Cefotaxime Mylan Generics: detailed information

Patient Information Leaflet: Information for the User

Cefotaxime Mylan Generics 1000 mg powder and solvent for injectable solution for

intramuscular or intravenous use
Cefotaxime Mylan Generics 1000 mg powder and solvent for injectable solution for
intramuscular use
Sodium cefotaxime
Generic 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Cefotaxime Mylan Generics is and what it is used for

Cefotaxime Mylan Generics contains the active substance cefotaxime sodium, which belongs to the class of beta-lactam antibiotics or third-generation cephalosporins, used to treat infections caused by bacteria.
Cefotaxime Mylan Generics is indicated for the treatment of severe bacterial infections caused by certain bacteria (difficult Gram-negative bacteria) or by a mixture of different types of bacteria including Gram-negative bacteria resistant to common antibiotics. In these cases, it is also indicated in weakened patients or those with reduced immune defences (immunocompromised).
This medicinal product is also indicated for the prevention of infections caused by surgical procedures.

2. What you need to know before using Cefotaxime Mylan Generics

Do not use Cefotaxime Mylan Generics

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 Mylan Generics called penicillins, because cross-allergic reactions may occur (see section “Warnings and Precautions”);
if you are pregnant or breastfeeding.

Cefotaxime Mylan Generics 1000 mg powder and solvent for injectable solution for intramuscular use,
when reconstituted with lidocaine (local anaesthetic), must not be administered in case of:

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given Cefotaxime Mylan Generics.
As with other similar medicines (antibiotics), the use of this medicine may promote the development of other infections caused by bacteria to which Cefotaxime Mylan Generics is not effective (superinfections). If you think this applies to you, consult your doctor, who will advise you on appropriate therapy.
During treatment with Cefotaxime Mylan Generics, the following may occur:

allergic reactions. Before starting treatment with this medicine, your doctor will carry out specific tests to confirm 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 immediately and contact your doctor or go to the nearest hospital;
development of blisters on the skin (severe blistering rashes 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 mild colitis, stop treatment to allow symptoms to resolve. If you develop moderate or severe colitis, contact your doctor. If you currently have or have previously had colitis or other intestinal diseases, inform your doctor. If you are taking medicines that affect intestinal motility (peristalsis inhibitors), cefotaxime must not be administered as these may promote the onset of Clostridium difficile-related diseases; if you have had intestinal diseases, particularly colitis, even in the past, inform your doctor;
irritation at the injection site following intravenous administration (can be avoided by injecting the medicine very slowly over 3–5 minutes);
blood abnormalities including reduced blood cell counts (leucopenia, neutropenia, bone marrow failure, pancytopenia, agranulocytosis, eosinophilia, thrombocytopenia, haemolytic anaemia), especially if you are using the medicine for prolonged periods. Your doctor will perform blood tests if treatment exceeds 7–10 days. Based on test results, your doctor will decide whether to continue or discontinue treatment;
a condition causing brain dysfunction (encephalopathy), which may include seizures, confusion, altered consciousness, and movement disorders. This type of antibiotic (beta-lactam antibiotic) increases this risk, particularly when taken at high doses or if you have kidney problems (renal failure). If you notice any of these symptoms, stop treatment immediately and contact 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 will determine the appropriate dose based on your condition. Inform your doctor if you are taking aminoglycoside antibiotics (for severe infections), probenecid (used to reduce blood uric acid levels), or other medicines harmful to the kidneys (nephrotoxic drugs). Your doctor will perform regular specific tests.
This medicine, if administered rapidly intravenously through a catheter (central venous catheter), may cause changes in heart rhythm (arrhythmia), which can be life-threatening (see section “How to use Cefotaxime Mylan Generics”).
If your immune defences are weakened or you are debilitated, Cefotaxime Mylan Generics may not be effective (antibiotic resistance), especially against certain families of bacteria (Enterobacteriaceae and Pseudomonas).
Cefotaxime Mylan Generics and laboratory tests
Inform your doctor that you are using this medicine before undergoing laboratory tests, as Cefotaxime Mylan Generics may interfere with certain tests, such as the Coombs test, urine sugar tests (Benedict, Fehling, “Clinitest” methods).
Other medicines and Cefotaxime Mylan Generics
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Cefotaxime Mylan Generics must not be mixed in the same syringe with other medicines, particularly other antibiotics.
Inform your doctor if you are taking any of the following medicines:

