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GANCICLOVIR- ganciclovir sodium injection, solution


  1. Patient Information
  2. Revised: 8/2018document Id:
  3. Manufactured By:

Patient Information 

Hematologic Toxicity

Inform patients that Ganciclovir Injection may cause hematologic toxicity, including granulocytopenia (neutropenia), anemia, and thrombocytopenia. Inform patients that their blood counts and platelet counts should be closely monitored while on treatment[see Warnings and Precautions (5.1)].

Impairment of Renal Function

Inform patients that Ganciclovir Injection has been associated with decreased renal function and that serum creatinine or creatinine clearance should be monitored while on treatment to allow for dosage adjustment in patients with renal impairment[see Warnings and Precautions (5.2)].

Impairment of Fertility

Inform patients that Ganciclovir Injection may cause temporary or permanent infertility in humans[see Warnings and Precautions (5.3), Use in Specific Populations (8.3)].

Pregnancy and Contraception

Advise female patients to use effective contraception during and for at least 30 days following treatment with Ganciclovir Injection. Similarly, advise men to practice barrier contraception during and for at least 90 days following treatment with Ganciclovir Injection[see Warnings and Precautions (5.4), Use in Specific Populations (8.1,8.3)].

Carcinogenicity

Inform patients that Ganciclovir Injection should be considered a potential carcinogen[see Warnings and Precautions (5.5)].

Drug Interactions

Inform patients that Ganciclovir Injection may interact with other drugs. Advise patients to report to their healthcare provider the use of any other medication[see Drug Interactions (7)].

Impairment of Cognitive Ability

Based on the adverse reaction profile, ganciclovir may affect cognitive abilities, including the ability to drive and operate machinery, as seizures, dizziness, and/or confusion have been reported with the use of Ganciclovir Injection[see Adverse Reaction (6.1)].

Ophthalmological Examination in Patients with CMV Retinitis

Inform patients that Ganciclovir Injection is not a cure for CMV retinitis, and they may continue to experience progression of retinitis during or following treatment. Advise patients to have frequent ophthalmological follow-up examinations while being treated with Ganciclovir Injection. Some patients may require more frequent ophthalmological follow-up[see Dosage and Administration (2.2), Adverse Reactions (6.1)].

Lactation

Advise nursing mothers not to breastfeed if they are receiving Ganciclovir Injection because of the potential for serious adverse events in nursing infants and because HIV can be passed to the baby in breast milk[see Use in Specific Populations (8.2)].

SAGENT
Mfd. for SAGENT Pharmaceuticals
Schaumburg, IL 60195 (USA)
Made in Canada
2018 Sagent Pharmaceuticals, Inc.

Revised: August 2018

SAGENT Pharmaceuticals

PACKAGE LABEL PRINCIPAL DISPLAY PANEL Vial Label

NDC 25021-185-10

Rx only

Ganciclovir Injection

500 mg per 10 mL

(50 mg per mL)

CAUTION Handle this product with great care because it is a potent cytotoxic agent and suspected carcinogen.

10 mL Single-Dose Vial

For Intravenous Infusion Only

Caution: Cytotoxic Agent

PACKAGE LABEL     PRINCIPAL DISPLAY PANEL     Vial Label
GANCICLOVIR
ganciclovir sodium injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:25021-185
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ganciclovir sodium(UNII: 02L083W284) (ganciclovir - UNII:P9G3CKZ4P5)ganciclovir50 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
sodium hydroxide(UNII: 55X04QC32I)
hydrochloric acid(UNII: QTT17582CB)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25021-185-1025 in 1 CARTON02/15/2018
110 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20764502/15/2018
Labeler -Sagent Pharmaceuticals (796852890)

Revised: 8/2018document Id: 

f6eb73dc-b317-4e2d-a1f1-e73cbe26827dSet id: 993151ed-cea7-49a7-a967-fac3e9b3c85fVersion: 2Effective Time: 20180821Sagent Pharmaceuticals

Manufactured By: 

Pharmascience Inc. Candiac Canada J5R 1J1

Pharmascience Inc. Material code: 36620

Revised: November 2018



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