Vancomycin pharmline

Package leaflet: Information for the user

Vancomycin Pharmline, 1000 mg, powder for solution for infusion
Vancomycini hydrochloridum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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

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

• Skin and soft 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 at-risk patients undergoing major surgical procedures.

2. Important information before using Vancomycin Pharmline

When not to use Vancomycin Pharmline

• if the patient is allergic to vancomycin.
• vancomycin must not be administered intramuscularly, as it may 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:

• the patient has ever experienced severe skin rash, skin peeling, blisters, and/or oral mucosal ulcers after receiving vancomycin. Serious skin reactions have been reported with vancomycin use, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If any of the symptoms described in section 4 occur, discontinue vancomycin immediately and seek medical help without delay.

• the patient has previously had an allergic reaction to teicoplanin, as this may indicate that the patient is also allergic to vancomycin;

• the patient has hearing problems, especially if elderly (hearing tests may be necessary during treatment);

• the patient has impaired kidney function (blood tests and kidney function monitoring will be required during treatment);

• the patient is receiving vancomycin by infusion for the treatment of Clostridium difficile-associated diarrhoea, instead of oral administration.

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

• the patient is receiving vancomycin treatment for a prolonged period (blood tests, liver and kidney function tests may be required during treatment);
• the patient develops any skin reaction during treatment;
• the patient develops severe or persistent diarrhoea during or after completion of vancomycin treatment; in such case, consult a doctor immediately. This may be a sign of intestinal inflammation (pseudomembranous colitis), which may occur during antibiotic therapy.

Severe adverse effects, potentially leading to vision loss, have occurred following accidental injection of vancomycin into the eye.
Children
Vancomycin will be used with special caution in premature infants and young infants,
because their kidneys are not fully developed, which may lead to accumulation of
vancomycin in the blood. In this age group, blood tests may be necessary to
monitor vancomycin blood levels.
Concomitant administration of vancomycin and anaesthetic agents has been associated with
skin redness (flushing) and allergic reactions in children. Additionally, concomitant use
with other drugs such as aminoglycoside antibiotics, non-steroidal anti-inflammatory drugs
(NSAIDs, e.g. ibuprofen), or amphotericin B (an antifungal agent) may increase the risk of kidney damage,
therefore more frequent blood and kidney function tests may be required.
Vancomycin Pharmline and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken,
as well as any medicines the patient plans to take. This is particularly important
for the following medicines, as they may interact with Vancomycin Pharmline:

• anaesthetic agents – may cause redness, flushing, fainting, collapse, and even heart attack. Therefore, inform the doctor about the use of Vancomycin Pharmline if surgery is planned;
• any medicine affecting nerves or kidneys, such as amphotericin B (used to treat fungal infections), aminoglycosides, bacitracin, polymyxin B, colistin, piperacillin with tazobactam, viomycin (antibiotics), or cisplatin (a chemotherapeutic agent);
• potent diuretics (strong medicines given to increase urine production), such as furosemide.

It may still be appropriate for the patient to receive Vancomycin Pharmline, and the doctor
will decide what is suitable for the patient.
Pregnancy, breastfeeding, and effects on fertility
Vancomycin Pharmline may be administered during pregnancy only if absolutely necessary,
and vancomycin blood levels should be monitored regularly to minimize the risk of harmful effects on the fetus.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Vancomycin Pharmline has no effect or has a negligible effect on the ability to drive
and operate machinery.

3. How to use Vancomycin Pharmline

Vancomycin Pharmline will be administered to the patient by medical personnel during hospitalization.
The physician will decide the daily dose of the medicine the patient should receive and how long
the treatment should last.
Dosage:
The dose administered will depend on:

• the patient's age;
• the patient's body weight;
• the type of infection;
• the patient's kidney function;
• the patient's hearing status;
• any other medications the patient is taking.

After reconstitution and dilution, Vancomycin Pharmline will be administered to the patient as an
intravenous infusion.
Adults and adolescents (aged 12 years and above)
Dosing will be determined based on the patient's body weight. The usual infusion dose is 15 to 20 mg
per kg of body weight. This dose is usually given every 8 to 12 hours. In some cases, the physician may
decide to use an initial dose of 30 mg per kg of body weight. The maximum daily dose should not exceed 2 g.
Use in children
Children aged one month to below 12 years
Dosing will be determined based on the patient's body weight. The usual infusion dose is 10 to 15 mg
per kilogram of body weight. This dose is usually administered every 6 hours.
Preterm and full-term newborns (from 0 to 27 days of age)
The dose will be calculated based on postconceptional age (gestational age—the time elapsed from
the first day of the mother's last menstrual period to birth—plus postnatal age—the time elapsed since birth).
Other populations
Different dosing may be required for elderly patients, pregnant women, and patients with impaired
renal function, including dialysis patients.
Method of administration
Intravenous infusion means that the medicine flows from an infusion bottle or bag through a tube into
one of the patient's blood vessels. The physician or nurse will always administer vancomycin into the
bloodstream, never into muscle.
Vancomycin should be infused intravenously 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 the individual patient's response to therapy.
During treatment, the patient may undergo blood tests and urine analysis, and may also have hearing
tests performed to monitor for potential adverse effects.
Administration of a higher than recommended dose of Vancomycin Pharmline
Since Vancomycin Pharmline will be administered to the patient in the hospital, it is unlikely that the
patient will receive too high or too low a dose; however, if the patient has any concerns, they should
inform the physician or nurse.
If there are any further doubts regarding the use of this medicine, consult the physician or nurse.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Vancomycin may cause allergic reactions, although severe allergic reactions (anaphylactic shock) occur rarely. If the patient develops sudden wheezing, difficulty breathing, redness of the upper body, rash or itching, inform a doctor immediately.
If the patient notices any of the following symptoms, vancomycin should be discontinued and medical advice should be sought immediately

• red, flat, target-like or circular rashes on the trunk, often with blisters in the center, skin peeling, ulceration of the mouth, throat, nose, genital organs and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome and toxic epidermal necrolysis).
• extensive rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• widespread red, peeling rash with subcutaneous nodules and blisters accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis).

