Cefuaar 0.750 g

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CEFUAAR 0.750 g (CEFUAAR 0.750 g)

Composition:

Active substance: cefuroxime;

1 vial contains sodium cefuroxime equivalent to cefuroxime 750 mg.

Pharmaceutical form. Powder for solution for injection.

Main physicochemical properties: crystalline powder, white to light yellow in color.

Pharmacotherapeutic group. Antibacterial agents for systemic use. Second-generation cephalosporins. ATC code J01D C02.

Pharmacological properties.

Pharmacodynamics.

Mechanism of action

Cefuroxime inhibits microbial cell wall synthesis by binding to penicillin-binding proteins (PBPs). This interrupts the biosynthesis of the cell wall (peptidoglycan), leading to lysis and death of bacterial cells.

Mechanism of resistance

Bacterial resistance to cefuroxime may be due to one or more of the following mechanisms:

• hydrolysis by beta-lactamases, including (but not limited to) extended-spectrum beta-lactamases (ESBLs) and AmpC enzymes, which may be inducible or stably expressed in certain aerobic Gram-negative bacterial species;
• reduced affinity of penicillin-binding proteins (PBPs) for cefuroxime;
• outer membrane impermeability, limiting access of cefuroxime to PBPs in Gram-negative bacteria;
• bacterial efflux pump systems.

Organisms that have developed resistance to other injectable forms of cephalosporins are expected to be resistant to cefuroxime. Depending on the resistance mechanism, organisms with acquired resistance to penicillins may exhibit reduced susceptibility or resistance to cefuroxime.

Breakpoint minimum inhibitory concentrations (MICs) for cefuroxime established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST):

Microorganism	Breakpoint concentrations (mg/l)
	Susceptible	Resistant
Enterobacteriaceae 1	≤82	>8
Staphylococcus spp.	Note3	Note3
Streptococcus A, B, C and G	Note4	Note4
Streptococcus pneumoniae	≤0.5	>1
Streptococcus (other)	≤0.5	>0.5
Haemophilus influenzae	≤1	>2
Moraxella catarrhalis	≤4	>8
Non-species-related breakpoint concentrations1	≤45	>85
1Breakpoint concentrations for determining cephalosporin activity against Enterobacteriaceae detect all clinically important resistance mechanisms (including plasmid-mediated ESBLs and AmpC). Some strains producing beta-lactamases may be susceptible or exhibit intermediate resistance to 3rd or 4th generation cephalosporins according to these breakpoints and should be reported as determined, i.e., the presence or absence of ESBLs alone does not affect susceptibility categorization. In many regions, detection and characterization of ESBLs are recommended or mandatory for infection control purposes. 2Breakpoint concentrations apply only to the 1.5 g × 3 dosage and to E. coli, P. mirabilis, and Klebsiella spp. strains. 3Staphylococcal susceptibility to cephalosporins is inferred from methicillin susceptibility, except for ceftazidime, cefixime, and cefditoren, which lack defined breakpoints and should not be used for treatment of staphylococcal infections. 4Streptococcal susceptibility of groups A, B, C, and G to cephalosporins is inferred from benzylpenicillin susceptibility. 5Breakpoint concentrations refer to a daily intravenous dose of 750 mg × 3 and high-dose regimens of at least 1.5 g × 3.

Microbiological susceptibility

Acquired resistance to the antibiotic varies by region and over time for individual microorganisms. Local antibiotic susceptibility data should be consulted, especially when treating severe infections. A specialist should be consulted if necessary, particularly when acquired resistance to the antibiotic is known and the benefit of using the medicinal product is at least questionable in the treatment of certain types of infections.

Cefuroxime generally has in vitro activity against the following microorganisms:

Susceptible strains

Gram-positive aerobes: Staphylococcus aureus (methicillin-susceptible)*, Streptococcus pyogenes, Streptococcus agalactiae

Gram-negative aerobes: Haemophilus parainfluenzae, Moraxella catarrhalis

Microorganisms for which acquired resistance may be a problem

Gram-positive aerobes: Streptococcus pneumoniae, Streptococcus mitis (viridans group)

Gram-negative aerobes: Citrobacter spp., excluding C. freundii, Enterobacter spp., excluding E. aerogenes and E. cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Proteus mirabilis, Proteus spp., excluding P. penneri and P. vulgaris, Providencia spp., Salmonella spp.

