Linezolid labels and packages: Difference between revisions

Jump to navigation Jump to search
VisualWikitext
(Created page with "__NOTOC__ {{Linezolid }} {{CMG}}; {{AE}} {{chetan}} <ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (...")
 
 
(One intermediate revision by the same user not shown)
Line 3: Line 3:
{{CMG}}; {{AE}} {{chetan}}
{{CMG}}; {{AE}} {{chetan}}


==Labels And Packages==


<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e70e63b-bfd5-478d-a8ee-8ba22c9efabd | publisher =  | date =  | accessdate =  }}</ref>
PRINCIPAL DISPLAY PANEL - 100 mL Bag Label
 
NDC 0009-5137-01
Rx only
ZYVOX®
(linezolid) injection
 
200 mg/100 mL
 
Store at 25°C (77°F);
excursions permitted
to 15-30°C (59-86°F) [see
USP Controlled Room
Temperature]. Do not freeze.
Each mL contains:
linezolid 2 mg
dextrose, USP 50.24 mg
sodium citrate, USP 1.64 mg
citric acid, USP 0.85 mg
water for injection, USP qs
pH adjusted to 4.8 with
sodium hydroxide or
hydrochloric acid. Sterile
and nonpyrogenic Single
dose container.
Do not add supplementary
medication. Do not use in
series connections.
817 988 202
LOT
 
For intravenous
administration
Check for leaks by squeezing
container. If leaks are found,
discard, as sterility may be
impaired. Check linezolid
solution for clarity; it may
exhibit a yellow color that
intensifies over time, with no
adverse effect on potency.
DOSAGE AND USE:
See accompanying
prescribing information.
MADE IN NORWAY
Mfd. by Fresenius
Kabi Norge AS
NO-1753 Halden, Norway
Pfizer
Distributed by:
Pharmacia &
Upjohn Co
Division of Pfizer Inc,
NY, NY 10017
7
OTHER
 
1234567890
FUU 0701 01-68-26-019
 
EXP
 
free flex
{|
|-
| [[File:|800px|thumb]]
|-
|}
 
PRINCIPAL DISPLAY PANEL - 300 mL Bag Label
 
NDC 0009-5140-01
Rx only
ZYVOX®
(linezolid) injection
 
600 mg/300 mL
 
Store at 25°C (77°F);
excursions permitted to
15-30°C (59-86°F) [see USP
Controlled Room
Temperature].
Do not freeze.
Each mL contains:
linezolid 2 mg
dextrose, USP 50.24 mg
sodium citrate, USP 1.64 mg
citric acid, USP 0.85 mg
water for injection, USP qs
 
pH adjusted to 4.8 with sodium
hydroxide or hydrochloric acid.
Sterile and nonpyrogenic
Single dose container.
 
817 999 303
 
LOT
 
Do not add supplementary
medication. Do not use in
series connections.
For intravenous administration
Check for leaks by squeezing
container. If leaks are found,
discard, as sterility may be
impaired.
Check linezolid solution for
clarity; it may exhibit a yellow
color that intensifies over time,
with no adverse effect on
potency.
DOSAGE AND USE:
See accompanying
prescribing information.
MADE IN NORWAY
Mfd. by Fresenius Kabi Norge AS
NO-1753 Halden, Norway
Pfizer
Distributed by:
Pharmacia & Upjohn Co
Division of
Pfizer Inc, NY, NY 10017
7
OTHER
 
EXP
 
freeflex
123456789
FUU 0703 01-68-26-020
 
{|
|-
| [[File:|800px|thumb]]
|-
|}
 
PRINCIPAL DISPLAY PANEL - 600 mg Tablet Bottle Label
 
NDC 0009-5135-02
 
20 Tablets
Rx only
 
ZYVOX®
(linezolid) tablets
 
600 mg
 
Pfizer
Distributed by
Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017
 
{|
|-
| [[File:|800px|thumb]]
|-
|}
 
PRINCIPAL DISPLAY PANEL - 600 mL Blister Pack
 
Zyvox®
(linezolid) tablets
600 mg
Distributed by
Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017
MADE IN SINGAPORE
 
{|
|-
| [[File:|800px|thumb]]
|-
|}
 
{|
|-
| [[File:|800px|thumb]]
|-
|}
 
PRINCIPAL DISPLAY PANEL - 600 mg Tablet Bottle Carton
 
UNIT DOSE
 
Pfizer
NDC 0009-5135-03
 
Zyvox®
(linezolid)
 
