SALOCEF 1 G Порошок и раствор для инъекционного раствора

Содержание инструкции

1. 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
   1. What SALOCEF is and what it is used for
   2. What you need to know before you use SALOCEF
2. SALOCEF 1 g/4 ml powder and solvent for injectable solution and SALOCEF 1 g/4 ml powder and
   1. How to use SALOCEF
   2. Possible side effects

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

Equivalent medicinal product

Read this leaflet carefully before 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 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 SALOCEF is and what it is used for
• 2. What you need to know before you use SALOCEF
• 3. How to use SALOCEF
• 4. Possible side effects
• 5. How to store SALOCEF
• 6. Contents of the pack and other information

1. What SALOCEF is and what it is used for

SALOCEF contains the active ingredient 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.
SALOCEF is indicated for the treatment of severe bacterial infections caused by certain bacteria (difficult Gram-negative germs) or by a set 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 problems in their immune defenses (immunocompromised).
This medicine is also indicated for the prevention of infections caused by surgical procedures.

2. What you need to know before you use SALOCEF

Do not use SALOCEF

• 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);
• if you are taking antibiotics belonging to the same group as SALOCEF called penicillins, because allergic cross-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 anesthetic called lidocaine, therefore it should not be administered in case of:

• allergy to lidocaine or other similar anesthetics;
• serious heart problems (heart block without a pacemaker and severe heart failure);
• administration performed intravenously (intravenous administration);
• newborns under 30 months of age.

Warnings and precautions
Consult 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 to which SALOCEF is not effective (superinfections). If this should occur, it is advisable to consult your doctor who will indicate a suitable therapy.
During the use of SALOCEF, the following may occur:

• allergic reactions. Before starting therapy with this medicine, your doctor will subject you to specific tests to ensure that you are not allergic to cefotaxime, cephalosporins, penicillins or other medicines. Use this medicine with caution and inform 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: a doctor, depending on your condition, will establish the appropriate therapy;
• appearance of blisters on the skin(severe blistering eruptions such as Stevens-Johnson syndrome or toxic epidermal necrolysis). If you notice the appearance of skin or mucous membrane reactions, with the presence of vesicles or blisters, stop treatment and immediately consult your doctor;
• problems with the intestinecaused by a bacterium called Clostridium difficile. You may experience mild or severe diarrhea in case of inflammation of the intestine (pseudomembranous colitis). If you experience severe diarrhea or for a prolonged period of time, during treatment with SALOCEF, your doctor may subject you to specific tests (endoscopy or a histological examination) to confirm whether it is a disease caused by this bacterium. If you experience cases of mild colitis, stop treatment to allow the symptoms to disappear. If you experience moderate or severe colitis, consult your doctor who will indicate the appropriate therapy. If you are taking medicines that act on the intestine (inhibitors of peristalsis), SALOCEF should not be administered to you as they may promote the occurrence of diseases associated with Clostridium difficile; if you have suffered, even in the past, from intestinal diseases, especially colitis, inform your doctor;
• irritationat the injection site following intravenous administration. This can be avoided by administering the medicine very slowly (3-5) minutes;
• alterations of the blood(leukopenia, neutropenia, bone marrow failure, pancytopenia, agranulocytosis, thrombocytopenia, hemolytic anemia), especially if you use the medicine for prolonged periods. Therefore, if you have been prescribed a treatment for 7-10 days or more, you should undergo blood tests. Stop treatment with SALOCEF if blood alterations occur as some problems disappear after stopping treatment;
• disease that causes alterations in the brain(encephalopathy) which may include convulsions, confusion, altered consciousness and movement disorders. This type of antibiotic (beta-lactam antibiotic) predisposes to this risk especially if taken at high doses or if you suffer from kidney problems (renal failure). If you notice the onset of any of these symptoms, stop treatment and immediately consult your doctor.

This medicine, if administered rapidly intravenously through a tube (central venous catheter)
may cause heart rhythm disturbances (arrhythmias), which may be life-threatening (see section “How to use SALOCEF”).
Use this medicine with caution and inform your doctor if you suffer from serious kidney problems
(severe renal failure). In this case, the doctor may decide to halve the maintenance dose based on your condition. Undergo kidney checks if, while
taking SALOCEF, you are taking medicines for the treatment of serious infections (aminoglycoside antibiotics), probenecid (medicine to lower uric acid concentration in
the blood), medicines harmful to the kidneys (nephrotoxic drugs), if you are elderly or if you suffer from kidney problems.
SALOCEF may not be effective (antibiotic resistance), especially against some families of
bacteria (Enterobacteriaceae and Pseudomonas), in people with immune deficiencies
(immunocompromised) or following the simultaneous use of similar medicines (antibiotics).

