Vancomycin Mip 500 mg powder for solution for infusion EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Vancomycin MIP 500 mg, powder for solution for infusion EFG

Read the entire leaflet carefully before you start using this medicine, because 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, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Vancomycin MIP is and what it is used for
2. What you need to know before using Vancomycin MIP
3. How to use Vancomycin MIP
4. Possible adverse effects
5. How to store Vancomycin MIP
6. Contents of the pack and other information

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

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

Vancomycin powder is reconstituted to form a solution for infusion.

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 mentioned above.

2. What you need to know before using Vancomycin MIP

Do not use Vancomycin MIP

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

Warnings and precautions

Serious side effects causing loss of vision have been reported after injection of vancomycin into the eyes.

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

• You have had an allergic reaction to teicoplanin, 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 (you will need blood tests and kidney function tests during treatment).
• You are receiving vancomycin by infusion for the treatment of Clostridium difficile-associated diarrhea instead of orally.
• You have previously developed a severe rash or skin peeling, blisters, and/or mouth sores after taking vancomycin.

Talk to your doctor, hospital pharmacist, or nurse during treatment with Vancomycin MIP if:

• You are receiving vancomycin for a prolonged period (you may need blood tests, and liver or kidney function tests during treatment).
• You develop any skin reaction during treatment.
• Contact your doctor immediately if you develop severe or chronic diarrhea during or after taking vancomycin. This may be a sign of inflammation of the intestine (pseudomembranous colitis), which can occur after antibiotic treatment.

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 notice any of the symptoms described in section 4.

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. Blood tests are performed to monitor vancomycin levels in this age group.

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

Use of Vancomycin MIP with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• Medicines potentially harmful to the kidneys and ears: If you take vancomycin together with other medicines that may harm the kidneys or ears (e.g., certain aminoglycoside antibiotics, piperacillin/tazobactam), this harmful effect may be increased. In such cases, thorough and regular monitoring of kidney and hearing function is necessary.
• Anesthetics: The use of anesthetics increases the risk of certain side effects associated with vancomycin, such as low blood pressure, skin redness, hives, and itching.
• Muscle relaxants: If you are using muscle relaxants (such as succinylcholine) at the same time, their effects may be intensified or prolonged.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before taking any medicine.

Vancomycin crosses the placenta and there is a risk of ear and kidney toxicity in the fetus. Therefore, if you are pregnant, your doctor should only administer vancomycin if clearly necessary and only after careful assessment of the benefits and risks.

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

Driving and using machines

Vancomycin MIP has no effect or has a negligible effect on the ability to drive and use machines.

3. How to use Vancomycin MIP

Medical personnel will administer vancomycin to you during your hospital stay. Your doctor will decide how much medicine you should receive each day and how long your 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 medicines you are taking.

Intravenous administration

Adults and adolescents (from 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 usually 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 dose should 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 usually administered every 6 hours.

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

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 the time elapsed after birth (postnatal age)).

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

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 bloodstream and never into the muscle.

Vancomycin is administered intravenously over at least 60 minutes.

Duration of treatment

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 possible side effects.

If you use more Vancomycin MIP than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Vancomycin MIP

Do not administer a double dose to make up for missed doses. A missed dose may only be administered before the next scheduled dose if the interval between administrations is sufficiently long.

In case of interruption or premature discontinuation of treatment with Vancomycin MIP

Low doses, irregular administration, or premature discontinuation of treatment may compromise treatment outcome or lead to relapses requiring more complicated treatment. Always follow your doctor's instructions.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• Red, flat spots, target-like or circular rashes on the trunk, often with central blisters, skin peeling, mouth ulcers, and sores in the throat, nose, genitals, and eyes. These serious 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 syndrome or drug hypersensitivity syndrome).
• Generalized red, scaly rash with bumps under the skin and blisters accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis).

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.

