Label: information for the user

Vancomycin Normon 1000 mg powder for concentrate for solution for infusion EFG

Vancomycin hydrochloride

Read this label carefully before starting to take this medicine, because it contains important information for you.

• Keep this label. You may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you consider that any of the adverse effects you are experiencing is serious or if you notice any effect This includes any adverse effect not mentioned in this label. See section4.

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

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

3. How to use Vancomycin Normon

4. Possible adverse effects

5. Storage of Vancomycin Normon

6. Contents of the package and additional information

This medication 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 perfusion solution or oral solution.

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

• Skin and subcutaneous tissue infections.
• Bone and joint infections.
• A type of 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.
• Central nervous system infections.
• Blood infections associated with the aforementioned infections.

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

No use Vancomicina Normon

• If you are allergic to vancomycin or any of the other components of this medication (listed in section6).

Warnings and precautions

Severe side effects have been reported that may 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 older person (you may need hearing tests during treatment).
• You have kidney problems (so you need to have blood tests and kidney function tests during treatment).
• You are receiving vancomycin by infusion for the treatment of diarrhea associated with Clostridioides difficile infection instead of oral administration.
• 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 generalized acute 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.

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

• You are receiving vancomycin for a long time (you may need to have 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.

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 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 required.

Use of Vancomycin with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This is especially important for the following medications, as they may interact with vancomycin:

• Anesthetic agents – may cause irritation, redness, dizziness, fainting, or even heart attacks.

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

• Any medication that affects the nerves or kidneys, for example, amphotericin B (for fungal infections), aminoglycosides, bacitracin, polymyxin B, colistin, viomicin, piperacillin/tazobactam (antibiotics), or cisplatin (a chemotherapy medication).
• Potent diuretics (strong medications that are administered to stimulate urine production) such as furosemide.

You may be able to continue receiving vancomycin and your doctor will be able to decide what is best 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 medication.

Driving and operating machinery

Vancomycin should not affect your ability to drive or 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,
• The functioning of your kidneys,
• 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 old

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

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 old)

The recommended dose is 125 mg every 6 hours. In some cases, your 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 (mucosal infections) before, you may need a different dose and duration of therapy.

Use in children

Neonates, infants, and children under 12 years old

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 intravenously for at least 60 minutes.

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

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 detect signs of possible side effects.

If you are given more Vancomycin than you should

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

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

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, upper body redness, 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 ulcers, nasal ulcers, genital ulcers, 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 start of treatment (acute generalized pustular psoriasis).

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, you may experience side effects that occur when vancomycin is administered by infusion.

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

• Low blood pressure.
• Shortness of breath, wheezing (a high-pitched sound produced by the obstruction of airflow in the upper airway).
• Mouth and throat mucosa inflammation, itching, hives, and urticaria.
• Kidney problems that can be detected by blood tests.
• Upper body and face redness, and 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) in the blood.
• Increased levels of some white blood cells in the blood.
• Loss of balance, ringing in the ears, dizziness.
• Vessel 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, which causes 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 liver function tests.
• Rash with blisters and fever.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 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.

Your doctor or pharmacist knows how to conserve this medication.

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

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

Before preparing it, store below 30 °C.

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

After preparing it, this infusion medication must 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 remaining solution of this medication after administering your dose.

Medications should not be thrown away through the drains or trash. Dispose of the containers and medications you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Vancomicina Normon Composition

Each vial contains 1000mg of vancomycin hydrochloride, equivalent to 1,000,000UI of vancomycin. It also contains hydrochloric acid.

Product appearance and packaging contents

Vials of 20ml, with rubber stopper, containing 1000mg of vancomycin hydrochloride in the form of white or off-white lyophilized powder. Packaging size: 1 or 100vials.

Only some packaging sizes may be commercially available.

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

Marketing authorization holder and manufacturer responsible

NORMON Laboratories, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos (Madrid)

SPAIN

Last review date of this leaflet:February 2023

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 may even help bacteria become resistant and, therefore, delay your recovery or reduce the effectiveness of antibiotics, if you do not follow the proper:

• dose,
• program
• 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.

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This information is intended solely for healthcare professionals

Preparation

Dissolve the contents of the vial in 20 ml of sterile water for injection. Dilute the reconstituted solution with at least 200 ml of sodium chloride 9mg/ml (at 0.9%) for injection or glucose 50mg/ml (at 5%) for injection.

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

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

Before administration, visually inspect the reconstituted solutions to discard 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 administration:

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

Infusion

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

Dose

Intravenous use:

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

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

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

Oral administration:

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

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

Storage

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

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

Reconstituted concentrate:

The reconstituted concentrate should be rediluted immediately after reconstitution.

Diluted product:

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

Oral administration:

It should be taken immediately after reconstitution.