Clindamycin in 5 Percent Dextrose (Page 5 of 5)

Compatibility

No incompatibility has been demonstrated with the antibiotics cephalothin, kanamycin, gentamicin, penicillin or carbenicillin.

DIRECTIONS FOR USE

Clindamycin in 5% Dextrose Injection in Cryovac Plastic Container

Premixed Clindamycin in 5% Dextrose Injection is for intravenous administration using sterile equipment. Check for minute leaks prior to use by squeezing bag firmly. If leaks are found, discard solution as sterility may be impaired. Do not add supplementary medication. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use unless solution is clear and seal is intact.

Caution

Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

Preparation for Administration

1.
Suspend container from eyelet support.
2.
Remove protector from outlet port at bottom of container.
3.
Attach administration set. Refer to complete directions accompanying set.

HOW SUPPLIED

Clindamycin in 5% Dextrose Injection in Cryovac plastic containers is a sterile solution of clindamycin phosphate with 5% dextrose. Each 50 mL contains clindamycin phosphate equivalent to 600 mg or 900 mg clindamycin. The single dose Cryovac plastic containers are available as follows:

600 mg/50 mL, Carton of 24 minibags

NDC 72572-074-24

900 mg/50 mL, Carton of 24 minibags

NDC 72572-076-24

Exposure of pharmaceutical products to heat should be minimized. It is recommended that Cryovac plastic containers be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid temperatures above 30° C.

REFERENCES

1.
Smith RB, Phillips JP: Evaluation of CLEOCIN HCl and CLEOCIN Phosphate in an Aged Population. Upjohn TR 8147-82-9122-021, December 1982.

Distributed by: Civica, Inc., Lehi, Utah 84043

Manufactured by: InfoRLife SA, Campascio, Switzerland

Rev. June 2022

L128USCLIN02

Package/Label Display Panel

NDC 72572-074 -24

Clindamycin

in 5% Dextrose Injection

600 mg/50 mL

For Intravenous Use

24 x 50 mL Single Dose Containers

CIVICA

Rx Only

Sterile, Nonpyrogenic

600mg_carton
(click image for full-size original)

Package/Label Display Panel

NDC 72572-076-24

Clindamycin

in 5% Dextrose Injection

900 mg/50 mL

For Intravenous Use

24 x 50 mL Single Dose Containers

CIVICA

Rx Only

Sterile, Nonpyrogenic

900mg_carton
(click image for full-size original)
CLINDAMYCIN IN 5 PERCENT DEXTROSE
clindamycin in 5 percent dextrose injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72572-074
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN (CLINDAMYCIN) CLINDAMYCIN 12 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE MONOHYDRATE 50 mg in 1 mL
EDETATE DISODIUM 0.04 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72572-074-24 24 BAG in 1 CARTON contains a BAG (72572-074-01)
1 NDC:72572-074-01 50 mL in 1 BAG This package is contained within the CARTON (72572-074-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201692 01/13/2022
CLINDAMYCIN IN 5 PERCENT DEXTROSE
clindamycin in 5 percent dextrose injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72572-076
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN (CLINDAMYCIN) CLINDAMYCIN 18 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE MONOHYDRATE 50 mg in 1 mL
EDETATE DISODIUM 0.04 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72572-076-24 24 BAG in 1 CARTON contains a BAG (72572-076-01)
1 NDC:72572-076-01 50 mL in 1 BAG This package is contained within the CARTON (72572-076-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201692 01/13/2022
Labeler — Civica, Inc. (081373942)

Revised: 06/2022 Civica, Inc.

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