Gentamicin Sulfate (Gentamicin Sulfate In Sodium Chloride)

Trade Name : Gentamicin Sulfate in Sodium Chloride

Baxter Healthcare Corporation

INJECTION, SOLUTION

Strength 80 mg/100mL

GENTAMICIN SULFATE Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Gentamicin Sulfate (Gentamicin Sulfate In Sodium Chloride) which is also known as Gentamicin Sulfate in Sodium Chloride and Manufactured by Baxter Healthcare Corporation. It is available in strength of 80 mg/100mL per ml. Read more

Gentamicin Sulfate (Gentamicin Sulfate In Sodium Chloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Rx Only
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Sulfate in 0.9% Sodium Chloride Injection and other antibacterial drugs, Gentamicin Sulfate in 0.9% Sodium Chloride Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Patients treated with aminoglycosides should be under close clinical observation because of the potential toxicity associated with their use.
As with other aminoglycosides, gentamicin sulfate is potentially nephrotoxic. The risk of nephrotoxicity is greater in patients with impaired renal function and in those who receive high dosage or prolonged therapy.
Neurotoxicity manifested by ototoxicity, both vestibular and auditory, can occur in patients treated with gentamicin sulfate, primarily those with pre-existing renal damage and in patients with normal renal function treated with higher doses and/or for longer periods than recommended. Aminoglycoside-induced ototoxicity is usually irreversible. Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions.
Renal and eighth cranial nerve function should be closely monitored, especially in patients with known or suspected reduced renal function at onset of therapy and also in those whose renal function is initially normal but who develop signs of renal dysfunction during therapy. Urine should be examined for decreased specific gravity, increased excretion of protein, and the presence of cells or casts. Blood urea nitrogen (BUN), serum creatinine, or creatinine clearance should be determined periodically. When feasible, it is recommended that serial audiograms be obtained in patients old enough to be tested, particularly high-risk patients. Evidence of ototoxicity (dizziness, vertigo, tinnitus, roaring in the ears or hearing loss) or nephrotoxicity requires dosage adjustment or discontinuance of the drug. As with the other aminoglycosides, on rare occasions changes in renal and eighth cranial nerve function may not become manifest until soon after completion of therapy.
Serum concentrations of aminoglycosides should be monitored when feasible to assure adequate levels and to avoid potentially toxic levels. When monitoring gentamicin peak concentrations, dosage should be adjusted so that prolonged levels above 12 mcg/mL are avoided. When monitoring gentamicin trough concentrations, dosage should be adjusted so that levels above 2 mcg/mL are avoided. Excessive peak and/or trough serum concentrations of aminoglycosides may increase the risk of renal and eighth cranial nerve toxicity. In the event of overdose or toxic reactions, hemodialysis may aid in the removal of gentamicin from the blood, especially if renal function is, or becomes compromised. The rate of removal of gentamicin is considerably lower by peritoneal dialysis than it is by hemodialysis.
Concurrent and/or sequential systemic or topical use of other potentially neurotoxic and/or nephrotoxic drugs, such as cisplatin, cephaloridine, kanamycin, amikacin, neomycin, polymyxin B, colistin, paromomycin, streptomycin, tobramycin, vancomycin, and viomycin, should be avoided (see section).
Other factors which may increase patient risk of toxicity are advanced age and dehydration (see and sections).
The concurrent use of gentamicin with potent diuretics, such as ethacrynic acid or furosemide, should be avoided, since certain diuretics by themselves may cause ototoxicity. In addition, when administered intravenously, diuretics may enhance aminoglycoside toxicity by altering the antibiotic concentration in serum and tissue (see section).
Aminoglycosides can cause fetal harm when administered to a pregnant woman (see and sections).