Gram-positive anaerobes: Peptostreptococcus spp., Propionibacterium spp.

Gram-negative anaerobes: Fusobacterium spp., Bacteroides spp.

Microorganisms with inherent resistance

Gram-positive aerobes: Enterococcus faecalis, Enterococcus faecium

Gram-negative aerobes: Acinetobacter spp., Burkholderia cepacia, Campylobacter spp., Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Morganella morganii, Proteus penneri, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens, Stenotrophomonas maltophilia

Gram-positive anaerobes: Clostridium difficile

Gram-negative anaerobes: Bacteroides fragilis

Others: Chlamydia spp., Mycoplasma spp., Legionella spp.

*All methicillin-resistant S. aureus are resistant to cefuroxime.

In vitro, the medicinal product Cefuarr in combination with aminoglycoside antibiotics exerts at least an additive effect, sometimes with signs of synergy.

Pharmacokinetics.

Absorption

After intramuscular administration of cefuroxime in healthy volunteers, mean peak serum concentrations ranged from 27 to 35 mcg/mL for a 750 mg dose and from 33 to 40 mcq/mL for a 1000 mg dose, achieved within 30–60 minutes after administration. Fifteen minutes after intravenous infusion of 750 mg and 1500 mg doses, serum concentrations were approximately 50 and 100 mcg/mL, respectively.

Following intramuscular and intravenous administration, pharmacokinetic parameters such as area under the concentration-time curve (AUC) and maximum concentration (Cmax) increase linearly with increasing dose within a single dose range of 250 mg to 1000 mg. There was no evidence of accumulation of cefuroxime in serum in healthy volunteers after repeated intravenous infusions of 1500 mg every 8 hours.

Distribution

Protein binding ranges from 33% to 50%, depending on the method of determination. The mean volume of distribution ranges from 9.3 to 15.8 L/1.73 m² after intramuscular or intravenous administration within the dose range of 250 to 1000 mg. Concentrations of cefuroxime exceeding the MIC for most common pathogenic microorganisms are achieved in tissues of the tonsils, nasal sinuses, bronchial mucosa, bones, pleural fluid, joint fluid, synovial fluid, interstitial fluid, bile, sputum, and intraocular fluid. Cefuroxime penetrates the blood-brain barrier during inflammation of the meninges.

Biotransformation

Cefuroxime is not metabolized.

Elimination

Cefuroxime is eliminated via glomerular filtration and tubular secretion. The elimination half-life from serum after intramuscular or intravenous injection is approximately 70 minutes. Within 24 hours after administration, the drug is almost completely (85–90%) excreted unchanged in urine. The majority of the drug is excreted within the first 6 hours. Mean renal clearance ranges from 114 to 170 mL/min/1.73 m² after intramuscular or intravenous injection within the dose range of 250 to 1000 mg.

Special patient groups

Gender

No differences in the pharmacokinetics of cefuroxime were observed between men and women after a single intravenous bolus injection of 1000 mg of cefuroxime as cefuroxime sodium.

Elderly patients

After intramuscular or intravenous administration, absorption, distribution, and excretion of cefuroxime in elderly patients are similar to those observed in younger patients with equivalent renal function. Since elderly patients are more likely to have reduced renal function, dose selection for this population should be cautious, and renal function should be monitored (see section "Dosage and administration").

Children

The elimination half-life of cefuroxime from serum is significantly prolonged in neonates depending on gestational age. However, in infants older than 3 weeks and in children, the elimination half-life from serum of 60–90 minutes is similar to that observed in adults.

Renal impairment

Cefuroxime is primarily eliminated by the kidneys. As with other similar antibiotics, patients with severe renal impairment (e.g., creatinine clearance <20 mL/min) should receive reduced doses of cefuroxime to compensate for slower drug excretion (see section "Dosage and administration"). Cefuroxime is effectively removed by hemodialysis and peritoneal dialysis.

Hepatic impairment

Since cefuroxime is primarily eliminated by the kidneys, hepatic impairment is not expected to affect the pharmacokinetics of cefuroxime.

Pharmacokinetic/pharmacodynamic relationship

For cephalosporins, the most important pharmacokinetic-pharmacodynamic index correlating with in vivo efficacy is the percentage of the dosing interval (%T) during which the concentration of the free fraction of the drug exceeds the MIC of cefuroxime for specific target strains (i.e., %T > MIC).

Clinical characteristics.

Indications.

