CEFOTAXIMA 500 mg /2 Ml Powder And Solvent For Injectable Solution

Зміст інструкції

1. CEFOTAXIMA ABC 500 mg / 2 ml
2. CEFOTAXIMA ABC 1 g / 4 ml
   1. What is Cefotaxima ABC and what is it used for
   2. What you need to know before using Cefotaxima ABC
   3. How to use Cefotaxima ABC
   4. Possible side effects
   5. How to store CEFOTAXIMA ABC
   6. Contents of the pack and other information

CEFOTAXIMA ABC 500 mg / 2 ml

Powder and solvent for injectable solution for intramuscular use

CEFOTAXIMA ABC 1 g / 4 ml

Powder and solvent for injectable solution for intramuscular use
cefotaxime sodium
Equivalent medicinal product

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 nurse.
• 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 may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What is Cefotaxima ABC and what is it used for

Cefotaxima ABC contains the active ingredient sodium cefotaxime, which belongs to a group of medicines
called antibiotics (beta-lactam antibiotics or 3rd generation cephalosporins) that are used for the
treatment of infections caused by bacteria.
Cefotaxima ABC is indicated for the treatment of severe bacterial infections caused by some bacteria (difficult Gram-negative germs) or by a set of bacteria of different types (mixed flora) with the presence of Gram-
negative bacteria resistant to the most common antibiotics. In these cases it is also indicated for debilitated people or with
problems in their immune defenses (immunocompromised).
This medicine is also indicated for the prevention of infections caused by surgical procedures.

2. What you need to know before using Cefotaxima ABC

Do not use Cefotaxima ABC

• if you are allergic to cefotaxime sodium, to other similar antibiotics (cephalosporins) or to any of the other ingredients of this medicine (listed in section 6);
• if you are taking antibiotics belonging to the same group as Cefotaxima ABC called penicillins, because cross-allergic reactions may occur (see section “Warnings and Precautions”).
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Cefotaxima ABC powder and solvent for injectable solution for intramuscular use contains a local anesthetic
called lidocaine, therefore it should not be administered in case of:

• allergy to lidocaine or other similar anesthetics;
• serious heart problems (heart block without a pacemaker and severe heart failure);
• administration performed intravenously;
• newborns under 30 months of age.

Warnings and precautions
Consult your doctor or nurse before you are given Cefotaxima ABC.
As with other similar medicines (antibiotics), the use of this medicine may promote the occurrence of other
infections caused by bacteria to which Cefotaxima ABC is not effective (superinfections). If this should occur,
it is advisable to consult your doctor who will indicate a suitable therapy.
During the use of Cefotaxima ABC, the following may occur:

• allergic reactions.Before starting therapy with this medicine, your doctor will subject you to specific tests to ensure that you are not allergic to cefotaxime, cephalosporins, penicillins or other medicines. Use this medicine with caution and inform your doctor if you have experienced allergic reactions in the past, especially to penicillins (beta-lactam antibiotics). If you notice the onset of an allergic reaction, stop treatment with this medicine and immediately inform your doctor, or go to the nearest hospital: the doctor, depending on your condition, will establish the appropriate therapy;
• appearance of blisters on the skin(severe blistering eruptions such as Stevens-Johnson syndrome or toxic epidermal necrolysis). If you notice the appearance of skin or mucous membrane reactions, with the presence of vesicles or blisters, stop treatment and immediately consult your doctor;
• problems with the intestinecaused by a bacterium called Clostridium difficile. You may experience mild or severe diarrhea in case of inflammation of the intestine (pseudomembranous colitis). If you experience severe or prolonged diarrhea during treatment with Cefotaxima ABC, your doctor may subject you to specific tests (endoscopy or a histological examination) to confirm whether it is a disease caused by this bacterium. If you experience mild cases of colitis, stop treatment to allow the symptoms to disappear. If you experience moderate or severe colitis, consult your doctor who will indicate the appropriate therapy. If you are taking medicines that act on the intestine (inhibitors of peristalsis), Cefotaxima ABC should not be administered to you as they may promote the occurrence of diseases associated with Clostridium difficile; if you have suffered, even in the past, from intestinal diseases, especially colitis, inform your doctor;
• alterations of the blood(leukopenia, neutropenia, bone marrow failure, pancytopenia, agranulocytosis, thrombocytopenia, hemolytic anemia), especially if you use the medicine for prolonged periods. Therefore, if you have been prescribed a treatment for 7-10 days or more, you must undergo blood tests. Stop treatment with Cefotaxima ABC if blood alterations occur, as some problems disappear after discontinuation of treatment;
• pathology that causes alterations in the brain(encephalopathy) which may include convulsions, confusion, altered consciousness and movement disorders. This type of antibiotic (beta-lactam antibiotic) predisposes to this risk, especially if taken at high doses or if you suffer from kidney problems (renal failure). If you notice the onset of any of these symptoms, stop treatment and immediately consult your doctor. Use this medicine with caution and inform your doctor if you suffer from severe kidney problems (severe renal failure). In this case, the doctor may decide to halve the maintenance dose based on your condition. Undergo kidney checks if, while taking Cefotaxima ABC, you are taking medicines for the treatment of severe infections (aminoglycoside antibiotics), probenecid (medicine to lower uric acid levels in the blood), medicines harmful to the kidneys (nephrotoxic drugs), if you are elderly or if you suffer from kidney problems.

