Vancomicin Pharmline

Leaflet accompanying the packaging: information for the user

Vancomycin Pharmline, 1000 mg, powder for concentrate for solution for infusion

Vancomycin hydrochloride

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

• 1. What is Vancomycin Pharmline and what is it used for
• 2. Important information before using Vancomycin Pharmline
• 3. How to use Vancomycin Pharmline
• 4. Possible side effects
• 5. How to store Vancomycin Pharmline
• 6. Contents of the pack and other information

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

Vancomycin Pharmline contains the active substance vancomycin. Vancomycin is an antibiotic belonging to the class of antibiotics called "glycopeptides". Vancomycin works by killing certain bacteria that cause infections. Vancomycin in powder form is used to prepare a solution for infusion. Vancomycin is used in the form of an infusion in patients of all age groups, for the treatment of the following severe infections:

• skin and subcutaneous tissue infections;
• bone and joint infections;
• lung infections, known as "pneumonia";
• infections of the inner lining of the heart (endocarditis) and prevention of endocarditis in patients at risk, undergoing major surgical procedures.

2. Important information before using Vancomycin Pharmline

When not to use Vancomycin Pharmline

• if you are allergic to vancomycin.
• vancomycin must not be given into a muscle (intramuscularly), as it can cause cell and tissue death (necrosis) at the injection site.

Warnings and precautions

Before starting treatment with Vancomycin Pharmline, discuss with your doctor, hospital pharmacist, or nurse if:

• you have ever had a severe skin rash or skin peeling after taking vancomycin. Serious skin reactions have been reported with vancomycin, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If you notice any of the symptoms described in section 4, you should stop taking vancomycin and seek medical help immediately.

After injecting vancomycin into the eye, serious side effects have occurred, which can lead to loss of vision.

Children

Vancomycin will be used with special caution in premature and young infants, as their kidneys are not fully developed, which can lead to vancomycin accumulation in the blood. In this age group, blood tests may be necessary to monitor vancomycin levels in the blood. Co-administration of vancomycin and anesthetics is associated with flushing and allergic reactions in children. Additionally, concomitant use with other medications, 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 more frequent blood and kidney function tests may be necessary.

Vancomycin Pharmline and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, as they may interact with Vancomycin Pharmline:

• anesthetics - may cause redness, flushing, fainting, collapse, or even heart attack. Therefore, inform your doctor if you are taking Vancomycin Pharmline and are scheduled for surgery;
• any medicine that affects the nerves or kidneys, such as amphotericin B (for fungal infections), aminoglycosides, bacitracin, polymyxin B, colistin, piperacillin with tazobactam, or viomycin (antibiotics), or cisplatin (a chemotherapy medication);
• strong diuretics (strong medicines given to increase urine production), such as furosemide.

Pregnancy, breastfeeding, and fertility

Vancomycin Pharmline can be used during pregnancy only if absolutely necessary, and vancomycin levels in the blood should be regularly monitored to minimize the risk of harmful effects on the fetus. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Vancomycin Pharmline has no or negligible influence on the ability to drive and use machines.

3. How to use Vancomycin Pharmline

Vancomycin Pharmline will be given to you by medical staff during your hospital stay. Your doctor will decide what dose you should receive each day and how long your treatment should last.

Dosage:

The dose will depend on:

• your age;
• your body weight;
• the type of infection;
• your kidney function;
• your hearing;
• any other medicines you are taking.

After reconstitution and dilution, Vancomycin Pharmline will be given to you as an intravenous infusion.

Adults and adolescents (12 years and older)

The dose will be determined based on your body weight. The usual dose used in infusion is 15 to 20 mg per kilogram of body weight. This dose is usually given every 8 to 12 hours. In some cases, your doctor may decide to use a loading dose of 30 mg per kilogram of body weight. The maximum daily dose should not exceed 2 g.

