Vancomycin Sala 1.000 mg powder for concentrate for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

Package leaflet contents:

1. What Vancomycin Sala is and what it is used for.
2. Before administration of Vancomycin Sala
3. How to use Vancomycin Sala
4. Possible side effects.
5. Storage of Vancomycin Sala
6. Contents of the pack and additional information

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

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

Vancomycin powder is reconstituted to form an infusion solution or an oral solution.

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

• Skin and soft tissue infections.

• Bone and joint infections.

• A lung infection called "pneumonia".

• Infection of the inner lining of the heart (endocarditis), and for prevention of endocarditis in at-risk patients undergoing major surgical procedures.

• Bloodstream infection associated with the infections listed above.

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

2. What you need to know before using Vancomycin Sala

Do not use vancomycin

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

Warnings and precautions

Talk to your doctor, hospital pharmacist, or nurse before using vancomycin if:

• You have had an allergic reaction to teicoplanina, as this may mean you are also allergic to vancomycin.
• You have a hearing problem, especially if you are elderly (you may need hearing tests during treatment).
• You have kidney problems (blood tests and kidney function tests may be required during treatment).
• You are receiving vancomycin by infusion for the treatment of Clostridium difficile-associated diarrhea instead of orally.
• You have ever developed a severe rash, skin peeling, blisters, and/or mouth sores after taking vancomycin.

Allergic reactions to this medicine, including breathing difficulties and chest pain, have been reported with vancomycin. Stop taking vancomycin immediately and contact your doctor or emergency medical services right away if you notice any of these signs.

Serious 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), associated with vancomycin treatment. Stop using vancomycin and seek immediate medical attention if you experience any of the symptoms described in section 4.

Serious adverse effects that may lead to vision loss have been reported following intravitreal injection of vancomycin.

Talk to your doctor, hospital pharmacist, or nurse during vancomycin treatment if:

• You are receiving vancomycin for a prolonged period (you may need blood tests and liver or kidney function monitoring during treatment).
• You develop any skin reaction during treatment.
• You develop severe or chronic diarrhea during or after vancomycin use. This may be a sign of intestinal inflammation (pseudomembranous colitis), which can occur after antibiotic therapy.

Children

Vancomycin is used with special caution in premature infants and young babies, because their kidneys are not fully developed and may accumulate vancomycin in the blood.

To monitor vancomycin blood levels, blood tests are performed in this age group.

Concomitant administration of vancomycin and anesthetic agents has been associated with skin redness (erythema) and allergic reactions in children. Likewise, simultaneous use with other medicines such as aminoglycoside antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen), or amphotericin B (an antifungal medication) may increase the risk of kidney damage, and therefore kidney and blood tests may need to be performed more frequently.

Other medicines and Vancomycin Sala

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

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

The following medicines may interact with Vancomycin:

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

• Anesthetic agents: concomitant administration of intravenous vancomycin and anesthetic agents has been associated with skin redness and allergic reactions.

• Medicines used for muscle relaxation.

• Medicines for bacterial infections (e.g., polymyxin B, colistin, bacitracin, and aminoglycosides).

• Medicines for fungal infections (amphotericin B).

• Medicines for tuberculosis (viomycin).

• Medicines for cancer (cisplatin).

• Should be administered with caution in patients allergic to another glycopeptide antibiotic called teicoplanin, as cross-allergic reactions have been reported.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or hospital pharmacist before using this medicine. Vancomycin should be administered during pregnancy and breastfeeding only if clearly needed. Vancomycin crosses the placenta and may cause fetal toxicity. Vancomycin passes into human milk. Your doctor may decide that you should discontinue breastfeeding.

Driving and using machines:

The effect of vancomycin on the ability to drive and use machines is negligible or none.

3. How to use Vancomycin Sala

Medical staff will administer vancomycin to you 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 dose administered will depend on:

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

Intravenous administration

Adults and adolescents (12 years of age 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 generally administered every 8 to 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 must not exceed 2 g.

Use in children

Children between one month and less than 12 years of age

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

Premature newborns and full-term newborns (from 0 to 27 days of age)

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

Elderly patients, 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 of age)

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

If you have previously experienced episodes (mucosal infection), you may require a different dose and duration of therapy.

Use in children

Neonates, infants, and children under 12 years of age

The recommended dose is 10 mg per kg of body weight. It is generally administered every 6 hours. The maximum daily dose must not exceed 2 g.

Method of administration

Intravenous infusion means that the medication 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 bloodstream and never into the muscle.

Vancomycin must be administered intravenously over at least 60 minutes.

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

Treatment duration

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

The duration of therapy may vary depending on the individual patient's response to treatment.

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

If you receive more Vancomycin Sala than you should

Contact your doctor or pharmacist immediately. In case of accidental overdose, contact the Toxicology Information Service (telephone: 915620420), indicating the medication and the amount administered. Take this leaflet with you.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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 experience sudden wheezing, difficulty breathing, redness of the upper body, skin rash, or itching.

Stop using vancomycin and inform your doctor or nurse immediately if you experience any of the following symptoms:

• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

• Reddish, non-elevated spots resembling targets or circles on the trunk, often with central blisters, skin peeling, and sores in the mouth, 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).

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

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

Vancomycin absorption in the gastrointestinal tract is negligible. However, if you have an inflammatory disorder of the digestive tract, especially if you also have kidney problems, side effects may occur that are typically seen when vancomycin is administered by infusion.

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

• Drop in blood pressure.

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

• Rash and inflammation of the mucous membranes in the mouth, itching, itchy rash, hives.

• Kidney problems detectable through a blood test.

• Redness of the upper body and face, inflammation of a vein.

