ZETAMICIN 15 mg /1,5 Ml Roztwór Do Wstrzykiwań

Treść ulotki

1. ZETAMICIN 15 mg/1.5 ml injectable solution, 50 mg/ml injectable solution, 100 mg/ml injectable solution, 150 mg/1.5 ml injectable solution, 200 mg/2 ml injectable solution, 300 mg/3 ml injectable solution
   1. What is ZETAMICIN and what is it used for?
   2. What you need to know before you take ZETAMICIN
2. ZETAMICIN 100 mg/ml injectable solution, ZETAMICIN 150 mg/1.5 ml injectable solution, 200 mg/2 ml injectable solution, ZETAMICIN 300 mg/3 ml injectable solution
   1. How to take ZETAMICIN
   2. Possible side effects
   3. How to store ZETAMICIN
   4. Contents of the pack and other information

ZETAMICIN 15 mg/1.5 ml injectable solution, 50 mg/ml injectable solution, 100 mg/ml injectable solution, 150 mg/1.5 ml injectable solution, 200 mg/2 ml injectable solution, 300 mg/3 ml injectable solution

Netilmicin sulfate

Read this leaflet carefully before you start to use 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, even if their symptoms are the same as yours, 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 ZETAMICIN is and what it is used for
• 2. What you need to know before you use ZETAMICIN
• 3. How to use ZETAMICIN
• 4. Possible side effects
• 5. How to store ZETAMICIN
• 6. Contents of the pack and other information

1. What is ZETAMICIN and what is it used for?

ZETAMICIN contains the active ingredient netilmicin sulfate and is an antibacterial that is
administered via routes that allow the drug to reach throughout the body (systemic use) belonging to the class of medicines called aminoglycosides used for the treatment
of some infections caused by bacteria.
ZETAMICIN is indicated in adults, children and newborns, including premature infants, for the treatment
of:

• Infections of the membrane surrounding the lungs (pleura) and the lungs themselves (pleuro-pulmonary infections), infections affecting the bronchi (bronchitis), the bronchi and lungs (bronchopneumonia) and the pleura (pleurisy), and accumulation of pus-rich fluid in a body cavity (empiemas).
• Infections of the kidney and genitourinary tract: infections of the urinary bladder (cystitis), infections at the level of the cavity in which urine formed by the kidney collects, called the renal pelvis or also the renal calyx (pyelitis), infections of the upper urinary tract (cystopyelitis and pyelonephritis), formation of stones at the renal level accompanied by an infection (infected calculus), infections of the duct that carries urine from the bladder, called the urethra (urethritis), infection at the level of the prostate (prostatitis), infections at the level of the seminal vesicles (vesiculitis).
• Surgical infections: infections that occur in the operated area during the period between hospitalization and the immediately subsequent phase of the surgery (peri-operative infections), inflammation at the level of the peritoneal cavity (peritonitis), accumulation of pus in a closed cavity originating from inflammation (abscesses), evolution of the abscess consisting of emptying and leakage of pus into the surrounding tissues (phlegmons), infections and inflammation involving both bone and its related marrow cavity

(osteomyelitis), post-traumatic infections, infections affecting bones or soft tissues,
infected wounds and burns.

• Obstetric-gynecological infections: inflammation of the uterus (metritis), inflammatory infectious diseases at the level of the pelvic region surrounding the uterus (parametritis), inflammation of the fallopian tubes (salpingitis), inflammation of ovaries and fallopian tubes (salpingo-ovaritis), inflammation of the pelvic peritoneum (pelvi-peritonitis), septic abortion caused by an infection in the uterus (septic abortion), inflammatory processes affecting the mammary gland (mastitis).
• Conditions characterized by the presence of bacteria in areas and tissues of the body normally free of germs (septic states): transient presence of bacteria in the bloodstream (bacteremia), the body's response to an infectious state due to the presence of germs in the blood (septicemia), septicemia complicated by a widespread appearance of abscesses (septicopyemia).
• Infections of the stomach and intestines (gastro-enteritis) and infections of the biliary tract caused by germs that are killed by the action of netilmicin (sensitive to netilmicin)

