BATIXIM 2 G/10 ML Proszek i rozpuszczalnik do roztworu do wstrzykiwań

Treść ulotki

1. BATIXIM 1g/4 ml powder and solvent for injectable solution for intramuscular use, 1 g/4 ml powder and solvent for injectable solution, 2g/10 ml powder and solvent for injectable solution for intravenous use
   1. What Batixim is and what it is used for
   2. What you need to know before you take Batixim
   3. How to take Batixim
   4. Possible side effects
   5. How to store Batixim
   6. Package contents and other information

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

Cefotaxime (as cefotaxime sodium)
Equivalent medicinal product

Read this leaflet carefully before you start to use 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use Batixim
• 3.How to use 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 cefotaxime sodium, 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.
Batixim is indicated for the treatment of severe bacterial infections caused by certain bacteria (called difficult Gram-
negative bacteria) or by a mixture 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 reduced defenses
immunocompromised.
This medicine is also indicated for the prevention of infections caused by surgical procedures.

2. What you need to know before you take Batixim

Do not take Batixim 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);
• you are taking antibiotics belonging to the same group as Batixim called penicillins, because cross-allergic reactions may occur (see section “Warnings and Precautions”);
• you have developed a severe skin rash or skin peeling, 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 should not be administered:

• in case of administration performed into a vein (intravenous administration);
• in case of allergy to lidocaine or other similar anesthetics;
• in case of severe heart problems (severe heart failure, rhythm disturbances)
• in infants under 30 months of age.

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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 you are given Batixim.
During the use of Batixim the following may occur:

• allergic reactions. Before starting therapy with this medicine, your doctor will perform specific tests to make sure you are not allergic to cefotaxime, cephalosporins, penicillins or other medicines. Use this medicine with caution and tell 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;
• intestinal problemscaused by a bacterium called Clostridium difficile. You may experience mild or severe diarrhea in case of inflammation of the intestine (pseudomembranous colitis which must be confirmed by endoscopy or histological examination). If you experience mild cases of colitis, stop treatment to allow the symptoms to disappear. If the colitis does not resolve with discontinuation of treatment or you experience moderate or severe colitis, consult your doctor who will indicate the appropriate therapy. You should not take medicines that act on the intestine (inhibitors of peristalsis) at the same time. If you have suffered from intestinal diseases in the past, especially colitis, tell your doctor;
• irritation of the tissues at the intravenous injection site (can be avoided by injecting the drug very slowly in 3-5 minutes).

Use this medicine with caution and tell your doctor if you suffer from severe kidney problems (severe
renal insufficiency). In this case, the doctor will establish the appropriate dose based on your condition. Undergo
checks to assess kidney function if, while taking Batixim, you are taking medicines
harmful to the kidneys (nephrotoxic drugs), or if you suffer from kidney problems.
Batixim may not be effective (antibiotic resistance), especially against some families of bacteria
(Enterobacteriaceae and Pseudomonas), in people with impaired immune defenses (immunocompromised) or
following the simultaneous use of similar medicines (antibiotics).
In early infancy, Batixim should be administered only when absolutely necessary and under direct medical
supervision.
Batixim and laboratory tests
Tell your doctor that you are using this medicine before undergoing certain tests because Batixim
may interfere with some laboratory tests, such as: Coombs' test, tests to measure sugar in
urine (Benedict, Fehling, “Clinitest” methods).

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

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

• aminoglycoside antibiotics, medicines for the treatment of bacterial infections. Consult your doctor because kidney function checks are necessary in this case.
• 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 Batixim with urine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or nurse for advice before using this medicine.
Pregnancy
If you are pregnant, use Batixim only in cases of absolute necessity and under direct medical supervision.
Breastfeeding
If you are breastfeeding, consult your doctor, who will assess the need to interrupt breastfeeding or
treatment with this medicine.

Driving and using machines
This medicine does not impair the ability to drive vehicles and operate machinery.

Batixim contains sodium (as cefotaxime sodium)
Batixim “1g/4mlpowder and solvent for injectable solution for intramuscular use”

Batixim “1g/4mlpowder and solvent for injectable solution”
This medicine contains 50.5mg of sodium (the main component of table salt) per vial.
This is equivalent to 2.5% of the maximum recommended daily intake with the diet of an adult.

Batixim “2g/10mlpowder and solvent for injectable solution for intravenous use”
This medicine contains 101 mg of sodium (the main component of table salt) per vial.
This is equivalent to 5% of the maximum recommended daily intake by the WHO, which corresponds to 2 g
of sodium for an adult.
Talk to your doctor or pharmacist if you need 2 or more doses a day for a prolonged period,
especially if you have been advised to follow a low-sodium diet.

3. How to take Batixim

Use this medicine following exactly the instructions of the doctor, nurse or pharmacist. If you have any doubts, ask your doctor, nurse or pharmacist.
The doctor will establish the necessary dose, the method of administration (intramuscular or intravenous) and the duration of treatment depending on the type of infection, your conditions and your body weight.
This medicine will be administered to you intravenously (into a vein) by medical personnel following exactly the instructions of the doctor.
Treatment is recommended continuously for at least 3 days after the fever has subsided.
In the case of administration of Batixim directly into a vein (intermittent intravenous administration), the solution must be injected in 3-5 minutes.
Adults:
The recommended dose for injections into muscle or into a vein is 2 grams per day divided into two administrations of 1 gram every 12 hours. This dose may be increased to 3-4 grams and in very serious cases up to 12 grams for intravenous administrations, reducing the interval between administrations to 8-6 hours.
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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.
Batixim 1 g/4 ml 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 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.

