MAXIVANIL 500 mg Powder For Intravenous Infusion Solution

Зміст інструкції

1. MAXIVANIL 250 mg Hard Capsules
   1. What is MAXIVANIL and what it is used for
   2. What you need to know before you use MAXIVANIL
   3. How to use MAXIVANIL
   4. Possible side effects
   5. How to store MAXIVANIL
   6. Contents of the pack and other information
2. MAXIVANIL 500 mg powder for solution for intravenous and oral infusion, 1 g powder for solution for intravenous and oral infusion
   1. WHAT MAXIVANIL IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING MAXIVANIL
   3. HOW TO USE MAXIVANIL
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE MAXIVANIL
   6. PACKAGE CONTENTS AND OTHER INFORMATION

MAXIVANIL 250 mg Hard Capsules

Vancomycin

Read this leaflet carefully before taking this medicine because 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, even if they have the same symptoms as you, as it could be harmful.
• 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 MAXIVANIL is and what it is used for
• 2. What you need to know before you take MAXIVANIL
• 3. How to take MAXIVANIL
• 4. Possible side effects
• 5. How to store MAXIVANIL
• 6. Contents of the pack and other information

1. What is MAXIVANIL and what it is used for

MAXIVANIL is an antibiotic that belongs to a group of antibiotics called "glycopeptides". Vancomycin works by eliminating some bacteria that cause infections. Vancomycin is used in adults and adolescents starting from 12 years of age for the treatment of infections of the mucous membrane of the small and large intestine with damage to the mucous membrane (pseudomembranous colitis) caused by the bacterium Clostridium difficile.

2. What you need to know before you use MAXIVANIL

Do not take MAXIVANIL:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking MAXIVANIL.
If you suffer from an inflammatory disease of the digestive tract (you may be at risk of undesirable effects, especially if you also have kidney disease).
Vancomycin capsules are not suitable for children under 12 years of age or adolescents who are unable to swallow them. Other forms of this medicine may be more suitable for children; ask your doctor or pharmacist.
In some patients with inflammatory processes of the intestinal mucosa (including those affected by a type of inflammation of the colon called pseudomembranous colitis from Clostridium difficile), absorption may be significant with the risk of developing the same undesirable effects that occur during parenteral administration of the drug. Therefore, it is appropriate to carefully monitor drug concentrations in the blood. This risk increases in elderly subjects or those who suffer from a kidney problem (renal insufficiency), because in these cases the total (clearance) systemic and renal vancomycin is reduced.
Patients with impaired renal function and over 60 years of age should undergo periodic checks of hearing and drug concentrations in the blood (vancomycin blood levels can be determined using the modified Rammelkamp method, using Streptococus C 203 as an indicator).
Patients at risk with renal dysfunction or who are receiving concomitant therapies with aminoglycosides (antibiotics) should undergo periodic checks of renal function.

Other medicines and MAXIVANIL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is appropriate to adequately monitor the possible intake of vancomycin in association or sequentially with other antibiotics potentially toxic to the kidneys (nephrotoxic) such as:

• aminoglycosides;
• cephaloridine;
• paramomycin;
• polymyxin B;
• colistin.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
In pregnant women, during breastfeeding and in early infancy, the safety of vancomycin has not been demonstrated; therefore, the drug should only be administered in cases of absolute necessity when, in the doctor's opinion, the potential benefits outweigh the possible risks.

Driving and using machines
It is not known whether MAXIVANIL affects the ability to drive and operate machinery.

3. How to use MAXIVANIL

Take this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.

Adults and adolescents (from 12 years of age)
The recommended dose is 125 mg every 6 hours. In some cases, your doctor may decide to give you a higher daily dose up to 500 mg every 6 hours. The maximum daily dose should not exceed 2 g.
If you have previously suffered from other episodes (mucosal infection) you may need a different dose and a different duration of therapy.

Method of administration
For oral use.
The capsules should be swallowed whole with water.
The usual duration of therapy is 10 days, but may vary depending on the individual response to treatment for each patient.

If you take more MAXIVANIL than you should
In case of accidental ingestion/intake of an excessive dose of MAXIVANIL, inform your doctor immediately or go to the nearest hospital.
The doctor will recommend supportive therapy and maintenance of a process consisting of the passage of water and other substances within the kidneys called “glomerular filtration”.

If you forget to take MAXIVANIL
Do not take a double dose to make up for the forgotten capsule.

If you stop taking MAXIVANIL
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

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.
The absorption of vancomycin from the gastrointestinal tract is negligible. Therefore, adverse events following the intake of capsules are unlikely.
However, if you have an inflammatory disease of the digestive tract, especially if you also have kidney disease, side effects similar to those that occur when vancomycin is administered by infusion may occur. Therefore, the side effects and frequencies that are reported for vancomycin administered as an infusion are included.