aminoglycoside antibiotics (used for severe infections) or diuretics such as furosemide (used to lower high blood pressure), because kidney function may need to be monitored;
probenecid (used to reduce blood uric acid levels), because it may alter the elimination of Cefotaxime Mylan Generics.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor, pharmacist, or nurse before using this medicine.
Cefotaxime crosses the placental barrier; therefore, Cefotaxime Mylan Generics should be used during pregnancy only if absolutely necessary and under direct medical supervision.
Cefotaxime passes into breast milk. If you are breastfeeding, consult your doctor, who will decide whether to discontinue breastfeeding or discontinue treatment with Cefotaxime Mylan Generics, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.
Driving and using machines
This medicine may cause dizziness or encephalopathy (a brain disorder) which may include seizures, confusion, altered consciousness, and movement disorders. This may impair your ability to drive or operate machinery. If these effects occur, avoid driving or operating machinery.
Cefotaxime Mylan Generics contains sodium
This medicine contains 50.5 mg of sodium (the main component of table salt) per vial. This is equivalent to approximately 2.5% of the maximum daily recommended dietary intake for an adult.

3. How to use Cefotaxime Mylan Generics

This medicine will be administered to you by a doctor or nurse, either by injection into the muscle (intramuscular) or by injection into a vein (intravenous).
The doctor will determine the required dose, the route of administration (intramuscular or intravenous), and the duration of treatment depending on the type of infection, your condition, and your body weight. However, treatment should continue for at least 3 days after the fever has resolved.
In case of intravenous administration of Cefotaxime Mylan Generics (intermittent intravenous infusion), the solution must be injected over 3–5 minutes. During post-marketing surveillance of the drug, cases of altered heart rhythm (arrhythmia), which may potentially be life-threatening, have been reported in a few patients who received rapid intravenous administration of cefotaxime via a catheter (central venous catheter).
It is recommended to always use freshly prepared solutions, although the medicine, once reconstituted with water, may be stored in the refrigerator for up to 24 hours. Do not mix Cefotaxime Mylan Generics with sodium bicarbonate solutions or with aminoglycoside antibiotics.

Use in adults
The recommended dose for adults for intramuscular or intravenous injections is 2 grams per day, divided into two doses of 1 gram every 12 hours. This dose may be increased to 3–4 grams, and in severe cases up to 12 grams for intravenous administration, 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. Cefotaxime Mylan Generics 1000 mg powder and solvent for injectable solution for intramuscular use must not be administered to children under 12 years of age because it contains lidocaine.

Use in premature neonates
The recommended dose should not exceed 50 mg/kg body weight per day, as kidney function is not yet fully developed. The doctor will determine the required dose based on the neonate's condition.

Use in patients with severe kidney problems
In case of severe renal impairment, lower doses are recommended.
If you are undergoing haemodialysis 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 haemodialysis, Cefotaxime Mylan Generics 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 Mylan Generics than you should
This medicine will be administered by a doctor or nurse, so 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 advise 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 Mylan Generics
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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience 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 white blood cell count (leucopenia), increase in eosinophil count (eosinophilia), decrease in platelet count (thrombocytopenia);
skin redness (rash), itching, hives;
increased liver values in blood tests (ALAT, ASAT, LDH, gamma-GT, alkaline phosphatase, bilirubin);
fever, chills, skin irritation, headache, muscle pain and joint disorders, skin irritation, breathing difficulties, decrease in white blood cells, changes in blood tests affecting the liver (Jarisch-Herxheimer reaction);
seizures (see section “Warnings and Precautions”);
diarrhoea (see section “Warnings and Precautions”);
reduced kidney function and increased creatinine (a substance indicating kidney function), especially during concomitant therapy with aminoglycoside antibiotics;
inflammation at the injection site, including inflammation of a vein with or without blood clot formation (thrombophlebitis/phlebitis).