SALOCEF and laboratory tests
Inform your doctor that you are using this medicine before undergoing some tests because
SALOCEF may interfere with some laboratory tests, such as: Coombs test, blood compatibility test, tests to measure sugar in the urine (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 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 any of the following medicines:

• aminoglycoside antibiotics, medicines for the treatment of bacterial infections or 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 SALOCEF with urine.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor, pharmacist or nurse for advice before using this medicine.
If you are pregnant, do not use SALOCEF unless your doctor deems it necessary.
If you are breastfeeding, consult your doctor, who will assess the need to stop
breastfeeding or treatment with this medicine. Babies breastfed by mothers taking
SALOCEF may have diarrhea.

Driving and operating machinery
This medicine can cause dizziness or encephalopathy (a brain condition) which may
include convulsions, confusion, altered consciousness, movement disorders. This can
impair your ability to drive and 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 (main component of table salt) per fla-
vial. This is equivalent to approximately 2.5% of the maximum recommended daily intake with the
diet of a man.
Talk to your doctor or pharmacist if you need 7 or more vials a day for a pro-
longed period, especially 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, always following the doctor's or nurse's instructions exactly. If you have any doubts, consult your doctor or nurse.
The doctor will determine the necessary dose, the method 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 the fever has subsided.
In the case of SALOCEF administration directly into a vein (intermittent intravenous administration), the solution must be injected in 3-5 minutes. This medicine, if administered rapidly into a vein, can cause alterations in heart rhythm (arrhythmias), which can be life-threatening.
It is advisable to always use freshly prepared solutions, even if the medicine, once dissolved in water, can be stored in the refrigerator for up to 24 hours, and not to mix SALOCEF with sodium bicarbonate solutions or with medicines for the treatment of bacterial infections (aminoglycoside antibiotics).
The recommended dose for adults, for injections into muscle or 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 severe cases, up to 12 grams for intravenous administrations, reducing the interval between administrations to 8-6 hours.

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 severe cases, the recommended dose is 200 mg/kg of body weight per day. SALOCEF 1 g/4 ml powder and solvent for injectable solution for intramuscular use should 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 renal function is not yet fully developed.

Use in people with severe kidney problems
In case of severe renal insufficiency, lower dosages are indicated.
If you are undergoing hemodialysis or peritoneal dialysis, the recommended dose varies from 1 to 2 g per day depending on the severity of your infection. On the day of hemodialysis, SALOCEF will be administered to you after the treatment. This precaution is not necessary in case of peritoneal dialysis.

If you use more SALOCEF than you should
This medicine will be administered by a doctor or nurse, so an overdose is unlikely.
The symptoms of an overdose may correspond to the undesirable effects (See section 4) and brain damage (encephalopathies) may occur. In this case, the administration of this medicine must be suspended and the doctor will indicate appropriate therapy.
If you think you have been given an excessive amount of this medicine, immediately inform your doctor or go to the nearest hospital.

If you forget to use SALOCEF
This medicine will be administered by a doctor or nurse, so it is unlikely that a dose will be forgotten.
Do not use a double dose to make up for a missed dose.
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.

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

• pain at the injection site for intramuscular administration (intramuscular administration).

Uncommon(may affect up to 1 in 100 people)

• reduction in the number of white blood cells (leukopenia), increase in the number of eosinophils (eosinophilia), reduction in the number of platelets (thrombocytopenia);
• redness of the skin (skin rash), itching, hives, fever, increase in liver enzyme levels (ALAT, ASAT, LDH, gamma-GT, alkaline phosphatase) and/or bilirubin, Jarisch-Herxheimer reaction (which manifests with fever, chills, headache, muscle pain and joint disorders, skin irritation, decreased white blood cells, changes in blood tests affecting the liver, breathing problems);
• convulsions (see Section “Warnings and Precautions”);
• diarrhea;
• decreased kidney function and increased creatinine, a substance that indicates kidney function, especially when this medicine has been prescribed together with other medicines for the treatment of infections caused by bacteria (aminoglycoside antibiotics);
• inflammatory reactions at the injection site, including inflammation of a vein with or without the formation of blood clots (thrombophlebitis/phlebitis).

