CEFAMEZIN - PACKAGE LEAFLET - LEAFLETS

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Cefamezin - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Unwanted Effects Shelf Life

Active ingredients: Cefazolin

CEFAMEZIN 250 mg / 2 ml powder and solvent for solution for injection for intramuscular use
CEFAMEZIN 500 mg / 2 ml powder and solvent for solution for injection for intramuscular use
CEFAMEZIN 1000 mg / 4 ml powder and solvent for solution for injection for intramuscular use
CEFAMEZIN 1000 mg / 10 ml powder and solvent for solution for injection for intravenous use

Why is Cefamezin used? What is it for?

Cefamezin contains the active substance cefazolin. Cefazolin is an antibiotic that belongs to a group of medicines called cephalosporins and works against infections that can affect different parts of the body. Cefazolin kills the sensitive bacteria responsible for infections.

Cefamezin is used in adults and children to treat:

respiratory tract infections
infections of the kidney, bladder, urethra and genital organs
infections in the woman during pregnancy, childbirth and after childbirth (obstetric infections) and infections of the female genital organs (gynecological infections)
infections of the skin and soft tissues (for example: muscles, tendons)
ear, nose and throat infections
eye infections
stomach and intestinal infections
liver and biliary tract infections
bone and joint infections
infection of the appendix (appendicitis)
infection of the inner wall of the abdomen and abdominal organs (peritonitis)
blood infection (septicemia)
infection of the inner surface of the heart (endocarditis)

Cefamezin is used in adults and children to prevent and treat:

infections that can develop before, during or after surgery.

Contraindications When Cefamezin should not be used

Do not use Cefamezin:

if you or your child are allergic to cefazolin, other antibiotics belonging to the cephalosporin class or any of the other ingredients of this medicine (listed in section 6).

Precautions for use What you need to know before taking Cefamezin

Talk to your doctor, doctor treating your child, pharmacist or nurse before using Cefamezin.

Tell the doctor or doctor treating your baby if you think any of the following apply to you or your baby:

you have had an allergic reaction to penicillin, cephalosporins or other similar antibiotics. If you or your child have had an allergy to these antibiotics in the past, it is more likely that a new, even severe, allergic reaction may occur following the administration of Cefamezin. If you have an allergic reaction, stop treatment with Cefamezin immediately and contact your doctor (see also section 4 "Possible side effects");
suffer from kidney problems (kidney failure) or are undergoing dialysis. Your doctor will regularly check how your kidneys are working and adjust the dose of Cafamezin according to your condition.

Talk to your doctor, doctor treating your child, pharmacist or nurse if you or your child experience any of the following conditions while taking Cefamezin (see also section 4 "Possible side effects"):

new onset of diarrhea, which can be mild in type, but can lead to death in some cases (fatal colitis). Diarrhea can occur with the use of almost all antibiotics, including Cefamezin, and is due to the alteration of the normal bacterial flora of the intestine which allows the overgrowth of a bacterium called Clostridium difficile. In case of diarrhea, the doctor will subject you or your child to careful checks;
onset of infections caused by microorganisms resistant to Cefamezin.

Interactions Which drugs or foods can modify the effect of Cefamezin

Tell your doctor, doctor treating your child, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

Tell your doctor, doctor treating your child, pharmacist or nurse if you or your child are taking any of the following medicines:

warfarin (medicine that slows down or stops the blood clotting process). Cefamezin may increase the action of warfarin and increase the risk of bleeding;
probenecid (medicine against gout and uric acid accumulation). Concomitant administration of this medicine may increase the efficacy of Cefamezin.

Laboratory tests

Cefamezin can alter the results of some laboratory tests. If you or your child have to undergo laboratory tests (eg blood or urine tests), you must inform your doctor about your treatment with Cefamezin.

Warnings It is important to know that:

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

If you are pregnant or breast-feeding, your doctor will evaluate the benefit / risk of treatment with this medicine.

Driving and using machines

It is not known whether Cefamezin alters the ability to drive or use machines.

