AQUASOL A- vitamin a palmitate injection, solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (RETINOL - UNII:G2SH0XKK91)

Inapatikana kutoka:

Hospira, Inc.

INN (Jina la Kimataifa):

VITAMIN A PALMITATE

Tungo:

RETINOL 15 mg in 1 mL

Njia ya uendeshaji:

INTRAMUSCULAR

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Vitamin A injection is effective for the treatment of vitamin A deficiency. The parenteral administration is indicated when the oral administration is not feasible as in anorexia, nausea, vomiting, pre- and postoperative conditions, or it is not available as in the "Malabsorption Syndrome" with accompanying steatorrhea. Pediatric Use: Vitamin A treatment for deficiency states has been recognized as an especially effective and important therapy in the pediatric population. Vitamin A supplementation for deficiency states in this population has been addressed by the Committee on Clinical Practice Issues of the American Society for Clinical Nutrition, by the American Society for Parenteral and Enteral Nutrition, and by the World Health Organization. The intravenous administration. Hypervitaminosis A. Sensitivity to any of the ingredients in this preparation. Use in Pregnancy: Safety of amounts exceeding 6,000 Units of vitamin A daily during pregnancy has not been established at this time. The use of vitamin A i

Bidhaa muhtasari:

AQUASOL ATM Parenteral (water-miscible vitamin A Palmitate) is available as: Store at 2–8°C (36–46°F). Do not freeze. Hospira, In Revised: 01/2018c., Lake Forest, IL 60045 USA                                                                                                                         LAB-1245-1.0

Idhini hali ya:

New Drug Application

Tabia za bidhaa

AQUASOL A- VITAMIN A PALMITATE INJECTION, SOLUTION
HOSPIRA, INC.
----------
AQUASOL A
PARENTERAL RX
ONLY
water-miscible vitamin A Palmitate
50,000 USP Units (15 mg retinol/mL)
THIS IS A STERILE PRODUCT FOR INTRAMUSCULAR INJECTION
DESCRIPTION
AQUASOL A
PARENTERAL (water-miscible vitamin A Palmitate) provides 50,000 USP
Units of vitamin A per mL as retinol (C
H
O) in the form of vitamin A palmitate, a light
yellow to amber oil. Contains 0.5% chlorobutanol as preservative; 12%
polysorbate 80,
0.1% citric acid, and sodium hydroxide to adjust pH. The structural
formula of retinol is:
Ordinarily oil-soluble, the vitamin A in this product has been water
solubilized by special
processing* and is available in a water solution for intramuscular
injection.
One USP Unit is equivalent to one international unit (IU) and to 0.3
mcg of retinol or 0.6
mcg of betacarotene.
CLINICAL PHARMACOLOGY
Beta-carotene, retinol, and retinal have effective and reliable
vitamin A activity. Retinal
and retinol are in chemical equilibrium in the body and have
equivalent antixerophthalmic
activity. Retinal combines with the rod pigment, opsin, in the retina
to form rhodopsin,
necessary for visual dark adaptation. Vitamin A prevents retardation
of growth and
preserves the epithelial cells' integrity. Normal adult liver storage
is sufficient to satisfy
two years' requirements of vitamin A.
Vitamin A is readily absorbed from the gastrointestinal tract, where
the biosynthesis of
vitamin A from beta-carotene takes place. Vitamin A absorption
requires bile salts,
pancreatic lipase, and dietary fat. It is transported in the blood to
the liver by the
chylomicron fraction of the lymph. Vitamin A is stored in Kupffer
cells of the liver mainly
as the palmitate. Normal serum vitamin A is 80–300 Units per 100 mL
(plasma range is
30–70 mcg per dl) and for carotenoids 270–753 Units per 100 mL.
The normal adult liver
contains approximately 100 to 300 micrograms per gram, mostly as
retinol palmitate.
*Oil-soluble vitamin A water solubilized with polysorbate