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GRANISETRON- granisetron hydrochloride injection, solution


  1. Patient Information
  2. Revised: 2/2017document Id:

Patient Information 

Patients should be informed that the most common adverse reactions for the indication of chemotherapy induced nausea and vomiting are headache and constipation (see Table 1).

Patients should be informed that the most common adverse reactions for the indication of postoperative nausea and vomiting are pain, headache, fever, abdominal pain and hepatic enzyme increased (see Table 2).

Patients should be advised of the risk of allergic reactions if they have a prior allergic reaction to a class of antiemetics known as 5-HT3receptor antagonists.

Electrocardiogram changes (QT prolongation) have been reported with the use of granisetron hydrochloride. Patients should be cautioned about the use of this drug if they have heart problems or take medications for heart problems.

17.1 Serotonin Syndrome

  • Advise patients of the possibility of serotonin syndrome with concomitant use of granisetron and another serotonergic agent such as medications to treat depression and migraines. Advise patients to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms with or without gastrointestinal symptoms.

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Lake Zurich, IL 60047


www.fresenius-kabi.us
451080G

Revised: February 2017

PACKAGE LABEL - PRINCIPAL DISPLAY - Granisetron 1 mL Single-Use Vial Label

Granisetron Hydrochloride
Injection, USP

1 mg per mL

For Intravenous use only

1 mLSingle Dose Vial

Rx only

Preservative Free

vial

PACKAGE LABEL - PRINCIPAL DISPLAY - Granisetron 1 mL Single- Use Vial Carton Panel

Granisetron Hydrochloride
Injection, USP

1 mg per mL*

For Intravenous use only

1 mLSingle Dose Vial

Rx only

carton

PACKAGE LABEL - PRINCIPAL DISPLAY - Granisetron 4 mL Multiple-Use Vial Label

Granisetron Hydrochloride
Injection, USP

4 mg per 4 mL*

(1 mg per mL)

For Intravenous use only

Rx only

4 mLMultiple Dose Vial


vial

PACKAGE LABEL - PRINCIPAL DISPLAY - Granisetron 4 mL Multiple-Use Vial Carton Panel
Granisetron Hydrochloride
Injection, USP

4 mg per 4 mL*
(1 mg per mL)

For Intravenous use only

4 mLMultiple Dose Vial

Rx only

carton

GRANISETRON
granisetron hydrochloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-319
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GRANISETRON HYDROCHLORIDE(UNII: 318F6L70J8) (GRANISETRON - UNII:WZG3J2MCOL)GRANISETRON1 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE(UNII: 451W47IQ8X)9 mg in 1 mL
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)0.67 mg in 1 mL
SODIUM CITRATE(UNII: 1Q73Q2JULR)2.12 mg in 1 mL
PHENOL(UNII: 339NCG44TV)5 mg in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-319-041 in 1 BOX11/20/2009
14 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07809011/20/2009
GRANISETRON
granisetron hydrochloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-318
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GRANISETRON HYDROCHLORIDE(UNII: 318F6L70J8) (GRANISETRON - UNII:WZG3J2MCOL)GRANISETRON1 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE(UNII: 451W47IQ8X)9 mg in 1 mL
SODIUM CITRATE(UNII: 1Q73Q2JULR)2.12 mg in 1 mL
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)0.67 mg in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-318-011 in 1 BOX11/20/2009
11 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07809611/20/2009
GRANISETRON
granisetron hydrochloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-317
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GRANISETRON HYDROCHLORIDE(UNII: 318F6L70J8) (GRANISETRON - UNII:WZG3J2MCOL)GRANISETRON0.1 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE(UNII: 451W47IQ8X)9 mg in 1 mL
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)0.67 mg in 1 mL
SODIUM CITRATE(UNII: 1Q73Q2JULR)2.12 mg in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-317-0110 in 1 TRAY11/20/200905/31/2016
11 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07852211/20/200905/31/2016
Labeler -Fresenius Kabi USA, LLC (608775388)
Establishment
NameAddressID/FEIBusiness Operations
Fresenius Kabi USA, LLC840771732MANUFACTURE(63323-318, 63323-319)

Revised: 2/2017document Id: 

18ed9a54-6933-4a2a-b881-a6d866285b05Set id: dddc8714-383f-4bc5-a468-ae89dbc802b4Version: 7Effective Time: 20170228Fresenius Kabi USA, LLC



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