Cefamezin contains sodium

Cefamezin 250 mg / 2 ml powder and solvent for solution for injection for intramuscular use contains less than 1 mmol (23 mg) sodium per vial, ie it is essentially "sodium free".

Cefamezin 500 mg / 2 ml powder and solvent for solution for injection for intramuscular use contains 1.1 mmol (or 25.3 mg) sodium per vial. To be taken into consideration in people with reduced kidney function or who follow a low sodium diet

Cefamezin 1000 mg / 4 ml powder and solvent for solution for injection for intramuscular use and Cefamezin 1000 mg / 10 ml powder and solvent for solution for injection for intravenous use contain 2.2 mmol (or 50.6 mg) sodium per vial.

To be taken into consideration in people with reduced kidney function or who follow a low sodium diet.

Dosage and method of use How to use Cefamezin: Dosage

Always use this medicine exactly as your doctor, doctor treating your child, pharmacist or nurse has told you.

The recommended daily dose in adults ranges from 1 to 3 grams, divided into 2 doses (given every 12 hours).

The recommended daily dose in children ranges from 20 to 50 mg per kg of body weight, divided into 2 doses (given every 12 hours).

Severe infections

The recommended daily dose in adults ranges from 4 to 12 grams, divided into 3 doses (given every 8 hours).

The recommended daily dose is 100 mg per kg of body weight, divided into 3 doses (given every 8 hours).

If you / your child have kidney problems

If you or your child have kidney problems (kidney failure), your doctor will prescribe lower doses of Cefamezin and less frequent doses than normal.

Method of administration

Cefamezin can be administered intramuscularly or intravenously.

Intramuscular injection

Cefamezin 250 mg / 2 ml powder and solvent for solution for injection, Cefamezin 500 mg / 2 ml powder and solvent for solution for injection and Cefamezin 1000 mg / 4 ml powder and solvent for solution for injection can only be administered by injection into a muscle (intramuscular ). The solvent vial included in the package contains lidocaine, a local anesthetic, to relieve pain during the injection.

Withdraw the liquid from the solvent vial with a syringe and inject it into the vial containing the powder.

Shake the vial well until the powder is completely dissolved. Inject Cefamezin deep into the thickness of a buttock or anterior thigh area.

If you are being treated with another intramuscular antibiotic, do not administer Cefamezin in the same syringe.

Intravenous injection

Cefamezin 1000 mg / 10 ml powder and solvent for solution for injection should only be given by injection into a vein (intravenously).

Reconstitute the powder with the solvent contained in the vial included in the carton or with any other compatible solution (see section "The following information is intended for medical or healthcare professionals only").

Let it stand until completely dissolved.

Cefamezin can be given into a vein slowly (infusion of 10 ml over approximately 3-5 minutes) either continuously or intermittently.

Instructions for opening the vial

To open, hold the vial vertically, making sure that the colored point is in the position shown in the figure

Push the top of the vial back as shown in the figure

Overdose What to do if you have taken too much Cefamezin

If you or your child receive more Cefamezin than they should

It is important that you or your child never use more medicine than prescribed. However, there are currently no known side effects caused by excessive doses of Cefamezin.

If you have any further questions on the use of this medicine, ask your doctor, the doctor treating your child or the pharmacist.

Side Effects What are the side effects of Cefamezin

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP using Cefamezin immediately if you or your child experience any of the following side effects as they can be serious:

severe allergic reaction (anaphylactic shock) (see section 2 "Warnings and precautions")
swelling of the face, tongue and throat resulting in an inability to swallow and breathe (angioedema)
severe inflammation of the last part of the intestine called the colon (colitis) caused by the overgrowth of a bacterium called Clostridium difficile (pseudomembranous colitis) (see section 2 "Warnings and precautions")
death (necrosis) and flaking of areas of the skin and mucous membranes of the mouth, eyes and urethra (Stevens-Johnson syndrome)
anemia due to excessive destruction of red blood cells (haemolytic anemia).

