Cefotaxime EG: detailed information

Package leaflet: Information for the user

CEFOTAXIME EG 1 g/4 ml powder and solvent for injectable solution for intramuscular use

Generic medicine
Please read this leaflet carefully before this medicine is administered to you, 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 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, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

What CEFOTAXIME EG is and what it is used for
What you need to know before being administered CEFOTAXIME EG
How to use CEFOTAXIME EG
Possible side effects
How to store CEFOTAXIME EG
Contents of the pack and other information

1. What CEFOTAXIMA EG is and what it is used for

CEFOTAXIMA EG contains the active substance cefotaxime sodium, which belongs to a group of medicines called antibiotics (beta-lactam antibiotics or third-generation cephalosporins) used to treat bacterial infections.
CEFOTAXIMA EG is indicated for the treatment of severe bacterial infections caused by certain bacteria (difficult-to-treat Gram-negative organisms) or by a mixture of different types of bacteria (mixed flora), including Gram-negative bacteria resistant to more common antibiotics. In such 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 must know before CEFOTAXIME EG is administered to you

Do not use CEFOTAXIME EG

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 EG called penicillins, because cross-allergic reactions may occur (see section “Warnings and Precautions”).

Cefotaxime EG contains a local anaesthetic called lidocaine; therefore, it must not be administered in case of:

allergy to lidocaine or to other similar anaesthetics;
severe heart problems (cardiac 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 CEFOTAXIME EG is administered to you.
As with other similar medicines (antibiotics), the use of this medicine, especially if prolonged, may promote the occurrence of other infections caused by bacteria to which Cefotaxime EG is not effective (superinfections). If this occurs, you should contact your doctor, who will indicate an appropriate treatment.
During treatment with CEFOTAXIME EG, the following may occur:

allergic reactions. Before starting therapy with this medicine, your doctor will perform specific tests to ensure that you are not allergic to cefotaxime, cephalosporins, penicillins or other medicines. Inform your doctor that this medicine should be administered with caution if you have previously experienced allergic reactions, especially to penicillins (beta-lactam antibiotics). If you notice the onset of an allergic reaction, stop treatment with this medicine and contact your doctor immediately or go to the nearest hospital where you will receive appropriate treatment;
appearance of blisters on the skin (severe blistering reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis). If you notice skin or mucosal reactions with blisters or vesicles, stop treatment and contact your doctor immediately;
intestinal problems caused by a bacterium called Clostridium difficile. You may experience mild or severe diarrhoea in case of intestinal inflammation (pseudomembranous colitis). If you develop severe diarrhoea or diarrhoea lasting for a prolonged period during treatment with Cefotaxime EG, your doctor may perform specific tests (endoscopy or histological examination) to confirm whether it is a disease caused by this bacterium. If you experience mild colitis, stop treatment to allow symptoms to resolve. If you experience moderate or severe colitis, contact your doctor, who will indicate the appropriate therapy. Cefotaxime EG must not be administered if you are taking medicines acting on the intestine (peristalsis inhibitors), as they may promote the occurrence of diseases associated with Clostridium difficile; if you have suffered, even in the past, from intestinal diseases, particularly colitis, inform your doctor;
blood disorders (leucopenia, neutropenia, eosinophilia, agranulocytosis, thrombocytopenia, haemolytic anaemia), especially if you are using the medicine 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 EG if blood abnormalities occur, as some problems resolve after discontinuation of treatment;
nervous system damage (neurotoxicity), especially if you have been prescribed high doses of this medicine, of other antibiotics of the same class, or if you have kidney problems (renal failure). Symptoms may include: loss of consciousness, abnormal movements and seizures (encephalopathies). If you notice the onset of any of these symptoms, stop treatment and contact your doctor immediately.

Inform your doctor that this medicine should be administered with caution if you suffer from severe kidney problems (severe renal failure). In this case, your doctor may decide to adjust the dose according to your condition.
Your doctor will monitor your kidney function if you are taking CEFOTAXIME EG together with medicines for the treatment of severe infections (aminoglycoside antibiotics), probenecid (a medicine to lower blood uric acid concentration), medicines harmful to the kidneys (nephrotoxic drugs), if you are elderly, or if you have kidney problems.
CEFOTAXIME EG may not be effective (antibiotic resistance), especially against certain families of bacteria (Enterobacteriaceae and Pseudomonas), in people with impaired immune defences (immunocompromised) or following concomitant use of similar medicines (antibiotics).

CEFOTAXIME EG and laboratory tests
Inform your doctor that you are using this medicine before undergoing certain laboratory tests, because CEFOTAXIME EG may interfere with some laboratory tests, such as: Coombs test (a test usually performed before blood transfusions), blood compatibility tests, urine sugar tests (Benedict, Fehling, "Clinitest" methods).

Other medicines and CEFOTAXIME EG
Inform your doctor or nurse if you are using, have recently used, or might use any other medicine.
CEFOTAXIME EG must not be mixed in the same syringe with other medicines, particularly with medicines for the treatment of bacterial infections (antibiotics).
This medicine should be administered to you with caution if you are taking any of the following medicines:

aminoglycoside antibiotics, medicines for the treatment of bacterial infections, or diuretics, medicines to facilitate fluid elimination such as furosemide. Contact your doctor, as in this case kidney function monitoring is required.
probenecid, a medicine used to reduce blood uric acid levels, because it may slow down the elimination of CEFOTAXIME EG in urine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or nurse before using this medicine.
If you are pregnant, CEFOTAXIME EG will be administered to you only in cases of absolute necessity and under direct medical supervision.
If you are breastfeeding, consult your doctor, who will assess whether it is necessary to discontinue breastfeeding or treatment with this medicine. Infants breastfed by mothers taking CEFOTAXIME EG may develop diarrhoea.

