Cefazolin
Cefazolin Dali Pharma contains the active substance cefazolin (as cefazolin sodium).
Cefazolin is an antibiotic belonging to the group of cephalosporins, which have a bactericidal effect.
Cefazolin Dali Pharma is used to treat bacterial infections caused by bacteria sensitive to cefazolin. Cefazolin Dali Pharma is used to treat the following infections:
Cefazolin Dali Pharma is also used before, during, or after surgery to prevent infections in patients.
Before starting treatment with Cefazolin Dali Pharma, discuss it with your doctor or pharmacist
Cefazolin Dali Pharma must not be administered into the spinal canal (intrathecally), as severe central nervous system toxicity (including seizures) has been reported.
Prolonged use of Cefazolin Dali Pharma may cause superinfections. Your doctor will then prescribe appropriate treatment.
Cefazolin Dali Pharma may give false-positive results in some laboratory tests.
Cefazolin should not be used in premature infants and newborns under 1 month of age, as the safety of the medicine in this age group has not been established.
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This includes medicines available without a prescription.
Pay special attention if you are taking any of the following medicines:
Cephalosporins like cefazolin may interfere with the conversion and utilization of vitamin K1 in the body, especially in patients with vitamin K1 deficiencies. During treatment with Cefazolin Dali Pharma, your doctor may recommend vitamin K1 supplementation.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor before using this medicine.
Pregnancy
Cefazolin crosses the placental barrier and may affect the unborn child. Therefore, cefazolin should only be used during pregnancy if it is absolutely necessary and after careful consideration by your doctor of the benefit-to-risk ratio.
Breastfeeding
Cefazolin passes into human milk in small amounts. Therefore, breastfeeding should be discontinued during treatment with Cefazolin Dali Pharma.
Fertility
In animal studies, no effect on fertility has been observed.
Cefazolin has no influence or negligible influence on the ability to drive and use machines. However, during treatment, side effects (e.g., allergic reactions, non-systemic dizziness) may occur that can affect these activities (see also section 4).
Cefazolin Dali Pharma contains 101.2 mg of sodium (the main component of table salt) per 2 g dose.
This corresponds to 5.1% of the maximum recommended daily sodium intake in the diet for adults. This should be taken into account in patients on a sodium-restricted diet.
This medicine should be administered to the patient by a qualified person, i.e., a doctor or nurse. This medicine should always be used as directed by your doctor. In case of doubts, consult your doctor.
Cefazolin Dali Pharma 2 g, after reconstitution, is administered intravenously in the form of an infusion. Your doctor will inform you about the required duration of treatment and the frequency of Cefazolin Dali Pharma administration.
The recommended dose of Cefazolin Dali Pharma is determined by your doctor based on the severity of the infection, body weight, and age, as well as kidney function.
The safety of the medicine in premature infants and newborns under 1 month old has not been established.
Dose adjustment is not necessary in elderly patients with normal kidney function
Surgical prophylaxis
1 g of cefazolin 30-60 minutes before surgery. In cases of prolonged operations (2 hours or longer), an additional dose of 0.5-1 g of cefazolin during surgery.
Patients with renal impairment
In patients with renal impairment, cefazolin excretion is slowed down. Therefore, your doctor will adjust the dosage according to the degree of renal impairment by reducing the maintenance dose or prolonging the interval between doses.
The duration of treatment depends on the severity of the infection and the patient's recovery.
Contact your doctor or nurse immediately if you think you have been given a higher dose than recommended.
Since the medicine is administered by a doctor or nurse, it is unlikely that the patient will be given a higher dose than recommended. Symptoms of overdose include systemic dizziness, feeling of pricking, itching, or tingling without an apparent cause (paresthesia) and (or) headache.
In patients with kidney disease, seizures may occur. Contact your doctor immediately if you experience any of the above symptoms! In emergency cases, immediate medical attention is required to treat overdose symptoms.
Contact your doctor immediately if you think you have missed a dose of the medicine.
Missed doses should still be administered. Do not take a double dose to make up for a missed dose. Missed doses should only be administered if the time before the next regular dose is long enough.
Small doses of the medicine, irregular dosing, or premature termination of treatment may affect the treatment outcome or cause a relapse of the infection, which is more difficult to treat. Follow your doctor's instructions.
In case of any further doubts related to the use of this medicine, consult your doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommonside effects (may occur in less than 1 in 100 patients, but more than 1 in 1,000 patients):
Rareside effects (may occur in less than 1 in 1,000 patients, but more than 1 in 10,000 patients):
Very rareside effects (may occur in less than 1 in 10,000 patients):
Commonside effects (may occur in less than 1 in 10 patients, but more than 1 in 100 patients):
Uncommonside effects (may occur in less than 1 in 100 patients, but more than 1 in 1,000 patients):
Rareside effects (may occur in less than 1 in 1,000 patients, but more than 1 in 10,000 patients):
Very rareside effects (may occur in less than 1 in 10,000 patients):
If you experience any side effects, tell your doctor or pharmacist. This includes any side effects not listed in this leaflet.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse. Side effects can be reported directly to: Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.
Store the medicine out of sight and reach of children.
Do not use this medicine after the expiration date stated on the outer packaging and label after EXP. The expiration date refers to the last day of the month stated.
This medicinal product does not require any special storage conditions. Store the vials in the outer packaging to protect them from light.