Gentamicin Sulfate, USP, a water soluble antibiotic of the aminoglycoside group, is derived from , and actinomycete.
Gentamicin Sulfate in 0.9% Sodium Chloride Injection is a sterile, nonpyrogenic solution of Gentamicin Sulfate, USP in water for injection with 9 mg/mL sodium chloride (NaCl) to provide isotonicity. The solution is intended for intravenous use and requires no further dilution. pH may be adjusted with sulfuric acid or sodium hydroxide and is approximately 4.5.
This VIAFLEX PLUS plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). VIAFLEX PLUS on the container indicates the presence of a drug additive in a drug vehicle. The VIAFLEX PLUS plastic container system utilizes the same container as the VIAFLEX plastic container system. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

After intramuscular (IM) administration of gentamicin sulfate, peak serum concentrations usually occur between 30 to 60 minutes and serum levels are measurable for 6 to 8 hours. When gentamicin is administered by intravenous (IV) infusion over a two-hour period, the serum concentrations are similar to those obtained by intramuscular administration.
In patients with normal renal function, peak serum concentrations of gentamicin (mcg/mL) are usually up to four times the single intramuscular dose (mg/kg); for example, a 1 mg/kg injection in adults may be expected to result in a peak serum concentration up to 4 mcg/mL; a 1.5 mg/kg dose may produce levels up to 6 mcg/mL. While some variation is to be expected due to a number of variables such as age, body temperature, surface area and physiologic differences, the individual patient given the same dose tends to have similar levels in repeated determinations. Gentamicin administered at 1 mg/kg every eight hours for the usual 7- to 10-day treatment period to patients with normal renal function does not accumulate in the serum.
Gentamicin, like all aminoglycosides, may accumulate in the serum and tissue of patients treated with higher doses and/or for prolonged periods, particularly in the presence of impaired renal function. In adult patients, treatment with gentamicin dosages of 4 mg/kg/day or higher for seven to ten days may result in a slight, progressive rise in both peak and trough concentrations. In patients with impaired renal function, gentamicin is cleared from the body more slowly than in patients with normal renal function. The more severe the impairment, the slower the clearance. n
Since gentamicin is distributed in extracellular fluid, peak serum concentrations may be lower than usual in adult patients who have a large volume of this fluid. Serum concentrations of gentamicin in febrile patients may be lower than those in afebrile patients given the same dose. When body temperature returns to normal, serum concentrations of the drug may rise. Febrile and anemic states may be associated with a shorter than usual serum half-life. (Dosage adjustment is usually not necessary.) In severely burned patients, the half-life may be significantly decreased and resulting serum concentrations may be lower than anticipated from the mg/kg dose.
Protein binding studies have indicated that the degree of gentamicin binding is low. Depending upon the methods used for testing, this may be between 0 and 30%.
After initial administration to patients with normal renal function, generally 70% or more of the gentamicin dose is recoverable in the urine in 24 hours; concentrations in urine above 100 mcg/mL may be achieved. Little, if any, metabolic transformation occurs; the drug is excreted principally by glomerular filtration. After several days of treatment, the amount of gentamicin excreted in the urine approaches the daily dose administered. As with other aminoglycosides, a small amount of the gentamicin dose may be retained in the tissues, especially in the kidneys. Minute quantities of aminoglycosides have been detected in the urine weeks after the drug administration was discontinued. Renal clearance of gentamicin is similar to that of endogenous creatinine.
In patients with marked impairment of renal function, there is a decrease in the concentration of aminoglycosides in urine and in their penetration into defective renal parenchyma. This decreased drug excretion, together with the potential nephrotoxicity of aminoglycosides, should be considered when treating such patients who have urinary tract infections.