Not known(frequency cannot be estimated based on 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), decreased bone marrow activity (bone marrow failure), decrease in all blood cells (pancytopenia) (see Section “Warnings and Precautions”), decrease in red blood cells (hemolytic anemia);
• allergic reactions, including severe ones (anaphylactic reactions, anaphylactic shock), swelling due to fluid accumulation around the mouth and eyes (angioedema), constriction of the bronchi with difficulty breathing (bronchospasm);
• headache, dizziness;
• encephalopathy (which may include convulsions, confusion, altered consciousness and movement disorders). This type of antibiotic predisposes to this risk especially if taken at high doses or if you have kidney problems (renal insufficiency) (see Section “Warnings and Precautions”);
• irregular heartbeat (arrhythmias) following a rapid infusion bolus through a tube inserted directly into a vein (central venous catheter);
• nausea, vomiting, abdominal pain, severe inflammation of the intestine (pseudomembranous colitis) (see Section “Warnings and Precautions”);
• skin lesions, including 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), acute generalized exanthematous pustulosis (red and infected widespread lesions) (see Section “Warnings and Precautions”);
• liver problems (hepatitis) sometimes with yellowing of the skin and eyes (jaundice);
• inflammation of the kidneys (interstitial nephritis), severe kidney failure (acute renal failure) (see Section “Warnings and Precautions”);
• reactions affecting multiple organs (systemic reactions) to lidocaine (a local anesthetic) present in the solvent for intramuscular administration only;
• loss of appetite (anorexia), inflammation of the tongue (glossitis), heartburn (pyrosis gastrica);
• vaginal inflammation caused by a fungus (Candida vaginitis), agitation, confusion, decreased muscle strength (asthenia), night sweats.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging after “Expiry”.
The expiry date refers to the last day of that month.
Store at a temperature below 25°C and protect from light.
It is recommended to always use solutions prepared extemporaneously.
The reconstituted product (dissolving the vial with the content of the solvent vial) can be stored in the refrigerator at +2 / + 8 °C for 24 hours (protected from light)
Solutions prepared, 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 constitution.
ATTENTION: 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 any medicine in the water 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 SALOCEF contains
SALOCEF 1g - powder and solvent for injectable solution for intramuscular use
The active ingredient is sodium cefotaxime: one vial of powder contains 1.048 g of sodium cefotaxime corresponding to 1 g of cefotaxime.
The other components of the solvent vial are: lidocaine hydrochloride, water for injections.

SALOCEF 1g - powder and solvent for injectable solution i.m./i.v
The active ingredient is sodium cefotaxime: one vial of powder contains 1.048 g of sodium cefotaxime corresponding to 1 g of cefotaxime.
The other components of the solvent vial are: water for injections.

Description 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 vial of solvent of 4 ml.

SALOCEF 1g - powder and solvent for injectable solution for intramuscular use
Pack containing 1 vial of powder + 1 vial of solvent of 4 ml.

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

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

The following information is intended exclusively for doctors or healthcare professionals
CLINICAL INFORMATION
Posology and method of administration
Regarding the intravenous administration of lower doses, resort to direct injection 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 brief 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.
When resorting to the intravenous route, it is still advisable to start therapy by administering 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 should only be used intramuscularly and therefore intravenous administration must be absolutely avoided.
Draw up the contents of the solvent vial with a syringe and pour it into the powder vial.
After complete dissolution, draw up the contents of the vial and proceed with the injection.
Caution: the solution for intramuscular use must never be used for intravenous administration.
The dissolved product, from the beginning, appears yellowish in color, which does not affect the efficacy and tolerability of the drug.

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

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

Shelf life
The reconstituted product (dissolving the contents of the vial with the contents of the corresponding solvent vial) can be stored in the refrigerator for up to 24 hours.
From a microbiological point of view, the reconstituted product should be used immediately.
If not used immediately, the storage times in use and the conditions before use are the responsibility of the user. These storage times should not exceed the values ​​above, provided that the opening, reconstitution and dilution have been carried out under controlled and validated aseptic conditions.

For further information, consult the Summary of Product Characteristics