Package leaflet: Information for the user

CEFOTAXIME ABC 500 mg / 2 ml

Powder and solvent for injectable solution for intramuscular use
CEFOTAXIME ABC 1 g / 4 ml
Powder and solvent for injectable solution for intramuscular use
cefotaxime sodium
Equivalent medicine
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

What Cefotaxime ABC is and what it is used for
What you need to know before using Cefotaxime ABC
How to use Cefotaxime ABC
Possible side effects
How to store Cefotaxime ABC
Contents of the pack and other information

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

Cefotaxima ABC contains the active substance cefotaxime sodium, belonging to a group of medicines
called antibiotics (beta-lactam antibiotics or third-generation cephalosporins) used to treat bacterial infections.
Cefotaxima ABC is indicated for the treatment of severe bacterial infections caused by certain bacteria (difficult Gram-negative organisms) or by a mixture of different types of bacteria (mixed flora), including Gram-negative bacteria resistant to common antibiotics. In these cases, it is also indicated for weakened patients or those with impaired 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 Cefotaxime ABC

Do not use Cefotaxime ABC

if you are allergic to sodium cefotaxime, 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 Cefotaxime ABC called penicillins, as cross-allergic reactions may occur (see section “Warnings and Precautions”);
if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

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

allergy to lidocaine or to other similar anesthetics;
severe heart problems (heart block without pacemaker and severe heart failure);
intravenous administration (endovenous administration);
infants under 30 months of age.

Warnings and precautions
Talk to your doctor or nurse before being administered Cefotaxime ABC.
As with other similar medicines (antibiotics), the use of this medicine may promote the occurrence of other infections caused by bacteria against which Cefotaxime ABC is not effective (superinfections). If this occurs, you should consult your doctor, who will indicate appropriate therapy.
During treatment with Cefotaxime ABC, the following may occur:

allergic reactions. Before starting therapy with this medicine, your doctor will perform specific tests to confirm that you are not allergic to cefotaxime, cephalosporins, penicillins, or other medicines. Use this medicine with caution and inform your doctor if you have previously experienced allergic reactions, especially to penicillins (beta-lactam antibiotics). If you notice signs of an allergic reaction, stop treatment with this medicine immediately and contact your doctor or go to the nearest hospital: your doctor will decide the appropriate treatment based on your condition;
appearance of blisters on the skin (severe blistering skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis). If you notice skin or mucosal reactions with blisters or vesicles, stop treatment immediately and consult your doctor without delay;
intestinal problems caused by a bacterium called Clostridium difficile. You may experience mild or severe diarrhea due to inflammation of the intestine (pseudomembranous colitis). If you develop severe or persistent diarrhea during treatment with Cefotaxime ABC, your doctor may perform specific tests (endoscopy or histological examination) to confirm whether the disease is caused by this bacterium. If you experience mild colitis, stop treatment to allow symptoms to resolve. If you experience moderate or severe colitis, consult your doctor, who will recommend appropriate therapy. Do not take Cefotaxime ABC if you are taking medicines that act on the intestine (peristalsis inhibitors), as they may promote the onset of diseases associated with Clostridium difficile; if you have previously suffered from intestinal diseases, particularly colitis, inform your doctor;
blood disorders (leukopenia, neutropenia, bone marrow failure, pancytopenia, agranulocytosis, thrombocytopenia, hemolytic anemia), especially if the medicine is used for prolonged periods. Therefore, if you have been prescribed treatment for 7–10 days or longer, you should undergo blood tests. Discontinue treatment with Cefotaxime ABC if blood abnormalities occur, as some problems resolve after stopping treatment;
a condition causing brain disturbances (encephalopathy), which may include seizures, confusion, altered consciousness, and movement disorders. This type of antibiotic (beta-lactam antibiotic) increases this risk, especially when taken at high doses or if you have kidney problems (renal failure). If you notice any of these symptoms, stop treatment immediately and consult your doctor. Use this medicine with caution and inform your doctor if you have severe kidney problems (severe renal failure). In such cases, your doctor may decide to halve the maintenance dose based on your condition. Undergo kidney function monitoring if you are simultaneously taking Cefotaxime ABC and medicines for severe infections (aminoglycoside antibiotics), probenecid (a medicine to lower blood uric acid levels), nephrotoxic drugs (medicines harmful to the kidneys), if you are elderly, or if you have kidney problems.

