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Cefazolin vial 2 g.

Product Code: Cefazolin vial 2 g.
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Qualitative and quantitative composition:
Active principle:
Cefazolin (CID) as the sodium salt of 2 g as a powder contained in a clear glass vial (15/17 ml), sealed with a rubber stopper and sealed with a cap covered by a two-component material.

Excipients: none.
Qualitative formula:
Cefazolin (CID) as the sodium salt - European Pharmacopoeia, latest edition. Clear glass vial (type III) - ref. European Pharmacopoeia, latest edition. Butyl rubber stopper - ref. European Pharmacopoeia, latest edition.

Powder for solution for injection.

4. Clinical data:

4.1 Indications
CEFAZOLIN PANPHARMA is effective in bacterial infektsiii and have pharmacokinetic characteristics of cefazolin. Indications are the result of studies carried out on this drug and the place of cefazolin in the series of currently available antibacterial drugs.
Cefazolin is indicated for infections caused by susceptible organisms, particularly in the following disorders:
- Bronchopulmonary,
- Septicemic, endocardial
- Kozhni.serozni,
- ENT and dental,
- Genitourinary,
- Bone - joint infections.
This antibiotic is not indicated for the treatment of meningitis (even if caused by susceptible organisms) due to poor penetration of cefazolin in cerebrospinal fluid.

Cefazolin is also indicated for perioperative prophylaxis of post-operative infections in:
- Neurosurgery (craniotomy, derivation of cerebrospinal fluid)
- Heart surgery
- Thoracic Surgery
- Vascular Surgery,
- Gastrointestinal surgery
- Hepatobiliary surgery
- Caesarean section
- Abdominal or vaginal hysterectomy,
- Surgery of the head and neck with the opening of the oropharynx,
- Orthopedic surgery.

4.2 Dosage and method of administration
• Method of application:

CEFAZOLIN PANPHARMA is administered by intravenous route after raztvaryane.f CEFAZOLIN PANPHARMA can be applied both by direct injection and by continuous or periodic infusion. Prepare primary Spacing by dissolving the powder with 2-3 ml of solvent.
How to prepare:
• Periodic perfusion:
Dilute the primary solution CEFAZOLIN PANPHARMA in 50 ml to 100 ml of distilled water for injection or in an intravenous solution of:
• 0.9% solution of NaCI,
• 5% glucose Ringer-lactate,
• 5- to -10% glucose,
• Solution Ha Ringer,
• 5% glucose & 0.9% sodium chloride (and possibly the use of 5% glucose & 0.45% or 0.2% sodium chloride)
• A solution of Hartman,
• 5% to 10% glucose in sterile water for injection
- Diluted solution with one of these solvents is stable for 48 hours if stored in a refrigerator.

• Direct intravenous injection:
- Dilute primary Cefazolin solution in 5 mL to 10 mL of distilled water for the preparation of the injection solution and inject slowly for 3 to 5 minutes or directly into a vein or into the sleeve of the system.
Usual dosage: Sledniite dosages may be adapted to the severity of infection.
• Adults: 500 mg to 1 g every 8 to 12 hours.
• Children & babies (more than 1 month): from 25 to 50 mg / kg every 24 hours

• Premature neonates (less than 1 month): do not use.
There are no safety in these patients; therefore recommended in these patients does not apply CEFAZOLIN PANPHARMA.
• Strictly follow the prescribed doses.

In patients with renal impairment:
• Severe and very severe infections:
Creatinine clearance STARTING DOSE maintenance dose
50 to 20 ml / min 500 mg 250 mg every 6 hours per day or 500 mg every 12 hours.
20 to 10 ml / min 500 mg 250 mg every 12 hours or 500 mg every 24 hours
10 to 5 mL / min 500 mg 250 mg every 24-36 hours or 500 mg every
48-72 hours
<5 mL / min in patients undergoing hemodialysis
500 mg by i.v. Annex 500 mg every 72 hours

50 to 20 ml / min 120 500 mg to 250 mg every 12 hours
20 to 10 ml / min 125 500 mg to 250 mg every 24 hours
10 to 5 mL / min 500 mg of 75 to 125 mg every 24 hours
<5 ml / min at
hemodialysis patients 500 mg by I.V. time 50 to 75 mg every 72 hours

4.3 Contraindications
• Allergy to cephalosporin antibiotics group.
Safety in these patients has not been established; therefore it is not recommended for use CEFAZOLIN PANPHARMA in these patients.

4.4 Special warnings and special precautions for use

• Treatment should be promptly discontinued if appear any sign of allergy.
• Before starting treatment with cephalosporins prescribers should waive thorough "medical history.
• As allergy to penicillin Cross allergy to cephalosporins in 5 to 10% of cases:
. Cephalosporins should be used with caution in patients allergic to penicillin; Patients should be monitored closely from the first application.
. Cephalosporins should not be administered to patients with a known history of immediate allergy to cephalosporins.
If there is any doubt, the physician should monitor patients at the first dose, as you will treat anaphylactic shock.
- Have been reported rare cases of pseudo-membranous colitis with broad-spectrum antibiotics. This diagnosis should be applied to patients suffering from long-term diarrhea that occurs during or subsequent antibiotic therapy. Diarrhea are reversible after discontinuation of treatment, but significant diarrhea require specific treatment.

• For combination of cefazolin with nephrotoxic antibiotics (especially aminosides) or diuretics (furosemide or ethacrynic acid) is recommended to continuously monitor renal function.
• In patients with renal insufficiency dose must comply with creatinine clearance and serum creatinine.
• The sodium content is 2.2 mole / gm (48.3 mg / g cefazolin).