Probenecid does not affect renal tubular transport of gentamicin.
The endogenous creatinine clearance rate and serum creatinine level have a high correlation with the half-life of gentamicin in serum. Results of these tests may serve as guides for adjusting dosage in patients with renal impairment (see ).
Following parenteral administration, gentamicin can be detected in serum, lymph, tissues, sputum, and in pleural, synovial, and peritoneal fluids. Concentrations in renal cortex sometimes may be eight times higher than the usual serum levels. Concentrations in bile, in general, have been low and have suggested minimal biliary excretion. Gentamicin crosses the peritoneal as well as the placental membranes (see section). Since aminoglycosides diffuse poorly into the subarachnoid space after parenteral administration, concentrations of gentamicin in cerebrospinal fluid are often low and dependent upon dose, rate of penetration, and degree of meningeal inflammation. There is minimal penetration of gentamicin into ocular tissues following intramuscular or intravenous administration.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Gentamicin Sulfate in 0.9% Sodium Chloride Injection and other antibacterial drugs, Gentamicin Sulfate in 0.9% Sodium Chloride Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Gentamicin Sulfate in 0.9% Sodium Chloride Injection is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: , species (indole-positive and indole-negative), , species, species, and species (coagulase-positive and coagulase-negative).
Clinical studies have shown gentamicin sulfate to be effective in bacterial neonatal sepsis; bacterial septicemia; and serious bacterial infections of the central nervous system (meningitis), urinary tract, respiratory tract, gastrointestinal tract (including peritonitis), skin, bone and soft tissue (including burns). Aminoglycosides, including gentamicin, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are susceptible to these antibiotics and are not susceptible to antibiotics having less potential for toxicity.
Specimens for bacterial culture should be obtained to isolate and identify causative organisms and to determine their susceptibility to gentamicin.
Gentamicin Sulfate in 0.9% Sodium Chloride Injection may be considered as initial therapy in suspected or confirmed gram-negative infections, and therapy may be instituted before obtaining results of susceptibility testing. The decision to continue therapy with this drug should be based on the results of susceptibility tests, the severity of the infection, and the important additional concepts contained in the boxed . If the causative organisms are resistant to gentamicin, other appropriate therapy should be instituted.
In serious infections when the causative organisms are unknown, Gentamicin Sulfate in 0.9% Sodium Chloride Injection may be administered as initial therapy in conjunction with a penicillin-type or cephalosporin-type drug before obtaining results of susceptibility testing. If anaerobic organisms are suspected as etiologic agents, consideration should be given to using other suitable antimicrobial therapy in conjunction with gentamicin. Following identification of the organism and its susceptibility, appropriate antibiotic therapy should then be continued.
Gentamicin injection has been used effectively in combination with carbenicillin for the treatment of life-threatening infections caused by . It has also been found effective when used in conjunction with a penicillin-type drug for the treatment of endocarditis caused by group D streptococci.
Gentamicin injection has also been shown to be effective in the treatment of serious staphylococcal infections. While not the antibiotic of first choice, gentamicin may be considered when penicillins or other less potentially toxic drugs are contraindicated and bacterial susceptibility tests and clinical judgement indicate its use. It may also be considered in mixed infections caused by susceptible strains of staphylococci and gram-negative organisms.
In the neonate with suspected bacterial sepsis or staphylococcal pneumonia, a penicillin-type drug is also usually indicated as concomitant therapy with gentamicin (see and sections).

