Package leaflet: Information for the user

SALOCEF 1 g / 4 ml powder and solvent for injectable solution for intramuscular use, 1 g / 4 ml powder and solvent for injectable solution for i.m./i.v. use

Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may 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 SALOCEF is and what it is used for
What you need to know before using SALOCEF
How to use SALOCEF
Possible side effects
How to store SALOCEF
Contents of the pack and other information

1. What SALOCEF is and what it is used for

SALOCEF 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.
SALOCEF 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 use in debilitated 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 should know before using SALOCEF

Do not use SALOCEF

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

SALOCEF 1 g / 4 ml powder and solvent for injectable solution for intramuscular use 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 (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 you are given SALOCEF.
As with other medicines (antibiotics), the use of this medicine may promote the occurrence of other
infections caused by bacteria against which SALOCEF is not effective (superinfections). If this occurs,
you should contact your doctor, who will advise you on appropriate therapy.
During treatment with SALOCEF, the following may occur:

allergic reactions. Before starting therapy with this medicine, your doctor will perform specific tests to ensure 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: a doctor will determine 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 mucous membrane 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 inflammation of the intestine (pseudomembranous colitis). If you develop severe or prolonged diarrhoea during treatment with SALOCEF, 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 until symptoms resolve. If you experience moderate or severe colitis, contact your doctor who will recommend appropriate therapy. Do not take SALOCEF if you are taking medicines that affect intestinal motility (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;
irritation at the injection site following intravenous administration. This can be avoided by administering the medicine very slowly (3–5 minutes);
blood disorders (leucopenia, neutropenia, bone marrow failure, pancytopenia, agranulocytosis, thrombocytopenia, haemolytic anaemia), 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 SALOCEF 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, particularly when administered at high doses or if you have kidney problems (renal failure). If you notice any of these symptoms, stop treatment and contact your doctor immediately.

This medicine, if administered rapidly intravenously via a catheter (central venous catheter), may
cause changes in heart rhythm (arrhythmias), which may be life-threatening (see section “How to use
SALOCEF”).
Use this medicine with caution and inform your doctor if you have severe kidney problems (severe
renal failure). In this case, your doctor may decide to halve the maintenance dose depending on your
condition. Undergo kidney function monitoring if you are taking SALOCEF together with medicines
used to treat serious infections (aminoglycoside antibiotics), probenecid (a medicine to lower blood
uric acid levels), medicines harmful to the kidneys (nephrotoxic drugs), if you are elderly, or if you
have kidney problems.
SALOCEF may not be effective (antibiotic resistance), particularly against certain families of
bacteria (Enterobacteriaceae and Pseudomonas), in people with weakened immune defences
(immunocompromised) or following concomitant use of similar medicines (antibiotics).
SALOCEF and laboratory tests
Inform your doctor that you are using this medicine before undergoing certain laboratory tests, as
SALOCEF may interfere with some laboratory tests, such as: Coombs test, blood compatibility test,
urine sugar tests (Benedict, Fehling, "Clinitest" methods).
Other medicines and SALOCEF
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicine.
SALOCEF 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 may be required in such cases;
probenecid, a medicine used to reduce blood uric acid levels, as it may slow down the elimination of SALOCEF in urine.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding,
ask your doctor, pharmacist, or nurse for advice before using this medicine.
Do not use SALOCEF during pregnancy unless your doctor considers it necessary.
If you are breastfeeding, consult your doctor, who will assess whether it is necessary to interrupt
breastfeeding or treatment with this medicine. Infants breastfed by mothers taking SALOCEF may
develop diarrhoea.
Driving and using machines
This medicine may cause dizziness or encephalopathy (a disorder affecting the brain) 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 vehicles and operating
machinery.
SALOCEF 1 g/4 ml powder and solvent for injectable solution and SALOCEF 1 g/4 ml powder and
solvent for injectable solution for intramuscular use contain sodium
These medicines contain 50.5 mg of sodium (the main component of table salt) per vial. This is
approximately 2.5% of the maximum daily dietary intake recommended for an adult male.
Talk to your doctor or pharmacist if you need 7 or more vials per day for a prolonged period,
particularly if you have been advised to follow a low-sodium diet.