Talk to your doctor if you or your child experience any of the following side effects:

Infections

vaginal Candida infections (a fungus)
infections with bacteria not sensitive to Cefamezin

Effects affecting the blood and bone marrow

increase in the number of a type of white blood cell called 'eosinophils' (eosinophilia) in the blood
reduction in the number of a type of white blood cell called 'neutrophils' in the blood (neutropenia)
reduction in the number of all types of white blood cells in the blood (leukopenia)

Effects affecting the ear and balance

vertigo

Effects affecting the heart

feeling short of breath or chest pain (chest tightness)

Effects affecting the blood vessels

low blood pressure (hypotension)

Effects affecting the stomach and intestines

inflammation of the tongue (glossitis)
nausea
He retched
diarrhea
heartburn
pain in the abdomen

Effects affecting the skin

rash
urticaria
skin rash with formation of small bumps and reddish spots (maculopapular eruptions)
redness of the skin
itch

Effects affecting the muscles and bones

joint pain (arthralgia)

Alteration of medical examinations

increase in the blood of certain substances normally produced by the liver (alanine aminotransferase, aspartate aminotransferase, bilirubin, nitrogen)

Reporting of side effects

If you or your child 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 via 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.

Expiry and Retention

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 carton, vial and ampoule after "EXP". The expiry date refers to the last day of that month.

Store in the original packaging.

After preparation, the solution is stable for 24 hours at room temperature and for 96 hours when stored in a refrigerator (5 ° C).

A crystalline deposit can form in the prepared solutions. To get the clear solution back, heat the vial in your hand or in lukewarm water.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

What Cefamezin contains

The active ingredient is cefazolin (as cefazolin sodium).

Cefamezin 250 mg / 2 ml powder and solvent for solution for injection for intramuscular use

Each vial of powder contains 262 mg of cefazolin sodium (corresponding to 250 mg of cefazolin).

The solvent vial contains lidocaine hydrochloride and water for injections.

Cefamezin 500 mg / 2 ml powder and solvent for solution for injection for intramuscular use

Each vial of powder contains 524 mg of cefazolin sodium (corresponding to 500 mg of cefazolin).

The solvent vial contains lidocaine hydrochloride and water for injections.

Cefamezin 1000 mg / 4 ml powder and solvent for solution for injection for intramuscular use

Each vial of powder contains 1048 mg of cefazolin sodium (corresponding to 1000 mg of cefazolin).

The solvent vial contains lidocaine hydrochloride and water for injections.

Cefamezin 1000 mg / 10 ml powder and solvent for solution for injection for intravenous use

Each vial of powder contains 1048 mg of cefazolin sodium (corresponding to 1000 mg of cefazolin).

The solvent vial contains water for injections.

What Cefamezin looks like and contents of the pack

After reconstitution, the solution is clear, colorless to pale yellow in appearance.

Cefamezin 250 mg / 2 ml powder and solvent for solution for injection for intramuscular use

Each pack contains 1 glass vial with rubber / aluminum closure containing the powder + 1 glass vial containing 2 ml of solvent.

Cefamezin 500 mg / 2 ml powder and solvent for solution for injection for intramuscular use

Each pack contains 1 glass vial with rubber / aluminum closure containing the powder + 1 glass vial containing 2 ml of solvent.

Cefamezin 1000 mg / 4 ml powder and solvent for solution for injection for intramuscular use

Each pack contains 1 glass vial with rubber / aluminum closure containing the powder + 1 glass vial containing 4 ml of solvent.

Cefamezin 1000 mg / 10 ml powder and solvent for solution for injection for intravenous use

Each pack contains 1 glass vial with rubber / aluminum closure containing the powder + 1 glass vial containing 10 ml of solvent.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Cefamezin can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

CEFAMEZIN POWDER AND SOLVENT FOR INJECTABLE SOLUTION FOR INTRAMUSCULAR USE

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

CEFAMEZIN 250 mg / 2 ml Powder and solvent for solution for injection for intramuscular use

Each 250 mg vial (IM use) contains:

Active principle: cefazolin sodium 262 mg equal to 250 mg of cefazolin.

CEFAMEZIN 500 mg / 2 ml Powder and solvent for solution for injection for intramuscular use

Each 500 mg vial (IM use) contains:

Active principle: cefazolin sodium 524 mg equal to 500 mg of cefazolin.

