CEPIMEX 1000 mg /3 Ml Порошок И Раствор Для Инъекционного Раствора

Содержание инструкции

1. CEPIMEX 1000 mg/ 3 ml powder and solvent for injectable solution
   1. What is CEPIMEX and what is it used for
   2. What you need to know before using CEPIMEX
   3. How to use CEPIMEX
   4. Possible side effects
   5. How to store CEPIMEX
   6. Contents of the pack and other information

CEPIMEX 1000 mg/ 3 ml powder and solvent for injectable solution

cefepime dihydrochloride monohydrate

Read this leaflet carefully before 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, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is CEPIMEX and what is it used for

CEPIMEX contains cefepime dihydrochloride monohydrate, the active ingredient which belongs to a group of
antibiotics called “cephalosporins”. These antibiotics are very similar to penicillin. CEPIMEX is
effective against some types of bacteria that are sensitive to the active ingredient cefepime.
CEPIMEX can be used alone, as a first-choice medication, after obtaining the results of the
test that evaluates whether a bacterium is sensitive to the action of this antibiotic (sensitivity test). If
necessary, CEPIMEX can be used safely in association with other antibiotics.
CEPIMEX is used:

• in ADULTSand in CHILDREN over 12 years of age (weighing more than 40 kg),for the treatment of:
• moderate and severe respiratory tract infections, for example of the lungs (pneumonia);
• complicated (i.e. associated with serious illnesses) and uncomplicated lower urinary tract infections (bladder and urethra) and upper urinary tract infections (kidneys and ureters);
• skin and underlying tissue infections;
• abdominal infections (such as peritonitis, gallbladder infections);
• blood infections (bacteremia) that are due to, or are suspected to be due to, one of the above infections, including episodes of fever in patients with poor immune defenses;
• fever in patients with a moderate or severe reduction in the number of some white blood cells (immunocompromised and neutropenic patients).
• in CHILDREN between 1 month and 12 years of age, for the treatment of:
• brain infections (bacterial meningitis).

CEPIMEX can also be used in ADULTS to prevent infections after abdominal surgical
operation.

2. What you need to know before using CEPIMEX

Do not use CEPIMEX if:

• you are allergic to cefepime or any of the other ingredients of this medicine (listed in section 6);
• you are allergic to other antibiotics belonging to the same class as CEPIMEX (cephalosporins);
• you are allergic to antibiotics belonging to the beta-lactam class (e.g. monobactam penicillins and carbapenems), because this could mean that you are also allergic to cefepime.

Warnings and precautions
Talk to your doctor or pharmacist before taking CEPIMEX if:

• you have kidney problems or conditions that may cause harmful effects on the kidney, such as if you are using diuretic drugs or other antibiotics belonging to the class of aminoglycosides (see “Other medicines and CEPIMEX”), as you have a higher probability of experiencing undesirable effects. In such cases, a dose reduction may be necessary.
• you suffer from asthma;
• you are prone to allergic reactions (allergic diathesis);
• you have previously had an allergic reaction to other beta-lactam antibiotics or other medicines. In such cases, your doctor will administer CEPIMEX with caution.

This active substance is not suitable for treating some types of infections unless the bacterium is,
after appropriate tests, sensitive to the action of this antibiotic.

Take special care

• CEPIMEX may alter the results of a blood test used to detect the presence of antibodies on red blood cells (Coombs' test). If you need to undergo this test, tell your doctor that you are taking this medicine.
• CEPIMEX may also alter the results of tests for sugar in the urine (glycosuria). If you are diabetic and undergo these tests regularly, inform your doctor: during treatment with this medicine, it may be appropriate to use other types of tests to monitor diabetes.

Risk of superinfections with the use of CEPIMEX
Like other antibiotics, CEPIMEX may cause uncontrolled growth of bacteria that are not sensitive
to this antibiotic. In this case, your condition may worsen, for example, a new infection may
occur in addition to the one already in progress. Contact your doctor, who will take
appropriate measures.

Other medicines and CEPIMEX
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
This is particularly important if you are taking:

• diuretic drugs or other antibiotics belonging to the class of aminoglycosides, as they may cause harmful effects on the kidney (see “Warnings and precautions”);
• antibiotics belonging to the class of bacteriostatics.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor for advice before using this medicine, as this medicine
must be used under strict medical supervision.