Use in children

Children from 1 month to less than 12 years of age: The dose will be determined based on your body weight. The usual dose used in infusion is 10 to 15 mg per kilogram of body weight. This dose is usually given every 6 hours. Premature and full-term newborns (from 0 to 27 days): The dose will be calculated based on gestational age (the time from the first day of the last menstrual period to birth) plus postnatal age (the time from birth).

Other populations

In elderly patients, pregnant women, and patients with kidney problems, including those on dialysis, a different dose may be necessary. Administration: Intravenous infusion means that the medicine flows from a bottle or infusion bag through a tube into one of your veins. Your doctor or nurse will always give vancomycin into your vein, not into your muscle. Vancomycin will be given into your vein over at least 60 minutes. Duration of treatment: The length of treatment depends on the type of infection and may last several weeks. The duration of treatment may vary depending on your response to treatment. During treatment, you may have blood tests and urine analysis, and you may also have a hearing test to look for signs of possible side effects.

Using more than the recommended dose of Vancomycin Pharmline

Since Vancomycin Pharmline will be given to you in the hospital, it is unlikely that you will receive too much or too little of the medicine. However, if you have any concerns, tell your doctor or nurse. If you have any further questions about using this medicine, ask your doctor or nurse.

4. Possible side effects

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

Vancomycin may cause allergic reactions, although severe allergic reactions (anaphylactic shock) are rare. You should immediately tell your doctor if you experience sudden wheezing, difficulty breathing, redness of the upper body and face, rash, or itching.

If you notice any of the following symptoms, stop taking vancomycin and seek medical help immediately:

• red, flat, target-like, or circular patches on the torso, often with blisters in the center, skin peeling, mouth ulcers, throat ulcers, nose ulcers, genital ulcers, and eye ulcers. The occurrence of these severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome and toxic epidermal necrolysis).
• widespread rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).
• red, peeling, widespread rash with bumps under the skin and blisters, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis).

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

• low blood pressure;
• shortness of breath, wheezing;
• rash, inflammation of the mouth, itching, itchy rash, hives;
• kidney problems, usually detected by blood tests;
• 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 the number of white blood cells, red blood cells, and platelets (blood cells responsible for blood clotting);
• increase in the number of certain white blood cells in the blood;
• balance disorders, ringing in the ears, dizziness;
• vein inflammation;
• nausea (sickness);
• 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 onset of a severe allergic skin reaction, including skin peeling or blistering. This may be accompanied by high fever and joint pain;
• cardiac arrest;
• inflammation of the intestine, causing abdominal pain and diarrhea, which may contain blood.

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

• vomiting, diarrhea;
• confusion, drowsiness, lack of energy, swelling, fluid retention, decreased urine production;
• rash with swelling and pain in the area behind the ears, neck, armpits, under the chin and under the arms (lymph node swelling), abnormal blood test results and liver function tests;
• rash with blisters and fever.

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.

5. How to store Vancomycin Pharmline

Medical staff will ensure that Vancomycin Pharmline is stored properly. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and vial after EXP. The expiry date refers to the last day of the month. Store in a temperature below 25°C. After preparation, the Vancomycin Pharmline solution for infusion should be used immediately. Your doctor will ensure that the solution has not discolored and does not contain particles. The vials are for single use only, and your doctor will discard any remaining solution after administration. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Vancomycin Pharmline contains

The active substance is vancomycin hydrochloride. Each vial contains 1000 mg of vancomycin hydrochloride, equivalent to 1,000,000 IU of vancomycin.

What Vancomycin Pharmline looks like and contents of the pack

This medicine is a white to light brown powder for concentrate for solution for infusion. The vial is made of colorless glass (type I) with a gray rubber stopper and an aluminum cap with a white plastic flip-off seal. The carton contains one vial of Vancomycin Pharmline, 1000 mg, and one leaflet.