The medicinal product Cefuwar is indicated for the treatment of the following infections in adults and children, including newborns (from birth) (see sections "Pharmacological properties" and "Special instructions").

• Community-acquired pneumonia.
• Acute exacerbation of chronic bronchitis.
• Complicated urinary tract infections, including pyelonephritis.
• Soft tissue infections: cellulitis, erysipelas, wound infections.
• Intra-abdominal infections (see section "Special instructions").
• Prophylaxis of postoperative infectious complications following gastrointestinal tract surgery, including the esophagus, orthopedic, gynecological surgeries (including cesarean section), and cardiovascular surgeries.

For the treatment and prevention of infections caused by anaerobic microorganisms, cefuroxime should be used in combination with appropriate additional antibacterial agents.

Official recommendations regarding the appropriate use of antibacterial agents should be taken into account.

Contraindications.

Hypersensitivity to cefuroxime or to any of the excipients of the medicinal product.

Hypersensitivity to cephalosporin antibiotics.

History of severe hypersensitivity (e.g., anaphylactic reactions) to other beta-lactam antibiotics (penicillins, monobactams, and carbapenems).

Interaction with other medicinal products and other types of interactions.

Like other antibiotics, the medicinal product Cefuwar may affect the intestinal flora, leading to reduced reabsorption of estrogens and decreased efficacy of combined oral contraceptives.

Cefuroxime is eliminated via glomerular filtration and tubular secretion. Concomitant use with probenecid is not recommended, as it prolongs the elimination half-life of the antibiotic and increases the maximum serum concentration.

Potentially nephrotoxic drugs and loop diuretics.

Cephalosporin antibiotics in high doses should be administered with caution in patients receiving treatment with potent diuretics (such as furosemide) or potentially nephrotoxic drugs (such as aminoglycoside antibiotics), since renal function impairment cannot be excluded with such combinations of medicinal products.

Other types of interactions

When using the medicinal product Cefuwar, blood and plasma glucose levels should be measured using the glucose oxidase or hexokinase method. Information on plasma glucose measurement is provided in the section "Special instructions."

Cefuroxime does not interfere with the results of enzymatic methods for detecting glucosuria.

Cefuroxime does not interfere with creatinine measurement by the alkaline picrate method.

Concomitant use with oral anticoagulants may lead to an increased international normalized ratio (INR).

Special precautions for use.

Hypersensitivity reactions.

As with other beta-lactam antibiotics, severe and sometimes fatal hypersensitivity reactions have been reported. Hypersensitivity reactions progressing to Kounis syndrome – acute allergic coronary artery spasm – which may lead to myocardial infarction, have been documented (see section "Adverse reactions"). In case of severe hypersensitivity reactions, cefuroxime therapy should be discontinued immediately and appropriate emergency measures should be initiated.

Prior to starting treatment, it is necessary to determine whether the patient has a history of severe hypersensitivity reactions to cefuroxime, cephalosporin antibiotics, or other beta-lactam antibiotics. The medicinal product should be administered with caution in patients who have experienced hypersensitivity reactions to other beta-lactam antibiotics.

Severe cutaneous adverse reactions (SCARs)

Severe cutaneous adverse reactions, including Stevens–Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome, which may be life-threatening or fatal, have been reported during cefuroxime treatment (see section "Adverse reactions").

When prescribing the medicinal product, patients should be informed about the signs and symptoms and carefully monitored for skin reactions. If signs or symptoms suggestive of these reactions occur, cefuroxime should be discontinued immediately and alternative therapy considered. If a patient develops a serious reaction such as Stevens–Johnson syndrome, toxic epidermal necrolysis, or DRESS syndrome during cefuroxime treatment, cefuroxime must never be re-administered to this patient.

Concomitant treatment with potent diuretics or aminoglycosides

Cephalosporin antibiotics administered in high doses should be used with caution in patients receiving treatment with potent diuretics such as furosemide or aminoglycoside antibiotics, as cases of adverse effects on renal function have been reported with such combinations. Renal function should be monitored in these patients, as in elderly patients and in patients with renal impairment (see section "Dosage and administration").

Overgrowth of resistant microorganisms

Cefuroxime use may lead to overgrowth of Candida species. Prolonged use of cefuroxime may result in overgrowth of resistant microorganisms (such as Enterococci, Clostridium difficile), which may necessitate discontinuation of therapy (see section "Adverse reactions").