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

• Decrease in blood pressure
• Shortness of breath, noisy breathing (a sharp sound 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 skin 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

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

• Vomiting, diarrhea
• Confusion, dizziness, loss of energy, swelling, fluid retention, decreased urination
• Rash with swelling or pain behind the ears, 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at 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 MAXIVANIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging “Exp.”. The
expiry date refers to the last day of that month.
Do not store above 30 °C.
Do not dispose of any medicine in wastewater 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 MAXIVANIL contains
MAXIVANIL 250 mg hard capsules
Each capsule contains:

• Active ingredient: vancomycin hydrochloride mg 256 equivalent to vancomycin mg 250;
• Other component: polyethylene glycol 6000.

Description of the appearance of MAXIVANIL and contents of the pack
Hard capsules of 250 mg.
Pack of 4 capsules.

Marketing Authorisation Holder
Genetic S.p.A., Via G. Della Monica n. 26, 84083 Castel San Giorgio (SA)

Manufacturer
Genetic S.p.A., Contrada Canfora - 84084 Fisciano (SA)
This leaflet was last updated on

Other sources of information
Advice/medical information
Antibiotics are used to treat bacterial infections. They are ineffective against viral infections.
If your doctor has prescribed antibiotics, these are precisely for your current illness.
Despite antibiotics, some bacteria may survive or grow. This phenomenon is
called resistance: some antibiotic treatments become ineffective.
The abuse of antibiotics increases resistance. It can also help bacteria become resistant and
therefore delay treatment or decrease antibiotic efficacy if you do not respect the appropriate:

• dosage
• schedule
• duration of treatment

Consequently, to maintain the effectiveness of this medicine:

• 1 - Use antibiotics only when prescribed.
• 2 - Follow the instructions strictly
• 3 - Do not reuse an antibiotic without a prescription, even if you want to treat a similar illness.
• 4 - Never give antibiotics to another person; it may not be suitable for their illness.
• 5 - After the end of treatment, return all unused medicines to the pharmacy for correct disposal.

MAXIVANIL 500 mg powder for solution for intravenous and oral infusion, 1 g powder for solution for intravenous and oral infusion

Vancomycin
Read this leaflet carefully before using this medicine

• 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 only for you. Never give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
• If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

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

1. WHAT MAXIVANIL IS AND WHAT IT IS USED FOR

MAXIVANIL is an antibiotic that belongs to a group of antibiotics called "glycopeptides". Vancomycin works by eliminating some bacteria that cause infections.
Vancomycin powder is transformed into a solution for infusion or oral solution.
MAXIVANIL is used to treat:

• severe infections caused by bacteria sensitive to vancomycin and resistant (insensitive) to many other antibiotics
• patients allergic to penicillins and cephalosporins.

Vancomycin is used in all age groups via infusion for the treatment of the following serious infections:

• Skin and underlying tissue infections.
• Bone and joint infections.
• Lung infection called "pneumonia".
• Infection of the inner lining of the heart (endocarditis) and to prevent endocarditis in patients at risk when undergoing major surgical procedures.
• Blood infection related to the aforementioned infections.

Vancomycin is used orally in adults and children for the treatment of infections of the mucous membrane of the small and large intestine with damage to the mucosa (pseudomembranous colitis),
caused by the bacterium Clostridium difficile.

2. WHAT YOU NEED TO KNOW BEFORE USING MAXIVANIL

Do not use MAXIVANIL

• if you are allergic to vancomycin

Warnings and precautions
Consult your doctor, hospital pharmacist or nurse before using 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 undergo blood and kidney tests during treatment).
• you receive vancomycin by infusion for the treatment of diarrhea associated with Clostridium difficileinfection instead of orally.

Consult your doctor, hospital pharmacist or nurse during treatment with
vancomycin:

• if you have received vancomycin for a long period (you may need liver and kidney blood tests during treatment).
• if you develop any skin reaction during treatment.
• if 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.

Pay special attention with MAXIVANIL especially in the following cases
Before treatment with vancomycin, make sure your doctor is aware of your
medical history, especially in the following cases:

• if you have a low blood count
• if you are pregnant or planning to become pregnant
• if you are breastfeeding
• if you are about to undergo surgery

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 vancomycin levels 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.

Other medicines and MAXIVANIL
Tell your doctor or pharmacist or nurse if you are taking, have recently taken or
may take any other medicine.
When taken together, some medicines can interact with vancomycin, for example the
medicines used for the treatment of:

• infections caused by bacteria(streptomycin, neomycin, gentamicin, kanamycin, amikacin, bacitracin, tobramycin, polymyxin B, colistin),
• tuberculosis(viomycin),
• fungal infections(amphotericin B),
• tumour(cisplatin) and
• medicines used for muscle relaxation
• anesthetic agents(if you are to undergo general anesthesia).

If vancomycin is administered concurrently with other drugs, your doctor may
need to monitor blood values and adjust the dosage.

Pregnancy and breastfeeding

Pregnancy
If you are pregnant, or suspect you may be pregnant, tell your doctor. Vancomycin should
only be administered during pregnancy if strictly necessary.