CEFAMEZIN 1000 mg / 4 ml Powder and solvent for solution for injection for intramuscular use

Each 1 g vial (IM use) contains:

Active principle: cefazolin sodium 1.048 g equal to 1 g of cefazolin.

CEFAMEZIN 1000 mg / 10 ml Powder and solvent for solution for injection for intravenous use

Each 1 g vial (i.v. use) contains:

Active principle: cefazolin sodium 1.048 g equal to 1 g of cefazolin.

For the full list of excipients, see section 6.1

03.0 PHARMACEUTICAL FORM

Powder and solvent for injection:

1 vial of 250 mg + 1 vial of 2 ml solvent

1 vial of 500 mg + 1 vial of 2 ml solvent

1 vial of 1000 mg + 1 vial of solvent of 4 ml

INTRAMUSCULAR USE

1 vial of 1000 mg + 1 vial of 10 ml solvent

INTRAVENOUS USE

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

CEFAMEZIN is indicated in the treatment of the following infections caused by susceptible microorganisms such as: respiratory tract infections, genitourinary infections, obstetric-gynecological infections, skin and soft tissue infections, ENT infections, ophthalmological infections, gastroenterological infections, hepatobiliary infections, osteoarticular infections, appendicitis, peritonitis, septicemia, endocarditis.

It is also indicated for the prophylaxis and therapy of surgical infections.

04.2 Posology and method of administration

Adults and children

The dosage of CEFAMEZIN is 1-3 g / day in adults and 20-50 mg / kg / day in children.

In patients with renal insufficiency the doses should be adjusted according to the degree of impairment (see the following table).

Creatinine clearance (ml / min) Initial dose Maintenance dose Approximate dosage range 0 500-1000 mg half initial dose 48 hours 5 500-1000 mg half initial dose 24 hours 10 500-1000 mg half initial dose 16 hours 15 500-1000 mg half initial dose 12 hours 20 500-1000 mg half initial dose 9-10 hours 25 500-1000 mg half initial dose 8 hours 30-50 500-1000 mg equal to the starting dose 16-24 hours 50-80 500-1000 mg equal to the starting dose 12 hours

CEFAMEZIN is usually given every 12 hours; in severe cases it is preferable to divide the daily dose into 3 administrations. In the treatment of particularly serious infections CEFAMEZIN was used at a dose of 4-12 g / day in adults and 100 mg / kg / day in children.

Method of administration

CEFAMEZIN can be administered both intramuscularly and intravenously.

Intramuscular administration: dissolve the contents of a bottle with the attached solvent.

The ampoule of solvent containing anesthetic, attached to the packs of 1 g, 500 mg, 250 mg, must be used only for intramuscular administration.

Intravenous administration: CEFAMEZIN can be administered by slow direct intravenous injection (10 ml of solution over 3-5 minutes) by continuous or intermittent intravenous infusion.

For intravenous administration dissolve the contents of the bottles in water for injections or in:

water for injections or in glucose solution, physiological solution, dextrose 5% and 10%, dextrose 5% + sodium chloride 0.90%, dextrose 5% + sodium chloride 0.45%, dextrose 5% + sodium chloride 0.20 %, 5% dextrose in Ringer's solution, Ringer's, Ringer's lactate, 5% sodium bicarbonate, 5% or 10% invertose.

04.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

CEFAMEZIN is contraindicated in patients with allergy to cephalosporins.

04.4 Special warnings and appropriate precautions for use

At both clinical and laboratory level there is evidence of partial cross allergenicity between penicillin and cephalosporins and, although rare, there have been reports of patients who have experienced reactions to both drugs, sometimes even of anaphylactic type, especially after parenteral administration.

Cefazolin, given prophylactically to patients undergoing open heart surgery, could have an additive effect to warfarin in producing hypoprothrombinemia. The response of prothrombin to warfarin after cefazolin was intermediate in intensity compared to cefamandal (greater hypoprothrombinemia) and vancomycin (less hypoprothrombinemia). Although the exact mechanism of this phenomenon is not fully known, precaution is recommended when administering warfarin in patients receiving cefazolin (see section 4.5).