3. How to use SALOCEF

This medicine will be administered to you by medical personnel who will always follow exactly the instructions given by your doctor or nurse. If you have any doubts, consult your doctor or nurse.
Your doctor will determine the necessary 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.
It is recommended to continue treatment for at least 3 days after your fever has resolved.
In case of intravenous administration of SALOCEF (intermittent intravenous injection), the solution must be injected over 3–5 minutes. Rapid intravenous administration of this medicine may cause disturbances in heart rhythm (arrhythmias), which can be life-threatening.
It is advisable to always use freshly prepared solutions, although the medicine, once dissolved in water, may be stored in the refrigerator for up to 24 hours. Do not mix SALOCEF with sodium bicarbonate solutions or with medicines used to treat bacterial infections (aminoglycoside antibiotics).
The recommended dose for adults for intramuscular or intravenous 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, and in very severe cases up to 12 grams administered intravenously, reducing the interval between doses to every 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.
If the child is life-threateningly ill or in very severe conditions, the recommended dose is 200 mg/kg body weight per day. SALOCEF 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 infants
The recommended dose must not exceed 50 mg/kg body weight per day, since renal function is not yet fully developed.

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, SALOCEF will be administered to you after the dialysis session. This precaution is not necessary during peritoneal dialysis.

If you use more SALOCEF 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 brain damage (encephalopathies) may occur. In such cases, administration of this medicine must be discontinued and your doctor will recommend appropriate therapy.
If you think you have been given too much of this medicine, inform your doctor immediately or go to the nearest hospital.

If you forget to use SALOCEF
Since this medicine will be administered by a doctor or nurse, 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 everyone experiences them.

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

Pain at the injection site when administered intramuscularly (intramuscular administration).

Uncommon (may affect up to 1 in 100 people)

Reduction in the number of white blood cells (leucopenia), increase in the number of eosinophils (eosinophilia), reduction in the number of platelets (thrombocytopenia);
Skin redness (cutaneous rash), itching, urticaria, fever, increased liver blood test values (ALAT, ASAT, LDH, gamma-GT, alkaline phosphatase) and/or bilirubin, Jarisch-Herxheimer reaction (characterized by fever, chills, headache, muscle pain and joint disturbances, skin irritation, decreased white blood cells, abnormal liver blood tests, breathing difficulties);
Seizures (see section “Warnings and Precautions”);
Diarrhea;
Reduced kidney function and increased creatinine, a substance indicating kidney function, especially when this medicine has been prescribed together with other medicines for treating bacterial infections (aminoglycoside antibiotics);
Inflammatory reactions at the injection site, including inflammation of a vein with or without blood clots (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), reduction in all blood cells (pancytopenia) (see section “Warnings and Precautions”), reduction in red blood cells (hemolytic anemia);
Allergic reactions, even severe ones (anaphylactic reactions, anaphylactic shock), swelling due to fluid accumulation around the mouth and eyes (angioedema), bronchial constriction causing breathing difficulty (bronchospasm);
Headache (cephalalgia), dizziness;
Encephalopathy (which may include seizures, confusion, altered consciousness, and movement disorders). This type of antibiotic increases the risk, particularly when taken at high doses or if you have kidney problems (renal failure) (see section “Warnings and Precautions”);
Changes in heart rhythm (arrhythmias) following rapid bolus infusion through a tube inserted directly into a vein (central venous catheter);
Nausea, vomiting, abdominal 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 on 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 anesthetic) present in the solvent used only for intramuscular administration;
Loss of appetite (anorexia), inflammation of the tongue (glossitis), heartburn (gastric pyrosis);
Fungal infection of the vagina (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 SALOCEF
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 below 25°C and protect from light.
It is recommended to always use freshly prepared solutions.
The reconstituted product (dissolving the vial content with the solvent from the ampoule) may be stored in the refrigerator at +2 / +8°C for up to 24 hours (protected from light).
Solutions prepared, including diluted ones using aseptic technique with infusion solutions, remain chemically stable for 24 hours at room temperature; however, in accordance with good pharmaceutical practices, it is recommended to use the solutions, whenever possible, within 3 hours of preparation.
WARNING: The product does not contain preservatives. After use, it must be discarded even if only partially used.
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 no longer in use. This will help protect the environment.