Marketing authorization holder

Pharmline Company Sp. z o.o., ul. Juliana Ursyna Niemcewicza 17/11, 02-306 Warsaw, Poland, tel: +48 780 008 085, e-mail: [email protected]

Manufacturer

S.C. Rompharm Company S.R.L., 1A, Eroilor Street, 075100 Otopeni, Romania

This medicine is authorized in the Member States of the European Economic Area under the following names:

Hungary: Vancomycin Rompharm 1000 mg por oldatos infúzióhoz való koncentrátumhoz, Romania: Vancomicină Rompharm 1000 mg pulbere pentru concentrat pentru soluţie perfuzabilă, Bulgaria: Ванкомицин Ромфарм 1000 mg прах за концентрат за инфузионен разтвор, Poland: Vancomycin Pharmline

Date of last revision of the leaflet:

Medical advice/education

Antibiotics are used to treat bacterial infections. They are not effective against viral infections. If your doctor has prescribed you antibiotics, they are necessary to treat your current illness. Despite antibiotic treatment, some bacteria may survive or continue to grow. This phenomenon is called resistance; some antibiotic treatments become ineffective. Improper use of antibiotics promotes the development of resistance. You can also facilitate the development of resistance and thereby delay recovery or reduce the effectiveness of antibiotic therapy if you do not follow the proper:

• dosing,
• treatment schedule,
• duration of treatment.

Therefore, to maintain the effectiveness of this medicine, you should:

• Use antibiotics only when prescribed by a doctor.
• Strictly follow the prescribed treatment regimen.
• Do not reuse an antibiotic without a doctor's recommendation, even to treat a similar illness.
• Never give an antibiotic to another person; it may not be suitable for their illness.
• After completing treatment, return any unused medicine to the pharmacy to ensure it is disposed of properly.

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Information intended for healthcare professionals only:

Reconstitution instructions

For single use only. Discard any unused contents.

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

Shelf-life after reconstitution and dilution of the solution:

Chemical and physical stability of the reconstituted concentrate and diluted solution has been demonstrated for 24 hours at 2°C-8°C. From a microbiological point of view, unless the method of reconstitution/dilution precludes the risk of microbial contamination, the solution should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user.

Preparation of the reconstituted solution

For use, add 20 mL of water for injection to the vial. Vials prepared in this way will give a solution with a concentration of 50 mg/mL. After dissolution in water, it forms a clear solution. Storage conditions for the medicinal product after reconstitution, see section 6.3 of the Summary of Product Characteristics, "Shelf-life". FURTHER DILUTION IS REQUIRED. Read the following instructions: The preferred method of administration is intermittent infusion. Solutions after reconstitution containing 1 g of vancomycin hydrochloride should be diluted in at least 200 mL of 0.9% sodium chloride infusion solution or 5% glucose infusion solution. The desired dose should be administered by intravenous infusion over at least 60 minutes. If administered over a shorter period or in higher concentrations, in addition to thrombophlebitis, there is a risk of significant hypotension. Rapid administration may also cause redness and transient rash on the neck and shoulders. Continuous infusion (should only be used when intermittent infusion is not possible). One or two vials (1-2 g) can be added to a sufficient volume of intravenous infusion solution of sodium chloride or 5% glucose to allow slow administration of the desired daily dose by drip over 24 hours. The recommended concentration should not exceed 5 mg/mL. In selected patients requiring fluid restriction, a concentration up to 10 mg/mL may be used (see section 4.2). Each dose should be administered at a rate not greater than 10 mg/min. After reconstitution and dilution with 0.9% sodium chloride infusion solution or 5% glucose infusion solution, the osmolality of the reconstituted and diluted solution is approximately 270 mOsm/kg, and the pH is between 2.5 and 4.5. Before administration, the reconstituted and diluted solutions should be inspected for the presence of particles and discoloration. Only use a clear and colorless to pale yellow solution without particles.

Disposal

Any unused product or waste material should be disposed of in accordance with local requirements.