Driving and operating machinery
CEPIMEX may cause altered consciousness, dizziness, confusion and hallucinations. Take
particular care before driving vehicles or using machinery.

3. How to use CEPIMEX

If your doctor has prescribed CEPIMEX, use this medicine following their instructions exactly. If you have any doubts, consult your doctor or pharmacist.
The dose of CEPIMEX is established by the doctor based on age and/or weight, the type of bacteria, the severity
of the infection, and kidney function. If you suffer from a serious infection that may lead to
death, especially if septic shock is present (a blood infection that can seriously endanger
the patient's life), your doctor will administer CEPIMEX intravenously.

Adults and children over 12 years of age and weighing more than 40 kg
The usual dose ranges from 500 mg to 2,000 mg, 2 times a day (every 12 hours). In such cases, CEPIMEX
may be administered by injection into a muscle or into a vein.
In case of severe infections, your doctor will administer CEPIMEX intravenously, in doses of 2,000 mg, 2-3
times a day (every 8 – 12 hours).

Children under 12 years of age or weighing less than 40 kg
The doctor will establish the correct dose by reducing the doses indicated for adults, based on age and weight,
the severity and type of infection, and the child's kidney function.

Patients with kidney problems
The doctor will establish the correct dose by reducing the doses indicated for adults, based on kidney function.

Method of administration
CEPIMEX can be administered:

• through an injection into a muscle( intramuscular) performed deeply. To prepare the injection, dissolve the powder contained in the vial with the solvent contained in the ampoule found inside the package;
• through a slow injection (for 3-5 minutes) or through an infusion (up to 30 minutes) into a vein( intravenous). In such cases, administration must be carried out exclusively in a hospital setting and by medical personnel.

The solution for injection must be prepared immediately before use.
CEPIMEX can be administered simultaneously with other antibiotics or other drugs, provided that
they are not mixed in the same syringe or infusion fluid.

Further “Information intended exclusively for doctors or healthcare professionals” is
If you take more CEPIMEX than you should, especially if you have kidney problems, you may notice:
reversible encephalopathy (a condition that manifests with alterations of consciousness, confusion,
hallucinations, stupor, and coma), involuntary muscle spasms (myoclonus), convulsions.
In case of taking high doses of CEPIMEX, immediately inform your doctor or go to the
nearest hospital, as appropriate measures (e.g., hemodialysis) may be necessary.

If you forget to take CEPIMEX
Do not take a double dose to make up for the missed dose, continue with therapy as normal.

If you stop taking CEPIMEX
Do not stop therapy with CEPIMEX even if you feel better; continue with the treatment as
indicated by your doctor. If you stop treatment, some bacteria may survive and
the infection may return.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, CEPIMEX can cause side effects, although not everybody gets them.
manifest.

Stop taking CEPIMEX and consult your doctor immediately ifyou notice:

• the following symptoms associated with severe allergic reactions: swelling (angioedema) of the face, eyes, lips, throat with difficulty breathing and possible sudden drop in blood pressure (anaphylaxis);
• reversible encephalopathy, a condition that manifests with alterations of consciousness, confusion, hallucinations, stupor (a state of daze that almost removes the ability to speak and act) and coma;
• sudden involuntary muscle contraction (myoclonus);
• seizures (violent and involuntary contractions of some muscles) including non-convulsive status epilepticus (brain disorder, without motor manifestations, caused by excessive activity of some brain nerve cells);
• severe diarrhea, blood in diarrheal stools, cramps and stomach pain or fever, possible signs of colitis or pseudomembranous colitis (colitis caused by a bacterium called Clostridium difficile). This side effect can also occur within two months of stopping CEPIMEX therapy.

Tell your doctor if you experience the following symptoms:

Very common side effects(may affect more than 1 in 10 people)

• positivity to a blood test used to highlight the presence of antibodies capable of attacking and destroying red blood cells (direct Coombs test).

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

• diarrhea;
• reactions at the site where you performed the injection, for example inflammation of a vein, if you administered CEPIMEX into a vein (intravenously);
• pain and inflammation in a muscle, if you administered CEPIMEX into a muscle (intramuscularly);
• skin rashes;
• decrease in the number of red blood cells (anemia), increase in eosinophils (eosinophilia);
• increased levels of transaminases in the blood, which may indicate liver problems;
• increased alkaline phosphatase in the blood (a protein present especially in the liver, bile ducts and bones), which may indicate the presence of skeletal or liver diseases;
• increased total bilirubin in the blood (a substance produced by aged or damaged red blood cells), an index of a liver problem;
• increased blood clotting time (prothrombin time and partial thromboplastin time).

