PHYSICIANS EZ USE B-12 COMPLIANCE kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)

Available from:

Asclemed USA, Inc.

INN (International Name):

Cyanocobalamin

Composition:

Cyanocobalamin 1000 ug in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Antiseptic For first aid to decrease germs in - minor cuts - scrapes - burns For preparation of the skin prior to injection Cyanocobalamin is indicated for Vitamin B 12 deficiencies due to malabsorption which may be associated with the following conditions: Addisonian (pernicious) anemia Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacterial overgrowth, total or partial gastrectomy Fish tapeworm infestation Malignancy of pancreas or bowel Folic acid deficiency It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug/Laboratory Test Interactions ), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin. Requirements of Vitamin B

Product summary:

Cyanocobalamin Injection, USP is supplied as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT. Use only if solution is clear and seal intact.

Authorization status:

unapproved drug other

Summary of Product characteristics

PHYSICIANS EZ USE B-12 COMPLIANCE - PHYSICIANS EZ USE B-12 COMPLIANCE
ASCLEMED USA, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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ISOPROPYL ALCOHOL 70% PREP PADS
ACTIVE INGREDIENT
Isopropyl Alcohol 70% v/v
PURPOS E
Antiseptic
US ES
For first aid to decrease germs in
minor cuts
scrapes
burns
For preparation of the skin prior to injection
WARNINGS
FOR EXTERNAL USE ONLY
FLAMMABLE - KEEP AWAY FROM FIRE OR FLAME
DO NOT USE
with electrocautery procedures
WHEN USING THIS PRODUCT DO NOT
get into eyes
apply over large areas of the body
in case of deep or puncture wounds, animal bites or serious burns
consult a doctor
STOP USE AND ASK A DOCTOR IF
condition persists or gets worse or lasts for more than 72 hours
do not use longer than 1 week unless directed by a doctor
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
apply to skin as needed
discard after single use
OTHER INFORMATION
Protect from freezing and avoid excessive heat
INACTIVE INGREDIENT
Water
CYANOCOBALAMIN INJECTION, USP
DESCRIPTION
Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin
for intramuscular or
subcutaneous use.
Each mL contains 1000 mcg cyanocobalamin; sodium chloride 0.9%; benzyl
alcohol 1.5%; Water for
Injection q.s. Hydrochloric acid and/or sodium hydroxide for pH
adjustment if necessary (4.5-7.0).
Cyanocobalamin appears as dark, red crystals or as an amorphous or
crystalline, red powder. It is very
hygroscopic in the anhydrous form, and sparingly soluble in water
(1:80). It is stable to autoclaving for
short periods at 121°C. The Vitamin B
coenzymes are very unstable in light.
The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide. The
cobalt content is 4.34%. The
structural formula is represented below:
CLINICAL PHARMACOLOGY
Vitamin B
is essential to growth, cell reproduction, hematopoiesis,
nucle