Cefazolin Pharmacare

Patient Information Leaflet

CEFAZOLIN PHARMACARE

1 g/4 ml powder and solvent for injectable solution for intramuscular use
Cefazolin
Generic medicine
Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, 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 pharmacist. See section 4.

Contents of this leaflet:

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

1. What CEFAZOLINA PHARMACARE is and what it is used for

CEFAZOLINA PHARMACARE contains the active substance cefazolin.
Cefazolin belongs to a class of medicines called beta-lactam antibiotics, which are used to treat infections caused by bacteria sensitive to this active ingredient.
CEFAZOLINA PHARMACARE is used to treat the following infections:

• respiratory tract infections,
• ear and throat infections,
• liver and biliary tract infections,
• genitourinary tract infections,
• skin, soft tissue, bone, and joint infections,
• obstetric and gynecological infections,
• eye infections,
• inflammation of the membrane lining the internal abdominal walls (peritoneum), of the blood (septicaemia), and of the tissue lining the internal chambers and valves of the heart (endocardium), caused by bacteria.

2. What you need to know before using CEFAZOLIN PHARMACARE

Do not use CEFAZOLIN PHARMACARE

• If you or your child are allergic to cefazolin, or to any of the other components of this medicine (listed in section 6).
• If you are allergic to other medicines chemically similar to cefazolin, particularly penicillins, cephalosporins, and other beta-lactam antibiotics; if you are allergic to lidocaine (a local anesthetic contained in CEFAZOLIN PHARMACARE formulations for intramuscular injection) or to other local anesthetics of the amide type;
• If your child was born prematurely (before full term) or is less than 1 month old.

Warnings and precautions
Talk to your doctor, your child’s doctor, pharmacist, or nurse before using
CEFAZOLIN PHARMACARE.
Pay special attention and inform your doctor if you or your child:

• Have previously experienced an allergic reaction to medicines, particularly to cefazolin, cephalosporins, penicillins, or other antibiotics known as beta-lactams (chemically similar to cephalosporins and penicillins), or if you have had allergic reactions to lidocaine (a local anesthetic) or other similar local anesthetics (amide type), as you may also be allergic to CEFAZOLIN PHARMACARE (risk of severe anaphylactic reactions); if you experience any allergic reaction following administration of CEFAZOLIN PHARMACARE. In this case, stop treatment immediately and contact your doctor; severe allergic reactions, and particularly anaphylaxis, may require emergency medical treatment;
• Have a history of stomach and/or intestinal diseases, particularly inflammation of the colon (colitis);
• Develop diarrhea during treatment with this medicine. Contact your doctor immediately, as antibiotic therapy may promote the growth of antibiotic-resistant microorganisms. Rarely, disruption of the normal bacterial flora of the colon may lead to a serious condition called pseudomembranous colitis;
• Are taking blood-thinning medicines (oral anticoagulants) for the treatment of coagulation disorders. Your doctor may consider it necessary to adjust the dose of oral anticoagulants;
• There is a suspicion that you have kidney problems, as careful assessment of kidney function by your doctor is required both before and during treatment with CEFAZOLIN PHARMACARE. This medicine may cause kidney damage, and such effects are more likely if you are over 50 years of age, already suffer from kidney problems, or are taking other medicines that may cause kidney damage (see "Other medicines and CEFAZOLIN PHARMACARE"). If you have renal impairment, your doctor will adjust the dose of CEFAZOLIN PHARMACARE according to your condition;
• Suffer from chronic kidney problems (chronic renal failure) treated with a procedure called peritoneal dialysis. In this case, the rate at which your blood is filtered by this procedure may alter CEFAZOLIN PHARMACARE levels in the blood. Your doctor must closely monitor your treatment;
• Have high blood pressure (hypertension) or heart problems (heart failure), as this medicine contains sodium (see "CEFAZOLIN PHARMACARE contains sodium").