Cases of pseudomembranous colitis, ranging from mild to life-threatening, have been reported with antibiotic use. Therefore, it is important to consider this diagnosis in patients who develop diarrhea during or after antibiotic therapy (see section "Adverse reactions"). Discontinuation of cefuroxime therapy and initiation of specific treatment against Clostridium difficile should be considered. Medicinal products that inhibit intestinal peristalsis are not recommended.

Intracameral administration and ocular adverse reactions

The medicinal product Cefuaar is not intended for intracameral administration. Individual cases and a series of serious ocular adverse reactions have been reported following intracameral use of sodium cefuroxime intended for intravenous/intramuscular administration. These reactions included macular edema, retinal edema, retinal detachment, retinal toxicity, visual disturbances, decreased visual acuity, blurred vision, corneal clouding, and corneal edema.

Intra-abdominal infections

Due to its spectrum of activity, cefuroxime is not used for the treatment of infections caused by gram-negative non-fermenting bacteria (see section "Pharmacodynamics").

Effects on diagnostic tests

Positive Coombs test results have been reported during cefuroxime therapy. This phenomenon may affect blood cross-matching tests (see section "Adverse reactions").

Minor interference with copper reduction methods (Benedict, Fehling, Clinitest) may occur. However, this should not lead to false-positive results as may be observed with some other cephalosporins.

Since a false-negative result may occur with the ferricyanide test, glucose oxidase or hexokinase methods are recommended for determination of glucose levels in blood/plasma in patients receiving sodium cefuroxime.

Important information on excipients

This medicinal product contains less than 1 mmol of sodium (23 mg) per vial, i.e., essentially "sodium-free".

Use during pregnancy or breastfeeding.

Pregnancy

Data on the use of cefuroxime in pregnant women are limited. Reproductive toxicity was not observed in animal studies. The medicinal product Cefuaar should be administered to pregnant women only if the expected benefit outweighs the potential risks.

Cefuroxime crosses the placenta and reaches therapeutic levels in amniotic fluid and umbilical cord blood after intramuscular or intravenous administration to the mother.

Period of breastfeeding

Cefuroxime passes into breast milk in small amounts. When therapeutic doses are used, adverse reactions are not expected, but the risk of diarrhea or fungal mucosal infections in the infant cannot be excluded. Therefore, a decision should be made whether to discontinue breastfeeding or to discontinue/abstain from cefuroxime therapy, taking into account the benefit of breastfeeding for the infant and the benefit of therapy for the mother.

Fertility

There are no data on the effect of sodium cefuroxime on fertility in humans. Studies on reproductive function in animals did not show any effect of this medicinal product on fertility.

Ability to affect reaction speed when driving vehicles or operating machinery.

No studies on the effect of cefuroxime on the ability to drive vehicles or operate machinery have been conducted. However, considering the known adverse reactions, it can be concluded that cefuroxime is unlikely to affect reaction speed when driving vehicles or operating machinery.

Method of administration and dosage.

Dosage

Table 1

Adults and children with body weight ≥ 40 kg

Indications	Dosage
Community-acquired pneumonia and acute exacerbations of chronic bronchitis	750 mg every 8 hours (intravenously or intramuscularly)
Soft tissue infections: cellulitis, erysipelas, wound infections
Intra-abdominal infections
Complicated urinary tract infections, including pyelonephritis	1.5 g every 8 hours (intravenously or intramuscularly)
Severe infections	750 mg every 6 hours (intravenously), 1.5 g every 8 hours (intravenously)
Prevention of postoperative infections following gastrointestinal surgery, orthopedic and gynecological surgeries (including cesarean section)	1.5 g at induction of anesthesia; may be supplemented with two additional doses of 750 mg (intramuscularly) given at 8 and 16 hours
Prevention of postoperative infections following cardiovascular surgery and esophageal surgery	1.5 g at induction of anesthesia, followed by 750 mg (intramuscularly) every 8 hours for an additional 24 hours

Table 2

Children with body weight < 40 kg

Indications	Infants and children older than 3 weeks and children with body weight < 40 kg	Neonates (from birth to 3 weeks)
Community-acquired pneumonia	30 to 100 mg/kg/day (intravenously), divided into 3 or 4 doses; for most infections, the optimal dose is 60 mg/kg/day	30 to 100 mg/kg/day (intravenously), divided into 2 or 3 doses
Complicated urinary tract infections, including pyelonephritis
Soft tissue infections: cellulitis, erysipelas, wound infections
Intra-abdominal infections

Renal Function Impairment

Cefuroxime is primarily eliminated via the kidneys. Therefore, as with other similar antibiotics, patients with severe impairment of renal function should receive reduced doses of the medicinal product Cefuaar to compensate for the slower drug excretion.