Common 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)
• Skin rash and inflammation of the mouth mucosa, itching, itchy rash, hives
• Kidney problems detectable through a blood test
• Redness of the upper body and face, inflammation of a vein

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

• Temporary or permanent loss of hearing

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 in the blood
• Loss of balance, ringing in the ears, 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, decreased urine output
• Rash with swelling or pain behind the ears, neck, groin, under the chin, and armpits (swollen lymph nodes), abnormal blood tests and abnormal liver function tests
• Rash with blisters and fever

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible side 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 MIP

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

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

Do not use this medicine after the expiry date stated on the outer packaging and label after "EXP". The expiry date is the last day of the month indicated.

Do not use this medicine if you notice particles or discoloration of the infusion solution.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point 1 at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Vancomycin MIP

• The active substance is vancomycin. Each vial contains 500 mg of vancomycin hydrochloride, equivalent to 500,000 IU of vancomycin.
• It contains no other excipients.

Appearance of the product and contents of the pack

Fine white powder with slight tints ranging from pink to brown.

Vancomycin MIP is available in packs of 1 or 5 glass vials with rubber stoppers and "flip-off" type seals.

Marketing Authorization Holder

MIP Pharma GmbH
Kirkeler Str. 41
66440 Blieskastel
Germany
Telephone: +49-6842/9609-0
Fax: +49-6842/9609-355

Manufacturer

Chephasaar Chem.-Pharm. Fabrik GmbH
Mühlstr. 50
66386 St. Ingbert
Germany

Date of the most recent review of this summary: 03/2021

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

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 antibiotic treatment, some bacteria may survive or multiply. 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 you do not adhere strictly to:

• 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 – Strictly follow the instructions given in the prescription.

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

This information is intended for healthcare professionals only:

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

Preparation of the concentrate for infusion

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

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

Preparation of the infusion solution

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

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

The concentration of vancomycin hydrochloride in the infusion solution must not exceed 2.5–5 mg/ml.

Appearance of the infusion solution

The solution should be visually inspected for particles or discoloration before administration.

The solution may only be used if it is clear and free from particles.

Compatibility with intravenous solutions

Vancomycin is compatible with sterile water for injectable preparations, 5% glucose solutions, and physiological saline (sodium chloride) solutions. Vancomycin solutions should generally be administered separately unless chemical and physical compatibility with another infusion solution has been demonstrated.

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

Important incompatibilities

Vancomycin solutions have a low pH, which may cause chemical or physical instability when mixed with other substances. Therefore, parenteral solutions should be visually checked for precipitation or color changes before use.

Vancomycin solutions are incompatible with penicillin and cephalosporin solutions (beta-lactam antibiotics). The risk of precipitation increases with higher vancomycin concentrations. To prevent precipitation, intravenous cannulas and catheters should be flushed with saline solution between the administration of vancomycin and these antibiotics.

Combined therapies

When vancomycin is used in combination with other antibiotics or chemotherapeutic agents, the preparations must be administered separately.

Storage after reconstitution

Stability of the infusion solution

Chemical and physical stability of the prepared infusion solution has been demonstrated for 96 hours at 2–8°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, the user is responsible for the storage time and conditions prior to use, and storage must not exceed 24 hours at 2–8°C, unless reconstitution/dilution has taken place under validated and controlled aseptic conditions.

Method of administration and duration of treatment

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

Patients with fluid restrictions may receive a solution of 500 mg/50 ml or 1,000 mg/100 ml, bearing in mind that the risk of infusion-related adverse effects may increase at higher concentrations.

An allergic (anaphylactic/anaphylactoid) reaction may occur during or immediately after a rapid infusion of vancomycin.

Rapid administration (i.e., over several minutes) may cause excessive hypotension (including shock-like reactions) and, less frequently, cardiac arrest, histamine-like reactions, and erythematous or maculopapular rashes (the "red man syndrome"). If severe hypersensitivity reactions occur (e.g., anaphylactic reaction), vancomycin treatment must be stopped immediately and standard emergency measures initiated.

Concomitant use of vancomycin and anesthetics increases the risk of trunk flushing and allergic reactions. To reduce the risk of these reactions, vancomycin should be administered over a 60-minute period prior to the administration of anesthetics.