Method of administration
The product once dissolved appears yellow in color.
Intravenous route
The doctor will establish whether you should take the antibiotic intravenously; in this case, Batixim will be administered to you by specialized healthcare personnel. The drug will be administered to you through a direct injection into a vein (in 3 - 5 minutes) or will be administered by short (20 minutes) or continuous (50-60 minutes) infusion.
Intramuscular route
The content of the solvent vial must be drawn up using a syringe and poured into the powder vial.
When the powder has completely dissolved, draw up the contents of the vial and proceed immediately with the administration.
If you are a sensitive subject and feel pain after intramuscular injection, the doctor will suggest the administration of Batixim 1g/4 ml powder and solvent for injectable solution for intramuscular use containing lidocaine (an anesthetic).
Caution: the solution for intramuscular use must never be used for intravenous administration.

If you use more Batiximthan you should
If you think that you have been administered an excessive amount of this medicine, immediately inform your doctor, nurse, pharmacist or go to the nearest hospital.

If you forget to use Batixim
If you think that you have not been administered a dose, contact your doctor, nurse or pharmacist. A double dose should not be used to compensate for the forgotten dose.
If you have any doubts about the use of this medicine, contact 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 tell your doctor immediately if you experience any of the
following symptoms:

• flat, reddish patches on the trunk, target-shaped or circular, often with blisters in the center, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis); Page. 4to 7
• widespread rash, high temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome);
• a widespread, red and scaly rash, with the formation of pustules under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

The following reactions have been reported during therapy with cefotaxime:

• pain, hardening at the injection site for intramuscular administration;
• reduction in the number of certain types of white blood cells (neutropenia, granulocytopenia, agranulocytosis), increase in the number of eosinophils (eosinophilia), decrease in red blood cells (hemolytic anemia);
• redness of the skin (skin rash), itching, hives, drug fever;
• increase in the values of blood tests (serum transaminases, SGOT, SGPT, alkaline phosphatase) and/or bilirubin, lactate dehydrogenase;
• joint pain;
• feeling of tightness in the chest;
• increase in blood urea nitrogen and increase in creatinine (a substance that indicates kidney function, see Warnings and Precautions);
• inflammatory reactions at the injection site following administration into a vein (thrombophlebitis/phlebitis);
• allergic reactions, including severe ones (anaphylactic reactions, anaphylactic shock);
• headache, dizziness;
• nausea, vomiting, abdominal pain, diarrhea (may be associated with pseudomembranous colitis, see section “Warnings and Precautions”);
• loss of appetite (anorexia), inflammation of the tongue (glossitis), heartburn (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, 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 https://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 Batixim

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 after “Exp.”.
The expiry date stated on the packaging refers to the product in intact packaging,
correctly stored. The expiry date refers to the last day of that month.
The reconstituted product (dissolution of the contents of the vial with the contents of the corresponding solvent vial
) can 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 should be discarded even if only
partially used.

6. Package contents and other information

What the product containsBatixim

Batixim 1g/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 preparations

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injectable.

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 injectable preparations.

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

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

Description of the appearance of Batixim and package contents
Powder and solvent for injectable solution.

Batixim 1g/4ml powder and solvent for injectable solution for intramuscular use: 1 vial of powder and 1
solvent vial of 4 ml.

Batixim 1g/4ml powder and solvent for injectable solution: 1 vial of powder and 1 vial of solvent of 4 ml.

Batixim 2g/10ml powder and solvent for injectable solution for intravenous use: 1 vial of powder and 1 vial
of solvent 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 doctors or healthcare professionals
Dosage and administration method
Regarding the intravenous administration of lower doses, direct injection is used, to be performed in 3-5 minutes (if an intravenous infusion is already in progress, the tube can be clamped about 10
cm above the needle and the cefotaxime injected into the tube below the clamp).
At higher doses, cefotaxime can be administered by short intravenous infusion (20 minutes)
after dissolving 2 g in 40 ml of water for injectable preparations, isotonic saline solution or glucose solution, or by continuous intravenous infusion (50-60 minutes) after dissolving 2 g in 100 ml of
solvent, plasma expander (Emagel or dextrans).
When using the intravenous route, it is still advisable to start therapy by administering the
cefotaxime directly into the vein.
Particularly sensitive patients may complain of pain after intramuscular injection; for the
treatment of these subjects, it is recommended to use, up to 2 times a day, a solvent containing
lidocaine hydrochloride solution 1% (except for subjects hypersensitive to lidocaine). This solution
must only be used intramuscularly and therefore intravenous administration must be absolutely avoided.
Withdraw the contents of the solvent vial with a syringe and pour it into the vial of powder.
Once completely dissolved, withdraw the contents of the vial and proceed with the injection.
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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, with antibiotics and other drugs.

Shelf life
The reconstituted product (dissolution of the contents of the vial with the contents of the corresponding vial
solvent) can be stored in the refrigerator at +2/+8°C for 24 hours (protected from light).
The dissolved product, from the beginning, appears yellowish in color, this does not affect the efficacy and tolerability
of the drug.

Special precautions for storage
Store at a temperature not exceeding 25° C and protected from light, keeping the containers
in the package.
Prepared solutions, including those diluted with aseptic technique with perfusion solutions, remain
chemically stable for 24 hours at room temperature, but in compliance with good pharmaceutical practice, it is recommended to use the solutions, where possible, within 3 hours of their preparation
ATTENTION: The product does not contain preservatives. After use, it should be discarded even if only used
partially.

For further information, consult the Summary of Product Characteristics.
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