From a microbiological point of view, the prepared solution should be used immediately after preparation. If the solution is not used immediately, the person administering the medicine is responsible for the storage conditions and the time after opening, which usually should not exceed 24 hours at a temperature of 2-8°C, unless the reconstitution and (or) dilution took place in controlled and validated aseptic conditions.
Do not use Cefazolin Dali Pharma if you notice any visible signs of degradation, such as solid particles and discoloration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
The active substance of the medicine is cefazolin. Each vial contains 2 g of cefazolin (as cefazolin sodium).
The medicinal product does not contain any other ingredients besides the active substances.
Cefazolin Dali Pharma, 2 g, is a white or almost white powder in a 20-mL vial made of colorless glass, closed with a gray stopper and a red cap.
The packaging contains 10 vials.
Dali Pharma GmbH
Brehmstraße 56
40239 Düsseldorf
Germany
Email: dali_ra@szzhijun.com
Health-Med sp. z o.o. sp.j.
ul. Chełmska 30/34
00-725 Warsaw
Germany
Cefazolin Dali Pharma 2 g Pulver zur Herstellung einer Infusionslösung
Poland
Cefazolin Dali Pharma
This leaflet contains practical information about the preparation and (or) handling of the medicinal product. Read the leaflet carefully before administering the medicine to the patient.
Note:this leaflet does not contain all the necessary information for this medicine. When deciding on the suitability of the medicine for a specific patient, the prescribing doctor should consult the Summary of Product Characteristics (SmPC).
Infections caused by microorganisms very sensitive to cefazolin:
The recommended total daily dose is 25-50 mg/kg body weight in 2-4 divided equal doses (1 dose every 6, 8, or 12 hours).
Infections caused by microorganisms less sensitive to cefazolin:
The recommended total daily dose may be increased to 100 mg/kg body weight in 3-4 divided equal doses (1 dose every 6-8 hours).
Body weight | 5 kg | 10 kg | 15 kg | 20 kg | 25 kg |
25 mg/kg body weight per day in 2 divided equal doses (1 dose every 12 hours) | 63 mg | 125 mg | 188 mg | 250 mg | 313 mg |
25 mg/kg body weight per day in 3 divided equal doses (1 dose every 8 hours) | 42 mg | 85 mg | 125 mg | 167 mg | 208 mg |
25 mg/kg body weight per day in 4 divided equal doses (1 dose every 6 hours) | 31 mg | 62 mg | 94 mg | 125 mg | 156 mg |
50 mg/kg body weight per day in 2 divided equal doses (1 dose every 12 hours) | 125 mg | 250 mg | 375 mg | 500 mg | 625 mg |
50 mg/kg body weight per day in 3 divided equal doses (1 dose every 8 hours) | 83 mg | 166 mg | 250 mg | 333 mg | 417 mg |
50 mg/kg body weight per day in 4 divided equal doses (1 dose every 6 hours) | 63 mg | 125 mg | 188 mg | 250 mg | 313 mg |
100 mg/kg body weight per day in 3 divided equal doses (1 dose every 8 hours) | 167 mg | 333 mg | 500 mg | 667 mg | 833 mg |
100 mg/kg body weight per day in 4 divided equal doses (1 dose every 6 hours) | 125 mg | 250 mg | 375 mg | 500 mg | 625 mg |
Do not mix cefazolin solutions with other medicines, except for those listed in the section on solution preparation.
The following active substances or solutions for reconstitution and (or) dilution should not be administered simultaneously: amikacin sulfate, sodium amobarbital, ascorbic acid, bleomycin sulfate, calcium glucoheptonate, calcium gluconate, cimetidine hydrochloride, colistin sulfate methanesulfonate, erythromycin glucoheptonate, kanamycin sulfate, oxytetracycline hydrochloride, sodium pentobarbital, polymyxin B sulfate, and tetracycline hydrochloride.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
Reconstitution/dilution of the product should be carried out under aseptic conditions. Before administration, the solution should be visually inspected for the presence of solid particles and discoloration.
Only use clear, colorless, or almost colorless solutions that are free from solid particles.
In cooled solutions, a precipitate may form, which dissolves again upon reaching room temperature. Before using the solution, ensure that the precipitate has completely dissolved.
Information on the volume and compatibility of solvents that can be used for dilution/reconstitution is provided below.
The dry powder should be reconstituted in 5 mL of water for injection or in one of the following solutions. Further dilution should be carried out with one of the following compatible solvents in accordance with the dilution table below:
Table containing the necessary data for reconstituting the powder in the case of intravenous infusion.
Vial content | Reconstitution | Dilution | Approximate concentration |
Volume of solvent to be added | Volume of solvent to be added | ||
2 g | 5 mL |
| 19 mg/mL – 36 mg/mL |
This medicinal product does not require any special storage conditions. Store the vials in the outer packaging to protect them from light.
Shelf life of the solution after reconstitution
The prepared solution shows chemical and physical stability for 12 hours at a temperature of ≤ 25°C and for 24 hours at a temperature of 2-8°C.
From a microbiological point of view, the prepared solution should be used immediately after preparation. If the solution is not used immediately, the person administering the medicine is responsible for the storage conditions and the time after opening, which usually should not exceed 24 hours at a temperature of 2-8°C, unless the reconstitution and (or) dilution took place in controlled and validated aseptic conditions.
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