NEFAZOL 1 G/4 ML Proszek i rozpuszczalnik do roztworu do wstrzykiwań

Treść ulotki

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

NEFAZOL

1 g / 4 ml powder and solvent for injectable solution for intramuscular use
Sodium cefazolin
Generic medicine

Read this leaflet carefully before you start to use 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 pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is NEFAZOL and what is it used for

NEFAZOL contains the active substance cefazolin sodium, a substance that belongs to a category of medicines called cephalosporins, beta-lactam antibiotics used to treat infections caused by bacteria sensitive to this active ingredient.
NEFAZOL is used in the treatment of the following infections:

• Respiratory tract infections,
• Ear and throat infections,
• Stomach and intestinal infections (gastroenterological)
• Liver and biliary tract infections (hepatobiliary),
• Genito-urinary tract infections,
• Skin, soft tissue, bone and joint infections,
• Obstetric-gynecological infections,
• Eye infections,
• Inflammation of the membrane that lines the inner walls of the abdominal cavity (peritoneum), the blood (septicemia) and the tissue that lines the internal cavities and the valves of the heart (endocardium) caused by bacteria.

Cefazolin is also indicated before, during and after a surgical intervention (perioperative prophylaxis), to prevent infections (see section 3).

2. What you need to know before you take NEFAZOL

You must not be given NEFAZOL

• If you are allergic (hypersensitive) to cefazolin sodium, to other similar substances (beta-lactam antibiotics such as other cephalosporins and penicillins), or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to lidocaine or other similar local anesthetics, of the amide type.
• Do not give NEFAZOL to premature babies or babies less than one month old.

Warnings and precautions
Consult your doctor, pharmacist or nurse before using NEFAZOL.
If you experience any allergic-type reaction following the administration of NEFA-
ZOL, immediately stop treatment and consult your doctor or go to the nearest
hospital; severe allergic reactions, and in particular anaphylaxis, may require emergency therapeutic intervention.

Pay particular attention and tell your doctor:

• If you have suffered from an allergy to cefazolin, cephalosporins, penicillins and other antibiotics that work with the same mechanism of action (beta-lactam) or to other drugs. It is likely that patients allergic to antibiotics of the cephalosporin class are also allergic to penicillins. Patients have been reported to have had severe reactions (including anaphylaxis) to both of these classes of drugs.
• If you suffer from an allergy to lidocaine or other amide-type local anesthetics, as in this case you may also be allergic to NEFAZOL (risk of severe anaphylactic-type reactions) (see “Do not take NEFAZOL”).
• If you have suffered or are suffering from gastrointestinal diseases and in particular colitis (inflammation of the colon).
• If you experience diarrhea during treatment. Consult your doctor immediately, as the use of NEFAZOL may cause the development of bacteria that are not sensitive to the medicine, up to an alteration of the normal flora of the colon which can lead to a serious condition called pseudomembranous colitis.

The simultaneous use of medicines that promote the accumulation of feces (fecal stasis) must
be absolutely prohibited.

• If you suffer from kidney problems, as in this case a careful assessment of kidney function by the doctor is necessary, both before and during therapy with NEFAZOL. This medicine can cause kidney damage and these effects are more likely if you are over 50 years of age, if you already have kidney problems or if you are taking other medicines that can cause kidney damage at the same time (see “Other medicines and NEFAZOL”). The doctor may reduce the dose of NEFAZOL based on your condition.

If you have high blood pressure (hypertension) or if you have heart problems (heart failure), as the medicine contains sodium (see “Nefazol contains sodium”).

• If you are being treated with drugs that thin the blood, due to the risk of coagulation disorders. Your doctor will monitor your therapy and indicate any dose adjustments (see “Other medicines and NEFAZOL”).

Laboratory tests
Tell your doctor if you are being treated with NEFAZOL and need to undergo laboratory tests
because this medicine can alter the result of some tests (false positive Coombs test, also in newborns whose mothers received Nefazol before delivery, false positive urine glucose test with Benedict, Fehling and “Clinitest” methods).

• Nefazol must not be administered directly into the intrathecal space, where the fluid around the spinal cord flows.

Children
NEFAZOL should not be administered to premature babies and newborns under one month of age
(see section “You must not be given Nefazol”). In early infancy, the product should be administered only when absolutely necessary, under the direct control of the doctor.

Other medicines and NEFAZOL
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.

In particular, contact your doctor if you are taking:

• Probenecid (a drug used in the treatment of gout to reduce uric acid levels. Concomitant use may increase NEFAZOL levels in the blood.
• Drugs that cause kidney damage (such as aminoglycosides, colistin, polymyxin B or vancomycin). Concurrent administration should be avoided.
• penicillins or chloramphenicol (antibiotics),
• Oral anticoagulants (drugs that inhibit blood clot formation). If co-administration of oral anticoagulants or high-dose heparin is necessary, your doctor will establish the correct therapy by modifying the dose of cefazolin and/or anticoagulants and will monitor your coagulation values (see “Warnings and precautions”).
• Oral contraceptives as NEFAZOL may affect their effectiveness. For this reason, alternative contraceptive methods are recommended in addition to hormonal contraceptives during treatment with cefazolin.