The tolerability of CEFAMEZIN is good, but the functionality of the kidney must in any case be checked, especially in cases of renal insufficiency and the simultaneous use of potentially nephrotoxic drugs.

In patients undergoing peritoneal dialysis (eg continuous ambulatory peritoneal dialysis, or continuous cyclic peritoneal dialysis), the presence of cefazolin in the body is strongly influenced by the flow rate of the dialyzed fluid. The increase in the speed of the dialyzed fluid to values> 5.50 ml / minute in patients on peritoneal dialysis leads to an increase in the elimination of cefazolin from the body. Therefore, drug doses should be reconsidered to avoid underdose situations and subsequent therapeutic failures. In addition, in patients with peritonitis secondary to peritoneal dialysis, the dialysate flow rate should be maintained at cefazolin antibiotic therapy values (see section 5.2).

Prolonged use of antibiotics can favor the development of non-sensitive microorganisms.

Particular caution in the administration of cefazolin is recommended in hospitalized patients, particularly the elderly, as a direct correlation has been demonstrated between the use of this antibiotic and the onset of diarrhea associated with Clostridium difficile (see section 4.8).

04.5 Interactions with other medicinal products and other forms of interaction

In case of combination with another antibiotic, it is recommended not to administer cefazolin in the same syringe or in the same infusion container.

Cefazolin, given in combination with warfarin, could have an additive effect with the latter in producing hypoprothrombinemia. The exact mechanism of this phenomenon is not fully known and particular caution is recommended in the concomitant administration of cefazolin and warfarin in patients requiring anticoagulant treatment (see section 4.4).

Probenecid, administered concomitantly with cefazolin, reduces the elimination of the latter by a competitive mechanism for renal tubular excretion (see section 5.1).

The administration of cephalosporins can interfere with some laboratory tests, causing pseudopositivity of glycosuria with the methods of Benedict, Felhing and "Clinitest", but not with the enzymatic methods.

Positive Coombs test (sometimes false) has been reported during treatment with cephalosporins.

04.6 Pregnancy and lactation

In pregnant and breastfeeding women, the product should be administered in cases of real need and under medical supervision.

04.7 Effects on ability to drive and use machines

No data are known in this regard.

04.8 Undesirable effects

As with other cephalosporins, side effects are generally limited to occasional hypersensitivity phenomena. Cases of shock and anaphylactic reactions, anaphylactoid reactions, drug hypersensitivity reactions and hypotension have also been reported. The possibility of the appearance of the latter is greater in individuals who have previously experienced hypersensitivity reactions and in those with a previous history of allergy, asthma, hay fever, urticaria.

The following secondary reactions have been reported: glossitis, nausea, vomiting, rash, urticaria, maculo-papular rash, erythema, pruritus, drug eruption, diarrhea, heartburn, abdominal pain reported by some patients; very rarely mild hives or skin rash, itching, arthralgia. Rare cases of Stevens-Johnson syndrome have been reported. The rare possibility of onset of diarrhea has been reported Clostridium difficile (see section 4.4) and the even rarer possibility of evolution to life-threatening pseudomembranous colitis. Occasionally transient changes in some laboratory parameters such as eosinophilia, leukopenia, neutropenia, increase in serum transaminases, total bilirubin and azotemia. Other reactions observed were dizziness, chest tightness, Candida vaginitis also related to the development of non-sensitive microorganisms. These collateral phenomena have rarely been so intense as to require discontinuation of therapy.

There have been reports of haemolytic anemia following treatment with cephalosporins.

04.9 Overdose

No toxic effects from overdosing of cefazolin have been reported in the literature.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: first generation cephalosporins, ATC code: J01DB04.

Antibacterial activity. Cefazolin works by inhibiting the synthesis of the bacterial cell wall. Its bactericidal action is carried out on numerous Gram-positive and Gram-negative germs, in particular: Staphylococcus aureus (penicilin-sensitive and penicilin-resistant), Streptococcus viridans,Streptococcus pyogenes, Staphylococcus epidermidis, Streptococcus pneumoniae, Klebsiella pneumoniae, Enterobacter aerogenes, Haemophilusinfluenzae, Neisseria gonorrhoeae, Escherichia coli, Proteus mirabilis.