Cefotaxima ABC may not be effective (antibiotic resistance), especially against some families of
bacteria (Enterobacteriaceaeand Pseudomonas), in people with immune deficiencies
(immunocompromised) or following the simultaneous use of similar medicines (antibiotics).

Cefotaxima ABC and laboratory tests
Inform your doctor that you are using this medicine before undergoing some tests because
Cefotaxima ABC may interfere with some laboratory tests, such as: Coombs test, blood compatibility
test, tests to measure sugar levels in the urine (Benedict, Fehling, “Clinitest” methods).

Other medicines and Cefotaxima ABC
Inform your doctor or nurse if you are taking, have recently taken or may take any other
medicines.
Cefotaxima ABC must not be mixed in the same syringe with other medicines and in particular
with medicines for the treatment of bacterial infections (antibiotics).
This medicine must be administered to you with caution if you are using one of the following medicines:

• aminoglycoside antibiotics, medicines for the treatment of bacterial infections or diuretics, medicines to facilitate the elimination of fluids such as furosemide. Consult your doctor because kidney function checks are necessary in this case.
• probenecid, a medicine used to reduce uric acid levels in the blood, because it may slow down the elimination of Cefotaxima ABC with urine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor, pharmacist or nurse for advice before using this medicine.
If you are pregnant, do not use Cefotaxima ABC unless your doctor deems it necessary.
If you are breastfeeding, consult your doctor, who will assess the need to discontinue breastfeeding or
treatment with this medicine.
Babies breastfed by mothers taking Cefotaxima ABC may have diarrhea.

Driving and operating machinery
This medicine may cause dizziness or encephalopathy (brain pathology) which may include
convulsions, confusion, altered consciousness, movement disorders. This may impair your ability
to drive and operate machinery. If you experience these effects, avoid driving and operating
machinery.

Cefotaxima ABC contains sodium
Cefotaxima ABC 500 mg / 2 ml contains 24 mg of sodium (the main component of table salt) per
vial. This is equivalent to 1.2% of the maximum recommended daily intake with the diet of an adult.
Cefotaxima ABC 1 g / 4 ml contains 48 mg of sodium (the main component of table salt) per vial.
This is equivalent to 2.4% of the maximum recommended daily intake with the diet of an adult.

3. How to use Cefotaxima ABC

This medicine will be administered to you by medical personnel, always following the doctor's or nurse's instructions exactly. If you have any doubts, consult your doctor or nurse.
The doctor will determine the necessary dose and the duration of treatment depending on the type of infection, your
condition, and your body weight.
It is recommended to continue the treatment for at least 3 days after the fever has subsided.

Warning: this medicine must be administered exclusively by injection into the muscle (intramuscular route). Therefore, administration into a vein (intravenous) must be absolutely avoided.

Instructions for use
Opening the solvent vial: using a syringe, draw the contents of the solvent vial and pour it into the
powder vial. When the medicine has completely dissolved, draw the contents of the vial and
proceed with the injection. The dissolved product, from the beginning, appears with a yellowish hue.
Do not mix Cefotaxima ABC with sodium bicarbonate solutions or with other medicines including antibiotics
(aminoglycosides).
The recommended dose for adults, for intramuscular injections, is 2 grams per day divided into two
administrations of 1 gram every 12 hours. This dose may be increased to 3-4 grams, reducing
the interval between administrations to 8-6 hours.
Following the administration of this medicine, you may experience pain at the injection site.
In this case, you can use, up to 2 times a day, the solvent vial containing a local anesthetic
(lidocaine), unless you are allergic to this medicine (see the paragraph “Do not use Cefotaxima
ABC”). This solution should only be used via the intramuscular route and therefore administration into a vein (intravenous) must be absolutely avoided.

Use in children under 12 years of age
The recommended dose is 50-100 mg/kg of body weight per day, to be divided into 2-4 injections.
If the child is in life-threatening danger or in very serious cases, the recommended dose is 200 mg/kg of body
weight per day.

Use in premature newborns
The recommended dose should not exceed 50 mg/kg of body weight per day, given that the function of the
kidneys is not yet fully developed.
The solvent containing lidocaine hydrochloride should not be used in children under 12 years of age, in whom the
intramuscular administration should be carried out with the solution in water for injectable preparations only.

Use in people with severe kidney problems
In case of severe renal insufficiency, lower dosages are indicated.
If you are undergoing hemodialysis or peritoneal dialysis, the recommended dose ranges from 1 to 2 g per day
depending on the severity of your infection. On the day of hemodialysis, CEFOTAXIMA ABC will be
administered to you after the treatment. This precaution is not necessary in case of peritoneal dialysis.