Breastfeeding
Tell your doctor if you are breastfeeding, as MAXIVANIL passes into breast milk. The doctor
will decide whether vancomycin is absolutely necessary or whether it is advisable to stop
breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
It is not known whether MAXIVANIL affects the ability to drive vehicles and operate machinery.

3. HOW TO USE MAXIVANIL

Vancomycin will be administered to you by medical personnel while you are in the hospital. The
doctor will decide how much of this medicine you need to 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,
• the state of your kidney function,
• your hearing ability,
• other medicines you are taking.

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
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
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)].
Elderly patients, pregnant women and patients with kidney disease, including those in
dialysis, may need a different dose.

Oral administration
For adults and adolescents (from 12 to 18 years)
The recommended dose is 125 mg every 6 hours. In some cases, the doctor may decide to give you a higher daily dose, up to 500 mg every 6 hours. The maximum daily dose should not exceed 2 g.
If you have previously suffered from other episodes (mucosal infection) you may need a different dose
and a different duration of therapy.

Use in children

Newborns, infants and children under 12 years of age
The recommended dose is 10 mg for each kg of body weight. It is generally
administered every 6 hours. The maximum daily dose should not exceed 2 g.

Method of administration
Intravenous infusion means that the medicine flows from a vial or infusion bag
through a tube into one of your blood vessels. The doctor or nurse will administer the
vancomycin always into the blood and not into the muscle.
Vancomycin will be administered into the vein for at least 60 minutes.
If administered for the treatment of gastrointestinal disorders (so-called pseudomembranous colitis),
the medicine must be administered as an oral solution (you will take the medicine by
mouth).

Duration of treatment
The duration of treatment depends on the infection you have and may last for several weeks.
The duration of therapy may vary depending on the individual response to treatment for each
patient.
During treatment, you may need to undergo blood tests, you may be asked to
provide urine samples and also have hearing tests to check for signs of possible side
effects.

If you are given more MAXIVANIL than you should
Because this medicine is administered in hospital, it is unlikely that you will receive an
excessive amount of vancomycin.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

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. Tell your doctor immediately if you experience sudden wheezing, difficulty breathing, flushing of the upper body, rash or itching.
Oral use
The absorption of vancomycin from the gastrointestinal tract is negligible. However, if you have an inflammatory disease of the digestive tract, especially if you also have kidney disease, side effects may occur that occur when vancomycin is administered
by infusion.

Side effectscommon (may affect up to 1 in 10 people):

• Decreased blood pressure Shortness of breath, noisy breathing (a sharp sound 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
• Flushing of the upper body and face, inflammation of a vein.

Side effectsuncommon (may affect up to 1 in 100 people):

• temporary or permanent hearing loss.

Side effectsrare (may affect up to 1 in 1,000 people):

• Decreased white blood cells, red blood cells and platelets (blood cells responsible for coagulation)
• Increased levels of 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

Side effectsvery rare (may affect up to 1 in 10,000 people):

• Sudden onset of a 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 that may contain blood.

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

• Vomiting, diarrhea
• Confusion, dizziness, loss of energy, swelling, fluid retention, decreased urination
• Rash with swelling or pain behind the ears, 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 the hospital pharmacist or nurse. You can also report side effects directly through the national reporting system
at 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 MAXIVANIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”. The
expiry date refers to the last day of that month.

Storage after dilution: see section “How to use MAXIVANIL”.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What MAXIVANIL contains
MAXIVANIL 500 mg powder for solution for intravenous and oral infusion
Each vial:
Active ingredient: vancomycin hydrochloride mg 512.57 equivalent to vancomycin mg 500.
MAXIVANIL 1 g powder for solution for intravenous and oral infusion
Each vial:
Active ingredient: vancomycin hydrochloride mg 1025.14 equivalent to vancomycin g 1.

Description of the appearance of MAXIVANIL and contents of the pack
Powder for solution for intravenous infusion and oral solution in packs of:
one vial containing 500 mg of vancomycin.
one vial containing 1 g of vancomycin.

MARKETING AUTHORISATION HOLDER
Genetic S.p.A., Via G. Della Monica 26, Castel San Giorgio (SA)

Manufacturer
Hikma Italia S.p.A. - Viale Certosa, 10 - 27100 PAVIA
This leaflet was last updated on

Other sources of information
Advice/medical information
Antibiotics are used to treat bacterial infections. They are ineffective against viral infections.
If your doctor has prescribed antibiotics, they are specifically for your current illness.
Despite antibiotics, some bacteria can survive or grow. This phenomenon is
called resistance: some antibiotic treatments become ineffective.
The misuse of antibiotics increases resistance. It can also help bacteria become resistant and
therefore delay cure or decrease antibiotic efficacy if you do not respect the appropriate:

• dosage
• schedule
• duration of treatment

Consequently, to maintain the effectiveness of this medicine:

• 1 - Use antibiotics only when prescribed.
• 2 - Follow the instructions strictly
• 3 - Do not reuse an antibiotic without a prescription, even if you want to treat a similar illness.