VANCOMICINA 500 mg Порошок Для Концентрата Для Инфузионного Раствора

Содержание инструкции

1. Vancomicina Reig Jofre 500 mg powder for concentrate for infusion solution, 1 000 mg powder for concentrate for infusion solution
   1. What is Vancomicina Reig Jofre and what is it used for?
   2. What you need to know before using Vancomicina Reig Jofre
   3. How to use Vancomicina Reig Jofre
   4. Possible side effects
   5. How to store Vancomicina Reig Jofre
   6. Contents of the pack and other information

Vancomicina Reig Jofre 500 mg powder for concentrate for infusion solution, 1 000 mg powder for concentrate for infusion solution

Vancomycin hydrochloride

Equivalent medicinal product

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. 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. Do not pass it on to others. It may be harmful to them, even if their symptoms are the same as yours.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Vancomicina Reig Jofre is and what it is used for
• 2. What you need to know before you use Vancomicina Reig Jofre
• 3. How to use Vancomicina Reig Jofre
• 4. Possible side effects
• 5. How to store Vancomicina Reig Jofre
• 6. Contents of the pack and other information

1. What is Vancomicina Reig Jofre and what is it used for?

Vancomicina Reig Jofre is an antibiotic that belongs to a group of antibiotics called “glycopeptides”.
Vancomicina Reig Jofre works by eliminating certain bacteria that cause infections.
Vancomicina Reig Jofre powder is transformed into a solution for infusion.
Vancomicina Reig Jofre is used in all age groups via infusion for the treatment of the following
severe infections:
Skin and underlying tissue infections.
Bone and joint infections.
Lung infection called “pneumonia”.
Infection of the inner lining of the heart (endocarditis).

2. What you need to know before using Vancomicina Reig Jofre

Do not use Vancomicina Reig Jofre
if you are allergic to vancomycin or any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions
Talk to your doctor or hospital pharmacist or nurse beforeusing vancomycin if:

• you have previously had an allergic reaction to the medicine teicoplanin, as this may mean that you are also allergic to vancomycin.
• you suffer from a hearing disorder, especially if you are elderly (you may need hearing tests during treatment).
• you have kidney disease (you will need to have blood and kidney tests during treatment).
• you receive vancomycin by infusion for the treatment of diarrhea associated with Clostridiumdifficileinfection instead of orally.
• you have ever developed a severe skin reaction or peeling of the skin, blisters and/or mouth ulcers after taking vancomycin.

Talk to your doctor or hospital pharmacist or nurse duringtreatment with vancomycin
if:

• you have received vancomycin for a long period (you may need blood, liver and kidney tests during treatment).
• you develop any skin reaction during treatment.
• you develop severe and prolonged diarrhea during or after use of vancomycin, contact your doctor immediately. This could be a sign of inflammation of the intestine (pseudomembranous colitis) which can occur following antibiotic treatment.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia
and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported in association with vancomycin treatment. Stop using
vancomycin and seek immediate medical attention if you notice any of the symptoms described in
section 4.
Serious adverse effects, which can lead to vision loss, have been reported following
injection of vancomycin into the eyes.

Children
Vancomycin will be used with particular caution in premature infants and newborns, as their
kidneys are not fully developed and may accumulate vancomycin in the blood. This
age group needs blood tests to check the levels of vancomycin in the blood.
The simultaneous administration of vancomycin and anesthetic agents has been associated with
skin flushing (erythema) and allergic reactions in children. Similarly, concomitant use
with other medicines such as aminoglycoside antibiotics, non-steroidal anti-inflammatory
agents (NSAIDs, e.g. ibuprofen) or amphotericin B (medicine for fungal infections) may increase the
risk of kidney damage and therefore more frequent blood and kidney tests may be necessary.

Elderly
If you are elderly, your doctor will adjust the dose of Vancomicina Reig Jofre because due to the natural decrease
in kidney filtration capacity due to age, the amount of medicine in the blood may
more easily increase.

Other medicines and Vancomicina Reig Jofre
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
The following medicines can affect the action of Vancomicina Reig Jofre or Vancomicina Reig Jofre
can affect their action and cause unwanted effects if used at the same time:

• Anesthetics: the use of anesthetics increases the risk of developing some unwanted effects of vancomycin, such as low blood pressure, skin flushing, hives, reduced heart function and itching.
• Muscle relaxants: if you are taking muscle relaxants (e.g. succinylcholine) at the same time, their muscle relaxant effect may be intensified or prolonged.
• Oral anticoagulants: if you are taking warfarin at the same time, the effect of this anticoagulant may be increased.
• Medicines potentially harmful to the kidneys or hearing: medicines for infections caused by bacteria (e.g. polymyxin B, colistin, bacitracin, aminoglycosides, piperacillin/tazobactam), medicines for fungal infections (amphotericin B), medicines against tuberculosis (viomycin), anti-cancer medicines (cisplatin), platinum-based chemotherapy products, some diuretics. If you take these drugs at the same time as vancomycin, this harmful effect may be increased. In this case, you must undergo careful and regular hearing monitoring.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Vancomicina Reig Jofre should be taken during pregnancy and breastfeeding only if it is considered
strictly necessary. Your doctor will decide whether to stop breastfeeding.