NEFAZOL contains sodium
This medicine contains 50.5 mg 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.
In patients with hypertension or heart failure, the sodium content of the injectable solution should be considered.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
If you are pregnant, you should only take NEFAZOL under direct medical supervision
who will assess whether the potential benefits outweigh the possible risks to you and your baby.
If cefazolin is administered before cesarean delivery, it may pass into the fetal blood in variable amounts lower than that present in the mother's blood. However, although cefazolin does not appear to be able to cause adverse effects on the fetus, it can only be administered after ligation of the umbilical cord.

Breastfeeding
This medicine is present in very low concentrations in breast milk; in any case it is
however necessary to ask your doctor for advice and still be cautious during the breastfeeding period. If diarrhea or candidiasis occurs in the newborn during breastfeeding, the mother should discontinue breastfeeding or treatment with cefazolin.

Driving and operating machinery
No effects on the ability to drive or operate machinery have been reported.

3. How to take NEFAZOL

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.

Adults
The recommended dose of cefazolin is 1-3 g/day, to be divided into 2-3 equal administrations depending on the type and severity of the infection, as reported in the following table:

* in exceptional cases, doses of cefazolin up to 12 g/day have been used.

Use in children
NEFAZOL should not be administered to premature infants and newborns under 1 month of age (see paragraph “You must not take NEFAZOL”).
The recommended total daily dosage is 25-50 mg/kg of body weight, to be divided into 3-4 equal administrations; Depending on the severity of the infection, the doctor may increase the dose up to 100 mg/kg of body weight.
In early infancy, NEFAZOL will be administered only in cases of actual need and under the direct control of the doctor.

Use in patients with renal insufficiency
If you suffer from renal insufficiency, your doctor will reduce the dose based on renal function tests as reported in the following table:

Note:In infections of particular severity, an appropriate loading dose is recommended before proceeding with the reduction of dosages as reported above.

Use in patients undergoing peritoneal dialysis (physical therapy adopted for the treatment of chronic renal failure)
If you are undergoing peritoneal dialysis (2L/h) after instillation for 24 hours of a dialysate solution containing, respectively, 50mg/L and 150mg/L of the drug, the concentrations of cefazolin in the blood have resulted in an average of 10 and 30 mg/ml. Peaks in the blood were 29 mg/ml (from 13 to 44 mg/ml) with 50 mg/L (3 patients) and 72 mg/ml (26 to 142 mg/ml) with 150 mg/L (6 patients).

Use in perioperative prophylaxis
If you are going to undergo surgery, you may be administered into the muscle a dose of 1 g 30 to 60 minutes before the operation. For long operations (e.g. 2 hours or more), you may be administered during the operation a supplementary dose of 0.5 to 1 g (to be modified according to the duration of the operation);
Treatment with NEFAZOL may be continued every 6-8 hours for 24 hours after the operation to avert the risk of infections.
It is important that:

• 1) the initial dose is administered from half an hour to an hour before the start of the operation to guarantee adequate blood and tissue levels of the antibiotic at the time of incision;
• 2) if exposure to pathogens is highly likely, cefazolin should be administered at regular intervals during the operation, to guarantee constant blood levels;
• 3) the use of cefazolin for prophylactic purposes ends within 24 hours after the end of the operation;
• 4) in surgical operations where the occurrence of infection can be particularly devastating (e.g. open heart operations, arthroplasty implants), prophylaxis with cefazolin may continue for 3-5 days after the operation.

Method of administration
The cefazolin solution reconstituted with the solvent vial containing lidocaine, attached to the package, can be administered intramuscularly.Once the solvent has been added, the vial must be shaken until the powder is completely dissolved.

Attention: the 4 ml solvent vial attached to the 1 g packages, containing 0.5% lidocaine hydrochloride, is reserved for intramuscular use only.
The solution must be used immediately after reconstitution.

Cefazolin should be reconstituted by dissolving the contents of the vial with the solvent vial attached to the package,

If you take more NEFAZOL than you should
If you are administered an excessive amount of cefazolin, immediately stop administering the drug and inform your doctor or go to the nearest hospital.
The symptoms and signs of administering an excessive amount of cefazolin are pain, inflammation and phlebitis at the injection site, dizziness, numbness of the limbs and headache. Sometimes, due to an overdose, seizures can be triggered, particularly in patients with kidney problems in whom drug accumulation can occur. Alterations in laboratory parameters: increase in the amount of creatinine and nitrogen in the blood (creatininemia and azotemia), liver enzymes and bilirubin, positivity to the Coombs test (examination for the diagnosis of anemia), alteration of the number of blood cells and prolongation of prothrombin time (parameter for evaluating blood coagulation capacity).
If you experience any of the symptoms mentioned above, your doctor or the hospital doctor will subject you to the most effective therapeutic treatments based on the symptoms you manifest.

