Composition

Ceftriaxone sodium 0.5gm.
Ceftriaxone sodium 1gm.

Ceftriaxone ATC code: J01DD04

Solvent

For CEFAJECT I.M: Lidocaine hydrochloride monohydrate, sodium hydroxide & water for injection.
For CEFAJECT I.V: water for injection.

Indications and potential uses

CEFAJECT is indicated for the treatment of the following infections when caused by susceptible organisms:

Lower respiratory tract infections, acute bacterial otitis media, skin and skin structure infections, urinary tract infections (complicated and uncomplicated), uncomplicated gonorrhea (cervical/urethral and rectal), and pharyngeal gonorrhea.

Pelvic inflammatory disease, bacterial septicemia, bone and joint infections, intra-abdominal infections, meningitis.

Surgical prophylaxis: The preoperative administration of a single 1 gm dose of CEFAJECT may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (eg, vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients, such as those over 70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (eg, during coronary artery bypass surgery).

When administered prior to surgical procedures for which it is indicated, a single 1 gm dose of CEFAJECT provides protection from most infections due to susceptible organisms throughout the course of the procedure.

CEFAJECT- Product information

Product	CEFAJECT I.M. Vial	CEFAJECT I.V. Vial
Available concentrations	500mg, 1gm	500mg, 1gm
Manufacturer Name	Tabuk Pharmaceutical Industries – KSA
Marketing Company	Abbott Laboratories GmbH
First agent in KSA	Farouk, Maamoun Tamer & CO
Active Ingredients	Ceftriaxone – brand name (Rocephin), pronounced as (sef try ax’ one).
Anatomical main group	ANTIINFECTIVES FOR SYSTEMIC USE
Therapeutic subgroup	ANTIBACTERIALS FOR SYSTEMIC USE( antibacterials for systemic use, except antimycobacterials)
Pharmacological subgroup	OTHER BETA-LACTAM ANTIBACTERIALS( beta-lactam antibacterials, other than penicillins).
Chemical subgroup	Third-generation cephalosporins (have a marked activity against gram-negative bacteria).
ATC code	J01DD04
Legal status	Prescription only

Dosage and administration

CEFAJECT may be administered intravenously or intramuscularly.

Precipitation of Ceftriaxone-calcium can also occur when CEFAJECT is mixed with calcium-containing solutions in the same IV administration line. CEFAJECT must not be administered simultaneously with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site. However, in patients other than neonates, CEFAJECT and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid.

There have been no reports of an interaction between Ceftriaxone and oral calcium-containing products or interaction between intramuscular Ceftriaxone and calcium-containing products (IV or oral).

Neonates: Hyperbilirubinemic neonates, especially prematures, should not be treated with CEFAJECT. CEFAJECT is contraindicated in neonates if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of Ceftriaxone-calcium.

Pediatric patients

For the treatment of skin and skin structure infections, the recommended total daily dose is 50 to 75 mg/kg given once a day (or in equally divided doses twice a day).The total daily dose should not exceed 2 grams.
For the treatment of acute bacterial otitis media, a single intramuscular dose of 50 mg/kg (not to exceed 1 gram) is recommended .
For the treatment of serious miscellaneous infections other than meningitis, the recommended total daily dose is 50 to 75 mg/kg, given in divided doses every 12 hours. The total daily dose should not exceed 2 grams.
In the treatment of meningitis, it is recommended that the initial therapeutic dose be 100 mg/kg (not to exceed 4 grams). Thereafter, a total daily dose of 100 mg/kg/day (not to exceed 4 grams daily) is recommended. The daily dose may be administered once a day (or in equally divided doses every 12 hours).The usual duration of therapy is 7 to 14 days.

Adults patients

The usual adult daily dose is 1 to 2 grams given once a day (or in equally divided doses twice a day) depending on the type and severity of infection.
For infections caused by Staphylococcus aureus (MSSA), the recommended daily dose is 2 to 4 grams, the total daily dose should not exceed 4 grams.
If Chlamydia trachomatis is a suspected pathogen, appropriate antichlamydial coverage should be added, because Ceftriaxone sodium has no activity -against this organism.
For the treatment of uncomplicated gonococcal infections, a single intramuscular dose of 250 mg is recommended.
For preoperative use (surgical prophylaxis), a single dose of 1 gram administered intravenously 1/2 to 2 hours before surgery is recommended.

General considerations

CEFAJECT therapy should be continued for at least 2 days after the signs and symptoms of infection have disappeared.
The usual duration of therapy is 4 to14 days; in complicated infections, longer therapy may be required.
When treating infections caused by Streptococcus pyogenes, therapy should be continued for at least 10 days.
No dosage adjustment is necessary for patients with impairment of renal or hepatic function.

Overdosage

In the case of overdosage, drug concentration would not be reduced by hemodialysis or peritoneal dialysis. There is no specific antidote. Treatment of overdosage should be symptomatic.

Contraindications

CEFAJECT is contraindicated in patients with known hypersensitivity to the active substance, to other cephalosporins or to any of the excipients. Previous immediate and/or severe hypersensitivity reaction to a penicillin or to any other beta-lactam medicinal products.

Neonates ( ≤ 28 days)

Hyperbilirubinemic neonates, especially prematures, should not be treated with CEFAJECT. In vitro studies have shown that Ceftriaxone can displace bilirubin from its binding to serum albumin, leading to a possible risk of bilirubin encephalopathy in these patients.
CEFAJECT is contraindicated in neonates if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium containing infusions such as parenteral nutrition because of the risk of precipitation of Ceftriaxone-calcium.
A small number of cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving CEFAJECT and calcium-containing fluids. In some of these cases, the same intravenous infusion line was used for both CEFAJECT and calcium-containing fluids and in some a precipitate was observed in the intravenous infusion line, At least one fatality has been reported in a neonate in whom CEFAJECT and calcium-containing fluids were administered at different time points via different intravenous lines; no crystalline material was observed at autopsy in this neonate. There have been no similar reports in patients other than neonates.

Warnings

Hypersensitivity: BEFORE THERAPY WITH Ceftriaxone IS INSTITUTED, Special caution is required to determine any other type of previous hypersensitivity reactions to penicillin or to other beta-lactam medicinal products because patients hypersensitive to these medicines may be hypersensitive to (Ceftriaxone) as well (cross- allergy).

Antibiotics should be administered with caution to any patient who has demonstrated some form of allergy, particularly to drugs. serious acute hypersensitivity reactions may require the use of subcutaneous epinephrine and other emergency measures.

As with other cephalosporins, anaphylactic reactions with fatal outcomes have been reported, even if a patient is not known to be allergic or previously exposed.

Interaction with Calcium-Containing Products: Do not use diluents containing calcium, such as Ringer’s solution or Hartmann’s solution, to reconstitute CEFAJECT vials or to further dilute a reconstituted vial for IV administration because a precipitate can form.

Precipitation of Ceftriaxone calcium can also occur when CEFAJECT is mixed with calcium-containing solutions in the same IV administration line. CEFAJECT must not be administered simultaneously with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site. However, in patients other than neonates, CEFAJECT and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid.

In vitro studies using adult and neonatal plasma from umbilical cord blood demonstrated that neonates have an increased risk of precipitation of Ceftriaxone-calcium.

calcium containing solution products must not be administered within 48 hours of the last Ceftriaxone administration. (Fatal cases in neonate due to calcium-Ceftriaxone precipitates in the I lungs and the kidneys)

Clostridium difficile: Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CEFAJECT and may range in severity from mild diarrhea to fatal colitis.

Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Hemolytic Anemia: An immune mediated hemolytic anemia has been observed in patients receiving cephalosporin class antibacterials including CEFAJECT. Severe cases of hemolytic anemia, including fatalities, have been reported during treatment in both adults and children. If a patient develops anemia while on Ceftriaxone, the diagnosis of a cephalosporin associated anemia should be considered and Ceftriaxone stopped until the etiology is determined.

Precautions

General: Prescribing CEFAJECT in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Although transient elevations of BUN and serum creatinine have been observed, at the recommended dosages, the nephrotoxic potential of CEFAJECT is similar to that of other cephalosporins.

Ceftriaxone is excreted via both biliary and renal excretion. Therefore, patients with renal failure normally require no adjustment in dosage when usual doses of CEFAJECT are administered. Dosage adjustments should not be necessary in patients with hepatic dysfunction; however, in patients with both hepatic dysfunction and significant renal disease, caution should be exercised and the CEFAJECT dosage should not exceed 2 gm daily.

Alterations in prothrombin times have occurred rarely in patients treated with CEFAJECT. Patients with impaired vitamin K synthesis or low vitamin K stores (eg, chronic hepatic disease and malnutrition) may require monitoring of prothrombin time during CEFAJECT treatment. Vitamin K administration (10 mg weekly) may be necessary if the prothrombin time is prolonged before or during therapy.

Prolonged use of CEFAJECT may result in overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy appropriate measures should be taken.

CEFAJECT should be prescribed with caution in individuals with a history of gastrointestinal disease, especially colitis.There have been reports of sonographic abnormalities in the gallbladder of patients treated with CEFAJECT; some of these patients also had symptoms of gallbladder disease. These abnormalities appear on sonography as an echo without acoustical shadowing suggesting sludge or as an echo with acoustical shadowing which may be misinterpreted as gallstones. The chemical nature of the sonographically detected material has been determined to be predominantly a Ceftriaxone-calcium salt. The condition appears to be transient and reversible upon discontinuation of CEFAJECT and institution of conservative management. Therefore, CEFAJECT should be discontinued in patients who develop signs and symptoms suggestive of gallbladder disease and/or the sonographic findings described above. Cases of pancreatitis, possibly secondary to biliary obstruction, have been reported rarely in patients treated with CEFAJECT. Most patients presented with risk factors for biliary stasis and biliary sludge (preceding major therapy, severe illness, total parenteral nutrition), A cofactor role of CEFAJECT-related biliary precipitation cannot be ruled out.

Information for Patients

Patients should be counseled that antibacterial drugs including CEFAJECT should only be used to treat bacterial infections. They do not treat viral infections leg, common cold).

When CEFAJECT is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by CEFAJECT or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued.

Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Pregnancy

There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when CEFAJECT is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of CEFAJECT in neonates, infants and pediatric patients have been established for the dosages described in the dosage and administration section.
CEFAJECT should not be administered to hyperbilirubinemic neonates, especially prematures.

Undesirable effects

CEFAJECT is generally well tolerated. In clinical trials, the following adverse reactions, which were considered to be related to Ceftriaxone therapy or of uncertain etiology, were observed:

Local reactions: pain, induration and tenderness was 1% overall. Phlebitis was reported in <1% after IV administration. The incidence of warmth, tightness or induration was 17% (3/17) after IM administration of 350 mg/mL and 5% (1/20) after IM administration of 250 mg/ml.

Hypersensitivity: rash ,(1.7%). Less frequently reported (<1%) were pruritus,. Fever, chills.

Hematologic: eosinophilia (6%), thrombocytosis (5.1%) and leukopenia (2.1%). Less frequently reported (<1%) were anemia, hemolytic anemia, neutropenia, lymphopenia, thrombocytopenia and prolongation of the prothrombin time.

Gastrointestinal: diarrhea (2.7%). Less frequently reported (<1%) were nausea or vomiting, and dysgeusia. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment .

Hepatic: elevations of SGOT (3.1%) or SGPT (3.3%). Less frequently reported (<1%) were elevations of alkaline phosphatase and bilirubin.

Renal: elevations of the BUN (12%). Less frequently reported (<1%) were elevations of creatinine and the presence of casts in the urine.

Central nervous system: headache or dizziness were reported occasionally (<1%). Genitourinary: moniliasis or vaginitis were reported occasionally (<1%).

Miscellaneous: diaphoresis and flushing were reported occasionally (<1%). Other rarely observed adverse reactions (<0,1%) include abdominal pain, agranulocytosis, allergic pneumonitis, anaphylaxis, basophilia, biliary lithiasis, bronchospasm, colitis, dyspepsia, epistaxis, flatulence, gallbladder sludge, glycosuria, hematuria, jaundice, leukocytosis, lymphocytosis, monocytosis, nephrolithiasis, palpitations, a decrease in the prothrombin time, renal precipitations, seizures, and serum sickness.

Postmarketing Experience: In addition to the adverse reactions reported during clinical trials, the following adverse experiences have been reported during clinical practice in patients treated with Ceftriaxone. Data are generally insufficient to allow an estimate of incidence or to establish causation.

A small number of cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving Ceftriaxone and calcium-containing fluids. In some of these cases, the same intravenous infusion line was used for both Ceftriaxone and calcium-containing fluids and in some a precipitate was observed in the intravenous infusion line. At least one fatality has been reported in a neonate in whom Ceftriaxone and calcium-containing fluids were administered at different time points via different intravenous lines; no crystalline material was observed at autopsy in this neonate. There have been no similar reports in patients other than neonates.

Gastrointestinal: stomatitis and glossitis.

Genitourinary: oliguria.

Dermatologic: exantherna. allergic dermatitis, urticaria, edema. As with many medications, isolated cases of severe cutaneous adverse reactions (erythema multiforme, Stevens-Johnson syndrome or Lyell’s syndrome/toxic epidermal necrolysis) have been reported.

Cephalosporin Class Adverse Reactions In addition to the adverse reactions listed above which have been observed in patients treated with Ceftriaxone, the following adverse reactions and altered laboratory test results have been reported for cephalosporin class antibiotics:

Adverse reactions: Allergic reactions, drug fever, serum Sickness-like reaction, renal dysfunction, toxic nephropathy, reversible hyperactivity, hypertonia, hepatic dysfunction Including cholestasis, aplastic anemia, hemorrhage, and superinfection.

Altered laboratory tests: Positive direct Coombs’ test, false-positive test for urinary glucose, and elevated LDH.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced . If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

Interactions and Compatibility

Ceftriaxone has been shown to be compatible with Flagyl IV (metronidazole hydrochloride). The concentration should not exceed 5 to 7.5 mg/mL metronidazole hydrochloride with Ceftriaxone 10 mg/mL as an admixture. The admixture is stable for 24 hours at room temperature only in 0.9% sodium chloride injection or 5% dextrose in water (D5W).

No compatibility studies have been conducted with the Flagyl IV RTU (metronidazole) formulation or using other diluents. Metronidazole at concentrations greater than 8 mg/mL will precipitate. Do not refrigerate the admixture as precipitation will occur.

Vancomycin, amsacrine, aminoglycosides, and fluconazole are physically incompatible with Ceftriaxone in admixtures. When any of these drugs are to be administered concomitantly with Ceftriaxone by intermittent intravenous infusion, it is recommended that they be given sequentially, with thorough flushing of the intravenous lines (with one of the compatible fluids) between the administrations.

Do not use diluents containing calcium, such as Ringer’s solution or Hartmann’s solution, to reconstitute CEFAJECT vials or to further dilute a reconstituted vial for IV administration. Particulate formation can result. CEFAJECT solutions should not be physically mixed with or piggybacked into solutions containing other antimicrobial drugs or into diluent solutions other than those listed above, due to possible incompatibility .

Properties and effects

Microbiology: The bactericidal activity of Ceftriaxone results from inhibition of cell wall synthesis. Ceftriaxone has a high degree of stability in the presence of beta lactamases, both penicillinases and cephalosporinases, of gram-negative and gram-positive bacteria. In an in vitro study antagonistic effects have been observed with the combination of chloramphenicol and Ceftriaxone.

Ceftriaxone has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections described in the Indications and usage section.

Aerobic gram negative microorganism: Acinetobacter cakoacetkus, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant and beta-lactamase producing strains), Haemophilus parainfluenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Moraxella catarrhalis including beta-lactamase producing strains), Morganella morganii, Neisseria gonorrhoeae (including penicillinase- and non penicillinase-producing strains), Neisseria meningitidis, Proteus mirabilis, Proteus vulgaris, Serratia marcescens. Ceftriaxone Is also active against many strains of Pseudomonas aeruginosa. Note: Many strains of the above organisms that are resistant to multiple antibiotics, eg, penicillins, cephalosporins, and aminoglycosides, are susceptible to Ceftriaxone.

Aerobic gram-positive microorganisms: Staphylococcus aureus (including penicillinase-producing strains) Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes, Viridans group streptococci. Note: Methicillin-resistant staphylococci are resistant to cephalosporins, including Ceftriaxone. Most strains of Group D streptococci and enterococci, eg, Enterococcus (Streptococcus) faecalis, are resistant.

Anaerobic microorganisms: Bacteroides fragilis, Clostridium species, Peptostreptococcus species. Note: Most strains of Clostridium difficile are resistant. The following in vitro data are available, but their clinical significance is unknown. Ceftriaxone exhibits in vitro minimal inhibitory concentrations (MICs) of ≤ 1 microgram/ ml or less against most strains of the following microorganisms, however, the safety and effectiveness of Ceftriaxone in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials. .

Aerobic gram-negative microorganisms: Citrobacter diversus, Citrobacter freundii, Providencia species (including Providencia rettgeri), Salmonella species (including Salmonella typhi), Shigella species.

Aerobic gram-positive microorganisms: Streptococcus agalactiae.

Anaerobic microorganisms: Prevotella (Bacteroides) bivius, Porphyromonas (Bacteroides) melaninogenicus.

Pharmacokinetics

The pharmacokinetics of Ceftriaxone are nonlinear. All pharmacokinetic parameters other than elimination half – life are dose – dependent if referred to total concentration (free and protein – bound Ceftriaxone).

Absorption: after a single i.m. injection of 1 g Ceftriaxone, a peak plasma concentration of 81 mg/L was reached after 2-3 h . After a single i.v infusion of 1 g, a concentration of 168.1 + 28.2 mg /L was reached after 30 min, After a single i.v. infusion of 2 g. a concentration of 256.9 ± 16.8 mg/L was reached after 30 min. the areas under the plasma-concentration-time curves after iv. and i.m, administration are identical. This means that bioavailability of Intramuscularly administered Ceftriaxone is 100%.

Distribution: The distribution volume is between 7 and 12 L. On intravenous administration Ceftriaxone diffuses rapidly into interstitial body fluid, where bactericidal concentrations against susceptible organisms are maintained for 24 hours. After a dose of 1-2 g, Ceftriaxone shows good penetration into tissue and body fluids. Concentrations above the minimal inhibitory concentrations for most pathogens are maintained for more than 24 hours in over 60 tissues or body fluids, including lung, heart, biliary tract, liver, middle ear, nasal mucosa and bone as well as cerebrospinal, pleural, synovial and prostatic fluid.

Ceftriaxone is reversibly bound to albumin, the degree of binding decreasing with increasing concentration. Thus, binding decreases from 95% at a plasma concentration of <100 mg/I to 85% at 300 mg/I. Owing to the lower albumin content, the proportion of free Ceftriaxone in interstitial fluid is correspondingly higher than in plasma.

Ceftriaxone penetrates the inflamed meninges of neonates, infants and children. Peak concentration in CSF is reached about 4 hours after i.v. injection and on average is 18 mg/I with a dose of 50-100 mg/kg.The average concentration in CSF during bacterial meningitis is 17% of the plasma concentration; in aseptic meningitis it is 4%. 24 hours after i.v. injection of CEFAJECT in doses of 50-100 mg/kg body weight, Ceftriaxone concentrations >1.4 mg/I were measured in CSF. In adult patients with meningitis, administration of 50 mg/kg leads within 2-24 hours to CSF concentrations several times higher than the minimum inhibitory concentrations required for the most common causative organisms of meningitis.

Ceftriaxone crosses the placental barrier. Ceftriaxone is excreted in breast milk at low concentrations (3-4% of maternal plasma concentrations after 4-6 hours).

Metabolism: Ceftriaxone is not metabolized in the organism itself. Only following biliary excretion into the intestinal lumen does the intestinal flora transform the active ingredient into inactive metabolites.

Elimination: Plasma clearance is 10-22 ml/min. Renal clearance is 5-12 ml/min. 50-60% of Ceftriaxone is excreted unchanged via the kidneys, while 40-50% is excreted unchanged in the bile. The plasma half-life in adults is about 8 hours.

Pharmacokinetics in special patient groups:

In neonates, renal elimination accounts for about 70% of the dose.

In infants aged less than 8 days and in persons aged over 75 years, the average plasma half-life is approximately 2-3 times that in healthy young adults.

In patients with mild to moderate renal failure or hepatic dysfunction, the pharmacokinetics of Ceftriaxone are only slightly altered. The plasma half-life is minimally increased. If kidney function alone is impaired, biliary elimination of Ceftriaxone is increased, whereas if liver function alone is impaired, renal elimination is increased.

Instructions for use and handling

Intramuscular injection: For i.m. Injection, CEFAJECT 0.5 g is dissolved In 2 ml. and CEFAJECT 1 g In 3.5 ml, of 1% Lidocaine solution and Injected well within a relatively large mass of muscle. It is recommended that not more than 1 g be injected at one site. The lidocaine – containing solution must never be administered Intravenously.

Intravenous Injection: For i.v. Injection, CEFAJECT 0.5 g is dissolved In 5 ml, and CEFAJECT 1 g in 10 ml, water for Injection and injected Intravenously over a period of 2 – 4 minutes.

Intravenous Infusion: The infusion should last at least 30 minutes. For i.v. infusion. 2 g CEFAJECT is dissolved in 40 ml of one of the following calcium – free infusion solutions: sodium chloride 0.9%. sodium chloride 0.45% + glucose 25%. glucose 5%, glucose 10%. dextran 6% in glucose 5%, hydroxyethyl starch 6 -10%, water for injection.

Owing to possible incompatibility. CEFAJECT solutions should not be mixed with or piggy – backed Into solutions containing other antibiotics Similarly. they must not be added to diluent solutions other than those listed above Nevertheless, 2 g Ceftriaxone and 1 g ornidazole are physically and chemically compatible in 250 ml physiological sodium chloride or glucose solution.

Diluents containing calcium (e.g. Ringer’s solution or Hartmann’s solution) must not be used to reconstitute CEFAJECT vials or to further dilute a reconstituted vial for intravenous administration because precipitates may form. Calcium Ceftriaxone precipitates may also form when CEFAJECT Is mixed with calcium – containing solutions in the same infusion line. CEFAJECT must not be administered simultaneously with calcium- containing infusion solutions, including continuous calcium – containing Infusions such as in parenteral nutrition via a Y-site. However, In patients other than neonates, CEFAJECT and calcium containing solutions may be administered consecutively if the infusion lines are thoroughly flushed between infusions with a compatible solution.

Stability: This medicine should be used before the date shown after Exp on the pack. Storage: Store at temperature not exceeding 30°C , Reconstituted solution to be used for 24 hours after reconstitution stored at 5°C, or for 6 hours at room temperature.

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