Cefazolin
Cefazolin Dali Pharma contains the active substance cefazolin (as cefazolin sodium).
Cefazolin is an antibiotic belonging to the group of cephalosporins, with 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. The doctor will then prescribe appropriate treatment.
In rare cases, 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 yet.
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes over-the-counter medicines.
Pay special attention if the patient is 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, the doctor may recommend vitamin K1 supplementation.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 the doctor of the benefit-to-risk ratio.
Breastfeeding
Cefazolin passes into breast 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 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 50.6 mg of sodium (the main component of common salt) per 1 g dose.
This corresponds to 2.5% of the maximum recommended daily sodium intake in the diet for adults. This should be taken into account in patients on a low-sodium 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 the doctor. In case of doubts, consult a doctor.
Cefazolin Dali Pharma 1 g, after dissolution, is administered deep intramuscularly or intravenously in the form of injections or infusions. The doctor will inform the patient about the required duration of treatment and the frequency of administration of Cefazolin Dali Pharma.
The recommended dose of Cefazolin Dali Pharma is determined by the doctor based on the severity of the infection, body weight, and age, as well as the patient's kidney function.
The safety of the medicine in premature infants and newborns under 1 month old has not been established.
No dose modification is necessary in elderly patients with normal kidney function
Prevention of infections during surgical procedures
1 g of cefazolin 30-60 minutes before the surgical procedure. In the case of prolonged operations (2 hours or longer), an additional dose of 0.5-1 g of cefazolin during the procedure.
Patients with renal impairment
In patients with renal impairment, the elimination of cefazolin is slowed down. Therefore, the 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 a doctor or nurse immediately if the patient thinks they have been given a dose larger than recommended.
Since the medicine is administered by a doctor or nurse, it is unlikely that the patient will be given a dose larger than recommended. Symptoms of overdose include systemic dizziness, feeling of tingling, itching, or numbness without visible cause (paresthesia) and (or) headache.
In patients with kidney disease, seizures may occur. Contact a doctor immediately if the above symptoms occur! In emergency cases, immediate medical attention is required to treat the symptoms of overdose.
Contact a doctor immediately if the patient thinks they have missed a dose.
A missed dose should still be administered. Do not take a double dose to make up for a missed dose. A missed dose 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 outcome of treatment or cause a recurrence of the infection, which is more difficult to treat. Follow the doctor's instructions.
In case of any further doubts related to the use of this medicine, consult a 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 any side effects occur, inform a doctor or pharmacist.
This includes any side effects not listed in this leaflet.
If any side effects occur, including any not listed in this leaflet, inform a doctor or nurse. Side effects can be reported directly to: Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration 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 to gather more information on the safety of the medicine.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and label after EXP. The expiry 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 from light.
After dissolution and (or) dilution, the prepared solution shows chemical and physical stability for 12 hours at a temperature ≤ 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 should not exceed 24 hours at a temperature of 2-8°C, unless the dissolution and (or) dilution took place in controlled and validated aseptic conditions.
Do not use Cefazolin Dali Pharma if visible signs of degradation are observed, such as solid particles and discoloration.
Medicines should not be disposed of via wastewater or household waste. Ask a 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 1 g of cefazolin (as cefazolin sodium).
The medicinal product does not contain any other ingredients.
Cefazolin Dali Pharma, 1 g, is a white or almost white powder in a 15-mL vial made of colorless glass, closed with a gray plug and a green 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 1 g Pulver zur Herstellung einer Injektions-/Infusionslösung
Poland
Cefazolin Dali Pharma
This leaflet contains practical information on 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 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 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 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 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 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 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 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 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 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 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 preparation of the solution.
The following active substances or solutions for dissolution/dilution should not be administered simultaneously:
Cefazolin solutions should not be mixed with the following:
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
Dissolution/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 use, ensure that the precipitate has completely dissolved.
Instructions for dissolution and (or) dilution vary depending on the strength of the product and the route of administration. Information on the volume and compatibility of solvents that can be used for dilution/dissolution is provided below.
For each route of administration, refer to the information in the table, which presents additional volumes and concentrations of solutions that may be useful in situations where divided doses are needed.
Cefazolin Dali Pharma 1 g should be dissolved in 2.5 mL of water for injections. Shake well until completely dissolved. Do not administer more than 500 mg of cefazolin in a single intramuscular injection.
Table containing data necessary for dissolving the powder in the case of intramuscular injection.
Content per vial | Amount of solvent to be added | Approximate concentration |
1 g | 2.5 mL | 330 mg/mL |
Cefazolin Dali Pharma 1 g should be dissolved in 10 mL of water for injections. Shake well until completely dissolved
Table containing data necessary for dissolving the powder in the case of intravenous injection.
Content per vial | Amount of solvent to be added | Approximate concentration |
1 g | 10 mL | 100 mg/mL |
Cefazolin should be injected slowly into a vein over 3-5 minutes. Injections should never be administered for less than 3 minutes. Injections should be administered directly into a vein or into a set from which the patient is receiving intravenous solutions.
Single doses greater than 1 g should be administered as an intravenous infusion over 30-60 minutes.
The dry powder should be dissolved in 5 mL of water for injections or in one of the following solutions. Further dilution should be carried out with one of the following compatible solvents according to the table below:
Table containing data necessary for dissolving the powder in the case of intravenous infusion.
Content per vial | Dissolution | Dilution | Approximate concentration |
Amount of solvent to be added | Amount of solvent to be added | ||
1 g | 5 mL |
| 10 mg/mL – 18 mg/mL |
This medicinal product does not require any special storage conditions. Store the vials in the outer packaging to protect from light.
Shelf-life of the solution for injection or infusion after dissolution
The prepared solution shows chemical and physical stability for 12 hours at a temperature ≤ 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 should not exceed 24 hours at a temperature of 2-8°C, unless the dissolution and (or) dilution took place in controlled and validated aseptic conditions.
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