ZETAMICIN has also proven effective in the treatment of infections due to microorganisms that are not
sensitive (resistant) to other drugs similar to netilmicin (other aminoglycoside drugs) and
therefore is recommended in the attack therapy of infections from Gram-type bacteria such as
inflammation of the outer ear (otitis externa), infections of the superficial layer of the skin
(folliculitis) caused by Pseudomonas aeruginosa, inflammation of the bladder (cystitis) caused by
enterobacteria such as Escherichia coli, Proteus, Enterobacter, whether suspected or confirmed; the
decision to continue therapy with ZETAMICIN should be based on tests performed to verify the
sensitivity of the microorganism to the antibiotic (antibiogram) and the patient's clinical response,
as well as the drug's tolerability.
In infections that endanger the patient's life, ZETAMICIN may be administered in
association with a beta-lactam type antibiotic, even before knowing the in vitro sensitivity data. If an infection is suspected to be caused also by microorganisms that do not
need oxygen to grow and multiply (anaerobes), it is necessary to establish an
adequate association therapy with antibacterial agents also active against these
microorganisms.
Contact your doctor if you do not feel better or if you feel worse after and/or during therapy.

2. What you need to know before you take ZETAMICIN

Do not take ZETAMICIN

• If you are allergic to the active ingredient, to other aminoglycosides or to any of the other components of this medicine (listed in section 6).
• If you have had, in the past, episodes of allergy or severe toxic reactions to drugs belonging to the same group as netilmicin (aminoglycosides).

ZETAMICIN injectable solutions of 100 mg/ml, 150 mg/1.5 ml, 200 mg/2 ml and 300 mg/3 ml should not
be administered to children under two years of age due to the presence of benzyl alcohol
(see section “Children and adolescents”).

Warnings and precautions
Talk to your doctor or pharmacist before taking ZETAMICIN.
During treatment with aminoglycosides, the doctor will need to assess any potential toxic effects
of the therapy, particularly in children and the elderly, who are the most at risk.
Following the administration of netilmicin, toxicity at the level of the kidneys
(nephrotoxicity) of a mild degree has been found. However, as with other aminoglycosides, renal function must
be carefully monitored during therapy. The risk of incurring undesirable nephrotoxic effects
may arise especially if you have reduced renal function, if you are treated with
higher doses and for longer periods of time than those recommended (more than 7-10
days) and if you are an elderly or pediatric patient.
Assessment of renal function and serum electrolytes (through blood tests):

• Is recommended at the beginning of treatment and periodically in case of treatment with ZETAMICIN for prolonged periods (more than 7-10 days) or that may require higher doses than those recommended based on age, weight or presumed renal function.
• Is mandatory periodically in adults and children who are treated with ZETAMICIN for more than 7-10 days for the treatment of severe infections or who may be treated with higher doses than those recommended in relation to age, weight or presumed renal function.

Take ZETAMICIN with caution:

• If you have previously suffered kidney damage or if you have normal kidney function but need to be treated with higher doses and/or for longer periods of time (more than 7-10 days) than those recommended. In these cases, hearing loss and symptoms such as dizziness, loss of balance, feeling lightheaded (vestibular dysfunction) may occur, although toxicity at the level of the ear (ototoxicity) with netilmicin has been observed rarely and in a milder manner compared to other aminoglycosides. In these cases it is important to monitor renal function, if necessary evaluating the concentration of creatinine in the blood (serum creatinine).
• If you have neuromuscular disorders such as diseases characterized by muscle weakness (myasthenia gravis), parkinsonism or botulism in children (infantile botulism), because aminoglycosides, theoretically, can worsen muscle weakness, given their paralyzing effect on voluntary muscle (curare-like effect on neuromuscular junctions).
• If you have extensive burns; in these cases there may be a decrease in the concentrations of aminoglycosides in the blood. During therapy with ZETAMICIN, monitoring is recommended:
• Of antibiotic concentrations in the blood, when possible. The doctor will adjust the dosage of the medicine to ensure adequate levels of netilmicin in the blood and avoid potentially toxic levels (see section 3 “How to take ZETAMICIN”). Excessive maximum and/or minimum concentrations in the blood may increase the risk of renal toxicity and damage to the nerve that transmits to the brain information about balance and hearing encoded by the ear (eighth cranial nerve). In patients with extensive burns, there may be a decrease in the concentrations of aminoglycosides in the blood. The determination of these concentrations is therefore important in these patients to adjust the dosage.
• Of renal function and the eighth cranial nerve, especially if you have known or suspected reduced renal function, both at the beginning and during therapy. Monitoring this function means checking for symptoms such as dizziness, rhythmic involuntary oscillatory movements of the eyeballs (nystagmus), tinnitus (ringing in the ears), hearing loss, which may indicate a problem. In fact, as with other aminoglycosides, in rare cases, changes in renal function and the eighth cranial nerve may only begin to appear after the end of treatment.
• Of the urine, to highlight a decrease in specific gravity, increased excretion of proteins and the presence of cells or filaments.
• Of the amount of urea nitrogen in the blood, which provides indications on the function of kidneys and liver, of creatinine in the blood and the assessment of renal function (creatinine clearance), especially if you are elderly and may have reduced renal function, which may not be evident from routine tests.
• Of hearing, especially in high-risk patients, if possible through a graph representing a person's hearing ability for each ear (audiogram).
• Of renal, vestibular and auditory functions if you are elderly, if you take ZETAMICIN at high doses for prolonged periods and if you have reduced renal function. In these cases, frequent monitoring is recommended.

The presence of ototoxicity or nephrotoxicity requires dose adjustments or discontinuation of
treatment.
During treatment, you must be and remain well hydrated.
Treatment with netilmicin may determine a new infection that overlaps with an
existing infection (superinfection) from germs that do not respond to treatment (insensitive): in
such cases, you should consult your doctor who will have to decide whether to suspend or not
treatment and establish a suitable therapy. In some adults and children treated with netilmicin, a
kidney disease (Fanconi-type syndrome) with the presence of amino acids in the urine
(aminoaciduria) and an increase in the amount of acids in the blood (metabolic acidosis) has been observed
(see section 4 “Possible side effects”).
Very rarely, following the use of aminoglycosides, including netilmicin, cases of severe skin disease induced by an allergy to certain drugs (Stevens-Johnson syndrome
and toxic epidermal necrolysis) have been reported (see section 4 “Possible side effects”).
Following topical application or local irrigation on a wound or sore, the water contained
in the medicine may cause absorption, by the body surface, of significant amounts of the drug that could have a toxic effect on the nerves or kidneys;
it is therefore necessary to take into consideration the potential toxic effect of antibiotics administered
in this way.

Children and adolescents
Children may be particularly at risk, and therefore careful clinical monitoring is recommended.
At the beginning of treatment and during therapy, renal function and blood electrolytes in children who are treated with ZETAMICIN for
more than 7-10 days for the treatment of severe infections or who may be treated with higher doses than
those recommended in relation to age, weight or presumed renal function must be periodically assessed.
ZETAMICIN injectable solutions of 100 mg/ml, 150 mg/1.5 ml, 200 mg/2 ml and 300 mg/3 ml should not
be administered to children under two years of age, due to the presence of benzyl alcohol
(see below).

Other medicines and ZETAMICIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
As with other aminoglycosides, you should avoid the administration of ZETAMICIN with other drugs
potentially nephrotoxic and/or neurotoxic, administered simultaneously or
sequentially via systemic or local route. The concomitant use of ZETAMICIN and other drugs
potentially nephrotoxic increases the risk of nephrotoxicity. These substances include
antibiotics such as: aminoglycosides, vancomycin, polymyxin B and colistin; anticancer drugs such as:
organoplatinums, high-dose methotrexate and ifosfamide; some antiviral drugs (pentamidine,
foscarnet, acyclovir, ganciclovir, adefovir, cidofovir, tenovir); systemic antifungals such as
amphotericin B; immunosuppressive drugs such as
cyclosporine or tacrolimus and products used in radiology and for magnetic resonance
imaging (iodine-based contrast agents).