Common adverse reactions (may occur in up to 1 in 10 patients)

• drop in blood pressure;
• shortness of breath, wheezing (a high-pitched sound caused by an obstruction in the upper airways);
• rash and inflammation of the oral mucosa, itching, itchy rash, urticaria;
• kidney function disorders, usually detectable in blood tests;
• redness of the upper body and face, phlebitis.

Uncommon adverse reactions (may occur in up to 1 in 100 patients)

• transient or permanent hearing loss.

Rare adverse reactions (may occur in up to 1 in 1,000 patients)

• decrease in the number of white blood cells, red blood cells and platelets (blood cells responsible for blood clotting);
• increase in certain white blood cells in the blood;
• disturbances in balance, ringing in the ears, dizziness;
• vasculitis;
• nausea;
• kidney inflammation and kidney failure;
• chest and back muscle pain;
• fever, chills.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients)

• sudden onset of severe skin allergic reaction involving skin peeling or blister formation. This may be accompanied by high fever and joint pain;
• cardiac arrest;
• intestinal inflammation causing abdominal pain and diarrhoea, which may contain blood.

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

• vomiting, diarrhoea;
• confusion, drowsiness, lack of energy, swelling, fluid retention, reduced urine output;
• rash with swelling and pain behind the ears, neck, groin, under the chin and under the arms (swelling of lymph nodes), abnormal blood test results and liver function tests;
• blistering rash and fever.

If any adverse reactions occur, talk to your doctor, pharmacist or nurse. This includes any adverse reactions not listed in this leaflet.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vancomycin Pharmline

Medical professionals will ensure appropriate storage conditions for Vancomycin Pharmline.
Keep the medicine out of 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 stated month.
Store below 25 °C.
After preparation, the Vancomycin Pharmline solution for infusion should be used immediately.
The physician will ensure that the solution is not discoloured and contains no particles.
Vials are for single use only, and the physician will dispose of any remaining solution of Vancomycin Pharmline after administration of the dose.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the package 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 I.U. of vancomycin.

What Vancomycin Pharmline looks like and contents of the pack
This medicine is a sterile white to light brown powder for solution concentrate for infusion.
The vial is made of colourless glass (type I), with a grey bromobutyl rubber stopper and an aluminium cap with a white plastic flip-off seal.
The cardboard pack contains one vial of Vancomycin Pharmline 1000 mg and one patient leaflet.

Marketing Authorisation 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 authorised for marketing in the European Economic Area countries 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

Medical advice/education
Antibiotics are used to treat bacterial infections. They are ineffective against viral infections. If your doctor has prescribed antibiotics, they are necessary for treating your current specific illness.

Despite antibiotic treatment, some bacteria may survive or continue to develop. This phenomenon is known as resistance; some antibiotic treatments become ineffective.
Improper use of antibiotics promotes the development of resistance. Patients can also contribute to the development of resistance, thereby delaying recovery or reducing the effectiveness of antibiotic therapy, if they do not adhere properly to:

• dosage,
• treatment schedule,
• duration of treatment.

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

• Use antibiotics only when prescribed by a doctor.
• Strictly follow the prescribed method of use.
• Do not reuse antibiotics without a doctor's recommendation, even to treat a similar illness.
• Never give antibiotics to another person; it may not be suitable for their condition.
• Return any unused medicines to the pharmacy after treatment is completed, to ensure they are properly disposed of.

Information intended exclusively for medical professionals:

Reconstitution instructions
For single use only. Discard any unused contents.
The powder must be reconstituted and the resulting concentrate diluted before use.
Stability after reconstitution of concentrate and dilution of solutions:
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 standpoint, unless the reconstitution/dilution method precludes the risk of microbial contamination, the solutions should be used immediately after reconstitution and dilution.
If not used immediately, the responsibility for storage conditions and duration prior to use lies with the user.
Preparation of reconstituted solution
At the time of use, add 20 mL of water for injections to the vial. Vials prepared in this manner will yield a solution with a concentration of 50 mg/mL. After dissolution in water, a clear solution is formed.
Storage conditions for the medicinal product after reconstitution, see section 6.3 of the Product Characteristics, "Shelf life".
FURTHER DILUTION IS REQUIRED. Read the following instructions:
The preferred method of administration is intermittent infusion. Reconstituted solutions 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 as an intravenous infusion lasting at least 60 minutes. When administered over a shorter period or at higher concentrations, in addition to thrombophlebitis, there is a risk of significant hypotension. Rapid administration may also cause flushing and transient rash on the neck and arms.
Continuous infusion (should only be used when intermittent infusion is not feasible). One or two vials (1–2 g) may be added to a sufficiently large volume of 0.9% sodium chloride infusion solution or 5% glucose infusion solution to allow slow administration of the desired daily dose via intravenous infusion over a 24-hour period.
A concentration not exceeding 5 mg/mL is recommended. In selected patients requiring restriction of fluid intake, concentrations up to 10 mg/mL may be used (see section 4.2).
Each dose should be administered at a rate not exceeding 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 ranges from 2.5 to 4.5.
Before administration, reconstituted and diluted solutions should be inspected visually for particulate matter and discoloration. Only clear, colorless to pale yellow solutions free from particulate matter should be used.
Disposal
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.