Hypersensitivity to gentamicin is a contraindication to its use. A history of hypersensitivity or serious toxic reactions to other aminoglycosides may contraindicate use of gentamicin because of known cross-sensitivity of patients to drugs in this class.

(See boxed .)
Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycoside antibiotics cross the placenta, and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Serious side effects to mother, fetus or newborn have not been reported in the treatment of pregnant women with other aminoglycosides. Animal reproduction studies conducted on rats and rabbits did not reveal evidence of impaired fertility or harm to the fetus due to gentamicin sulfate. It is not known whether gentamicin sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. If gentamicin is used during pregnancy or if the patient becomes pregnant while taking gentamicin, she should be apprised of the potential hazard to the fetus.
Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.

No data

Nephrotoxicity
Neurotoxicity
Peripheral neuropathy or encephalopathy, including numbness, skin tingling, muscle twitching, convulsions, and a myasthenia gravis-like syndrome, have been reported.
Note
Other reported adverse reactions possibly related to gentamicin include: respiratory depression, lethargy, confusion, depression, visual disturbances, decreased appetite, weight loss, hypotension and hypertension; rash, itching, urticaria, generalized burning, laryngeal edema, anaphylactoid reactions, fever, and headache; nausea, vomiting, increased salivation, and stomatitis; purpura, pseudotumor cerebri, acute organic brain syndrome, pulmonary fibrosis, alopecia, joint pain, transient hepatomegaly, and splenomegaly.
Laboratory abnormalities possibly related to gentamicin include: increased levels of serum transaminase (SGOT, SGPT), serum LDH and bilirubin; decreased serum calcium, magnesium, sodium and potassium; anemia, leukopenia, granulocytopenia, transient agranulocytosis, eosinophilia, increased and decreased reticulocyte counts and thrombocytopenia. While clinical laboratory test abnormalities may be isolated findings, they may also be associated with clinically related signs and symptoms. For example, tetany and muscle weakness may be associated with hypomagnesemia, hypocalcemia, and hypokalemia.
While local tolerance of gentamicin sulfate is generally excellent, there has been an occasional report of pain at the injection site. Subcutaneous atrophy or fat necrosis suggesting local irritation has been reported rarely.
Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

In the event of overdosage or toxic reactions, hemodialysis may aid in the removal of gentamicin from the blood, and is especially important if renal function is, or becomes compromised. The rate of removal of gentamicin is considerably lower by peritoneal dialysis than it is by hemodialysis.

Gentamicin Sulfate in 0.9% Sodium Chloride Injection is for intravenous use only
The patientu2019s pretreatment body weight should be obtained for calculation of correct dosage. The dosage of aminoglycosides in obese patients should be based on an estimate of the lean body mass. It is desirable to limit the duration of treatment with aminoglycosides to short term.

Gentamicin Sulfate in 0.9% Sodium Chloride Injection in VIAFLEX PLUS plastic container is available in the following sizes and concentrations.
Do not remove unit from overwrap until ready for use. The overwrap is a moisture barrier. The inner bag maintains the sterility of the product. After removing overwrap, check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25u00b0C); brief exposure up to 40u00b0C does not adversely affect the product.

Warning:

Baxter Healthcare Corporation
07-19-00-0359
Rev. May 2018
Baxter, Viaflex and Viaflex Plus are trademarks of Baxter International Inc.

