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Rx Item-Granisetron 1Mg/Ml(1) Single Dose Vial 1Ml By Fresenius Kabi USA

NDC 63323-0318-01 UPC/GTIN No.3-63323-31801-7 Mfg.Part No.361801BRAND: GRANISETRON NDC: 63323-0318-01,63323031801 UPC: 3-63323-31801-7,363323318017 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Granisetron 1Mg/Ml(1) Single Dose Vial 1Ml By Fresenius Kabi USA

$28.00$24.95

Item No.:RX124776 NDC No.63323031801 UPC No.:363323318017 NDC No. 63323-0318-01 UPC/GTIN No. 3-63323-31801-7 MPN 361801 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No. Rx124776 Granisetron 1mg/ml(1) Single Dose Vial 1ml by Fresenius Kabi USA Item No. 3124776 NDC No. 63323031801 UPC No. 36332331801

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GRANISETRON- granisetron hydrochloride injection
Sandoz Inc

1 INDICATIONS AND USAGE

Granisetron hydrochloride injection, USP is a serotonin-3 (5-HT3 ) receptor antagonist indicated for:


The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.
2 DOSAGE AND ADMINISTRATION

2.1 Prevention of Chemotherapy-Induced Nausea and Vomiting


Adult Patients

The recommended dosage for granisetron hydrochloride injection is 10 mcg/kg administered intravenously within 30 minutes before initiation of chemotherapy, and only on the day(s) chemotherapy is given.

Infusion Preparation

Granisetron hydrochloride injection may be administered intravenously either undiluted over 30 seconds, or diluted with 0.9% Sodium Chloride or 5% Dextrose and infused over 5 minutes.

Stability

Intravenous infusion of granisetron hydrochloride injection should be prepared at the time of administration. However, granisetron hydrochloride injection has been shown to be stable for at least 24 hours when diluted in 0.9% Sodium Chloride or 5% Dextrose and stored at room temperature under normal lighting conditions.

As a general precaution, granisetron hydrochloride injection should not be mixed in solution with other drugs. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration whenever solution and container permit.

Pediatric Patients

The recommended dose in pediatric patients 2 to 16 years of age is 10 mcg/kg [see CLINICAL STUDIES ( 14)]. Pediatric patients under 2 years of age have not been studied.

3 DOSAGE FORMS AND STRENGTHS

Single-Use Vials for Injection: 1 mg/mL

Multi-Use Vials for Injection: 4 mg/4 mL
DESCRIPTION

Granisetron hydrochloride injection, USP is a serotonin-3 (5-HT3 ) receptor antagonist. Chemically it is endo -N-(9-methyl-9-azabicyclo [3.3.1] non-3-yl)-1-methyl-1H-indazole-3-carboxamide hydrochloride with a molecular weight of 348.9 (312.4 free base). Its molecular formula is C18 H24 N4 O�HCl
Granisetron hydrochloride is a white to off-white solid that is readily soluble in water and normal saline at 20�C. Granisetron hydrochloride injection, USP is a clear, colorless, sterile, nonpyrogenic, aqueous solution for intravenous administration.

Granisetron hydrochloride injection, USP 1 mg/mL is available in 1 mL single-use, and 4 mL multi-use vials.

1 mg/mL: Each mL contains 1.12 mg granisetron hydrochloride equivalent to granisetron, 1 mg; sodium chloride, 9 mg; citric acid, 2 mg; benzyl alcohol, 10 mg, as a preservative; sodium hydroxide and hydrochloric acid, as pH adjusters.

The solution's pH ranges from 4.0 to 6.0.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
Granisetron is a selective 5-hydroxytryptamine3 (5-HT3 ) receptor antagonist with little or no affinity for other serotonin receptors, including 5-HT1 ; 5-HT1A ; 5-HT1B/C ; 5-HT2 ; for alpha1 -, alpha2 - or beta-adrenoreceptors; for dopamine-D2 ; or for histamine-H1 ; benzodiazepine; picrotoxin or opioid receptors.

Serotonin receptors of the 5-HT3 type are located peripherally on vagal nerve terminals and centrally in the chemoreceptor trigger zone of the area postrema. During chemotherapy-induced vomiting, mucosal enterochromaffin cells release serotonin, which stimulates 5-HT3 receptors. This evokes vagal afferent discharge and may induce vomiting. Animal studies demonstrate that, in binding to 5-HT3 receptors, granisetron blocks serotonin stimulation and subsequent vomiting after emetogenic stimuli such as cisplatin. In the ferret animal model, a single granisetron injection prevented vomiting due to high-dose cisplatin or arrested vomiting within 5 to 30 seconds.

In most human studies, granisetron has had little effect on blood pressure, heart rate or ECG. No evidence of an effect on plasma prolactin or aldosterone concentrations has been found in other studies.

Granisetron hydrochloride injection exhibited no effect on oro-cecal transit time in normal volunteers given a single intravenous infusion of 50 mcg/kg or 200 mcg/kg. Single and multiple oral doses slowed colonic transit in normal volunteers.
PRINCIPAL DISPLAY PANEL

NDC 66758-035-01

Granisetron HCl Injection, USP

1 mg/mL

1 mL single-use vial

Rx only

SANDOZ

NDC 63323-0318-01 UPC/GTIN No.3-63323-31801-7 Mfg.Part No.361801
RX ITEM-Granisetron 1Mg/Ml(1) Single Dos
NDC 63323-0318-01 UPC/GTIN No.3-63323-31801-7 Mfg.Part No.361801

BRAND: GRANISETRON NDC: 63323-0318-01,63323031801 UPC: 3-63323-31801-7,363323318017
Granisetron 1Mg/Ml(1) Single Dose Vial
BRAND: GRANISETRON NDC: 63323-0318-01,63323031801 UPC: 3-63323-31801-7,363323318017

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
Click above for GRANISETRON
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.