Batixim

Package leaflet: Information for the patient

BATIXIM 1 g/4 ml powder and solvent for injectable solution for intramuscular use, 1 g/4 ml powder and solvent for injectable solution, 2 g/10 ml powder and solvent for injectable solution for intravenous use

Cefotaxime (as cefotaxime sodium)
Equivalent medicine
Please read carefully this leaflet before taking this medicine 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 adverse reaction, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What Batixim is and what it is used for

Batixim contains the active substance sodium cefotaxime, which belongs to a group of medicines called antibiotics (beta-lactam antibiotics or third-generation cephalosporins) used to treat infections caused by bacteria.
Batixim is indicated for the treatment of severe bacterial infections caused by certain bacteria (called difficult Gram-negative bacteria) 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 in debilitated patients or those with reduced immune defenses (immunocompromised).
This medicine is also indicated for the prevention of infections caused by surgical procedures.

2. What you should know before using Batixim

Do not take Batixim 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);
• you are taking antibiotics belonging to the same group as Batixim called penicillins, as cross-allergic reactions may occur (see section “Warnings and Precautions”);
• you have previously developed a severe skin rash or skin peeling, skin rash with blisters and/or mouth ulcers after taking cefotaxime or other cephalosporins.

Batixim 1 g/4 ml powder and solvent for injectable solution for intramuscular use contains a local anesthetic called lidocaine; therefore, it must not be administered:

• by intravenous route (intravenous administration);
• if you are allergic to lidocaine or to other similar anesthetics;
• if you have severe heart problems (severe heart failure, cardiac arrhythmias);
• in infants under 30 months of age.

The use of Batixim is not recommended during pregnancy and breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions

Talk to your doctor or nurse before receiving Batixim.

While using Batixim, the following may occur:

• Allergic reactions. Before starting treatment with this medicine, your doctor will perform 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 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.
• Intestinal problems caused by a bacterium called Clostridium difficile. You may experience mild or severe diarrhea due to inflammation of the intestine (pseudomembranous colitis, which must be confirmed by endoscopy or histological examination). If you develop mild colitis, stop treatment to allow symptoms to resolve. If colitis does not improve after stopping treatment, or if you develop moderate to severe colitis, consult your doctor, who will recommend appropriate therapy. Do not take medications that affect intestinal motility (peristalsis inhibitors) at the same time. If you have previously suffered from intestinal diseases, particularly colitis, inform your doctor.
• irritation of tissues at the site of intravenous injection (can be avoided by injecting the drug very slowly over 3–5 minutes).

Use this medicine with caution and inform your doctor if you have severe kidney problems (severe renal insufficiency). In such cases, your doctor will determine the appropriate dose based on your condition. Undergo regular monitoring to assess kidney function if you are taking nephrotoxic medicines (nephrotoxic drugs) concurrently with Batixim, or if you have kidney problems.

Batixim may not be effective (antibiotic resistance), particularly against certain bacterial families (Enterobacteriaceae and Pseudomonas), in individuals with weakened immune defenses (immunocompromised patients) or following concomitant use of similar medicines (antibiotics).

In very early infancy, Batixim should only be administered when strictly necessary and under direct medical supervision.

Batixim and laboratory tests

Inform your doctor that you are taking this medicine before undergoing certain laboratory tests, as Batixim may interfere with some laboratory examinations, such as: Coombs test, urine glucose tests (Benedict, Fehling, “Clinitest” methods).

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported during treatment with cefotaxime. Discontinue cefotaxime and contact your doctor immediately if you experience any of the symptoms related to these severe skin reactions described in section 4.

Other medicines and Batixim

Inform your doctor or nurse if you are currently taking, have recently taken, or might take any other medicines.

Batixim 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. Consult your doctor, as kidney function monitoring is required in such cases.
• 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 Batixim.

Pregnancy and breastfeeding

If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or nurse before using this medicine.

Pregnancy

If you are pregnant, use Batixim only when strictly necessary and under direct medical supervision.

Breastfeeding

If you are breastfeeding, consult your doctor, who will assess whether it is necessary to discontinue breastfeeding or treatment with this medicine.

Driving and using machines

This medicine does not affect the ability to drive or operate machinery.

Batixim contains sodium (as sodium cefotaxime)

Batixim “1g/4ml” powder and solvent for injectable solution for intramuscular use
Batixim “1g/4ml” powder and solvent for injectable solution

This medicine contains 50.5 mg of sodium (the main component of table salt) per vial.
This corresponds to 2.5% of the maximum daily dietary intake recommended for an adult.

Batixim “2g/10ml” powder and solvent for injectable solution for intravenous use

This medicine contains 101 mg of sodium (the main component of table salt) per vial.
This corresponds to 5% of the maximum daily intake recommended by the WHO, which is 2 g of sodium for an adult.

Talk to your doctor or pharmacist if you require 2 or more doses per day over a prolonged period, especially if you have been advised to follow a low-sodium diet.

3. How to take Batixim

Use this medicine exactly as directed by your doctor, nurse, or pharmacist. If you have any doubts, consult your doctor, nurse, or pharmacist.

Your doctor will determine the required dose, route of administration (intramuscular or intravenous), and duration of treatment depending on the type of infection, your condition, and your body weight.

This medicine will be administered to you intravenously (into a vein) by medical personnel, strictly following the doctor's instructions.

Treatment is recommended to continue uninterrupted for at least 3 days after your fever has resolved.

In case of direct intravenous administration of Batixim (intermittent intravenous administration), the solution must be injected over 3–5 minutes.

Adults:
The recommended dose 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 administered intravenously, 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.

Batixim 1 g/4 ml powder and solvent for injectable solution for intramuscular use must not be administered in children under 12 years of age because it contains lidocaine.