Not known (frequency cannot be estimated from the available data)

occurrence of infections caused by bacteria or fungi, superinfection (see section “Warnings and Precautions”);
nausea, vomiting, stomach pain (abdominal pain), diarrhoea (pseudomembranous colitis, see section “Warnings and Precautions”);
allergic reactions, even severe (anaphylactic reactions, anaphylactic shock), skin swelling due to fluid accumulation (angioedema), bronchial constriction with breathing difficulty (bronchospasm);
headache (cephalalgia), dizziness, brain disease that may present with seizures, confusion, altered consciousness and movement disorders (encephalopathy). This type of antibiotic increases this risk, particularly when taken at high doses or if you have kidney problems (renal impairment). See section “Warnings and Precautions”);
severe skin allergic reactions, even serious (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), generalized acute exanthematous pustulosis (GEP) (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), reduction in red blood cells (haemolytic anaemia) (see section “Warnings and Precautions”);
liver problems (hepatitis), sometimes with yellowing of the skin and eyes (jaundice);
acute kidney failure (see section “Warnings and Precautions”), severe kidney inflammation (interstitial nephritis);
changes in heart rhythm (arrhythmia) following rapid infusion as a single dose (bolus) through a central venous catheter;
allergic reactions to lidocaine with intramuscular injections (intramuscular administration);
loss of appetite (anorexia), inflammation of the tongue (glossitis), heartburn (gastric pyrosis);
vaginal inflammation caused by a fungus (Candida vaginitis);
restlessness, confusion, reduced muscle strength (asthenia), night sweats.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store Cefotaxime Mylan Generics
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.
Once reconstituted with water, the medicine may be stored in the refrigerator for up to 24 hours.
Store in the original packaging to protect from light and do not store above 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information
What Cefotaxime Mylan Generics contains 1000 mg powder and solvent for injectable solution for intramuscular or intravenous use

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 component of the solvent vial is water for injections.

What Cefotaxime Mylan Generics contains 1000 mg powder and solvent for injectable solution for intramuscular use

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 40 mg of lidocaine.

Description of the appearance of Cefotaxime Mylan Generics and contents of the pack
Cefotaxime Mylan Generics 1000 mg powder and solvent for injectable solution for intramuscular or intravenous use: pack containing one vial of powder + one 4 ml solvent vial.
Cefotaxime Mylan Generics 1000 mg powder and solvent for injectable solution for intramuscular use: pack containing one vial of powder + one 4 ml solvent vial containing 1% lidocaine hydrochloride.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A. - Via Vittor Pisani, 20 - 20124 Milan
Manufacturer
Mitim S.r.l., Via Cacciamali 34-36-38, 25125 Brescia

Package leaflet: information for the physician

Cefotaxime Mylan Generics 1000 mg powder and solvent for injectable solution for

intramuscular or intravenous use
Cefotaxime Mylan Generics 1000 mg powder and solvent for injectable solution for
intramuscular use
Sodium cefotaxime
The following information is intended exclusively for physicians or healthcare professionals
CLINICAL INFORMATION
Dosage and method of administration
For intravenous administration of lower doses, direct injection over 3-5 minutes is recommended (if intravenous infusion is already in progress, the tubing may be clamped approximately 10 cm above the needle, and cefotaxime injected into the tubing below the clamp).
For higher doses, cefotaxime may be administered by short intravenous infusion (20 minutes) after dissolving 2 g in 40 ml of water for injections, isotonic saline solution, or glucose solution, or by continuous intravenous infusion (50-60 minutes) after dissolving 2 g in 100 ml of solvent, plasma expanders (Emagel or dextrans).
When using the intravenous route, it is generally advisable to initiate therapy by administering cefotaxime directly into the vein.
Particularly sensitive patients may experience pain after intramuscular injection; for treatment of such patients, use of a solvent containing 1% lidocaine hydrochloride solution is recommended, up to twice daily (except in patients hypersensitive to lidocaine). This solution is intended only for intramuscular use and must absolutely not be administered intravascularly.
Incompatibilities
Mixing Cefotaxime Mylan Generics with sodium bicarbonate solutions, antibiotics, or other drugs is not recommended.
Shelf life
The reconstituted product (dissolving the vial contents with the corresponding solvent vial contents) may be stored in a refrigerator at +2/+8°C for 24 hours (protected from light).
The reconstituted solution initially appears yellowish, which does not impair its efficacy or tolerability.
Special precautions for storage
Solutions prepared, including those diluted aseptically with infusion solutions, remain chemically stable for 24 hours at room temperature; however, in accordance with good pharmaceutical practice, it is recommended to use the solutions, whenever possible, within 3 hours after preparation.
Warning: the product contains no preservatives. After use, any remaining solution must be discarded, even if only partially used.
For further information, consult the Summary of Product Characteristics.