6. Contents of the pack and other information
What SALOCEF contains
SALOCEF 1g - 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.
Other components of the solvent ampoule: lidocaine hydrochloride, water for injectable preparations.

SALOCEF 1g - powder and solvent for injectable solution for i.m./i.v. use
The active substance is cefotaxime sodium: one vial of powder contains 1.048 g of cefotaxime sodium, equivalent to 1 g of cefotaxime.
Other components of the solvent ampoule: water for injectable preparations.

Description of the appearance of SALOCEF and contents of the pack
SALOCEF 1g - powder and solvent for injectable solution for intramuscular use
Pack containing 1 vial of powder + 1 solvent ampoule of 4 ml.
SALOCEF 1g - powder and solvent for injectable solution for intramuscular use
Pack containing 1 vial of powder + 1 solvent ampoule of 4 ml.

Marketing Authorization Holder
NEW RESEARCH srl
Via Tiburtina, n° 1143 - 00156 Rome

Manufacturer
ESSETI FARMACEUTICI S.R.L.
Via Campobello n° 15 - 00040 Pomezia (Rome)
December 2022

The following information is intended exclusively for physicians or healthcare professionals

CLINICAL INFORMATION
Dosage and method of administration
For lower doses administered intravenously, direct injection over 3–5 minutes is recommended. If an intravenous infusion is already in progress, the tube may be clamped approximately 10 cm above the needle, and cefotaxime injected into the tube below the clamp.
For higher doses, cefotaxime may be administered via short intravenous infusion (20 minutes) after dissolving 2 g in 40 ml of water for injectable preparations, isotonic saline solution, or glucose solution, or via continuous intravenous infusion (50–60 minutes) after dissolving 2 g in 100 ml of solvent, plasma expanders.
When using the intravenous route, it is generally advisable to start therapy by administering cefotaxime directly into a vein.
Particularly sensitive patients may experience pain after intramuscular injection; for treating such patients, use of a solvent containing 1% lidocaine hydrochloride solution (except in patients hypersensitive to lidocaine) up to twice daily is recommended. This solution is for intramuscular use only and must absolutely not be administered intravenously.
Using a syringe, withdraw the solvent from the ampoule and transfer it into the vial of powder.
After complete dissolution, withdraw the solution from the vial and proceed with injection.
Warning: The solution for intramuscular use must never be used for intravenous administration.
The dissolved product has a yellowish hue from the beginning, which does not affect the drug's efficacy or tolerability.

Overdose
Symptoms of overdose may largely correspond to the profile of adverse effects. There is a risk of encephalopathy when beta-lactam antibiotics, including cefotaxime, are administered, particularly in cases of overdose or renal impairment. In case of overdose, cefotaxime should be discontinued and supportive treatment initiated, including measures to accelerate elimination and symptomatic treatment of adverse effects (e.g., seizures). There is no specific antidote. Serum levels of cefotaxime may be reduced by hemodialysis. Peritoneal dialysis is not effective in removing cefotaxime.

Incompatibilities
It is recommended not to mix SALOCEF with sodium bicarbonate solutions, antibiotics (especially aminoglycosides), or other drugs.

Shelf life after reconstitution
The reconstituted product (dissolving the vial content with the corresponding solvent ampoule) may 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 duration and conditions of storage prior to use are the responsibility of the user. Such storage times should not exceed the values stated above, provided that opening, reconstitution, and dilution were performed under controlled, validated aseptic conditions.

For further information, consult the Summary of Product Characteristics