Driving and operating machinery
Vancomicina Reig Jofre has minimal or no effect on the ability to drive vehicles safely and to
operate machinery.

3. How to use Vancomicina Reig Jofre

Vancomycin will be administered to you by medical personnel while you are in the hospital. The doctor
will decide the daily dosage and the duration of treatment.

Dosage
The administered dose will depend on:
age,
weight,
the infection you have,
renal function,
hearing ability,
any other medications you are taking.

Method of administration
Intravenous infusion means that the medication flows from a bottle or infusion bag through a
tube into one of your blood vessels and into your body. The doctor or nurse will administer Vancomycin
always into the blood and not into the muscle.
Vancomycin will be administered into the vein for at least 60 minutes.
If you have further questions about the use of this medicine, ask your doctor or healthcare professional.

Intravenous administration
Adults and adolescents (from 12 years of age)
The dose will be calculated based on your body weight. The usual infusion dose is 15-20 mg per each
kg of body weight. It is generally administered every 8-12 hours. In some cases, the doctor may
decide to administer an initial dose of up to 30 mg for each kg of body weight. The maximum
daily dose should not exceed 2 g.

Use in children

Children from one month up to less than 12 years of age
The dose will be calculated based on your body weight. The usual infusion dose is 10-15 mg per each
kg of body weight. It is generally administered every 6 hours.

Premature infants and newborns (from 0 to 27 days)
The dosage will be calculated based on post-menstrual age (time elapsed from the first day
of the last menstrual period and birth (gestational age) plus the time elapsed after birth (postnatal age)).

Other populations
The elderly, pregnant women and patients with kidney disease, including those in
dialysis, may need a different dose.

If you take more Vancomicina Reig Jofre than you should
Contact your doctor or healthcare professional if you think you have taken too much Vancomicina Reig Jofre and you do not
feel well because of it. The doctor will check the amount of Vancomicina Reig Jofre you receive. If the
blood tests and other tests show that you have an excessive amount in your body, the amount of
Vancomicina Reig Jofre will be reduced or the treatment will be suspended or discontinued altogether. The amount remaining
in the blood will then be reduced.

4. Possible side effects

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

Vancomycin can cause allergic reactions, although severe allergic reactions (anaphylactic shock) are rare. Tell your doctor immediately if you experience sudden wheezing, difficulty breathing, redness of the upper body, rash or itching.
Stop using vancomycin and consult your doctor immediately if you notice any of the following symptoms:

• Reddish, non-raised, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of 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).
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Widespread, red and scaly 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, noisy breathing (a sharp noise caused by obstruction of airflow in the upper airways)
Rash and inflammation of the inside of the mouth, itching, itchy rash, hives
Kidney problems that can be detected mainly in blood tests
Redness of the upper body and face, inflammation of a vein

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 white blood cells, red blood cells and platelets (blood cells responsible for coagulation)
Increase in some white blood cells in the blood.
Loss of balance, ringing in the ears, dizziness
Inflammation of blood vessels
Nausea (feeling of disgust)
Inflammation of the kidneys 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 severe allergic reaction with blistering or peeling of the skin. 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

Not known (frequency cannot be estimated from available data):
Feeling unwell (vomiting), diarrhea
Confusion, dizziness, loss of energy, swelling, fluid retention, decreased urine output
Rash with swelling or pain behind the ears, in the neck, groin, under the chin and armpits (swollen lymph nodes), abnormal liver and blood function tests
Rash with blisters and fever.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Vancomicina Reig Jofre

The doctor will be responsible for the storage of the medicine.
Keep this medicine out of the reach of children.
Do not use this medicine after the expiry date which is reported on the package and the vial (after
“Exp.”). The expiry date refers to the last day of that month.
Powder packaged for sale:
Do not store at a temperature above 25ºC.
Reconstituted concentrate:
The reconstituted concentrate must be further diluted immediately after reconstitution.