Signs of allergic reaction to cefazolin, including breathing difficulties and chest pain, have been reported.
Stop taking cefazolin immediately and contact your doctor or go to the emergency room if you notice any of
these symptoms.
Other medicines and CEFAZOLIN PHARMACARE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
In particular, inform your doctor if you are taking:

• Probenecid (used in the treatment of gout to reduce uric acid levels in the body), as it increases the concentration of CEFAZOLIN PHARMACARE in the blood;
• Antibiotic medicines that may cause kidney damage (e.g. aminoglycosides, colistin, polymyxin B, or vancomycin). Concomitant use with CEFAZOLIN PHARMACARE should be avoided if possible;
• Penicillins or chloramphenicol (antibiotics used to treat bacterial infections);
• Medicines that thin the blood (oral anticoagulants), used for the treatment of coagulation disorders. If, in addition to CEFAZOLIN PHARMACARE, concomitant administration of oral anticoagulants or high-dose heparin is strictly necessary, your doctor must closely monitor the treatment and possibly adjust the dose of anticoagulant medicines.

Concomitant use of medicines that promote slowing of fecal transit in the intestine (fecal stasis) must be absolutely avoided.
Laboratory tests
CEFAZOLIN PHARMACARE may alter the results of certain laboratory tests. Inform your doctor and laboratory staff if you or your child are being treated with this medicine. CEFAZOLIN PHARMACARE may alter the results of the Coombs test (a laboratory test used to detect autoimmune diseases). Changes in Coombs test results may also occur in your child if you were treated with CEFAZOLIN PHARMACARE before delivery. In addition, administration of CEFAZOLIN PHARMACARE may alter the results of a laboratory test measuring sugar in the urine (glycosuria), as this medicine may interfere with certain laboratory methods.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy, CEFAZOLIN PHARMACARE should be administered only if clearly needed and under the direct supervision of a doctor.
This medicine passes into breast milk in very low concentrations; however, caution should still be exercised during breastfeeding.
Driving and using machines
It is not known whether CEFAZOLIN PHARMACARE affects the ability to drive or use machinery.
CEFAZOLIN PHARMACARE contains sodium
CEFAZOLIN PHARMACARE contains 2.2 mmol (or 50.6 mg) of sodium per vial.
This should be taken into account in patients with impaired kidney function or those on a low-sodium diet.

3. How to use CEFAZOLIN PHARMACARE

Use this medicine exactly as instructed by your doctor, the doctor treating your
child, pharmacist, or nurse.
The recommended daily dose in adults ranges from 1 to 3 grams, divided into 2 or 3 doses.
The recommended daily dose in children ranges from 20 to 50 mg per kg of body weight, divided into 2 or 3
doses.
Severe infections
The recommended daily dose in adults ranges from 4 to 12 grams.
The recommended daily dose in children is 100 mg per kg of body weight.
If you/your child have kidney problems
If you or your child have kidney problems (renal insufficiency), your doctor will prescribe lower doses of
CEFAZOLIN PHARMACARE and less frequent administration than normal.
Method of administration
CEFAZOLIN PHARMACARE 1 g/4 ml powder must be administered exclusively by intramuscular injection. The solvent vial supplied in the pack contains lidocaine, a local anaesthetic, to reduce injection pain.
Draw the liquid from the solvent vial into a syringe and inject it into the vial containing the powder.
Shake the vial well until the powder is completely dissolved.
Inject CEFAZOLIN PHARMACARE deeply into the gluteal muscle or the anterior part of the thigh.
If treatment with another intramuscular antibiotic is required, do not administer CEFAZOLIN PHARMACARE in the same syringe.
If you or your child have received more CEFAZOLIN PHARMACARE than you should
It is important that you or your child never use more medicine than prescribed. However, to date, no adverse effects due to overdosage of CEFAZOLIN PHARMACARE have been reported. If you have any doubts about using this medicine, consult your doctor, the doctor treating your child, or the pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking the medicine IMMEDIATELY if you or your child experience any of the following side effects, as they may be serious:

• severe allergic reaction (anaphylactic shock) (see section 2 “Warnings and precautions”)
• swelling of the face, tongue and throat, leading to difficulty in swallowing and breathing (angioedema)
• severe inflammation of the final part of the intestine called the colon (colitis) caused by excessive growth of a bacterium called Clostridium difficile (pseudomembranous colitis) (see section 2 “Warnings and precautions”)
• death (necrosis) and shedding of areas of the skin and mucous membranes of the mouth, eyes and urethra (Stevens-Johnson syndrome)
• anaemia due to excessive destruction of red blood cells (haemolytic anaemia).