If you forget to take NEFAZOL
If you are not administered a dose of NEFAZOL, inform your doctor who will indicate how to proceed with the therapy.
If you miss an injection, you should receive it as soon as possible. However, if it is almost time to receive the next scheduled injection, skip the missed injection.
It is not necessary to administer a double dose to compensate for the missed dose.

If you stop taking NEFAZOL
Do not stop administering the medicine without first consulting your doctor.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• positive Coombs test, direct and indirect (laboratory test used to reveal the presence of autoimmune diseases);
• severe allergic reaction (anaphylactic) manifesting with shortness of breath, often followed by serious problems with blood circulation (cardiovascular collapse) or shock, manifestations at the skin level (essentially itching and hives, with or without swelling of the skin and mucous membranes) and at the level of the stomach and intestines (nausea, vomiting, abdominal pain with cramps and diarrhea);
• mild and transient changes in the blood, for example: increased number of platelets (thrombocy- temia), reduction in the number of white blood cells (neutropenia, leucopenia, agranulocytosis) or platelets (thrombocytopenia), reduction in the number of red blood cells (anemia, hemolytic anemia), reduction in the number of all cells present in the blood (aplastic anemia, pancytopenia) and bleeding;
• insufficient kidney function (acute renal failure) associated with kidney inflammation (ne- phritis interstitial);
• severe inflammation of the colon associated with the use of antibiotics (pseudomembranous colitis), possibly fatal. Colitis may occur even after discontinuation of treatment;
• hives, itching, skin rashes of various types (maculopapular, erythematous or morbilliform);
• fever and chills;
• reactions similar to serum sickness (fever, hives, joint pain, swelling and enlargement of the lymph nodes);
• increased number of white blood cells (eosinophilia);
• joint pain;
• swelling;
• skin redness;
• anal and genital itching;
• swelling of the skin and mucous membranes (angioedema);
• severe allergic skin reactions, possibly fatal (Stevens-Johnson syndrome, erythema multi- forme, toxic epidermal necrolysis);
• skin peeling (exfoliative dermatitis); Hypersensitivity reactions can occur especially in patients who have already experienced allergic reactions in the past, particularly to penicillin.
• increased values indicating impaired liver function, for example transaminases (AST/SGOT, ALT/SGPT), alkaline phosphatase, lactate dehydrogenase (LDH), gamma-glutamyltranspeptidase (GGTP) or bilirubin, or liver dysfunction, including blockage of bile excretion (cholesta- sis). These effects are generally mild and disappear with discontinuation of therapy;
• transient increase in values indicating impaired kidney function, for example azotemia and creatinine;
• nausea, vomiting and diarrhea;
• thrush (oral candidiasis);
• abdominal pain;
• continuous need to urinate/defecate;
• indigestion;
• inflammation of the tongue;
• heartburn;
• reactions at the injection site, for example pain, hardening of the tissues, swelling;
• inflammation of the vein (phlebitis) following administration of the medicine into a vein;
• feeling of tightness in the chest;
• dizziness, headache;
• discomfort, fatigue;
• fungal infection and inflammation of the vagina, with itching in the genital and anal area.

These side effects require the adoption of the necessary therapeutic measures and careful con-
sideration by the doctor who, if necessary, will decide whether to discontinue treatment.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. 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 NEFAZOL

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 pack after “Scad.”. The
expiry date refers to the last day of that month and the product in intact packaging
correctly stored.
From a microbiological point of view, the product after reconstitution with its solvent, must be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and normally should not exceed 24 hours at 2° - 8° C, unless the reconstitution has taken place under controlled and validated aseptic conditions.
Do not dispose of any medicine in wastewater 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 NEFAZOL contains
The active ingredient is cefazolin.
One vial of lyophilized NEFAZOL contains 1048 mg of cefazolin sodium equivalent to 1000 mg of
cefazolin.
One vial of solvent of 4 ml for intramuscular use contains lidocaine hydrochloride monohydrate and wa-
ter for injectable preparations.

Description of the appearance of NEFAZOL and contents of the pack
NEFAZOL is available as powder and solvent for injectable solution for intramuscular use.
Cardboard box containing one glass vial of
1g powder and 1 glass vial of 4 ml containing the solvent.

Marketing Authorisation Holder and Manufacturer
HOLDER
NEW RESEARCH S.r.l.
Via Tiburtina, 1143 00156 Rome

MANUFACTURER
ESSETI Farmaceutici S.r.l.
Via Campobello, 15
00040 Pomezia (RM)
Italy