Shelf life of the diluted product:
Chemical and physical stability in use has been demonstrated for 8 hours at temperatures below 25 °C and for 14
days at 2-8 °C if dissolved in a sodium chloride solution 9 mg/mL (0.9 %) or in a glucose
solution 50 mg/mL (5 %) and protected from light.
From a microbiological point of view, the medicine must be used immediately.
If not used immediately, the storage times and conditions in use before
administration are the responsibility of the user and normally do not exceed 24 hours at 2-8 ºC, unless the
reconstitution and dilution have been carried out under controlled and validated aseptic conditions.
Before administration, the reconstituted and diluted solutions must be visually inspected to
check for the presence of particles and color change. Only a clear and colorless solution, free of
particles, must be used.
Do not dispose of any medicine in the drain or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Vancomicina Reig Jofre contains:
The active ingredient is vancomycin hydrochloride.
Vancomicina Reig Jofre 500 mg powder for concentrate for solution for infusion:
Each vial contains 500 mg of vancomycin hydrochloride equivalent to 500,000 IU of vancomycin.
When reconstituted with 10 mL of water for injections, the concentrate for solution for
infusion final contains 50 mg/mL of vancomycin hydrochloride.
Vancomicina Reig Jofre 1,000 mg powder for concentrate for solution for infusion contains:
Each vial contains 1,000 mg of vancomycin hydrochloride equivalent to 1,000,000 IU of vancomycin.
When reconstituted with 20 mL of water for injections, the concentrate for solution for
infusion final contains 50 mg/mL of vancomycin hydrochloride.

Description of the appearance of Vancomicina Reig Jofre and contents of the pack:
Vancomicina Reig Jofre 500 mg powder for concentrate for solution for infusion:

• A white to off-white powder in a transparent vial with a white flip-off cap.

Pack size: 1 vial, 10 x 1 vial.
Vancomicina Reig Jofre 1,000 mg powder for concentrate for solution for infusion:

• A white to off-white powder in a transparent vial with a blue flip-off cap

Pack size: 1 vial, 10 x 1 vial.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorio Reig Jofre, S.A.
Gran Capitán, 10
08970 Sant Joan Despí (Barcelona)
Spain

Manufacturer responsible for batch release
Laboratorio Reig Jofre, S.A.
Gran Capitán, 10
08970 Sant Joan Despí, Barcelona
Spain

The following information is intended for physicians or healthcare professionals:
500 mg:
Dissolve the contents of the vial in 10 mL of sterile water for injections. Dilute the
reconstituted solution with at least 100 mL of sodium chloride 9 mg/mL (0.9%) and
glucose 50 mg/mL (5%) solution for injection.
1,000 mg:
Dissolve the contents of the vial in 20 mL of sterile water for injections. Dilute the
reconstituted solution with at least 200 mL of sodium chloride 9 mg/mL (0.9%) and
glucose 50 mg/mL (5%) solution for injection.
The concentration of Vancomycin in the final infusion solution must not exceed 5 mg/mL.
For patients who need to restrict fluid intake, a concentration of up to 10 mg/mL may be used. The use of these high concentrations increases the risk of infusion-related events.
Before administration, the reconstituted and diluted solutions must be visually inspected to
check for the presence of particles and colour change. Only solutions that are free of particles, clear and colourless must be used.
The infusion solution must not be mixed with other medicines.

Infusion
To be administered by slow intravenous infusion of at least 60 minutes at a maximum rate of 10 mg/min, equivalent to 2 mL/min at a concentration of 5 mg/mL.

Dosage
Adults and children over 12 years
The recommended daily intravenous dose is 2,000 mg (2 g) administered as 500 mg every 6 hours
or 1,000 mg (1 g) every 12 hours. Recovery usually occurs within 48-72 hours. The total duration of
administration is determined by the nature and severity of the infection and the patient's clinical response.
Paediatric population

• Children from 1 month to 12 years 40 mg/kg/day: dose usually divided into four doses (e.g. 10 mg/kg every 6 hours). Each dose must be administered over a period of at least 60 minutes.
• Neonates (at term) 0-7 days: initial dose of 15 mg/kg followed by 10 mg/kg every 12 hours. 7-30 days: initial dose of 15 mg/kg followed by 10 mg/kg every 8 hours. Each dose must be administered over a period of at least 60 minutes. Careful monitoring of serum vancomycin concentrations may be necessary in these patients.

Elderly
Lower maintenance doses may be necessary due to the age-related decline in renal function.

Pregnancy
Significant dose increases may be required to achieve therapeutic serum concentrations.

Storage
Vancomicina Reig Jofre, powder for concentrate for solution for infusion must not be stored at
a temperature above 25°C.
Vancomicina Reig Jofre must not be used after the expiry date stated on the packaging.
For the storage conditions of reconstituted and further diluted products, refer to section 5.