Uncommon side effects(may affect up to 1 in 100 people)

• headache, fever;
• nausea, vomiting, mouth infections due to fungi of the genus Candida (oral candidiasis);
• decrease in the number of platelets (thrombocytopenia), decrease in white blood cells (leukopenia), neutrophils (neutropenia);
• increased levels of nitrogen and creatinine in the blood (values that indicate kidney damage);
• redness, urticaria, itching;
• inflammation at the site where you performed the injection, if you administered CEPIMEX into a vein (intravenously);
• vaginal infection (vaginitis).

Rare side effects(may affect up to 1 in 1,000 people)

• abdominal pain, difficulty evacuating (constipation);
• alteration of the sensitivity of some parts of the body (paresthesia), dizziness, alterations of taste;
• dilation of blood vessels;
• difficulty breathing (dyspnea);
• infections due to fungi (unspecified candidiasis), genital itching;
• chills.

Frequency not known(the frequency cannot be estimated on the basis of available data)

• severe skin reactions, which manifest with redness, formation of blisters or pus and detachment of the skin (for example erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis);
• decrease in the number of red blood cells due to destruction of red blood cells (hemolytic anemia) or bone marrow problems (aplastic anemia), severe decrease in granulocytes (agranulocytosis);
• kidney problems caused by chemicals, physical factors or drugs (toxic nephropathy or renal failure);
• bleeding;
• positivity to a test used to highlight the presence of sugar in the urine (glucosuria).

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 the address “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 CEPIMEX

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 30°C, protected from light.
The reconstituted solution (powder and solvent mixed together) not used, may be stored at
a temperature not exceeding 25°C for 24 hours or in a refrigerator (2°C - 8°C) for 7 days.
As with other cephalosporins, CEPIMEX solutions may vary in colour depending on the
storage period. This characteristic does not affect the efficacy and tolerability of the medicine.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date
refers to the last day of that month.
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 CEPIMEX contains
The active ingredient is: cefepime dihydrochloride monohydrate.
Each vial of CEPIMEX 1000 mg contains: 1000 mg of cefepime dihydrochloride monohydrate.
The excipients are:

• in the powder vial: L-arginine;
• in the solvent vial: water for injections.

Description of the appearance of CEPIMEX and contents of the pack
CEPIMEX 1000 mg is available in a pack of 1 vial of 1000 mg and 1 vial of solvent of 3 ml.
CEPIMEX is available in packs containing 1 vial of powder and 1 vial of solvent (usable
for intramuscular administration).

Marketing Authorisation Holder
Bruno Farmaceutici S.p.A., Via delle Ande, 15 – 00144 ROMA (RM)

Manufacturer
Mitim S.r.l., Via Cacciamali 34-38, 25125 Brescia
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Information intended exclusively for physicians or healthcare professionals.For more details,
consult the Summary of Product Characteristics.
ADMINISTRATION
CEPIMEX can be administered by intravenous and intramuscular route. When
administered intramuscularly alone, CEPIMEX generally does not cause pain.
The dose and route of administration vary according to the susceptibility of the organism involved, the
severity of the infection, renal function and the general condition of the patient.

Adultsand children over 12 years of age (> 40Kg)
A guide to the dose of cefepime for adults and children over 12 years of age (> 40Kg) with normal
renal function is provided in Table 1.
Intravenous administration is preferable for patients with severe infections, especially
those that endanger the patient's life, especially if septic shock is present.
Table 1

Adults and Children over 12 years of age (> 40 kg) with normal renal function*

* The duration of therapy usually ranges from 7 to 10 days; more severe infections may
require longer treatment. Empiric treatment of febrile neutropenia (immunocompromised patients) should last 7 days or until resolution of neutropenia.

Surgical prophylaxis (adults): the recommended doses for the prevention of bacterial infections during
and after surgical procedures are as follows:

• A single dose of 2 g IV of CEPIMEX (infusion of 30 minutes) to be started 60 minutes before the surgical procedure. A single dose of 500 mg IV of metronidazole, if deemed appropriate, may be administered immediately after the end of the CEPIMEX infusion. The dose of metronidazole must be prepared and administered in accordance with the product technical information. Due to incompatibility CEPIMEX and metronidazole must not be mixed in the same container; it is recommended to flush the tubing with a compatible liquid before administering metronidazole.
• If the duration of the surgery exceeds 12 hours, a second dose of CEPIMEX followed by metronidazole, if appropriate, must be administered 12 hours after the initial prophylactic dose.

