated treatment. Follow your doctor's instructions at all times.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop using vancomycin and seek medical attention immediately if you notice any of the following symptoms:

• Flat, red spots, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome and toxic epidermal necrolysis).

• Generalized rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

• Red, scaly, and generalized rash with skin protuberances and blisters accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis).

Vancomycin can cause allergic reactions, although severe allergic reactions (anaphylactic shock) are rare. Inform your doctor immediately if you notice any sudden wheezing, difficulty breathing, upper body redness, skin rash, or itching.

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

-Low blood pressure

-Shortness of breath, noisy breathing (a high-pitched sound produced by obstruction of airflow in the upper airway)

-Mouth and throat mucosa inflammation, itching, pruritic rash, urticaria

-Kidney problems that can be detected by blood tests

-Upper body and face redness, vein inflammation

Less frequent 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):

-Decreased white blood cells, red blood cells, and platelets (cells responsible for blood clotting)

Increase in some white blood cells.

-Loss of balance, ringing in the ears, dizziness

-Vein inflammation

-Nausea (feeling of discomfort)

-Kidney inflammation and renal insufficiency

-Chest and back muscle pain

-Fever, chills

Very rare side effects (may affect up to 1 in 10,000 people):

-Sudden appearance of a severe allergic reaction on the skin, with peeling or blistering. This may be associated with high fever and joint pain

-Cardiac arrest

-Intestinal inflammation, causing abdominal pain and diarrhea (which may contain blood)

Unknown frequency (cannot be estimated from available data):

-Vomiting, diarrhea

-Confusion, drowsiness, lack of energy, swelling, fluid retention, decreased urine output

-Rash with swelling or pain behind the ears, neck, groin, under the chin, and armpits (inflamed lymph nodes), abnormal blood tests, and abnormal liver function tests.

-Rash with blisters and fever.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store below 25°C. Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the outer packaging and on the label after "CAD". The expiration date is the last day of the month indicated.

Do not use this medication if you observe particles or discoloration of the infusion solution.

Medications should not be disposed of through drains or trash. Dispose of containers and medications you no longer need at the SIGRE1Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

Vancomycin MIP Composition

Appearance of the product and contents of the package

Fine white powder with faint shades of pink and brown tones.

Vancomycin MIP is available in packages of 1 or 5 vials of glass with rubber stopper and "flip-off" type seal.

Marketing Authorization Holder

MIP Pharma GmbH

Kirkeler Str. 41

66440 Blieskastel

Germany

Phone 0049-6842/9609-0

Fax 0049-6842/9609-355

Responsible Manufacturer

Chephasaar Chem.-Pharm. Fabrik GmbH

Mühlstr. 50

66386 St. Ingbert

Germany

Last review date of this leaflet: 03/2021.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

Other sources of information

Medical advice/education

Antibiotics are used to cure infections caused by bacteria. They are ineffective against infections caused by viruses.

If your doctor has prescribed antibiotics, you need them precisely to treat your current illness.

Despite antibiotics, some bacteria may survive or grow. This phenomenon is known as resistance: some antibiotic treatments become ineffective.

The misuse of antibiotics increases resistance. You can even help bacteria become resistant and therefore delay your recovery or reduce the effectiveness of antibiotics if you do not follow the proper:

- dose

- schedule

- duration of treatment

Therefore, to preserve the effectiveness of this medication:

1 - Use antibiotics only when prescribed.

2 - Follow the prescription instructions strictly.

3 - Do not reuse an antibiotic without a doctor's prescription, even if you want to treat a similar illness.

-------------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

The powder must be reconstituted and the resulting concentrate must be diluted before use.

Preparation of the concentrate for infusion

Dissolve the contents of each 500 mg vial in 10 ml of sterile water for injection preparations.

One ml of the reconstituted solution contains 50 mg of vancomycin hydrochloride.

Preparation of the infusion solution

The infusion concentrate can be diluted in sterile water for injection, sodium chloride 9 mg/ml, or glucose 50 mg/ml.

Vial of 500 mg: to obtain an infusion solution of 5 mg/ml, dilute 10 ml of the infusion concentrate with 90 ml of diluent.

The concentration of vancomycin hydrochloride in the infusion solution cannot exceed 2.5-5 mg/ml.

Appearance of the infusion solution

The infusion solution should be visually inspected for the presence of particles or discoloration before administration.

The solution can only be used if it is clear and does not contain particles.

Compatibility with intravenous solutions

Vancomycin is compatible with water for injection preparations, 5% glucose solutions, and physiological saline solutions. Vancomycin solutions are administered basically separately if their chemical and physical compatibility with another infusion solution has not been demonstrated.

To avoid precipitation due to the low pH of vancomycin hydrochloride in solution, all intravenous cannulas and catheters must be washed with physiological saline.

Important incompatibilities

Vancomycin solutions have a low pH, which can cause chemical or physical instability after mixing with other substances. Therefore, parenteral solutions should be visually inspected to detect precipitations or color changes before use.

Vancomycin solutions are not compatible with penicillin or cephalosporin solutions (beta-lactam antibiotics). The risk of precipitation increases when the vancomycin concentration is higher. To avoid precipitation, intravenous cannulas and catheters must be washed with saline solution between the administration of vancomycin and these antibiotics.

Combined treatments

In the case of combined treatments of vancomycin with other antibiotics or chemotherapeutic agents, the preparations should be administered separately.

Storage after reconstitution

Validity period of the infusion solution

The chemical and physical stability of the infusion solution prepared has been demonstrated for 96 hours between 2-8°C. From a microbiological point of view, the product should be used immediately. If not, the user will be responsible for the storage times and conditions before use and should not exceed 24 hours between 2-8°C, unless the reconstitution/dilution has taken place in validated and controlled aseptic conditions.

Method of application and duration of treatment

Vancomycin is only administered as a slow intravenous infusion, lasting at least one hour or at a maximum rate of 10 mg/min (whichever is longer) and should be sufficiently diluted (at least 100 ml per 500 mg or at least 200 ml per 1,000 mg).

Patients with fluid restrictions can receive a solution of 500 mg/50 ml or 1,000 mg/100 ml, taking into account that the risk of adverse effects related to perfusion may increase at high concentrations.

A hypersensitivity reaction (anaphylactic/anaphylactoid) may occur during or immediately after a rapid vancomycin infusion.

Fast administration (i.e., over several minutes) may cause excessive hypotension (including reactions and, less frequently, cardiac arrest), histamine-like reactions, and erythematous or maculopapular rashes ("red man syndrome"). In the event of severe hypersensitivity reactions (e.g., anaphylaxis), treatment with vancomycin should be immediately discontinued and standard emergency measures taken.

The simultaneous use of vancomycin and anesthetics increases the risk of trunk redness and allergic reactions. To reduce the risk of these reactions, vancomycin should be administered over a period of 60 minutes before anesthetics.