Label: Information for the Patient

Vancomycin 500 mg powder for concentrate for solution for infusion EFG

Vancomycin is an antibiotic that belongs to the group of "glycopeptides" and works by eliminating certain bacteria that cause infections.

Vancomycin powder is converted into a solution for infusion or oral solution.

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".
• Heart lining infection (endocarditis) and to prevent endocarditis in patients at risk undergoing major surgical procedures.
• Blood infection linked to the aforementioned infections.

Vancomycin can be administered orally in adults and children for the treatment of intestinal mucosa infection, small intestine, and large intestine with mucosal damage (pseudomembranous colitis)caused by the bacteriaClostridium difficile.

Do not use vancomycin

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

Warnings and precautions

Speak with your doctor or hospital pharmacist or nurse before using vancomycin if:

• 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 tests during treatment).
• Vancomycin is being administered by infusion for the treatment of diarrhea associated with Clostridium difficile infection instead of orally.
• You have ever developed severe skin rash, skin peeling, blisters, and/or mouth sores after taking 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 in association with vancomycin treatment. Stop using vancomycin and seek medical attention immediately if you notice any of the symptoms described in section 4.

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 during vancomycin treatment if:

• Vancomycin is being administered 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.
• 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.

Children

Vancomycin should be used with special care in premature babies and small babies, as their kidneys are not fully developed and may accumulate vancomycin in the blood.

Blood tests are performed to control vancomycin levels in the blood 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 simultaneous use with 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 required.

Other medications and Vancomycin

Inform your doctor or hospital pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Special care is needed if you are taking or using other medications, as some may interact with vancomycin.

The following medications may interact with Vancomycin:

• Piperacillin/tazobactam, as they may affect the kidneys.

• Anesthetics: The simultaneous administration of intravenous vancomycin and anesthetics has been associated with skin redness and allergic reactions.
• Muscle relaxants.
• Medications for bacterial infections (for example, polymyxin B, colistin, bacitracin, and aminoglycosides).
• Medications for fungal infections (amphotericin B).
• Medications for tuberculosis (viomycin).
• Medications for cancer (cisplatin).
• It should be administered with caution in patients allergic to another glycopeptide antibiotic called teicoplanin, as cross-allergic reactions have been detected.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or hospital pharmacist before using this medication. Vancomycin should only be administered during pregnancy and breastfeeding if there is a clear need. Vancomycin crosses the placenta and may cause toxicity in the fetus. Vancomycin passes into breast milk. Your doctor may decide that you should stop breastfeeding.

Driving and operating machinery:

The influence of vancomycin on the ability to drive and operate machinery is negligible or insignificant.

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.

Oral administration

Adults and adolescents (12 to 18 years)

The recommended dose is 125 mg every 6 hours. In some cases, your doctor may decide to give you a higher daily dose of up to 500 mg every 6 hours. The maximum daily dose should not exceed 2 g.

If you have had other episodes (mucosal infections) before, you may need a different dose and duration of therapy.

Use in children

Neonates, infants, and children under 12 years

The recommended dose is 10 mg per kilogram of body weight. It is usually administered every 6 hours. The maximum daily dose should not exceed 2 g.

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.

If administered for the treatment of gastrointestinal disorders (pseudomembranous colitis), the medication must be administered as an oral solution.

Treatment duration

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

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

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

If You Receive More Vancomycin Than You Should

Consult your doctor or pharmacist immediately. In case of accidental overdose,consult the Toxicology Information Service (phone: 915620420) indicating themedication and the amount administered. Bring this leaflet with you.

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

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

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

-Flat, red spots, often with central blisters, 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 enlarged 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).

The absorption of vancomycin in the gastrointestinal tract is insignificant. However, if you have an inflammatory disorder of the digestive tract, especially if you also have a kidney disorder, you may experience side effects that occur when vancomycin is administered by infusion.

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

• Low blood pressure.
• Shortness of breath, noisy breathing (a high-pitched sound produced by the obstruction of airflow in the upper airway).
• Mouth mucosa inflammation, itching, pruritic rash, urticaria.
• Renal problems that can be detected by blood tests.
• Redness of the upper body and face, inflammation of a vein.

Rare side effects (may affect up to 1 in 100 people):

• Temporary or permanent hearing loss.

Uncommon 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) in the blood.
• Increased levels of some white blood cells in the blood.
• Loss of balance, tinnitus, dizziness.
• Vein inflammation.
• Nausea (feeling of discomfort).
• Renal 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, which produces 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 tests.
• Rash with blisters and fever.

Reporting of 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 prospectus. You can also report them directly through the Spanish System for the 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 out of sight and reach of children.

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

Store protected from light.

Before reconstitution: Do not store above 30°C.

After reconstitution: Store between 2°C and 8°C (in the refrigerator). Storage time:14 days (when using 5% dextrose or 0.9% sodium chloride as a solvent) or 96 hours(when using a mixture of 5% dextrose and 0.9% sodium chloride; or Ringer-lactate solution; or a mixture of Ringer-lactate solution and 5% dextrose; or Ringer-acetate solution).