If the use of these combinations is necessary, renal function must be carefully
monitored with appropriate laboratory tests. Other factors that may increase the risk of
nephrotoxicity are dehydration and advanced age.
You should avoid taking together with ZETAMICIN drugs that increase urine production
(diuretics) such as furosemide or ethacrinic acid, as these can be toxic to the ear (ototoxic) in themselves. In addition, if administered intravenously, diuretics may
increase the toxicity of aminoglycosides by altering the concentration of the antibiotic in the blood
and tissues.
The product should not be mixed in the same syringe with other medicines (see section 3 “How to
take ZETAMICIN”).
Although in clinical studies conducted on humans, neuromuscular blockade and
respiratory paralysis have not been reported, these phenomena have occurred in animals administered
netilmicin at doses considerably higher than those recommended in clinical use. Therefore, the
possibility that these phenomena occur must be taken into consideration, especially in
case of concomitant administration of aminoglycosides and drugs used during surgical interventions to block the muscles (neuromuscular blockers), such as succinylcholine, tubocurarine,
decamethonium, anesthetics or massive blood transfusions containing citrate used to slow
or stop the blood clotting process (as an anticoagulant). In this case, the
block can be removed with calcium salts or neostigmine.
A form of allergy to a group of substances with a similar chemical structure has been demonstrated
which is triggered between aminoglycosides.
The concomitant administration of an aminoglycoside antibiotic and a beta-
lactam antibiotic (penicillins or cephalosporins) may cause a reciprocal and significant inactivation.
Even when an aminoglycoside antibiotic and a penicillin-like antibiotic are administered
through two different routes, a decrease in plasma levels
of the aminoglycoside may occur, which may have important clinical consequences in patients with severe
renal insufficiency.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Aminoglycoside antibiotics cross the placenta and can cause harm to the fetus if
administered to pregnant women. Cases of irreversible congenital deafness in both ears have been reported in children whose mothers had received aminoglycosides, including netilmicin,
during pregnancy.
If ZETAMICIN is administered during pregnancy or if you realize you have become
pregnant while taking ZETAMICIN, you should be warned of the potential risk to the fetus.
Breastfeeding
Studies conducted in breastfeeding women have shown that a small amount of ZETAMICIN
is excreted in breast milk. Due to potential serious adverse reactions, you should decide whether to
discontinue breastfeeding or stop treatment.

Driving and using machines
ZETAMICIN does not impair the ability to drive vehicles or operate machinery.
ZETAMICIN contains sulphites: sulphites can rarely cause severe hypersensitivity reactions and
bronchospasm.
Zetamicin contains less than 1mmol (23mg) of sodium per vial, i.e. essentially ‘sodium-free’.
ZETAMICIN 50mg/ml injectable solution contains para-hydroxybenzoates:
Zetamicin 50 mg/ml injectable solution may cause allergic reactions (including delayed ones) and,
exceptionally, bronchospasm.

ZETAMICIN 100 mg/ml injectable solution, ZETAMICIN 150 mg/1.5 ml injectable solution, 200 mg/2 ml injectable solution, ZETAMICIN 300 mg/3 ml injectable solution

contain benzyl alcohol.
ZETAMICIN 100 mg/ml injectable solution contains 10 mg of benzyl alcohol per vial, equivalent
to 10 mg / 1 mL.
ZETAMICIN 150 mg/1.5 ml injectable solution contains 15 mg of benzyl alcohol, equivalent to 15
mg/1.5 mL.
ZETAMICIN 200 mg/2 ml injectable solution contains 20 mg of benzyl alcohol, equivalent to 20
mg/2 mL.
ZETAMICIN 300 mg/3 ml injectable solution contains 30 mg of benzyl alcohol, equivalent to 30
mg/3 mL.
Benzyl alcohol may cause allergic reactions.
Benzyl alcohol has been associated with the risk of serious adverse effects including breathing problems
(agonal respiratory syndrome) in young children. Do not administer to infants under 4 weeks of
age unless otherwise recommended by the doctor.
Do not use for more than one week in young children (under 3 years of age) unless otherwise
recommended by the doctor or pharmacist.
Ask your doctor or pharmacist for advice if you are pregnant or breastfeeding. This is because
large amounts of benzyl alcohol can accumulate in the body and cause adverse effects
(such as metabolic acidosis).
Ask your doctor or pharmacist for advice if you have a liver or kidney condition. This is because
large amounts of benzyl alcohol can accumulate in the body and cause adverse effects
(such as metabolic acidosis).