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

Method of administration
Once reconstituted, the product appears yellow in colour.

Intravenous route
Your doctor will decide whether you should receive the antibiotic intravenously. In this case, Batixim will be administered by specialized healthcare personnel. The medicine may be given as a direct intravenous injection (over 3–5 minutes), or administered as a short infusion (20 minutes) or continuous infusion (50–60 minutes).

Intramuscular route
The solvent from the ampoule should be withdrawn with a syringe and added to the vial containing the powder.
Once the powder is completely dissolved, withdraw the solution from the vial and administer immediately.

If you are sensitive and experience pain after intramuscular injection, your doctor may recommend using Batixim 1 g/4 ml powder and solvent for injectable solution for intramuscular use containing lidocaine (an anaesthetic).

Warning: The solution intended for intramuscular use must never be used for intravenous administration.

If you use more Batixim than you should
If you think you have been given too much of this medicine, contact your doctor, nurse, pharmacist immediately, or go to the nearest hospital.

If you forget to use Batixim
If you think a dose has been missed, contact your doctor, nurse, or pharmacist. Do not use a double dose to make up for the forgotten dose.

If you have any doubts about how to use this medicine, consult your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking cefotaxime and inform your doctor immediately if you experience any of the following symptoms:

• flat, reddish spots on the trunk, target-shaped or circular, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome);
• a widespread, red, scaly rash, with formation of subcutaneous pustules and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

The following reactions have been reported during cefotaxime therapy:

• pain, hardening at the injection site following intramuscular administration (intramuscular administration);
• reduction in the number of certain types of white blood cells (neutropenia, granulocytopenia, agranulocytosis), increase in eosinophils (eosinophilia), decrease in red blood cells (haemolytic anaemia);
• skin redness (cutaneous rash), itching, urticaria, drug fever;
• increased blood test values (serum transaminases, SGOT, SGPT, alkaline phosphatase) and/or bilirubin, lactate dehydrogenase;
• joint pain;
• tightness in the chest;
• increased blood urea nitrogen and increased creatinine (a substance indicating kidney function, see Warnings and Precautions);
• inflammatory reactions at the injection site following intravenous administration (thrombophlebitis/phlebitis);
• allergic reactions, even severe ones (anaphylactic reactions, anaphylactic shock);
• headache (cephalalgia), dizziness;
• nausea, vomiting, stomach pain (abdominal pain), diarrhoea (may be associated with pseudomembranous colitis, see section “Warnings and Precautions”);
• 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 get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Batixim

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 stated on the packaging refers to the product in its original, undamaged packaging
and correctly stored. The expiry date refers to the last day of that month.
The reconstituted product (dissolving the contents of the vial with the corresponding solvent vial)
may be stored in the refrigerator at +2°C ÷ +8°C for 24 hours (protected from light).
Store in the original packaging to protect the medicine from light.
Store at a temperature below 25°C.
WARNING: The product does not contain preservatives. After use, it must be discarded even if only partially used.

6. Package contents and other information

What Batixim contains
Batixim 1 g/4 ml powder and solvent for injectable solution for intramuscular use

• One vial of powder contains 1.048 g of cefotaxime sodium corresponding to 1 g of cefotaxime.
• One solvent vial contains 40 mg of lidocaine hydrochloride; the other component is water for injections.

Batixim 1 g/4 ml powder and solvent for injectable solution

• One vial of powder contains 1.048 g of cefotaxime sodium corresponding to 1 g of cefotaxime.
• One solvent vial contains water for injections.

Batixim 2 g/10 ml powder and solvent for injectable solution for intravenous use

• One vial of powder contains 2.096 g of cefotaxime sodium corresponding to 2 g of cefotaxime.
• One solvent vial contains water for injections.

Description of the appearance of Batixim and contents of the pack
Powder and solvent for injectable solution.
Batixim 1 g/4 ml powder and solvent for injectable solution for intramuscular use: 1 vial of powder and 1 solvent vial of 4 ml.
Batixim 1 g/4 ml powder and solvent for injectable solution: 1 vial of powder and 1 solvent vial of 4 ml.
Batixim 2 g/10 ml powder and solvent for injectable solution for intravenous use: 1 vial of powder and 1 solvent vial of 10 ml.

Marketing Authorization Holder and Manufacturer
So.Se.PHARM S.r.l.
Via dei Castelli Romani n. 22
00071 Pomezia (RM)

Manufacturer
Esseti Farmaceutici S.r.l.
Via Campobello, 15
00071 Pomezia – Roma

The following information is intended exclusively for physicians or healthcare professionals

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 physiological saline, 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 intravenous administration is required, it is generally advisable to initiate therapy by direct intravenous injection of cefotaxime.
Particularly sensitive patients may experience pain after intramuscular injection; for treatment of such patients, use up to twice daily of a solvent containing 1% lidocaine hydrochloride solution is recommended (except for patients hypersensitive to lidocaine). This solution must be used only for intramuscular administration and must absolutely not be administered intravascularly.
Using a syringe, withdraw the contents of the solvent vial and transfer it into the vial of powder.
After complete dissolution, withdraw the solution from the vial and proceed with injection.
Caution:
The solution for intramuscular use must never be used for intravenous administration.

Incompatibilities
It is recommended not to mix Batixim with sodium bicarbonate solutions, antibiotics, or other drugs.

Shelf life
The reconstituted product (dissolution of the vial contents with the corresponding solvent vial) may be stored in the refrigerator at +2/+8°C for 24 hours (protected from light).
The dissolved solution initially appears yellowish; this does not affect the efficacy or tolerability of the medicinal product.

Special precautions for storage
Store at a temperature not exceeding 25°C and protect from light, keeping the containers in their outer carton.
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 unused portion must be discarded, even if only partially used.

For further information, consult the Summary of Product Characteristics.