Gemcitabine (Page 12 of 12)
Embryo-Fetal Toxicity
Advise females and males of reproductive potential that gemcitabine for injection can cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment with gemcitabine for injection and for 6 months after the final dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with gemcitabine for injection and for 3 months after the final dose [see Warnings and Precaution (5.6), Use in Specific Populations (8.1, 8.3)].
Lactation
Advise women not to breastfeed during treatment with gemcitabine for injection and for at least one week after the last dose [see Use in Specific Populations (8.2)].
Infertility
Advise males of reproductive potential of the potential for reduced fertility with gemcitabine for injection [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].
Manufactured by:
THYMOORGAN PHARMAZIE GmbH
Schiffgraben 23, 38690 Goslar, Germany
Distributed by:
Hikma Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922
Revised: December 2020
127.207.011/01
Pincipal Display Panel
NDC 0143-9394 -01 Rx only
Gemcitabine
for Injection, USP
200 mg per vial
For Intravenous use ONLY
Discard unused portionSterile Single-Dose Vial
NDC 0143-9394 -01 Rx only
Gemcitabine
for Injection, USP
200 mg per vial
For Intravenous use ONLY
Discard unused portionSterile Single-Dose Vial
Principal Display Panel
NDC 0143-9395 -01 Rx only
Gemcitabine
for Injection, USP
1 gram per vial
For Intravenous use ONLY
Discard unused portionSterile Single-Dose Vial
NDC 0143-9395 -01 Rx only
Gemcitabine
for Injection, USP
1 gram per vial
For Intravenous use ONLY
Discard unused portionSterile Single-Dose Vial
Representative Serialization Image
GEMCITABINE gemcitabine injection, powder, lyophilized, for solution | |||||||||||||||||
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GEMCITABINE gemcitabine injection, powder, lyophilized, for solution | |||||||||||||||||
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Labeler — Hikma Pharmaceuticals USA Inc. (001230762) |
Revised: 06/2021 Hikma Pharmaceuticals USA Inc.
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