3. How to take ZETAMICIN

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
ZETAMICIN can be administered both intramuscularly (into the muscles) and intravenously (into a vein): the dosage is identical.
Intravenous and intramuscular administration
It is recommended in patients with infectious disease due to the persistent presence of bacteria in the blood (septicemia) or in shock and is preferable in patients with a situation of inability of the heart to provide oxygen-rich blood to the body (congestive heart failure), blood disorders (hematological disorders), severe burns and reduced muscle mass. In adults, the single dose can be diluted in 50-200 ml of compatible solutions (see below). The duration of the infusion must be between half an hour and two hours.
ZETAMICIN can also be injected slowly into a vein, either directly or through a tube, also known as a line, which allows the administration of a given drug to the patient, over a period of 3 to 5 minutes.
ZETAMICIN must not be mixed in the same syringe or infusion bottle with other drugs (see “Warnings and precautions”).
ZETAMICIN is physically compatible without loss of activity with the following parenteral solutions (solutions that can be introduced into the body through a needle):

• Physiological saline;
• 5% - 10% Dextrose;
• Ringer's and Ringer's Lactate;
• Isolyte P,M,E with 5% dextrose;
• Travert 10% with Electrolyte n. 2 - n. 3;
• 40% Dextran and 5% dextrose;
• 5% Dextrose in Polysal,
• Sterile water for injections. In these solutions ZETAMICIN, at a concentration of 0.8 mg/ml, is stable for 48 hours at room temperature.

Patients with normal kidney function
The recommended dosage of ZETAMICIN is as follows:
Approximately for adults weighing between 50 and 90 kg, a dose of 100-150 mg every 8 hours or 150-200 mg every 12 hours or 300 mg every 24 hours is recommended for non-severe systemic infections (affecting multiple parts of the body). Generally, the lower dose is indicated for urinary tract infections and the higher dose for systemic infections.
In any case, the dosage must be adjusted to the severity of the infection and the patient's condition.
In uncomplicated urinary tract infections, a dosage of 3 mg/kg/day in a single daily dose (e.g. for an adult patient 150 or 200 mg/day) may be sufficient.
In life-threatening infections, up to 2.5 mg/kg every 8 hours can be administered to adults, decreasing to 2 mg/kg as soon as possible, usually within 48 hours.
The usual duration of treatment is 7-14 days for all patients, although a longer treatment may be necessary for complicated infections.
Although prolonged therapies with ZETAMICIN are well tolerated, in patients treated for periods longer than those recommended, it is advisable to monitor renal, vestibular and auditory function (see “Warnings and precautions”).
During therapy with ZETAMICIN, monitoring of antibiotic concentrations in the blood is recommended, when possible. The doctor will adjust the dosage of the medicine to ensure adequate levels of netilmicin in the blood and avoid potentially toxic levels. It is recommended to adjust the dosage to avoid blood levels of netilmicin persistently higher than 16 µg/ml (micrograms/ml) and not to administer further doses until the minimum blood levels are between 0.5 and 2 µg/ml (micrograms/ml) at the recommended doses. Minimum concentrations greater than 4 µg/ml (micrograms/ml) should be avoided.
Patients with impaired kidney function
The dosage must be adjusted according to the degree of impairment of kidney function.
Based on blood creatinine values, the doctor may adjust the dosage in individual cases by one of the following methods:

Extension of the interval between doses, calculated as for patients with intact kidney function.
The interval between doses to be taken will be calculated as follows:

Interval in hours between doses = blood creatinine level (mg/100 ml) x 8
For example: for a 60 kg patient with a blood creatinine level of 3 mg/100 ml, 60 mg x 2 = 120 mg (2 mg/kg) is administered every 24 hours (3x8).
Reduction of doses, after an initial dose calculated as for a patient with intact kidney function:

Reduced dose every 8 hours = Initial dose (mg/kg)___________

Blood creatinine level (mg/100 ml)
The dosage regimens above serve as a guide when it is not possible to obtain data on netilmicin blood concentrations. If not, individual administrations of ZETAMICIN, at the doses for patients with intact kidney function, must be carried out when blood levels are less than or equal to 3 µg/ml (0.003 mg/ml).
Hemodialysis (renal replacement therapy)
In patients undergoing dialysis, the amount of netilmicin removed from the blood varies depending on several factors, including the dialysis method used.
An 8-hour hemodialysis can reduce serum ZETAMICIN concentrations by 63%. The recommended dose at the end of each dialysis treatment is 2 mg/kg for adults, 2-2.5 mg/kg for children.
Combination therapy
ZETAMICIN in combination with other antibiotics should be administered at full doses (i.e. no dose reduction of the drug is necessary).

Use in children and adolescents
Patients with normal kidney function
The recommended dosage of ZETAMICIN is as follows:

The usual duration of treatment is 7-14 days, although a longer treatment may be necessary for complicated infections.
Although prolonged therapies with ZETAMICIN are well tolerated, in patients treated for periods longer than those recommended, it is advisable to monitor renal, vestibular and auditory function (see “Warnings and precautions”).
ZETAMICIN must not be mixed in the same syringe or infusion bottle with other drugs (see section “Warnings and precautions”).

If you take more ZETAMICIN than you should
In case of overdose or the appearance of toxic reactions, immediately contact your doctor. In such cases, hemodialysis may be necessary, which will allow for rapid removal of netilmicin from the blood. The percentage of removal is considerably lower with peritoneal dialysis.
In newborns, blood transfusions may be performed.
These procedures are particularly important in patients with renal failure.

If you forget to use ZETAMICIN
Do not take a double dose to make up for the missed dose.

If you stop taking ZETAMICINthe symptoms of the infection for which you took the medicine may reappear.
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.
With the use of ZETAMICIN, the following side effects may occur:

• Nephrotoxicity. Renal adverse effects have sometimes been reported following the administration of netilmicin, generally mild in type, as evidenced by the presence of filaments, cells or proteins in the urine, or an increase in blood urea nitrogen, non-protein nitrogen or serum creatinine, or decreased urinary secretion (oliguria). These effects, very often reversible, are more frequent in the elderly, in subjects who have previously suffered from renal insufficiency and in patients treated for long periods or with doses higher than those recommended.
• Neurotoxicity. Unlike other aminoglycosides, the incidence of balance (vestibular) and hearing (cochlear) disorders with ZETAMICIN is very low. Vestibular function disturbance may be transient and reversible. Cochlear disturbance, reported rarely, is normally irreversible. These effects are more frequent in subjects who have previously had renal insufficiency and in patients treated with high doses and/or for long periods. Loss of large amounts of water (dehydration), the simultaneous administration of diuretic drugs such as ethacrynate or furosemide, or a previous exposure to other ototoxic drugs constitute other factors that can increase the risk of aminoglycoside-induced ototoxicity. The symptoms of aminoglycoside-induced ototoxicity are mostly transient and may include a feeling of instability, vertigo, tinnitus, ringing in the ears, decreased or loss of hearing (hypoacusis) in the high tones. Total deafness has never been reported. Some patients with previous ototoxic manifestations from other aminoglycosides have been treated with ZETAMICIN without further impairment. The risk of toxic reactions is low in patients with normal renal function who do not take ZETAMICIN at higher doses and for longer periods than recommended.

Other reactions rarely observed and probably related to the use of netilmicin are:

• Skin rash and skin lesions (exanthem).
• Pruritus, allergic or anaphylactic reactions.
• Alterations in the sensitivity of the limbs or other parts of the body (paresthesia).
• Chilling, fever, headache, malaise, disorientation.
• Visual disturbances, depression, confusion.
• Anorexia, vomiting, abdominal pain, fluid retention, diarrhea.
• Excessive salivation (sialorrhea), inflammation of the oral mucosa (stomatitis).
• Accelerated heartbeat (tachycardia), low blood pressure, palpitations.
• Increased blood sugar levels (glycemia), occasional increase in the enzyme measured to determine the presence or control the evolution of diseases of the skeleton and liver (alkaline phosphatase), indicators of liver function (SGOT or SGPT) generally transient, sometimes with mild increase in liver size (mild hepatomegaly), abnormalities in liver function values, bilirubin concentration in the blood (bilirubinemia), increased potassium, decreased hemoglobin, white blood cells and platelets, elevated eosinophil concentration in the blood (eosinophilia), decreased production by the bone marrow of blood cells, in particular red blood cells (anemia), increased prothrombin time, a substance that intervenes in the process of repairing damage to blood vessels, reduction in white blood cells (leukopenia), decrease in granulocytes in the blood (granulocytopenia), elevated platelet count (thrombocytosis), severe decrease in the number of circulating granulocytes in the blood (agranulocytosis) normally reversible (see “Warnings and precautions”).