LOTEXPNDC 0338-0507-41
Gentamicin Sulfaten- in 0.9% Sodium Chloride Injection
60 mg / 50 mLn
Cautions For n- ntravenous n- se n- nlyMaintain unit in overwrap until ready n- or use n- o not add supplen- entary n- edin- ationn n- Sterile n- ingle dose n- ontainer n- x n- nly
Arrayn- Baxter Logo
2B0851
Lot: T787987
Exp: DEC 2025
QTY: 24-50 mL
Code: 2B0851
NDC: 0338-0507-41
Gentamicin Sulfate in 0.9% Sodium Chloride Injection 60 mg / 50 mL
Bar Code(01) 50303380507417(17)250800(21)000000150000(10)T787987
Bar Code(01) 50303380507417 (17)250800(21)000000150000(10)T787987
07/07/16
LOTEXPNDC 0338-0509-41
Gentamicin Sulfatein 0.9% Sodium ChlorideInjection
80 mg / 50 mLn
Cautions For n- ntravenous n- se n- nlyMaintain unit in overwrap until ready n- or use n- o not add supplen- entary medin- ationn n- terile n- ingle dose n- ontainer n- x n- nly
Arrayn- Baxter Logon
2B0852
Lot: T123456
Exp: JAN9999
QTY: 24-50 mLn- Code: 2B0852
NDC: 0338-0509-41
Gentamicin Sulfate in 0.9% Sodium Chloride Injection 80 mg / 50 mL
Bar Code(01) 50303380509411(17)990100(21)000000000009(10)T123456
Bar Code(01)50303380509411(17)990100(21)000000000009(10)T123456
07/07/16
LOT EXPNDC 0338-0505-48
Gentamicin Sulfatein 0.9% Sodium Chloride Injection
100 mg / 100 mL n
Cautions For Intravenous Use OnlyMaintain unit in overwrap until readyfor use Do not add supplementarymedicationn n- Sterile Single Dose ContainerRx Only
Arrayn- Baxter Logon
2B0863
Lot: T123456
Exp: JAN9999
QTY: 24-100 mLn- Code: 2B0863
NDC: 0338-0505-48
Gentamicin Sulfate in 0.9% Sodium Chloride Injection 100 mg / 100 mL
Bar Code(01) 50303380505482 (17)990100(21)000000000002(10)T123456
Bar Code(01)50303380505482(17)990100(21)000000000002(10)T123456
07/07/16
LOT EXPNDC 0338-0511-41
Gentamicin Sulfaten- in 0.9% Sodium Chloride Injection
100 mg / 50 mLn
Cautions For Intravenous Use OnlyMaintain unit in overwrap until ready foruse Do not add supplementary medicationn n- Sterile Single dose container Rx Only
Arrayn- Baxter Logo n
2B0853
Lot: T123456
Exp: JAN 9999
QTY: 24-50 mLn- Code: 2B0853
NDC: 0338-0511-41
Gentamicin Sulfate in 0.9% Sodium Chloride Injection 100 mg / 50 mL
Bar Code(01) 503033805011414(17)990100(21)000000000002(10)T123456
Bar Code(01)50303380511414(17)990100(21)000000000002(10)T123456
07/07/16
LOT EXPNDC 0338-0503-48
Gentamicin Sulfatein 0.9% Sodium ChlorideInjection
80 mg / 100 mLn
Cautions For Intravenous Use OnlyMaintain unit in overwrap until readyfor use Do not add supplementarymedicationn n- Sterile Single Dose ContainerRx Only
Arrayn- Baxter Logo n- Array
2B0862
Lot: T123456
Exp: JAN 9999
QTY: 24-100 mLn- Code: 2B0862
NDC: 0338-0503-48
Gentamicin Sulfate in 0.9% Sodium Chloride Injection 80 mg / 100 mL
Bar Code(01) 50303380503488 (17)990100(21)000000000002(10)T123456
Bar Code(01)50303380503488(17)990100(21)000000000002(10)T123456
07/07/16
LOT EXP
NDC 0338-0507-48
Gentamicin Sulfaten
120 mg / 100 mLn
CAUTIONS FOR INTRAVENOUS USE ONLYMAINTAIN UNIT IN OVERWRAP UNTIL READY FOR USE DO NOT ADD SUPPLEMENTARY MEDICATION
EACH 100 mL CONTAINS GEN TAMICIN SULFATE USP (EQUIVALEN T TO 120 mg GENTAMICIN) 900 mg SODIUM CHLORIDE USP pH MAY HAVE BEEN ADJUSTED WITH SODIUM HYDROXIDE OR SULFURIC ACIDSEE PRESCRIBING INFORMATION FOR DOSINGSTORE AT ROOM TEMPE RATURE (25u00b0C)AVOID EXCE SSIVE HEATn n
Arrayn- Baxter Logon n- Array
Lot: T123456Exp: JAN 2000
QTY: 24-100 mLNDC: 0338-0507-48Code: 2B0864
Gentamicin Sulfate in 0.9% Sodium ChlorideInjection 120 mg/100.L
Barcode
(01)50303380507486(17)000131(21)100000000000(10)T123456
(01)50303380507486(17)000131(21)100000000000(10)T123456
Barcode
02/24/20 14:05:45 PALIS#1

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Gentamicin Sulfate (Gentamicin Sulfate In Sodium Chloride)

Trade Name : Gentamicin Sulfate in Sodium Chloride

INJECTION, SOLUTION

Delivery Process

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About GNH

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Gentamicin Sulfate (Gentamicin Sulfate In Sodium Chloride)

Trade Name : Gentamicin Sulfate in Sodium Chloride

INJECTION, SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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