Table 3

Recommended doses of the medicinal product Cefuaar in renal function impairment

Creatinine clearance	T½ (hours)	Dosage (mg)
>20 mL/min/1.73 m²	1.7–2.6	No need to reduce standard dose (750 mg–1.5 g three times daily)
10–20 mL/min/1.73 m²	4.3–6.5	750 mg twice daily
<10 mL/min/1.73 m²	14.8–22.3	750 mg once daily
Patients undergoing hemodialysis	3.75	During hemodialysis, administer 750 mg intravenously or intramuscularly at the end of each dialysis session. In addition to parenteral administration, sodium cefuroxime may be added to peritoneal dialysis fluid (usually 250 mg per 2 liters of dialysis fluid).
Patients with renal insufficiency undergoing continuous arteriovenous hemodialysis (CAVH) or high-flux hemofiltration (HFH) in intensive care units	7.9–12.6 (CAVH) 1.6 (HFH)	750 mg twice daily. Patients undergoing low-flux hemofiltration should follow the dosing regimen appropriate for treatment in renal impairment.

Hepatic impairment

Cefuroxime is primarily eliminated by the kidneys. No influence on the pharmacokinetics of cefuroxime has been observed in patients with hepatic dysfunction.

Method of administration

The medicinal product Cefuaar should be administered by intravenous injection over 3–5 minutes directly into the vein or via an intravenous infusion line, or by intravenous infusion over 30–60 minutes, or by deep intramuscular injection.

The site for intramuscular injection is the gluteal muscle, and no more than 750 mg should be injected at a single site. Doses exceeding 1.5 g should be administered intravenously.

Instructions for dilution of the medicinal product prior to administration

	Additional volumes and concentrations that may be useful when fractional doses are required
Vial size	Route of administration	Physical state	Water added (ml)	Approximate cefuroxime concentration (mg/ml)**
	750 mg powder for solution for injection or infusion
750 mg	Intramuscular Intravenous bolus Intravenous infusion	Suspension Solution Solution	3 ml At least 6 ml At least 6 ml	216 116 116
	1.5 g powder for solution for injection or infusion
1.5 g	Intramuscular Intravenous bolus Intravenous infusion	Suspension Solution Solution	6 ml At least 15 ml 15 ml*	216 94 94

* Reconstituted solution for addition to 50 or 100 mL of a compatible infusion fluid (see compatibility information below).

** The resulting volume of cefuroxime solution in the reconstituted medium increases due to the displacement factor of the active substance, resulting in the listed concentrations in mg/mL.

Compatibility

1.5 g of the medicinal product Cefuar, dissolved in 15 mL of water for injections, can be administered together with metronidazole injection (500 mg/100 mL); both agents retain their activity for 24 hours at temperatures below 25 °C.

1.5 g of the medicinal product Cefuar is compatible with 1 g of azlocillin (in 15 mL of diluent) or with 5 g (in 50 mL of diluent) for 24 hours at 4 °C and for 6 hours at temperatures up to 25 °C.

The medicinal product Cefuar (5 mg/mL) can be stored for 24 hours at 25 °C in 5 % or 10 % xylitol injection solution.

Cefuar is compatible with solutions containing up to 1 % lidocaine hydrochloride.

Cefuar is compatible with most commonly used intravenous infusion solutions. It retains its properties for 24 hours at room temperature in the following solutions: 0.9 % sodium chloride injection solution; 5 % glucose injection solution; 0.18 % sodium chloride with 4 % glucose injection solution; 5 % glucose with 0.9 % sodium chloride injection solution; 5 % glucose with 0.45 % sodium chloride injection solution; 5 % glucose with 0.225 % sodium chloride injection solution; 10 % glucose injection solution; 10 % invertose solution in water for injections; Ringer's solution; Ringer's lactate solution; M/6 sodium lactate solution; Hartmann's solution.

The stability of the medicinal product Cefuar in 0.9 % sodium chloride injection solution with 5 % glucose is not affected by the presence of hydrocortisone sodium phosphate.