• Increased liver enzymes.

Uncommon adverse effects (may affect up to 1 in 100 people):

• Temporary or permanent hearing loss.

Rare adverse 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).
• Increase in certain white blood cells.
• Loss of balance, ringing in the ears (tinnitus), dizziness.
• Inflammation of blood vessels.
• Nausea (feeling unwell).
• Inflammation of the kidneys and kidney failure.
• Chest and back muscle pain.
• Fever, chills.

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

• Sudden onset of a severe allergic skin reaction with skin peeling or blistering. This may be associated with high fever and joint pain.
• Cardiac arrest.
• Inflammation of the intestine causing abdominal pain and diarrhea (which may contain blood).

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

• Vomiting, diarrhea.
• Confusion, drowsiness, lack of energy, swelling, fluid retention, reduced urine output.
• Rash with swelling or pain behind the ears, in the neck, groin, under the chin, and armpits (swollen lymph nodes), abnormal blood tests and abnormal liver tests.
• Rash with blisters and fever.
• Excessive destruction of red blood cells leading to fatigue and pale skin (hemolytic anemia).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vancomycin Sala

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the outer packaging and on the vial as EXP. The expiry date refers to the last day of the month indicated.

Protect 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 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 and 5% dextrose; or Ringer-acetate solution).

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vancomycin Sala

The active substance is vancomycin.

Vancomycin Sala 1000 mg powder for concentrate for solution for infusion:

Each vial contains 1000 mg vancomycin hydrochloride equivalent to 1,000,000 IU of vancomycin.

Appearance of the product and contents of the container

Vancomycin Sala 1000 mg powder for concentrate for solution for infusion:

Pack containing 1 vial with white or almost white or slightly pink lyophilized powder for intravenous administration containing 1 g of vancomycin, and clinical pack with 100 vials.

Other sources of information

Medical advice/education

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

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

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

Improper use of antibiotics increases resistance. You may even contribute to bacteria becoming resistant, thereby delaying your recovery or reducing the effectiveness of antibiotics if the following are not respected:

• the dose
• the timing
• the duration of treatment

Therefore, to preserve the effectiveness of this medicine:

1- Use antibiotics only when prescribed by a doctor.

2- Follow the prescription instructions strictly.

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

Marketing Authorization Holder and Manufacturer

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

Date of the most recent revision of this leaflet: January 2026

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

Additional information for healthcare professionals

This information is intended exclusively for doctors or healthcare professionals.

Route of administration:

Vancomycin hydrochloride is irritating to tissues and must be administered by safe intravenous route and intermittent infusion. Efficacy and safety of vancomycin administered via intrathecal, intralumbar, or intraventricular routes have not been established. Vancomycin must not be administered by intramuscular route due to the risk of necrosis.

Pain and thrombophlebitis may occur in many patients treated with intravenous vancomycin, sometimes severe. Frequency and severity can be minimized by administering the drug slowly as a diluted solution and by regularly changing the infusion sites.

Rapid bolus administration (over several minutes) may be associated with hypotension (including shock and, very rarely, cardiac arrest) as well as histamine-related reactions and maculopapular or erythematous rash (red man syndrome or red neck syndrome).

The frequency of infusion-related reactions (hypotension, flushing, erythema, urticaria, and pruritus) increases with concomitant administration of anesthetic agents. This can be minimized by administering vancomycin via infusion lasting at least 60 minutes, prior to induction of anesthesia.

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

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

Mixtures of vancomycin solutions and beta-lactam antibiotics have been shown to be physically incompatible. The likelihood of precipitate formation increases with higher concentrations of vancomycin. It is recommended to adequately flush intravenous lines between administration of these antibiotics. It is also recommended to dilute vancomycin solutions to a concentration of ≤5 mg/ml.

Preparation method for VANCOMYCIN SALA 1000 mg:

For intravenous administration:

1. Reconstitution: At the time of use, add 20 ml of water for injection to the vial containing 1000 mg of vancomycin; this yields a concentration of 50 mg/ml.
2. Dilution: Immediately after reconstitution, dilute the reconstituted solution by adding it to 200 ml of diluent.

The desired dose, diluted in this manner, may be administered by intravenous infusion over at least 60 minutes.

For oral administration

Intravenous vancomycin is not effective for the treatment of Clostridium difficile infection; for this indication, oral administration is required.

-Administration in children aged 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 cases of severe or complicated disease, this dose may 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 treating the current CDI episode with vancomycin 125 mg four times daily for 10 days, followed by a gradual dose reduction to 125 mg/day or an intermittent regimen, e.g., 125–500 mg every 2–3 days for at least 3 weeks.

-Administration in neonates, infants, and children under 12 years of age:

• 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.

• Duration of treatment should be adapted to the individual patient's clinical course. Whenever possible, the antibiotic suspected of causing Clostridium difficile infection should be discontinued. Adequate fluid and electrolyte replacement should also be ensured.

The dose to be administered may be reconstituted in 30 ml of water and may be given orally or via nasogastric tube. Common flavored syrups may be added to the solution to improve taste.

Rate of administration:

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

Vancomycin must be infused slowly in a diluted solution (2.5 to 5.0 mg/ml) at a rate not exceeding 10 mg/min and over a period of no less than 60 minutes to avoid rapid-infusion-related reactions. Interruption of the infusion usually results in immediate cessation of these reactions. The solution should be sufficiently diluted (at least 100 ml per 500 mg or at least 200 ml per 1000 mg).

Patients with fluid restrictions may receive a solution of 500 mg/50 ml or 1000 mg/100 ml, bearing in mind that the risk of infusion-related adverse effects may increase at higher concentrations.