VANCOMYCIN NORMON 500 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

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

This medicine 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 through intravenous infusion for the treatment of the following severe infections:

• Infections of the skin and tissues under the skin.
• Infections of the bones and joints.
• A lung infection called "pneumonia".
• Infection of the inner lining of the heart (endocarditis) and to prevent endocarditis in patients at risk when undergoing major surgical procedures.
• Infection in the central nervous system.
• Infection in the blood related 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 bacteria Clostridioides difficile.

2. What you need to know before you use Vancomycin Normon

Do not use Vancomycin Normon

• If you are allergic to vancomycin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

Consult your doctor, hospital pharmacist, or nurse before starting to use 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 elderly person (you may need hearing tests during treatment).
• You have kidney problems (you will need to have blood tests and kidney tests during treatment).
• You are being given vancomycin by infusion for the treatment of diarrhea associated with Clostridioides difficileinfection instead of orally.
• You have ever developed a severe rash or skin peeling, blisters, and/or sores in the mouth after taking vancomycin.

Severe skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) in association with vancomycin treatment. Stop using vancomycin and seek immediate medical attention if you notice any of the symptoms described in section 4.

Consult your doctor or hospital pharmacist or nurse during treatment with vancomycin if:

• You are being given vancomycin for a long time (you may need to have blood tests, a test to check liver or kidney function 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 can be a sign of inflammation of the intestine (pseudomembranous colitis) that can occur after antibiotic treatment.

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 for this age group, blood tests are performed.

The simultaneous administration of vancomycin and anesthetic agents has been associated with skin redness (erythema) and allergic reactions in children. Similarly, the simultaneous use with other medications such as aminoglycoside antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen), or amphotericin B (a medication to treat fungal infections) may increase the risk of kidney damage, and therefore, kidney and blood tests will be required more frequently.

Using Vancomycin with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This is especially important for the following medicines, as they may interact with vancomycin:

• Anesthetic agents – can cause irritation, redness, fainting, syncope, or even heart attacks.

Therefore, you should inform your doctor that you are using vancomycin if you are going to undergo surgery.

• Any medicine that affects the nerves or kidneys, such as amphotericin B (to treat fungal infections), aminoglycosides, bacitracin, polymyxin B, colistin, viomycin, piperacillin/tazobactam (antibiotics), or cisplatin (a chemotherapeutic agent).
• Powerful diuretics (strong medicines given to stimulate urine production) such as furosemide.

You may still be able to receive vancomycin, and your doctor will decide what is suitable for you.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Vancomycin should not affect your ability to drive or use machines.

3. How to use Vancomycin Normon

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

Dosage

The dose administered will depend on:

• your age,
• your weight,
• the infection you have,
• kidney function,
• your hearing ability,
• any other medicine you are taking.

Intravenous administration

Adults and adolescents (from 12years and older)

The dose will be calculated according to your body weight. The usual infusion dose is 15 to 20 mg per kg of body weight. It is usually administered every 8 - 12 hours. In some cases, the doctor may decide to give an initial dose of up to 30 mg per kg of body weight. The maximum daily dose should not exceed 2 g.

Use in children

Children from 1 month to less than 12years of age

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

Preterm and term newborns (from 0 to 27days)

The dose will be calculated according to the post-menstrual age [time elapsed between the first day of the last menstrual period and birth (gestational age) plus the time elapsed after birth (post-natal age)].

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

Oral administration

Adults and adolescents (from 12to 18years)

The recommended dose is 125 mg every 6 hours. In some cases, the doctor may decide to increase the daily dose up to 500 mg every 6 hours. The maximum daily dose should not exceed 2 g.

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

Use in children

Neonates, infants, and children under 12years

The recommended dose is 10 mg per kg of body weight. It is usually 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 into the blood and not into the muscle.

Vancomycin is administered into a vein over at least 60 minutes.

If you are being treated for stomach disorders (called pseudomembranous colitis), the medicine must be administered as an oral solution (you will take the medicine by mouth).

Duration of treatment

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

The duration of treatment 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 detect signs of possible side effects.

If you are given too much Vancomycin

Since vancomycin will be administered to you during your hospital stay, it is unlikely that you will receive too little or too much; however, inform your doctor or nurse if you have any doubts.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

• Red patches, like targets or circles, on the trunk, often with central blisters, skin peeling, mouth ulcers, throat, nose, genitals, 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 body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

• Red, scaly, and widespread rash with bumps under the skin and blisters accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis).