600 mg
 
tablets
 
For in-institution use only
 
30 Tablets
Rx only
 
{|
|-
| [[File:|800px|thumb]]
|-
|}
 
PRINCIPAL DISPLAY PANEL - 150 mL Bottle Label
 
NDC 0009-5136-01
 
150 mL (when constituted)
Rx only
 
ZYVOX®
 
(linezolid) for
oral suspension
 
100 mg/5 mL
 
Pfizer
Distributed by
Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017
 
 
{|
|-
| [[File:|800px|thumb]]
|-
|}
 
PRINCIPAL DISPLAY PANEL - 150 mL Bottle Carton
 
NDC 0009-5136-01
150 mL (when constituted)
Rx only
 
ZYVOX®
 
(linezolid) for
oral suspension
 
100 mg/5 mL
 
Pfizer
Distributed by
Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e70e63b-bfd5-478d-a8ee-8ba22c9efabd | publisher =  | date =  | accessdate =  }}</ref>
 
 
 
{|
|-
| [[File:|800px|thumb]]
|-
|}


==References==
==References==

Latest revision as of 04:41, 9 January 2014

Linezolid
ZYVOX® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

Labels And Packages

PRINCIPAL DISPLAY PANEL - 100 mL Bag Label

NDC 0009-5137-01 Rx only ZYVOX® (linezolid) injection

200 mg/100 mL

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Do not freeze. Each mL contains: linezolid 2 mg dextrose, USP 50.24 mg sodium citrate, USP 1.64 mg citric acid, USP 0.85 mg water for injection, USP qs pH adjusted to 4.8 with sodium hydroxide or hydrochloric acid. Sterile and nonpyrogenic Single dose container. Do not add supplementary medication. Do not use in series connections. 817 988 202 LOT

For intravenous administration Check for leaks by squeezing container. If leaks are found, discard, as sterility may be impaired. Check linezolid solution for clarity; it may exhibit a yellow color that intensifies over time, with no adverse effect on potency. DOSAGE AND USE: See accompanying prescribing information. MADE IN NORWAY Mfd. by Fresenius Kabi Norge AS NO-1753 Halden, Norway Pfizer Distributed by: Pharmacia & Upjohn Co Division of Pfizer Inc, NY, NY 10017 7 OTHER

1234567890 FUU 0701 01-68-26-019

EXP

free flex

[[File:|800px|thumb]]

PRINCIPAL DISPLAY PANEL - 300 mL Bag Label

NDC 0009-5140-01 Rx only ZYVOX® (linezolid) injection

600 mg/300 mL

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Do not freeze. Each mL contains: linezolid 2 mg dextrose, USP 50.24 mg sodium citrate, USP 1.64 mg citric acid, USP 0.85 mg water for injection, USP qs

pH adjusted to 4.8 with sodium hydroxide or hydrochloric acid. Sterile and nonpyrogenic Single dose container.

817 999 303

LOT

Do not add supplementary medication. Do not use in series connections. For intravenous administration Check for leaks by squeezing container. If leaks are found, discard, as sterility may be impaired. Check linezolid solution for clarity; it may exhibit a yellow color that intensifies over time, with no adverse effect on potency. DOSAGE AND USE: See accompanying prescribing information. MADE IN NORWAY Mfd. by Fresenius Kabi Norge AS NO-1753 Halden, Norway Pfizer Distributed by: Pharmacia & Upjohn Co Division of Pfizer Inc, NY, NY 10017 7 OTHER

EXP

freeflex 123456789 FUU 0703 01-68-26-020

[[File:|800px|thumb]]

PRINCIPAL DISPLAY PANEL - 600 mg Tablet Bottle Label

NDC 0009-5135-02

20 Tablets Rx only

ZYVOX® (linezolid) tablets

600 mg

Pfizer Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, NY, NY 10017

[[File:|800px|thumb]]

PRINCIPAL DISPLAY PANEL - 600 mL Blister Pack

Zyvox® (linezolid) tablets 600 mg Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, NY, NY 10017 MADE IN SINGAPORE

[[File:|800px|thumb]]
[[File:|800px|thumb]]

PRINCIPAL DISPLAY PANEL - 600 mg Tablet Bottle Carton

UNIT DOSE

Pfizer NDC 0009-5135-03

Zyvox® (linezolid)

600 mg

tablets

For in-institution use only

30 Tablets Rx only

[[File:|800px|thumb]]

PRINCIPAL DISPLAY PANEL - 150 mL Bottle Label

NDC 0009-5136-01

150 mL (when constituted) Rx only

ZYVOX®

(linezolid) for oral suspension

100 mg/5 mL

Pfizer Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, NY, NY 10017


[[File:|800px|thumb]]

PRINCIPAL DISPLAY PANEL - 150 mL Bottle Carton

NDC 0009-5136-01 150 mL (when constituted) Rx only

ZYVOX®

(linezolid) for oral suspension

100 mg/5 mL

Pfizer Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, NY, NY 10017[1]


[[File:|800px|thumb]]

References

  1. ↑ "ZYVOX (LINEZOLID) INJECTION, SOLUTION ZYVOX (LINEZOLID) TABLET, FILM COATED ZYVOX (LINEZOLID) SUSPENSION [PHARMACIA AND UPJOHN COMPANY]".

Adapted from the FDA Package Insert.

Retrieved from "https://www.wikidoc.org/index.php?title=Linezolid_labels_and_packages&oldid=929356"