If you use more Cefotaxima ABC than you should
This medicine will be administered by a doctor or a nurse, so an overdose is unlikely.
The symptoms of an overdose may correspond to the undesirable effects (see paragraph 4) and
brain damage (encephalopathies) may occur. In this case, the administration of this medicine
must be suspended and the doctor will indicate an appropriate therapy.
If you think that you have been given an excessive amount of this medicine, immediately notify
your doctor or go to the nearest hospital.

If you forget to use CEFOTAXIMA ABC
This medicine will be administered by a doctor or a nurse, so it is unlikely that a dose will be forgotten. Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

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

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

• pain at the injection site for intramuscular administration (intramuscular administration). Uncommon(may affect up to 1 in 100 people)
• reduction in the number of white blood cells (leukopenia), increase in the number of eosinophils (eosinophilia), reduction in the number of platelets (thrombocytopenia);
• redness of the skin (skin rash), itching, hives, fever, increased values in blood tests for liver function (ALAT, ASAT, LDH, gamma-GT, alkaline phosphatase, bilirubin), Jarisch-Herxheimer reaction (which manifests with fever, chills, headache, muscle pain and joint disorders, skin irritation, decreased white blood cells, alteration of blood tests affecting the liver, breathing difficulties);
• convulsions (see section “Warnings and precautions”);
• diarrhea (see section “Warnings and precautions”);
• decreased kidney function and increased creatinine, a substance that indicates kidney function, especially when this medicine has been prescribed together with other medicines for the treatment of infections caused by bacteria (aminoglycoside antibiotics);
• inflammatory reactions at the injection site, including inflammation of a vein with or without the formation of blood clots (thrombophlebitis/phlebitis).

Not known(frequency cannot be estimated from available data)

• infections caused by bacteria or fungi (superinfections, see section “Warnings and precautions”);
• reduction in the number of some types of white blood cells (neutropenia, agranulocytosis), reduced activity of the bone marrow (bone marrow failure), decrease in all blood cells (pancytopenia) (see section “Warnings and precautions”), decrease in red blood cells (hemolytic anemia);
• allergic reactions, including severe ones (anaphylactic reactions, anaphylactic shock), swelling due to fluid accumulation around the mouth and eyes (angioedema), constriction of the bronchi with difficulty breathing (bronchospasm);
• headache, dizziness;
• encephalopathy (which may include convulsions, confusion, altered consciousness and movement disorders). This type of antibiotic predisposes to this risk especially if taken at high doses or if you have kidney problems (renal failure). See section “Warnings and precautions”);
• nausea, vomiting, stomach pain (abdominal pain), severe inflammation of the intestine (pseudomembranous colitis) (see section “Warnings and precautions”);
• skin lesions, even severe ones such as: erythema multiforme (widespread redness), Stevens Johnson syndrome and toxic epidermal necrolysis (blisters, vesicles and bleeding on lips, eyes, mouth, nose and genitals), acute generalized exanthematous pustulosis (widespread inflamed and infected lesions) (see section “Warnings and precautions”);
• liver problems (hepatitis) sometimes with yellowing of the skin and eyes (jaundice);
• inflammation of the kidneys (interstitial nephritis), severe kidney malfunction (acute renal failure) (see section “Warnings and precautions”);
• reactions affecting several organs (systemic reactions) to lidocaine (a local anesthetic) present in the solvent for intramuscular administration only;
• loss of appetite (anorexia), inflammation of the tongue (glossitis), heartburn (pyrosis gastrica);
• vaginal inflammation caused by a fungus (Candida vaginitis), agitation, confusion, reduced muscle strength (asthenia), night sweats.

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 http://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 CEFOTAXIMA ABC

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. The expiry date refers to
the last day of that month.
Store in the original packaging to protect the medicine from light and do not store at a temperature
above 30 °C.
The reconstituted product must be used immediately. Any remaining product must be discarded.
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 CEFOTAXIMA ABC 500 mg / 2 ml powder and solvent for injectable solution for use
intramuscularly contains
The active ingredient is cefotaxime sodium.
One vial of powder contains 524 mg of cefotaxime sodium corresponding to 500 mg of cefotaxime.
The other components of the solvent vial are: water for injections and lidocaine hydrochloride.

What CEFOTAXIMA ABC 1 g / 4 ml powder and solvent for injectable solution for use
intramuscularly contains
The active ingredient is cefotaxime sodium.
One vial of powder contains 1.048 g of cefotaxime sodium corresponding to 1 g of cefotaxime.
The other components of the solvent vial are: water for injections and lidocaine hydrochloride.

Description of the appearance of Cefotaxima ABC and contents of the pack
CEFOTAXIMA ABC 500 mg / 2 ml powder and solvent for injectable solution for use intramuscularly
Pack containing 1 vial of 500 mg of cefotaxime sterile powder and 1 solvent vial of 2 ml
containing lidocaine hydrochloride.
CEFOTAXIMA ABC 1 g / 4 ml powder and solvent for injectable solution for use intramuscularly
Pack containing 1 vial of 1 g of cefotaxime sterile powder and 1 solvent vial of 4 ml containing
lidocaine hydrochloride.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Torino

Manufacturer
Esseti Farmaceutici S.p.A. – Via Campobello, 15 – Pomezia (RM)