Medicines should not be disposed of in the drains or trash. Deposit the containers and

the medicines that you do not need at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and the medicines that you do not need. In this way, you will help protect the environment.

Composition of Vancomycin Solution

The active ingredient is vancomycin.

Vancomycin Solution 500 mg powder for concentrate for solution for infusion:

Each vial contains 500 mg of vancomycin hydrochloride equivalent to 500,000 IU of vancomycin.

Appearance of the product and contents of the container

Vancomycin Solution 500 mg powder for concentrate for solution for infusion:

Container containing 1 vial with lyophilized powder of white or almost white or pinkish color for intravenous administration containing 500 mg of vancomycin and clinical container with 100 vials.

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.

Abuse 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 exactly the instructions on the prescription.

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

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Responsible manufacturer

BIOMENDI, S.A.

Industrial Park s/n

01118 Bernedo (Álava). Spain

Laboratorio Reig Jofré, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona). Spain

Last review date of this leaflet:January 2021

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

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Additional information for healthcare professionals

This information is intended only for doctors or healthcare professionals

Route of administration

The hydrochloride of vancomycin is irritating to tissues and should be administered by safe and secure intravenous infusion. There is no established efficacy and safety of the administration of vancomycin by intrathecal, intralumbar, or intraventricular route. Vancomycin should not be administered by intramuscular route due to the risk of necrosis.

Pain and thrombophlebitis may occur in many patients treated with vancomycin by intravenous route, sometimes severe.

Frequency and severity can be minimized by administering the drug slowly as a diluted solution and changing the infusion sites regularly.

The rapid administration in bolus form (over several minutes) may be associated with hypotension (including shock and very rarely, cardiac arrest) as well as with histamine responses and maculopapular or erythematous rash (syndrome of the red man or red neck syndrome).

The frequency of reactions related to infusion (hypotension, redness, erythema, urticaria, and pruritus) increases with the concomitant administration of anesthetic agents. This can be minimized by administering vancomycin by infusion of at least 60 minutes before inducing anesthesia.

Although intravitreal injection is not an authorized route of administration for vancomycin, precipitation has been reported after intravitreal injection of vancomycin and ceftazidime for the treatment of endophthalmitis, using different syringes and needles. The precipitates dissolved gradually, with complete clearance of the vitreous cavity over two months, and with improvement of visual acuity.

Vancomycin solutions are acidic and should remain so to prevent precipitation, as they may cause chemical or physical instability when mixed with other substances. Therefore, they should be avoided with alkaline solutions.

It has been demonstrated that mixtures of vancomycin solutions and beta-lactam antibiotics are physically incompatible. The probability of precipitation increases with higher concentrations of vancomycin. It is recommended to wash the intravenous lines properly between the administration of these antibiotics. It is also recommended to dilute vancomycin solutions to a concentration of 5 mg/ml or less.

Preparation of VANCOMICINA SALA 500 mg

For intravenous administration

1. Reconstitution: at the time of use, add 10 ml of injection water to the vial containing 500 mg of vancomycin; this will result in a concentration of 50 mg/ml.
2. Dilution: immediately after reconstitution, dilute the reconstituted solution by adding it to 100 ml of diluent.

The desired dose, diluted in this way, can be administered by intravenous infusion for at least 60 minutes.

For oral administration

Intravenous administration of vancomycin is not effective for the treatment of Clostridium difficile infection, for this indication it should be administered orally.

• Administration in children 12 years and older:

• For the first episode of a non-severe Clostridium difficile infection (CDI), the recommended dose of vancomycin is 125 mg every 6 hours for 10 days. In case of severe or complicated disease, this dose can be increased to 500 mg every 6 hours for 10 days. The maximum daily dose should not exceed 2 g.

• In patients with multiple recurrences, consider the possibility of treating the current episode of CDI with vancomycin 125 mg four times a day for 10 days, followed by a gradual reduction in dose to 125 mg/day or an intermittent regimen, for example, 125-500 mg/day every 2-3 days for at least 3 weeks.

• Administration in neonates, infants, and children under 12 years:
• 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 treatment should be adapted to the individual clinical evolution of patients. Whenever possible, the suspected antibiotic should be discontinued. In addition, adequate fluid and electrolyte intake should be ensured.

The dose to be administered can be reconstituted in 30 ml of water and can be administered orally or through a nasogastric tube. Common flavorings can be added to the solution to improve the taste.

Administration rate:

The rapid administration in bolus form (i.e., over several minutes) may be associated with hypotension, including shock and, very rarely, cardiac arrest.

Vancomycin should be infused slowly in a diluted solution (2.5 to 5.0 mg/ml) at a rate not exceeding 10 mg/min and for a period of at least 60 minutes to avoid rapid infusion-related reactions. Interruption of infusion usually results in immediate cessation of these reactions. It should be sufficiently diluted (at least 100 ml per 500 mg or at least 200 ml per 1,000 mg).

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