Cefotaxime ABC may not be effective (antibiotic resistance), especially against certain families of bacteria (Enterobacteriaceae and Pseudomonas), in people with weakened immune defenses (immunocompromised) or following concomitant use of similar medicines (antibiotics).
Cefotaxime ABC and laboratory tests
Inform your doctor that you are using this medicine before undergoing certain laboratory tests, as Cefotaxime ABC may interfere with some laboratory tests, such as: Coombs test, blood compatibility test, urine glucose tests (Benedict, Fehling, “Clinitest” methods).
Other medicines and Cefotaxime ABC
Inform your doctor or nurse if you are using, have recently used, or might use any other medicine.
Cefotaxime ABC must not be mixed in the same syringe with other medicines, particularly antibiotics used to treat bacterial infections.
This medicine should be administered with caution if you are taking any of the following medicines:

aminoglycoside antibiotics, medicines used to treat bacterial infections, or diuretics, medicines that help eliminate fluids such as furosemide. Consult your doctor, as kidney function monitoring is required in such cases.
probenecid, a medicine used to reduce blood uric acid levels, as it may slow down the urinary elimination of Cefotaxime ABC.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor, pharmacist, or nurse before using this medicine.
Do not use Cefotaxime ABC during pregnancy unless your doctor considers it necessary.
If you are breastfeeding, consult your doctor, who will assess whether breastfeeding or treatment with this medicine should be discontinued.
Infants breastfed by mothers taking Cefotaxime ABC may develop diarrhea.
Driving and using machines
This medicine may cause dizziness or encephalopathy (a brain disorder) that may include seizures, confusion, altered consciousness, and movement disorders. This may impair your ability to drive or operate machinery. If you experience these effects, avoid driving or operating machinery.
Cefotaxime ABC contains sodium
Cefotaxime ABC 500 mg / 2 ml contains 24 mg of sodium (the main component of table salt) per vial. This corresponds to 1.2% of the maximum daily dietary intake recommended for an adult.
Cefotaxime ABC 1 g / 4 ml contains 48 mg of sodium (the main component of table salt) per vial. This corresponds to 2.4% of the maximum daily dietary intake recommended for an adult.

3. How to use Cefotaxime ABC

This medicine will be administered to you by medical personnel, strictly following the instructions provided by your doctor or nurse. If you have any doubts, consult your doctor or nurse.
Your doctor will determine the required dose and duration of treatment depending on the type of infection, your condition, and your body weight.
It is recommended to continue treatment for at least 3 days after your fever has subsided.
Warning: This medicine must be administered exclusively via intramuscular injection. Therefore, intravenous (endovenous) administration must be absolutely avoided.
Instructions for use
Opening the solvent vial: withdraw the contents of the solvent vial using a syringe and pour it into the vial containing the powder. Once the medicine has completely dissolved, withdraw the solution from the vial and proceed with the injection. The reconstituted product has a yellow tint from the beginning.
Do not mix Cefotaxime ABC with sodium bicarbonate solutions or with other medicinal products, including antibiotics (aminoglycosides).
The recommended dose for adults for intramuscular injections is 2 grams per day, divided into two 1-gram doses administered every 12 hours. This dose may be increased to 3–4 grams, reducing the interval between doses to 8–6 hours.
After administration of this medicine, you may experience pain at the injection site.
In such cases, the solvent vial containing a local anesthetic (lidocaine) may be used up to twice daily, unless you are allergic to this substance (see section “Do not use Cefotaxime ABC”). This solution is intended for intramuscular use only; therefore, intravenous (endovenous) administration must be absolutely avoided.
Use in children under 12 years of age
The recommended dose is 50–100 mg/kg body weight per day, divided into 2–4 injections.
If the child is critically ill or in very severe conditions, the recommended dose is 200 mg/kg body weight per day.
Use in premature infants
The recommended dose must not exceed 50 mg/kg body weight per day, as kidney function is not yet fully developed.
The solvent containing lidocaine hydrochloride must not be used in children under 12 years of age. For intramuscular administration in these patients, the powder should be reconstituted with water for injections only.
Use in patients with severe kidney problems
In cases of severe renal impairment, lower doses are recommended.
If you are undergoing hemodialysis or peritoneal dialysis, the recommended dose ranges from 1 to 2 grams per day, depending on the severity of your infection. On the day of hemodialysis, CEFOTAXIME ABC will be administered to you after the dialysis session. This precaution is not necessary in the case of peritoneal dialysis.
If you use more Cefotaxime ABC than you should
This medicine will be administered by a doctor or nurse, so overdose is unlikely.
Symptoms of overdose may correspond to the undesirable effects (see section 4) and may include brain damage (encephalopathies). In such cases, administration of this medicine must be stopped and your doctor will provide appropriate treatment.
If you think you have been given too much of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to use CEFOTAXIME ABC
This medicine will be administered by a doctor or nurse, so it is unlikely that a dose will be missed. Do not use a double dose to make up for a forgotten dose.
If you have any doubts about how to use 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 with intramuscular administration (intramuscular injection).