In case of body fluid infections caused by strains of Staphylococcus aureus methicillin-sensitive (MSSA), cefazolin can be used as a drug of first choice associated with an aminoglycoside. However, in some circumstances such as the development of peritonitis related to peritoneal dialysis, strains of Staphylococcus MSSA can develop biofilm formation due to the presence of the synthetic surface of the catheters used for dialysis. Once the biofilm is formed, MSSA strains undergo changes in their structure and this requires much higher concentrations of the antibiotic to inhibit their proliferation. The modified bacteria can become resistant to cefazolin and the evaluation of their sensitivity to the drug by the classical methods for the determination of the minimum inhibitory concentration (MIC) may be inadequate for a correct estimate of the real concentration of antibiotic useful for inhibiting the biofilm. In this case, the determination of the Minimum Biofilm Eradication Concentration (MBEC) must be performed in laboratories that are experienced in performing this technique in vitro.

Cefazolin is eliminated predominantly by the kidney and, when administered concomitantly with probenecid, the latter reduces its elimination as it competes for renal tubular excretion. This effect can be used profitably in selected cases to increase concentrations of cefazolin in serum.

05.2 Pharmacokinetic properties

Parenterally administered to humans, cefazolin rapidly reaches maximum blood levels and is maintained in useful concentrations for 8-12 hours. Plasma protein binding is 60-80%. Cefazoline is detectable in effective concentrations in many tissues. and organs such as lungs, tonsils, gallbladder wall, appendix.

Cefazolin reaches high levels (about half of the blood levels) in the bile and synovial fluid. In a pharmacokinetic study conducted by continuous intravenous infusion in 7 adult patients, the percentage of the free fraction in interstitial fluid (17.5%) was similar to the percentage of the free fraction in plasma not bound to serum proteins (26.6%). , when the measurement takes place at steady-state. In the study, the ratio of interstitial free concentration / free plasma concentration was 0.84.

Cefazolin, on the other hand, diffuses poorly in the liquor and negligibly in milk. Its biological half-life is 1.8-2 hours and elimination is predominantly urinary, reaching 70-80% of the dose at 24 hours. The maximum urinary concentrations of antibiotic are in the order of 2400 mcg / ml and 4000 mcg / ml respectively after the im injection of 500 mg and 1 g.

In patients undergoing peritoneal dialysis (e.g. continuous ambulatory peritoneal dialysis or continuous cyclic peritoneal dialysis), the pharmacokinetics of Cefamezin are strongly influenced by the flow rate of the dialysate. Increasing the dialysate rate to> 5.50 mL / minute in patients on peritoneal dialysis leads to an increase in total body clearance, a decrease in the plasma elimination half-life and a decrease in the peritoneal elimination half-life of Cefamezin. Therefore, drug doses should be reconsidered to avoid underdose situations and subsequent therapeutic failures. In addition, in patients with peritonitis secondary to peritoneal dialysis, the dialysate flow rate should be maintained at antibiotic values with Cefamezin (see section 4.4 ).

05.3 Preclinical safety data

Acute toxicity data, studied in various animal species and by different routes of administration indicate that Cefamezin is devoid of toxic effect at therapeutic doses. With prolonged oral and intravenous administration to rats and dogs, the drug was well tolerated at all doses and did not cause alterations in the various organs. Furthermore, Cefamezin did not induce embryotoxic and teratogenic effects.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Each solvent ampoule for intramuscular administration contains:

Lidocaine hydrochloride, water for injections;

Each solvent vial for intravenous administration contains:

Water for injections

06.2 Incompatibility

Physico-chemical incompatibility has been found with non-steroidal anti-inflammatory drugs belonging to the group of phenyl-propionic acid derivatives.

06.3 Period of validity

In intact packaging: 24 months

After reconstitution of the product: after extemporaneous preparation, the solution is stable for 24 hours at room temperature and for 96 hours if stored in the refrigerator (5 ° C).