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

• positive direct and indirect Coombs test (a laboratory test used to detect autoimmune diseases)
• severe allergic (anaphylactic) reaction presenting as shortness of breath, often followed by serious circulatory problems (cardiovascular collapse) or shock, skin manifestations (mainly itching and hives, with or without swelling of the skin and mucous membranes), and gastrointestinal symptoms (nausea, vomiting, abdominal pain with cramps and diarrhoea)
• mild and transient blood abnormalities, for example: increased number of platelets (thrombocytosis), reduced number of white blood cells (neutropenia, leucopenia, agranulocytosis) or platelets (thrombocytopenia), reduced number of red blood cells (anaemia, haemolytic anaemia), reduced number of all blood cells (aplastic anaemia, pancytopenia), and bleeding
• impaired kidney function (acute renal failure) associated with kidney inflammation (interstitial nephritis)
• severe inflammation of the colon associated with antibiotic use (pseudomembranous colitis), possibly fatal. Colitis may occur even after treatment has been stopped
• hives, itching, various types of skin rashes (maculopapular, erythematous or morbilliform)
• fever and chills
• serum sickness-like reactions (fever, hives, joint pain, swelling and enlarged 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 skin allergic reactions, possibly fatal (Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis)
• skin peeling (exfoliative dermatitis).

Hypersensitivity reactions may occur especially in patients who have previously shown allergic reactions, particularly to penicillin.

• Increased liver function test values, such as transaminases (AST/SGOT, ALT/SGPT), alkaline phosphatase, lactate dehydrogenase (LDH), gamma-glutamyl transferase (GGTP), or bilirubin, or liver dysfunction, including impaired bile excretion (cholestasis). These effects are usually mild and resolve upon discontinuation of therapy
• transient increase in values indicating kidney dysfunction, such as azotemia and creatininemia
• nausea, vomiting and diarrhoea
• oral thrush (oral candidiasis)
• abdominal pain
• persistent urge to urinate/defecate
• indigestion
• inflammation of the tongue
• stomach burning
• injection site reactions, such as pain, tissue hardening, swelling
• inflammation of the vein (phlebitis) following intravenous administration
• chest tightness
• dizziness, headache
• malaise, fatigue
• fungal infection and inflammation of the vagina, with genital and anal itching.

These side effects require appropriate therapeutic measures and careful evaluation by the doctor, who will decide, if necessary, whether treatment should be discontinued.
Other possible side effects
Not known (frequency cannot be estimated from the available data)
Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
Reporting of side effects
If you or your child 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 the following website:
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 CEFAZOLIN PHARMACARE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp.". The expiry date refers to the
last day of that month and applies to the product in its original, undamaged packaging stored correctly.
Store below 25°C and keep the vial tightly closed.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What CEFAZOLINA PHARMACARE contains
The active substance is cefazolin.
One vial of CEFAZOLINA PHARMACARE lyophilisate contains 1050 mg of cefazolin sodium,
equivalent to 1000 mg (1 g) of cefazolin.
One 4 ml solvent ampoule for intramuscular use contains lidocaine hydrochloride and sterile water for
injectable preparations.
Description of the appearance of CEFAZOLINA PHARMACARE and package contents
Powder and solvent for injectable solution for intramuscular use.
CEFAZOLINA PHARMACARE is available in a cardboard carton containing one 1 g glass vial of powder and one 4 ml glass ampoule containing the solvent.
Marketing Authorization Holder and Manufacturer
MARKETING AUTHORIZATION HOLDER
PHARMACARE S.r.l.
Via Marghera 29
20149 Milan
Italy
MANUFACTURER
ESSETI Farmaceutici
Via Campobello, 15
00071 Pomezia (RM)
Italy
The following information is intended exclusively for physicians or healthcare professionals:
Dosing recommendations
In patients with renal impairment, doses should be adjusted according to the degree of kidney dysfunction,
following the dosing recommendations reported in the table below:

Incompatibilities
The reconstituted solution is incompatible with:

• non-steroidal anti-inflammatory drugs belonging to the phenylpropionic acid group.