Uncommon (may affect up to 1 in 100 people)

decrease in the number of white blood cells (leucopenia), increase in the number of eosinophils (eosinophilia), decrease in the number of platelets (thrombocytopenia);
skin redness (cutaneous rash), itching, hives, fever, increased liver blood test values (ALAT, ASAT, LDH, gamma-GT, alkaline phosphatase, bilirubin), Jarisch-Herxheimer reaction (manifesting as fever, chills, headache, muscle pain and joint discomfort, skin irritation, decrease in white blood cells, liver function test abnormalities, breathing difficulties);
seizures (see section “Warnings and precautions”);
diarrhoea (see section “Warnings and precautions”);
reduced kidney function and increased creatinine, a substance indicating kidney function, especially when this medicine has been prescribed together with other medicines for the treatment of bacterial infections (aminoglycoside antibiotics);
inflammatory reactions at the injection site, including inflammation of a vein with or without blood clot formation (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 certain types of white blood cells (neutropenia, agranulocytosis), reduced bone marrow activity (bone marrow failure), decrease in all blood cells (pancytopenia) (see section “Warnings and precautions”), reduction in red blood cells (haemolytic anaemia);
allergic reactions, even severe ones (anaphylactic reactions, anaphylactic shock), swelling due to fluid accumulation around the mouth and eyes (angioedema), bronchial constriction with breathing difficulty (bronchospasm);
headache (cephalalgia), dizziness;
encephalopathy (which may include seizures, confusion, altered consciousness, and movement disorders). This type of antibiotic increases this risk, particularly when taken at high doses or if you have kidney problems (renal insufficiency). 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 at lips, eyes, mouth, nose and genitals), generalized exanthematous pustulosis (widespread red and infected lesions) (see section “Warnings and precautions”);
liver problems (hepatitis), sometimes with yellowing of the skin and eyes (jaundice);
kidney inflammation (interstitial nephritis), severe kidney dysfunction (acute renal failure) (see section “Warnings and precautions”);
reactions affecting multiple organs (systemic reactions) to lidocaine (a local anaesthetic) present in the solvent for intramuscular administration only;
loss of appetite (anorexia), inflammation of the tongue (glossitis), heartburn (gastric pyrosis);
vaginal inflammation caused by a fungus (Candida vaginitis), agitation, confusion, reduced muscle strength (asthenia), night sweats.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 CEFOTAXIME ABC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 above 30 °C.
The reconstituted product must be used immediately. Any unused portion must be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Contents of the pack and other information

What CEFOTAXIME ABC 500 mg / 2 ml powder and solvent for injectable solution for
intramuscular use contains
The active substance is cefotaxime sodium.
One vial of powder contains 524 mg of cefotaxime sodium, equivalent to 500 mg of cefotaxime.
The other components of the solvent vial are: water for injections and lidocaine hydrochloride.

What CEFOTAXIME ABC 1 g / 4 ml powder and solvent for injectable solution for
intramuscular use contains
The active substance is cefotaxime sodium.
One vial of powder contains 1.048 g of cefotaxime sodium, equivalent to 1 g of cefotaxime.
The other components of the solvent vial are: water for injections and lidocaine hydrochloride.

Description of the appearance of Cefotaxime ABC and contents of the pack
CEFOTAXIME ABC 500 mg / 2 ml powder and solvent for injectable solution for intramuscular use
Pack containing 1 vial of 500 mg sterile cefotaxime powder and 1 solvent vial of 2 ml containing lidocaine hydrochloride.

CEFOTAXIME ABC 1 g / 4 ml powder and solvent for injectable solution for intramuscular use
Pack containing 1 vial of 1 g sterile cefotaxime powder and 1 solvent vial of 4 ml containing lidocaine hydrochloride.

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

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