4.5 Interactions:
Clinical examinations :
Upon treatment with cephalosporin antibiotics has been reported positive direct test Coombs. This can occur in patients treated with tsefazopin. • premature neonates, infants & generally defined - children under 1 month:

4.6 Pregnancy and lactation

• Pregnancy:
Studies carried out on animals have established teratogenic effects. In view of the absence of teratogenicity in animals, malformations in humans are not expected. Indeed, until now, in studies on both species, substances responsible for malformation in humans have proved to be teratogenic in animals.
In hospitals and clinics survey a large number of treated pregnant women not identified until now malformations or special foetotoxic effect.
However, further studies are needed to assess the implications of such use during pregnancy.
Cefazolin may be prescribed if necessary during pregnancy.

• Breastfeeding:
Cefazolin passes into breast milk low (<5.0%) ingested amount is far lower than therapeutic doses.
Hence, breast-feeding is possible at the time of treatment with this medication. In the event of diarrhea, thrush or skin rash, however, nursing (or treatment with this medication) should be stopped. Traces of cefazolin were found in breast milk.


4.7 Effects on ability to drive and use machines.
No reported impact on driving CEFAZOLIN PANPHARMA Injection.

4.8 Undesirable effects
• Allergic reactions: skin rash, fever.
• Gastrointestinal disorders: diarrhea, nausea, anorexia, vomiting, and oral candidiasis.
• Hematologic disorders: eosinophilia, leukopenia, reversible thrombocytopenia.
• Liver disorders: Transient elevations of SGOT & SGPT transaminases and alkaline phosphatase.
• Nephrotoxicity: abnormal renal function have been reported in antibiotics of the same group, especially in the case of joint treatment aminosides and strong diuretics.
• Drug induced phlebitis after IV injection. Have been reported rare cases of pseudo-membranous colitis.

4.9 Overdose * in urine can register a false positive reaction to glucose.
Pain, inflammation and phlebitis at the injection site symptoms of overdose of cefazolin. Dizziness, paresthesia and headache have been reported after administration of high doses of cephalosporins. Metabolic encephalopathy (mental disorder, unstable movements, convulsive crisis) may occur, especially in patients with renal insufficiency.
In cases of accidental overdose of cefazolin treatment with this drug should be discontinued and in case of convulsive crises should be given anticonvulsant lechenie.V cases of severe overdose, especially in renal insufficiency may be recommended dialysis associated with hemoperfusion by measure of last resort, although efficacy have not been established.

5. Pharmacological:
This drug is bactericidal antibiotic belonging to the beta-lactam family, the group of injectable cephalosporins of the first generation.

ATC Code: J01DA04 (J: Anti-infectious)


5.1 Pharmacodynamic properties
Serum concentrations distinguish susceptible strains from strains with intermediate susceptibility and resistance of these: S <8mg / l and R> 32mg / l for some types of existence of a resistance may vary depending on geography and time. Fruitful is to have information on the presence of local resistance, particularly for the treatment of serious infections. These data can only give orientation to the possibility of sensitivity of a bacterial strain to this antibiotic. 5.2 Pharmacokinetic properties
Administration by continuous I.V. perfusion (healthy volunteers), a first dose of 3.5 mg / kg of Cefazolin for one hour (i.e. about 250 mg) and then doses of 1.5 mg / kg over the next two consecutive hours (i.e. about 100 mg ) showed steady serum levels of about 28 mcg / ml during the third hour. Weather elimination half-life is approximately 100 minutes in patients with normal renal function.
Therapeutic levels are achieved in pleural fluid, joint fluid and ascites technost.Bez biliary obstruction concentrations of cefazolin in the gallbladder and bile are high and more significant than those in serum.
But in case of obstruction, the antibiotic concentration in bile was much lower than that of the serum.
Cefazolin crosses the placental barrier rapidly towards the cordon blood and amniotic fluid. In breast milk levels of cefazolin are very low. The degree of protein binding is between 85 and 90% in physiological condition. Passage of cefazolin in cerebrospinal fluid is low.

Cefazolin is not metabolized.

Cefazolin eliminated in active form, mainly in the urine and only slightly by zhlachkata.Sled IM administration of 500 mg, between 56 and 89% of the administered dose was recovered in urine of six hours; the rate reaches 80 to nearly 100% after 24 hours. Following IM administration of 500 mg and 1 g, the values ​​found in urine fraction of 0-6 h are respectively 1000/2000 mg / ml and 2000 / 4000mg / ml.

5.3 Preclinical safety data
Fertility studies conducted in rats at doses of 500 mg to 1 g / kg cefazolin showed no decrease in fertility or fetotoxic effects of medikamenta.Ne are carried prouchvaniv mutagenicity and long-term carcinogenicity study.

6. Pharmaceutical particulars
6.1 List of ingredients and their quantities
not implemented

6.2 incompatibilities
4.3 Contraindications
4.5 Interaction with other medicinal products and other forms of interaction
4.8 Undesirable effects
It is not recommended dissolution, respectively dilution with solvents other than those listed in paragraph 4.2..

6.3 Shelf life
• 2 years under normal storage conditions

6.4 Special precautions for storage
of the dry powder in the original vial:
• keep away from light, in a cool, dry place at a temperature no higher than 25 ° C. the diluted solution:
• Once reconstituted with water for injection or with one of the previously described solutions for infusion, the mixture remains stable for 48 hours if stored in a refrigerator at a temperature between + 2 ° C and + 8 ° SPrahat injection is stored in a clear glass vial (type III
• Cartons c vials of 2 g x 10 pcs. and 'x 50 pcs. pack

6.6 Recommendations for use
• Reconstitution and dilution of Cefazolin Panpharma should be performed immediately before injection.

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