Vancomycin Mip 1000 mg powder for solution for infusion EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Vancomycin MIP 1000 mg, powder for solution for infusion EFG

Read all of this 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 pass it on to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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 side 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 "glycopeptides" group 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 listed 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 components of this medicine (listed in section 6).

Warnings and precautions

Serious side effects leading to vision loss have been reported following 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 may 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 ever 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 tests to monitor liver or kidney function 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 intestinal inflammation (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 must be 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.

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 (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, careful and regular monitoring of kidney and hearing function is required.
• Anesthetics: The use of anesthetics increases the risk of certain vancomycin-related side effects, such as low blood pressure, skin redness, hives, and itching.
• Muscle relaxants: If you are also using muscle relaxants (such as succinylcholine), 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 fetal ear and kidney toxicity. 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 infant 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 influence 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 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 (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 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 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 generally 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 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 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 length of therapy may vary depending on the individual patient's response to treatment.

During treatment, blood samples, urine samples, and possibly hearing tests should be performed to monitor for signs of potential 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 medication 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 therapy. 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 resembling targets or circles on the trunk, often with central blisters, skin peeling, and mouth, throat, nose, genital, or eye ulcers. 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 on 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, vein inflammation

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 in the blood
• Loss of balance, ringing in the ears, dizziness
• Inflammation of blood vessels
• Nausea (feeling of discomfort)
• Kidney inflammation and renal 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 skin allergic reaction with skin peeling or blistering. This may be associated with high fever and joint pain
• Cardiac arrest
• Intestinal inflammation 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, 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 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 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 refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vancomycin MIP

• The active substance is vancomycin. Each vial contains 1000 mg of vancomycin hydrochloride, equivalent to 1,000,000 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" 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, it is because you need them to treat your current illness.

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

Inappropriate use of antibiotics increases resistance. You may even contribute to bacteria becoming resistant, thereby delaying your recovery or reducing antibiotic effectiveness if you do not follow the appropriate:

• dosage
• timing
• 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 provided 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 solely for healthcare professionals:

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

Preparation of the concentrate for infusion

Dissolve the contents of each 1000 mg vial in 20 ml of sterile water for injections.

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

Preparation of the solution for infusion

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

1000 mg vial: to obtain a 5 mg/ml infusion solution, dilute 20 ml of concentrate with 180 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 water for injections, 5% glucose solutions, and physiological saline 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

Period of validity 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, the user is responsible for the storage times and conditions prior to use, and storage must not exceed 24 hours at 2–8°C, unless reconstitution/dilution was performed under validated and controlled aseptic conditions.

Method of administration and duration of treatment Vancomycin is administered only 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 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.

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

Rapid administration (i.e., over several minutes) may cause excessive hypotension (including shock), 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 reddening and allergic reactions. To reduce the risk of these reactions, vancomycin should be administered over a 60-minute period before the administration of anesthetics.