Driving and using machines
This medicine may cause dizziness when administered at high doses; in people with kidney problems, it may cause loss of consciousness, abnormal movements and seizures. This may impair your ability to drive vehicles and use machinery. If these effects occur, avoid driving and operating machinery.

CEFOTAXIME EG contains sodium
This medicine contains 50.48 mg of sodium (the main component of table salt) per dose.
This is equivalent to 2.5% of the maximum daily dietary intake recommended for an adult.

3. How to use CEFOTAXIME EG

This medicine will be administered to you by medical personnel, strictly following the instructions of your doctor or nurse. If you have any doubts, consult your doctor or nurse.
Your doctor will determine the required dose, route of administration, and duration of treatment depending on the type of infection, your condition, body weight, and your response to therapy.
It is recommended to continue treatment for at least 3 days after your fever has resolved.
The recommended dose for adults for intramuscular injection is 2 grams per day, divided into two doses of 1 gram every 12 hours. This dose may be increased to 3–4 grams per day, reducing the interval between doses to 8–6 hours.

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.
In life-threatening situations or very severe cases, the recommended dose is 200 mg/kg body weight per day. The solvent containing lidocaine hydrochloride must not be used in children under 12 years of age; intramuscular administration in these patients must be performed using the solution in water for injections only.

Use in premature newborns
The recommended dose must not exceed 50 mg/kg body weight per day, since kidney function is not yet fully developed.

Use in patients with severe kidney problems
Lower doses are recommended in case of severe renal impairment.

If you use more CEFOTAXIME EG than you should
Since this medicine will be administered by a doctor or nurse, overdose is unlikely.
Symptoms of overdose may correspond to the side effects (see section 4) and may include brain damage (encephalopathies). In such cases, administration of this medicine must be discontinued and your doctor will initiate appropriate therapy.
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 EG
Since this medicine will be administered by a doctor or nurse, it is unlikely that a dose will be missed.
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 everyone will experience them.
With cephalosporins, side effects are mainly limited to gastrointestinal disturbances and, occasionally, allergic reactions. The likelihood of such allergic reactions is higher if you have previously experienced allergic reactions and/or suffer from allergies, asthma, hay fever, or urticaria.

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

Pain at the injection site (intramuscular administration).

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 (skin rash), itching, urticaria, increased liver blood test values (ALAT, ASAT, LDH, gamma-GT, alkaline phosphatase, bilirubin), Jarisch-Herxheimer reaction (characterized by fever, chills, headache, muscle pain and joint discomfort, skin irritation, decrease in white blood cells, liver function abnormalities in blood tests, 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 antibiotics for bacterial infections (aminoglycoside antibiotics); increased blood urea nitrogen;
Fever;
Inflammatory reactions at the injection site, including inflammation of a vein with or without blood clot formation (thrombophlebitis/phlebitis) (these side effects occurred only after intravenous administration).

Not known (frequency cannot be estimated from available data)

Infections caused by bacteria or fungi (superinfections, see section “Warnings and Precautions”);
Decrease in certain types of white blood cells (neutropenia, agranulocytosis) (see section “Warnings and Precautions”), decrease 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 causing breathing difficulties (bronchospasm);
Headache (cephalalgia), dizziness;
Loss of consciousness and abnormal movements (encephalopathy) due to brain damage (neurotoxicity), especially if high doses of this medicine, or other antibiotics of the same class, have been prescribed, or if you suffer from kidney problems (renal failure) (see section “Warnings and Precautions”);
Changes in heart rhythm (arrhythmias) following rapid bolus infusion via a catheter inserted directly into a vein (central venous catheter) (this side effect occurred only after intravenous administration);
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) (see section “Warnings and Precautions”);
Liver problems (hepatitis), sometimes with yellowing of the skin and eyes (jaundice);
Kidney inflammation (interstitial nephritis);
Reactions affecting various organs (systemic reactions) to lidocaine (a local anaesthetic) present in the solvent for intramuscular administration only;
Chest pain (chest tightness);
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, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store CEFOTAXIMA EG
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp”. The expiry date refers to the last day of that month.
Store in the original container to protect the medicine from light. Do not dispose of medicines via 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 EG 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 ampoule are: lidocaine hydrochloride, water for injections.

Description of the appearance of CEFOTAXIMA EG and contents of the pack
Pack containing 1 vial of powder + 1 ampoule of solvent (4 ml).

Marketing Authorisation Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan

Manufacturer
Laboratorio Farmaceutico C.T. S.r.l., Via Dante Alighieri, 71 - 18038 Sanremo – IM

The following information is intended exclusively for physicians or healthcare professionals

CLINICAL INFORMATION
Dosage and administration
Particularly sensitive patients may experience pain after intramuscular injection; for the treatment of
such patients, it is recommended to use, up to twice daily, a solvent containing 1% lidocaine hydrochloride
solution (except for subjects hypersensitive to lidocaine). This solution is intended for intramuscular use only
and must absolutely not be administered intravenously.
Incompatibilities
It is recommended not to mix CEFOTAXIME EG with sodium bicarbonate solutions, antibiotics, or
other drugs.
Shelf life
The reconstituted product (dissolving the vial contents with the corresponding solvent ampoule contents)
can be stored in the refrigerator for up to 24 hours.
From a microbiological standpoint, the reconstituted product should be used immediately. If not used
immediately, the storage times and conditions prior to use are the responsibility of the user. These storage
times should not exceed the values stated above, provided that opening, reconstitution, and dilution have
been carried out under controlled and validated aseptic conditions.
For further information, please refer to the Summary of Product Characteristics.

Cefotaxime EG