CEFAZOLIN

The dosage as well as the method of administration are dependent on the location and severity of the infection and on the clinical and bacteriological progress. Adults and adolescents (above 12 years of age and ≥ 40 kg bodyweight) • Infections caused by sensitive micro-organisms: 1 g - 2 g cefazolin per day divided into 2-3 equal doses.

• Infections caused by moderately sensitive micro-organisms : 3 g - 4 g cefazolin per day divided into 3-4 equal doses. In severe infections, doses of up to 6 g per day can be administered in three or four equal doses (one dose every 6 or 8 hours).

5 - 1 g cefazolin during the intervention. • Prolonged continuation of administration beyond the surgical intervention should be supported by national official guidance. It is important that (1) the preoperative dose be given just (30 min to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms.

Adult patients with renal impairment Adults with renal impairment may need a lower dose to avoid overlapping. This lower dose may be guided by determining blood levels. If not possible the dosage of creatinine clearance can be established.

6 Half of the normal dose every 18-24 hours In haemodialysis patients, the treatment schedule depends on the dialysis conditions.

Paediatric population:

Infections caused by sensitive microorganisms A dose of 25-50 mg / kg body weight divided into two to four equal doses per day is recommended (one dose every 6, 8 or 12 hours). Infections caused by moderately sensitive microorganisms A dose of up to 100 mg / kg body weight divided in three or four equal doses is recommended (one dose every 6 or 8 hours).

Prematures and infants below the age of 1 month Since safety of use in prematures and infants below the age of one month has not been determined, the use of Cefazolin in these patients is not recommended. See also section

Dependent on the dose and duration of the treatment, patients are expected to experience one or several of the adverse reactions mentioned below. System Organ Class Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Infections and infestations Oral candidiasis (prolonged use).

Genital candidiasis (monoliasis), vaginitis System Organ Class Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Blood and lymphatic system disorder Increase or decrease in blood glucose concentration (hyperglycemia or hypoglycemia).

Leukopenia, granulocytopenia, neutropenia, thrombocytopenia, leukocytosis, granulocytosis, monocytosis, lymphocytopenia, basophilia and eosinophilia were observed in blood counts. These effects are rare and reversible. Coagulation (blood clotting) disorders and bleeding as a consequence.

, haemophilia, stomach and duodenal ulcers). 5. Decreased haemoglobin and/or hematocrit, anaemia, agranulocytosis, aplastic anaemia, pancytopenia and hemolytic anaemia. Immune system disorders Erythema, erythema multiforme, exanthema, urticaria, reversible local permeability of the blood vessels, joints, or mucous membranes (angioedema), drug-induced fever and interstitial pneumonia or pneumonitis Toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome.

Anaphylactic shock, swelling of the larynx with narrowing of the airways , increased heart rate, shortness of breath, falling blood pressure, swollen tongue, anal pruritus, genital pruritus, face edema. System Organ Class Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Nervous system disorders Seizures (in patients with renal dysfunction, with inappropriate high treated doses).

Dizziness, malaise, fatigue. Nightmares, vertigo, hyperactivity, nervousness or anxiety, insomnia, drowsiness, weakness, hot flushes, disturbed colour vision, confusion and epileptogenic activity. Respiratory, thoracic and mediastinal disorders Pleural effusion, chest pain, dyspnoea or respiratory distress, cough, rhinitis.

Gastrointestinal disorders Loss of appetite, diarrhoea, nausea and vomiting. These symptoms are usually moderate and often disappear during or after treatment. 4) Hepatobiliary disorders Temporary increase in serum concentrations of AST, ALT, gamma GT, bilirubin and / or LDH and alkaline phosphatase, transient hepatitis, transient cholestatic jaundice.

System Organ Class Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Renal and urinary disorders Nephrotoxicity, interstitial nephritis, undefined nephropathy, proteinuria, temporary increase in blood urea nitrogen (BUN) usually in patients treated concomitantly with other potential nephrotoxic medicines.

General disorders and administration site conditions Pain at the site of intramuscular injection, sometimes with induration Intravenous administration may cause thrombophlebitis. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via

4. e. concentration approx. 200 mg/ml). The respective volume of this solution to be used is indicated in the following table in addition to the dose in mg. 6. 15 ml Paediatric patients with renal impairment Children with renal impairment (like adults) may need a lower dose to avoid overlapping.

This lower dose may be guided by determining blood levels. If not possible, the dosage of creatinine clearance may be determined according to the following guidelines. In children with moderate impairment (creatinine clearance 40-20 ml / min), 25% of the normal daily dose, divided into doses every 12 hours are sufficient.

In children with severe impairment (creatinine 20-5 ml / min) will be 10% of normal daily dose, given every 24 hours are sufficient. All these guidelines are valid after an initial starting dose. 4.

Elderly patients:

In elderly patients with normal renal function no dosage adjustment is necessary. Method of administration Cefazolin 2 g may be administered by slow intravenous injection or by intravenous infusion after dilution. The volume of diluent to be used for the reconstitution is dependent upon the method of administration.

6. Duration of treatment The duration of the treatment depends on the severity of the infection as well as on the clinical and bacteriological progress. 3 Contraindications Hypersensitivity to cefazolin. Patients with known hypersensitivity to cephalosporin antibiotics.

g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems). 3). As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported.

In case of severe hypersensitivity reactions, treatment with cefazolin must be discontinued immediately and adequate emergency measures must be initiated. Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to cefazolin, to other cephalosporins or to any other type of beta-lactam agent.

Caution should be used if cefazolin is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents. Cefazolin should be administered only with special caution to patients with allergic reactivity (e. g.

allergic rhinitis or bronchial asthma) as the risk for a serious hypersensitivity reaction is increased. Antibacterial agent-associated pseudomembranous colitis has been reported with use of cefazolin and may range in severity from mild to life threatening.

8). Discontinuation of therapy with cefazolin and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.

Paediatric use:

As there are no sufficient experiences available so far, Cefazolin 2 g must not be applied to new-borns and babies in the first month of life. Precautions In case of a renal insufficiency with a glomerular filtration rate under 55 ml/min, an accumulation of cefazolin must be taken into consideration.

2). In patients with renal impairment the use of cefazolin may be associated with seizures. Prolonged prothrombin time may occur in patients with renal or hepatic impairment or poor nutritional state, as well as in patients receiving a protracted course of antimicrobial therapy, and patients previously stabilised on anticoagulant therapy.

8). g. g. g. g. by heparin or […]

Hypersensitivity to cefazolin. Patients with known hypersensitivity to cephalosporin antibiotics. g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems).