Ceftriaxone Dailymed

Precautions

General

Prescribing Ceftriaxone Injection 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 Ceftriaxone Injection is similar to that of other cephalosporins.

Ceftriaxone is excreted via both biliary and renal excretion (see CLINICAL PHARMACOLOGY). Therefore, patients with mild to moderate renal impairment normally require no adjustment in dosage when usual doses of Ceftriaxone Injection 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 Ceftriaxone Injection dosage should not exceed 2 gm daily.

Ceftriaxone has been associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.

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

Ceftriaxone Injection 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 ceftriaxone; 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 ceftriaxone and institution of conservative management. Therefore, Ceftriaxone Injection 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 ceftriaxone. Most patients presented with risk factors for biliary stasis and biliary sludge (preceding major therapy, severe illness, total parenteral nutrition). A cofactor role of ceftriaxone related biliary precipitation cannot be ruled out.

Information for Patients

Advise patients that neurological adverse reactions could occur with Ceftriaxone Injection use. Instruct patients or their caregivers to inform their healthcare provider at once of any neurological signs and symptoms, including encephalopathy (disturbance of consciousness including somnolence, lethargy, and confusion), seizures, myoclonus, and nonconvulsive status epilepticus, for immediate treatment, or discontinuation of Ceftriaxone Injection (see WARNINGS AND PRECAUTIONS).

Patients should be counseled that antibacterial drugs including Ceftriaxone Injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Ceftriaxone Injection 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 Ceftriaxone Injection 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Considering the maximum duration of treatment and the class of the compound, carcinogenicity studies with ceftriaxone in animals have not been performed. The maximum duration of animal toxicity studies was 6 months.

Genetic toxicology tests included the Ames test, a micronucleus test and a test for chromosomal aberrations in human lymphocytes cultured in vitro with ceftriaxone. Ceftriaxone showed no potential for mutagenic activity in these studies.

Ceftriaxone produced no impairment of fertility when given intravenously to rats at daily doses up to 586 mg/kg/day, approximately 20 times the recommended clinical dose of 2 gm/day.

Pregnancy

Reproductive studies have been performed in mice and rats at doses up to 20 times the usual human dose and have no evidence of embryotoxicity, fetotoxicity or teratogenicity. In primates, no embryotoxicity or teratogenicity was demonstrated at a dose approximately 3 times the human dose.

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.

In rats, in the Segment I (fertility and general reproduction) and Segment III (perinatal and postnatal) studies with intravenously administered ceftriaxone, no adverse effects were noted on various reproductive parameters during gestation and lactation, including postnatal growth, functional behavior and reproductive ability of the offspring, at doses of 586 mg/kg/day or less.

Nursing Mothers

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

Pediatric Use

Safety and effectiveness of Ceftriaxone Injection in neonates, infants and pediatric patients have been established for the dosages described in the DOSAGE AND ADMINISTRATION section. In vitro studies have shown that ceftriaxone, like some other cephalosporins, can displace bilirubin from serum albumin. Ceftriaxone Injection should not be administered to hyperbilirubinemic neonates, especially prematures (see CONTRAINDICATIONS).

Geriatric Use

Of the total number of subjects in clinical studies of ceftriaxone, 32% were 60 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

The pharmacokinetics of ceftriaxone were only minimally altered in geriatric patients compared to healthy adult subjects and dosage adjustments are not necessary for geriatric patients with ceftriaxone dosages up to 2 grams per day (see CLINICAL PHARMACOLOGY).

Adverse Reactions

Ceftriaxone 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.

HYPERSENSITIVITY — rash (1.7%). Less frequently reported (<1%) were pruritus, fever or 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 (see WARNINGS).

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 (1.2%). 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 – exanthema, 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.

NEUROLOGIC – Encephalopathy, seizures, myoclonus, and non-convulsive status epilepticus (see WARNINGS AND PRECAUTIONS).

Cephalosporin Class Adverse Reactions

In addition to the adverse reactions uled 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:

Allergic reactions, drug fever, serum sickness-like reaction, renal dysfunction, toxic nephropathy, reversible hyperactivity, hypertonia, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage, fall in prothrombin activity, and superinfection.

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 (see DOSAGE AND ADMINISTRATION). If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

Overdosage

Ceftriaxone overdosage has been reported in patients with severe renal impairment. Reactions have included neurological outcomes, including encephalopathy, seizures, myoclonus, and non-convulsive status epilepticus. In the event of overdosage, discontinue Ceftriaxone Injection therapy and provide general supportive treatment (see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS).

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.

Dosage And Administration

Ceftriaxone Injection is administered intravenously.

Do not further dilute ceftriaxone injection with products containing calcium, such as Ringer’s solution or Hartmann’s solution, because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same IV administration line. Ceftriaxone 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, ceftriaxone and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid (see WARNINGS).

There have been no reports of an interaction between ceftriaxone and oral calcium-containing products.

Neonates

Hyperbilirubinemic neonates, especially prematures, should not be treated with Ceftriaxone Injection (see CONTRAINDICATIONS).

Ceftriaxone 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 (see CONTRAINDICATIONS).

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 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

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, in order to achieve >90% target attainment. 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 preoperative use (surgical prophylaxis), a single dose of 1 gram administered intravenously 1/2 to 2 hours before surgery is recommended.

Generally, Ceftriaxone Injection 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 to 14 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 hepatic impairment or mild to moderate renal impairment.

Directions For Use

Ceftriaxone Injection is for intravenous administration using sterile equipment. It should be administered intravenously by infusion over a period of 30 minutes.

Do not add supplementary medication. 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.

Storage

Store in a freezer capable of maintaining a temperature of -20°C/-4°F.

Thawing of Plastic Container

Thaw frozen container at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). [DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION.]

Check for minute leaks by squeezing container firmly. If leaks are detected, discard solution as sterility may be impaired.

Do not add supplementary medication.

Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Agitate after solution has reached room temperature. If after visual inspection the solution remains cloudy or if an insoluble precipitate is noted, or if any seals are not intact, the container should be discarded.

The thawed solution is stable for 21 days under refrigeration (5°C/41°F) or 48 hours at room temperature (25°C/77°F). Do not refreeze thawed antibiotics.

Caution: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

Preparation for Intravenous Administration:

• 1.Suspend container from eyelet support.
• 2.Remove protector from outlet port at bottom of container.
• 3.Attach administration set. Refer to complete directions accompanying set.

Animal Pharmacology

Concretions consisting of the precipitated calcium salt of ceftriaxone have been found in the gallbladder bile of dogs and baboons treated with ceftriaxone.

These appeared as a gritty sediment in dogs that received 100 mg/kg/day for 4 weeks. A similar phenomenon has been observed in baboons but only after a protracted dosing period (6 months) at higher dose levels (335 mg/kg/day or more). The likelihood of this occurrence in humans is considered to be low, since ceftriaxone has a greater plasma half-life in humans, the calcium salt of ceftriaxone is more soluble in human gallbladder bile and the calcium content of human gallbladder bile is relatively low.

How Supplied/storage And Handling

Ceftriaxone Injection, USP is supplied premixed as a frozen, iso-osmotic, sterile, nonpyrogenic solution of ceftriaxone sodium in a case of 24 x 50 mL single dose Galaxy containers. The following strengths are available:

1 gm equivalent of ceftriaxone, iso-osmotic with approximately 1.9 gm Dextrose Hydrous, USP, added (NDC 0338-5002-41).

2 gm equivalent of ceftriaxone, iso-osmotic with approximately 1.2 gm Dextrose Hydrous, USP, added (NDC 0338-5003-41).

NOTE: Store Ceftriaxone Injection, USP in the frozen state at or below -20°C/-4°F. See DIRECTIONS FOR USE:

Handle frozen product containers with care. Product containers may be fragile in the frozen state.

Baxter Healthcare Corporation Deerfield, IL 60015 USA

Printed in USA

Baxter and Galaxy are trademarks of Baxter International Inc. or its subsidiaries.

ATCC is a trademark of the American Type Culture Collection.

07-19-06-948

Rev. March 2024

Package Label - Principal Display Panel

Container Label 1 g
Container Label 1 g

Baxter Ceftriaxone Injection, USP (In Dextrose)

1 g

GALAXY Single Dose Container

50 mL Iso-osmotic

NDC 0338-5002-41 Code 2G3505 Sterile Nonpyrogenic

Each 50 mL contains: Ceftriaxone Sodium, USP equivalent to 1 g ceftriaxone with approx. 1.9 g Dextrose Hydrous, USP, added to adjust osmolality. pH may have been adjusted with sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0.

Usual Dosage: See package insert.

Cautions: Administer IV using sterile equipment. Must not be used in series connections. Do not add supplementary medication. Check for minute leaks and solution clarity. Rx only.

Store at or below -20°C (-4°F). Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature. Do not refreeze.

Baxter and GALAXY are trademarks of Baxter International Inc. Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in USA

PL 2040 Plastic

07-34-63-668

*BAR CODE POSITION ONLY 303385002417
Carton Label - 1 g - Panel 1
Carton Label - 1 g - Panel 1

Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature. Do not refreeze.

Handle frozen product containers with care. Product containers may be fragile in the frozen state. Baxter and Galaxy are registered trademarks of Baxter International Inc. PL 2040 Plastic

07-04-65-179

Baxter Logo Ceftriaxone Injection, USP (In Dextrose) 12 - 50 mL Single-Dose Containers Iso-osmotic Store at or below -20°C/-4°F. Do not refreeze.

Rx only

1 g Baxter Healthcare Corporation Deerfield, IL 60015 USA

Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE THAW BYIMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature. Do not refreeze.

Handle frozen product containers with care. Product containers may be fragile in the frozen state. Baxter and Galaxy are registered trademarks of Baxter International Inc. PL 2040 Plastic

07-04-65-179

Baxter Logo Ceftriaxone Injection, USP (In Dextrose) 12 - 50 mL Single-Dose Containers Iso-osmotic Store at or below -20°C/-4°F. Do not refreeze.

Rx only

1 g Baxter Healthcare Corporation Deerfield, IL 60015 USA
Carton Label - 1 g - Panel 2
Carton Label - 1 g - Panel 2

NDC 0338-5002-41 Code 2G3504 *FOR BAR CODE POSITION ONLY (01) 503385002412

GALAXY ContainerSterile NonpyrogenicEach 50 mL contains: Ceftriaxone Sodium, USP equivalent to 1 g ceftriaxone with approx. 1.9 g of Dextrose Hydrous, USP, added to adjust osmolality. pH may have been adjusted with sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0.

Usual dosage: See package insert.

Cautions: Administer IV using sterile equipment. Must not be used in series connections. Do not add supplementary medication. Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear.

NDC 0338-5002-41 Code 2G3504 *FOR BAR CODE POSITION ONLY (01) 503385002412

GALAXY ContainerSterile NonpyrogenicEach 50 mL contains: Ceftriaxone Sodium, USP equivalent to 1 g ceftriaxone with approx. 1.9 g of Dextrose Hydrous, USP, added to adjust osmolality. pH may have been adjusted with sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0.

Usual dosage: See package insert.

Cautions: Administer IV using sterile equipment. Must not be used in series connections. Do not add supplementary medication. Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear.

Baxter Logo Ceftriaxone Injection, USP (In Dextrose) 2 g

GALAXY Single Dose Container

50 mL Iso-osmotic

NDC 0338-5003-41 Code 2G3505 Sterile Nonpyrogenic

Each 50 mL contains: Ceftriaxone Sodium, USP equivalent to 2 g ceftriaxone with approx. 1.2 g of Dextrose Hydrous, USP, added to adjust osmolality. pH may have been adjusted with sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0.

Usual dosage: See package insert.

Cautions: Administer IV using sterile equipment. Must not be used in series connections. Do not add supplementary medication. Check for minute leaks and solution clarity. Rx only.

Store at or below -20°C (-4°F). Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature. Do not refreeze.

Baxter and GALAXY are trademarks of Baxter International Inc. Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in USA

PL 2040 Plastic

07-34-63-670

*BAR CODE POSITION ONLY 303385003414
Carton Label - 2 g - Panel 1
Carton Label - 2 g - Panel 1

Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE THAW BYIMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature. Do not refreeze. Handle frozen product containers with care. Product containers may be fragile in the frozen state. Baxter and Galaxy are registered trademarks of Baxter International Inc. PL 2040 Plastic

07-04-65-180

Baxter Logo Ceftriaxone Injection, USP (In Dextrose) 12 - 50 mL Single-Dose Containers Iso-osmotic Store at or below -20°C/-4°F. Do not refreeze.

Rx only

2 g

Baxter Healthcare Corporation Deerfield, IL 60015 USA

Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). DO NOT FORCE THAW BYIMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION. The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature. Do not refreeze. Handle frozen product containers with care. Product containers may be fragile in the frozen state. Baxter and Galaxy are registered trademarks of Baxter International Inc. PL 2040 Plastic

07-04-65-180

Baxter Logo Ceftriaxone Injection, USP (In Dextrose) 12 - 50 mL Single-Dose Containers Iso-osmotic Store at or below -20°C/-4°F. Do not refreeze.

Rx only

2 g

Baxter Healthcare Corporation Deerfield, IL 60015 USA
Carton Label - 2 g - Panel 2
Carton Label - 2 g - Panel 2

NDC 0338-5003-41 Code 2G3505 *FOR BAR CODE POSITION ONLY (01) 503385003419

GALAXY ContainerSterile NonpyrogenicEach 50 mL contains: Ceftriaxone Sodium, USP equivalent to 2 g ceftriaxone with approx. 1.2 g of Dextrose Hydrous, USP, added to adjust osmolality. pH may have been adjusted with sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0.

Usual dosage: See package insert.

Cautions: Administer IV using sterile equipment. Must not be used in series connections. Do not add supplementary medication. Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear.

NDC 0338-5003-41 Code 2G3505 *FOR BAR CODE POSITION ONLY (01) 503385003419

GALAXY ContainerSterile NonpyrogenicEach 50 mL contains: Ceftriaxone Sodium, USP equivalent to 2 g ceftriaxone with approx. 1.2 g of Dextrose Hydrous, USP, added to adjust osmolality. pH may have been adjusted with sodium hydroxide and/or hydrochloric acid. pH range 6.0 to 8.0.

Usual dosage: See package insert.

Cautions: Administer IV using sterile equipment. Must not be used in series connections. Do not add supplementary medication. Check for minute leaks by squeezing thawed bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use unless solution is clear.