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

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

• Low blood pressure.
• Shortness of breath, wheezing (a high-pitched sound produced by obstruction of air flow in the upper airway).
• Rash, inflammation of the mouth mucosa, itching, itchy rash, hives.
• Kidney problems that can be detected by a blood test.
• Redness of the upper body and face, vein inflammation.

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 (cells responsible for blood clotting) in the blood.
• Increase in some white blood cells in the blood.
• Loss of balance, ringing in the ears, dizziness.
• Vein inflammation.
• Nausea (feeling of discomfort).
• Kidney inflammation and kidney failure.
• 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 can be associated with high fever and joint pain.
• Cardiac arrest.
• Inflammation of the intestine, which causes abdominal pain and diarrhea (which may contain blood)

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

• Vomiting, diarrhea.
• Confusion, drowsiness, lack of energy, swelling, fluid retention, decreased urine output.
• Rash with swelling or pain behind the ears, in the neck, groin, under the chin, and armpits (inflamed lymph nodes), abnormal blood tests and liver function tests.
• Rash with blisters and fever.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: //www.notificaram.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vancomycin Normon

Your doctor or pharmacist knows how to store this medicine. 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 label after EXP. The expiry date is the last day of the month stated.

Before preparation, store below 30 °C.

Store the vial in the outer packaging to protect it from light

After preparation, this medicine for infusion should be used immediately.

Your doctor will ensure that the solution is not discolored and does not contain particles.

The vials are for single use and your doctor will discard any leftover solution of this medicine after administering your dose.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vancomycin Normon

Each vial contains 500 mg of vancomycin hydrochloride, equivalent to 500,000 IU of vancomycin. It also contains hydrochloric acid.

Appearance of the product and packaging content

Vials of 12 ml, with a rubber stopper, containing 500 mg of vancomycin hydrochloride in the form of a white or off-white lyophilized powder. Package size: 1 or 100 vials.

Only some package sizes may be marketed.

After preparation with water, the solution of this medication is transparent, colorless, or slightly colored.

Marketing authorization holder and manufacturer

NORMON Laboratories, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos (Madrid)

SPAIN

Date of the last revision of this prospectus:February 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (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.

Misuse of antibiotics increases resistance. You can even help bacteria become resistant and, therefore, delay your recovery or decrease the effectiveness of antibiotics if you do not respect the following:

• the dose,
• the program,
• the duration of treatment.

Consequently, to preserve the effectiveness of this medication:

1. Use antibiotics only when they are prescribed.
2. Strictly follow the prescription instructions.
3. Do not reuse an antibiotic without a medical prescription, even if you want to treat a similar illness.

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This information is intended only for healthcare professionals

Preparation

Dissolve the contents of the vial in 10 ml of sterile water for injection. Dilute the reconstituted solution with at least 100 ml of sodium chloride 9 mg/ml (0.9%) for injection or glucose 50 mg/ml (5%) for injection.

The concentration of vancomycin in the prepared infusion liquid should not exceed 0.5% m/v (5 mg/ml).

In the case of specific patients who need to restrict the volume of infused fluid, it is possible to use a concentration of 10 mg/ml; the administration of these high concentrations may increase the risk of adverse effects associated with infusion.

Before administration, the reconstituted solutions should be visually inspected to rule out the presence of particles or discoloration. Only transparent and colorless solutions without particles should be used.

The infusion should not be mixed with other medications.

Oral route:

The dose for oral administration can be reconstituted with 30 ml of water and given to the patient to drink.

Infusion

It should be administered by intravenous infusion for at least 60 minutes at a rate of 10 mg/min, equivalent to 2 ml/min in an infusion with a concentration of 5 mg/ml.

Dose

Intravenous use:

The dose is adjusted individually and according to renal function. The usual dose is as follows:

Adults: 500 mg every 6 hours or 1 g every 12 hours administered by slow intravenous infusion or 30 to 40 mg/kg/day in 2 to 4 daily administrations.

Children: 10 mg/kg of body weight every 6 hours administered by slow intravenous infusion.

Oral route:

Adults: 125 mg every 6 hours or 500 mg every 6 hours administered orally.

Children: 10 mg/kg of body weight every 6 hours.

Storage

Store below 30 °C. Keep the vial in the outer carton to protect it from light.

Do not use this medication after the expiration date shown on the packaging.

Reconstituted concentrate:

The reconstituted concentrate should be diluted immediately after reconstitution.

Diluted product:

From a microbiological and physicochemical point of view, the product should be used immediately.

Oral route:

It should be taken immediately after reconstitution.