Cefuar is also compatible for 24 hours at room temperature when diluted in infusion solution:

• with heparin (10 or 50 units/mL) in 0.9 % sodium chloride injection solution;
• with potassium chloride solution (10 or 40 mEq/L) in 0.9 % sodium chloride injection solution.

Any unused medicinal product or waste material must be disposed of in accordance with local requirements.

Children.

Can be administered to children from the first days of life. The safety profile of cefuroxime in children is similar to that in adult patients.

Overdose.

Overdose with cephalosporins may cause neurological complications, including encephalopathy, seizures, and coma. Symptoms of overdose may occur if the dose of the medicinal product has not been appropriately adjusted in patients with impaired renal function (see sections "Special precautions" and "Dosage and administration").

Cefuroxime levels can be reduced by hemodialysis or peritoneal dialysis.

Adverse Reactions

The most commonly reported adverse reactions are neutropenia, eosinophilia, and transient elevations in liver enzymes or bilirubin, particularly in patients with pre-existing liver disease. However, there is no evidence of harmful effects on the liver or injection site reactions.

Adverse reactions are predominantly rare (less than 1/10,000) and generally mild and reversible in nature. The frequency of occurrence listed below is approximate, as sufficient data are not available for most reactions to allow precise estimation. In addition, the frequency of adverse reactions varies depending on the indication.

Data from clinical trials were used to classify adverse reactions from very common to rare. The frequency of other adverse reactions (e.g., < 1 in 10,000) is primarily based on post-marketing data and reflects the reporting rate rather than the true incidence.

All treatment-related adverse reactions are listed below by system organ class, frequency of occurrence, and severity according to the MedDRA classification. The following classification of adverse reaction frequencies is used: very common (≥ 1/10); 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); and frequency not known (cannot be estimated from available data).

Infections and infestations

Frequency not known – overgrowth of non-susceptible microorganisms, e.g., Candida, Clostridium difficile.

Blood and lymphatic system disorders

Common – neutropenia, eosinophilia, decreased hemoglobin levels.
Uncommon – leukopenia, positive Coombs test.
Frequency not known – thrombocytopenia, hemolytic anemia.

Immune system disorders

Frequency not known – drug fever, interstitial nephritis, anaphylaxis, cutaneous vasculitis.

Cardiac disorders

Frequency not known – Kounis syndrome.

Gastrointestinal disorders

Uncommon – gastrointestinal discomfort.
Frequency not known – pseudomembranous colitis (see section "Special precautions for use").

Hepatobiliary disorders

Common – transient elevation of liver enzymes.
Uncommon – transient elevation of bilirubin levels.

Skin and subcutaneous tissue disorders

Uncommon – skin rash, urticaria, pruritus.
Frequency not known – erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioneurotic edema, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).

Renal and urinary disorders

Frequency not known – increased serum creatinine, blood urea nitrogen (BUN), and decreased creatinine clearance (see section "Special precautions for use").

General disorders and administration site conditions

Common – reactions at the injection site, which may include pain and thrombophlebitis.

Description of selected adverse reactions

Cephalosporins as a class have the property of binding to the surface of red blood cell membranes and interacting with antibodies, which may lead to a positive Coombs test (which may affect cross-matching of blood compatibility) and, very rarely, to hemolytic anemia.

Transient elevations in serum liver enzymes or bilirubin were reversible in nature.

The likelihood of pain at the intramuscular injection site is higher with higher doses, but this is unlikely to lead to discontinuation of treatment.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after drug authorization is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, patients, and their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life

2 years.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Incompatibilities

Cefuroxime should not be mixed in the same syringe with aminoglycoside antibiotics.

The pH of a 2.74% solution of sodium bicarbonate for injection significantly affects the color of the solution; therefore, this solution is not recommended for reconstitution of the medicinal product Cefuaar. However, if necessary, when a patient is receiving intravenous sodium bicarbonate infusion, Cefuaar may be administered directly into the infusion line.

Packaging

Vials of 750 mg. 1 or 10 vials per cardboard box.

Prescription status

Prescription only.

Manufacturer

Zeiss Pharmaceuticals Pvt. Ltd.

Manufacturer's address

Plot No. 72, EPIP, Phase-I, Jharmajri, Baddi, Distt. Solan, (H. P.), India.

Marketing Authorization Holder

AAR PHARMA FZ-LLC.

Address of the Marketing Authorization Holder

Premises 702, 7th Floor, Building: DSC Tower, Post Box - 478837, Dubai, United Arab Emirates.