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Gadobenate Dimeglumine (Multihance)

Trade Name : MultiHance

BRACCO DIAGNOSTICS INC

INJECTION, SOLUTION

Strength 529 mg/mL

GADOBENATE DIMEGLUMINE Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA]

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

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Gadobenate Dimeglumine (Multihance) which is also known as MultiHance and Manufactured by BRACCO DIAGNOSTICS INC. It is available in strength of 529 mg/mL per ml. Read more

Gadobenate Dimeglumine (Multihance) 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

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • Gadolinium-based contrast agents (GBCAs) increasenthe risk for NSF among patients with impaired elimination of the drugs.nAvoid use of GBCAs in these patients unless the diagnostic informationnis essential and not available with non-contrasted MRI or other modalities.nNSF may result in fatal or debilitating systemic fibrosis affectingnthe skin, muscle and internal organs.
  • WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
  • See full prescribing informationnfor complete boxed warningSee full prescribing information for completenboxed warning
  • Gadolinium-based contrast agents (GBCAs)nincrease the risk for NSF among patients with impaired eliminationnof the drugs. Avoid use of GBCAs in these patients unless the diagnosticninformation is essential and not available with non-contrast MRI ornother modalities.
  • The risk for NSF appears highest among patients with:
  • Screen patients for acute kidney injury and othernconditions that may reduce renal function. For patients at risk fornchronically reduced renal function (e.g. age >60 years, hypertensionnor diabetes), estimate the glomerular filtration rate (GFR) throughnlaboratory testing. n
  • No data
  • magnetic resonance imaging (MRI) of the central nervousnsystem (CNS) in adults and pediatric patients (including term neonates),nto visualize lesions with abnormal blood-brain barrier or abnormalnvascularity of the brain, spine, and associated tissues n
  • magnetic resonance angiography (MRA) to evaluate adultsnwith known or suspected renal or aorto-ilio-femoral occlusive vascularndisease. n
  • p1066122
  • PHARMACY BULK PACKAGE u2013 NOT FOR DIRECTnINFUSION
  • The recommended dose of MultiHance is 0.2 mL/kg (0.1 mmol/kg)nadministered as a rapid bolus intravenous injection.
  • For MRI of the CNS in pediatric patients below 2 years ofnage the recommended dosage range is 0.1 to 0.2 mL/kg.
  • To ensure complete injection of the contrast medium, follownthe injection with a saline flush of at least 5 mL in MRI of the CNSnand at least 20 mL in MRA. n
  • MultiHance is a sterile, nonpyrogenic, clear,ncolorless to slightly yellow aqueous solution for intravenous usenonly, containing 529 mg gadobenate dimeglumine per mL.
  • Each mL of MultiHance Injection containsn529 mg gadobenate dimeglumine. n
  • MultiHance is contraindicated in patients with known allergic ornhypersensitivity reactions to gadolinium-based contrast agents .
  • MultiHance is contraindicated in patientsnwith known allergic or hypersensitivity reactions to gadolinium-basedncontrast agents. n
  • No data
  • Nephrogenic Systemic Fibrosis has occurred in patients withnimpaired elimination of GBCAs. Higher than recommended dosing or repeatedndosing appears to increase the risk n
  • Hypersensitivity: anaphylactic/anaphylactoid reactions withncardiovascular, respiratory and cutaneous manifestations, rangingnfrom mild to severe reactions including shock can occur. Monitor patientsnclosely for need of emergency cardiorespiratory support. n
  • Gadolinium is retained for months or years in brain, bone,nand other organs. n
  • The following adverse reactions are discussed in greater detail innother sections of the label:
  • The most commonly reported adverse reactionsnare nausea (1.3%) and headache (1.2%). n n
  • To report SUSPECTED ADVERSE REACTIONS,ncontact Bracco Diagnostics Inc. at 1-800-257-5181 or FDA at 1-800-FDA-1088nor n
  • MultiHance and other drugs may compete for the canalicular multispecificnorganic anion transporter (MOAT also referred to as MRP2 or ABCC2).n Therefore MultiHance may prolong the systemic exposure of drugs suchnas cisplatin, anthracyclines (e.g. doxorubicin, daunorubicin), vincanalkaloids (e.g. vincristine), methotrexate, etoposide, tamoxifen,nand paclitaxel. In particular, consider the potential for prolongedndrug exposure in patients with decreased MOAT activity (e.g. DubinnJohnson syndrome).
  • Pregnancy: Use only if imagingnis essential during pregnancy and cannot be delayed. ()
  • Clinicalnconsequences of overdosage with MultiHance have not been reported.n Treatment of an overdosage should be directed toward support of vitalnfunctions and prompt institution of symptomatic therapy. In a Phasen1 clinical study, doses up to 0.4 mmol/kg were administered to patients.n MultiHance has been shown to be dialyzable .
  • MultiHance injection is supplied as a sterile,nnonpyrogenic, clear, colorless to slightly yellow aqueous solutionnintended for intravenous use only. Each mL of MultiHance containsn529 mg gadobenate dimeglumine and water for injection. MultiHancencontains no preservatives.
  • Gadobenatendimeglumine is chemically designated as (4RS)-[4-carboxy-5,8,11-tris(carboxymethyl)-n1-phenyl-2-oxa-5,8,11-triazatridecan-13-oato(5-)] gadolinate(2-) dihydrogenncompound with 1-deoxy-1-(methylamino)-D-glucitol (1:2) with a molecularnweight of 1058.2 and an empirical formula of CHGdNO u2022 2CHNO. The structural formula is as follows:
  • MultiHance has a pH of 6.5-7.5. Pertinent physicochemical parametersnare provided below:
  • MultiHance has an osmolality 6.9ntimes that of plasma (285 mOsmol/kg water) and is hypertonic undernconditions of use.
  • No data
  • Long-term animal studies have not been performednto evaluate the carcinogenic potential of MultiHance.
  • The results for MultiHance were negative in the followingngenetic toxicity studies: 1) bacteria reversenmutation assays, 2) an gene mutation assaynin mammalian cells, 3) an chromosomal aberrationnassay, 4) an unscheduled DNA synthesis assay,nand 5) an micronucleus assay in rats.
  • MultiHance had no effect on fertility andnreproductive performance at IV doses of up to 2 mmol/kg/day (3 timesnthe human dose on body surface basis) for 13 weeks in male rats andnfor 32 days in female rats. However, vacuolation in testes and abnormalnspermatogenic cells were observed when MultiHance was intravenouslynadministered to male rats at 3 mmol/kg/day (5 times the human dosenon body surface basis) for 28 days. The effects were not reversiblenfollowing 28-day recovery period. The effects were not reported inndog and monkey studies (at doses up to about 11 and 10 times the humanndose on body surface basis for dogs (28 days dosing) and monkeys (14ndays dosing), respectively).
  • No data
  • 16.1u2003u2003HownSupplied
  • Five 50 mL PharmacynBulk Packages u00a0u00a0u00a0u00a0 u00a0u00a0 u00a0u00a0(NDC 0270-5264-16)Five 100 mLnPharmacy Bulk Packages u00a0u00a0u00a0u00a0 u00a0u00a0 (NDC 0270-5264-17)
  • 16.2u2003u2003Storage and Handling
  • Nephrogenic SystemicnFibrosis
  • Instruct patientsnto inform their physician if they:
  • GBCAs increase the risk for NSF amongnpatients with impaired elimination of the drugs. To counsel patientsnat risk for NSF:
  • Instruct the patients to contactntheir physician if they develop signs or symptoms of NSF followingnMultiHance administration, such as burning, itching, swelling, scaling,nhardening and tightening of the skin; red or dark patches on the skin;nstiffness in joints with trouble moving, bending or straighteningnthe arms, hands, legs or feet; pain in the hip bones or ribs; or musclenweakness.
  • Common Adverse Reactions
  • Inform patients that they may experience:
  • Gadolinium Retentionn- [see Warnings and Precautions ()]
  • Arrayn- Rx only
  • Manufactured for Bracco DiagnosticsnInc.Monroe Twp, NJ 08831
  • By BIPSO GmbH78224 Singen (Germany)
  • Revised April 2018
  • No data
  • Multihance Multipack 50 mLNDC 0270-5264-16

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