Very rarely, following the use of aminoglycosides, including netilmicin, cases of severe skin disease induced by an allergy to certain drugs (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported.
Although the local tolerability of ZETAMICIN is generally high, one occasional case of pain at the injection site or localized reaction has been reported.

Additional side effects in children and adolescents
The side effects listed above can occur indistinguishably in both adults and children and adolescents.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store ZETAMICIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in the 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 ZETAMICN contains
ZETAMICIN 15 mg/1.5 ml injectable solution
1 vial contains:

Active ingredient: netilmicin sulfate 22.72 mg (equivalent to netilmicin anhydrous 15 mg).

Other ingredients:sodium metabisulfite, anhydrous sodium sulfite, sodium chloride, water for injections
.
ZETAMICIN 50 mg/ml injectable solution
1 vial contains:

Active ingredient:netilmicin sulfate 75.75 mg (equivalent to netilmicin anhydrous 50 mg).

Other ingredients:sodium metabisulfite, anhydrous sodium sulfite, sodium edetate, anhydrous sodium sulfate,
propyl p-hydroxybenzoate, methyl p-hydroxybenzoate, water for injections.
ZETAMICIN 100 mg/ml injectable solution
1 vial contains:

Active ingredient: netilmicin sulfate 151.51 mg (equivalent to netilmicin anhydrous 100 mg).

Other ingredients: sodium metabisulfite, anhydrous sodium sulfite, sodium edetate, benzyl alcohol, water
for injections.
ZETAMICIN 150 mg/1.5 ml injectable solution
1 vial contains:

Active ingredient: netilmicin sulfate 227.26 mg (equivalent to netilmicin anhydrous 150 mg).

Other ingredients: sodium metabisulfite, anhydrous sodium sulfite, sodium edetate, benzyl alcohol, water
for injections.
ZETAMICIN 200 mg/2 ml injectable solution
1 vial contains:

Active ingredient: netilmicin sulfate 303.02 mg (equivalent to netilmicin anhydrous 200 mg).

Other ingredients: sodium metabisulfite, anhydrous sodium sulfite, sodium edetate, benzyl alcohol, water
for injections.
ZETAMICIN 300 mg/3 ml injectable solution
1 vial contains:

Active ingredient: netilmicin sulfate 454.53 mg (equivalent to netilmicin anhydrous 300 mg).

Other ingredients: sodium metabisulfite, anhydrous sodium sulfite, sodium edetate, benzyl alcohol, water
for injections.

Description of the appearance of ZETAMICIN and contents of the pack
Injectable solution for intramuscular and intravenous administration.
ZETAMICIN 15 mg/1.5 ml clear injectable solution. 1 colorless glass vial.
ZETAMICIN 50 mg/ml clear injectable solution. 1 colorless glass vial.
ZETAMICIN 100 mg/ml clear injectable solution. 1 colorless glass vial.
ZETAMICIN 150 mg/1.5 ml clear injectable solution. 1 colorless glass vial.
ZETAMICIN 200 mg/2 ml clear injectable solution. 1 colorless glass vial.
ZETAMICIN 300 mg/3 ml clear injectable solution. 1 colorless glass vial.

Marketing Authorisation Holder

• A. Menarini Industrie Farmaceutiche Riunite s.r.l. - Via Sette Santi 3, Firenze. Distributor for sales: Laboratori Guidotti S.p.A. – Pisa

Manufacturer

• A. Menarini Manufacturing Logistics and Services s.r.l , via Sette Santi, 3 – Firenze (IT).