Children aged between 1 month and 12 years with normal renal function

Bacterial meningitis
Recommended dose: patients over two months of age and weighing  40 kg: 50 mg/kg every 8 hours for 7 - 10
days.
Experience with the use of CEPIMEX in patients under two months of age is limited. While
this experience has been obtained at 50 mg/kg, pharmacokinetic data obtained in individuals over 2
months suggest that a dose of 30 mg/kg every 12 or 8 hours may be considered adequate for
pediatric patients between the first and second month of age. The doses of 30 mg/kg between 1 and 2 months and those of
50 mg/kg between 2 months and 12 years are comparable to the 2 g of the adult. The administration of
CEPIMEX in these patients should be carefully monitored.
For pediatric patients weighing more than 40 kg, adult regimens can be applied (see
Table 1). For patients over 12 years of age and weighing  40 kg, the regimen for the
younger ones weighing  40 kg should be used.
The pediatric dose should not exceed the adult dose (2 g every 8 hours). Experience with
intramuscular administration in pediatric patients is limited.

Elderly
No dose adjustment is required, except in case of concomitant renal insufficiency.

Impaired hepatic function
No dose adjustment is required, except in case of concomitant renal insufficiency.

Impaired renal function
In patients with renal dysfunction, the dose of cefepime must be adjusted to compensate for the lower
renal elimination. The initial recommended dose of cefepime in patients with mild to moderate renal dysfunction must be the same as for patients with normal renal function. The recommended maintenance dose of cefepime in adult patients with renal insufficiency is reported in the
following table.
Table 2

Maintenance dose in adults with renal insufficiency*
Patients undergoing hemodialysis
In patients undergoing hemodialysis, approximately 68% of the total amount of cefepime present
in the body at the start of dialysis is eliminated within 3 hours.
For these patients, the pharmacokinetic model indicates that a dose reduction is necessary. Patients receiving cefepime and undergoing hemodialysis at the same time should receive
the following dose: a loading dose of 1 g on the first day of therapy and, subsequently, 500 mg of
cefepime per day for all infections, except for febrile neutropenia, which requires 1 g per
day.

On dialysis days, cefepime should be administered immediately after it. When
possible, cefepime should be administered at the same time each day.

Patients undergoing continuous peritoneal dialysis
In continuous peritoneal dialysis, CEPIMEX can be administered at the doses normally
recommended for patients with normal renal function (i.e. 500 mg, 1 g or 2 g depending on the severity
of the infection) but with an interval of 48 hours between one dose and the next.

Pediatric patients with impaired renal function
Since urinary excretion is the predominant route of elimination of cefepime, it is recommended to
adjust the dose in pediatric patients and with impaired renal function.
As recommended in Table 2, the same increments of the intervals between doses should be used
and/or a reduction of the latter.

METHOD OF ADMINISTRATION
Intravenous administration
To prepare the CEPIMEX solution for intravenous administration, the following diluents must be used:

• Water for injections Ph. Eur.
• Sodium chloride solution (0.9% sodium chloride solution), with or without 5% glucose
• Ringer's solution with or without 5% glucose
• 5% or 10% glucose solution
• Sodium lactate 6 M CEPIMEX can be injected slowly into a vein, over a period of 3-5 minutes. The drug can also be administered directly into infusion tubes or via continuous intravenous infusion while the patient is receiving an intravenous compatible fluid. In case of infusion administration, inject the drug in about 30 minutes.

Reconstitution volumes
The reconstitution volumes of CEPIMEX for intravenous and intramuscular administration are
summarized in the following table:
Instructions for reconstitution
It is preferable to administer the drug immediately after its reconstitution.
CEPIMEX can be administered concurrently with other antibiotics or other drugs provided
they are not mixed in the same syringe or infusion fluid.

Intramuscular administration
CEPIMEX 1 g should be diluted with 3 ml of water for injections (supplied in the package).

Treatment of overdose
In case of severe overdose, especially in patients with impaired renal function, serum levels of CEPIMEX can be reduced by hemodialysis. Peritoneal dialysis is not helpful.
Accidental overdose may occur in case of taking high doses of the drug by
patients with renal dysfunction.