PREMASOL - SULFITE-FREE (AMINO ACID)- leucine, lysine, isoleucine, valine, histidine, phenylalanine, threonine, methionine, tryptophan, tyrosine, n-acetyl-tyrosine, arginine, proline, alanine, glutamic acide, serine, glycine, aspartic acid, taurine, cysteine hydrochloride injection, solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C), LYSINE ACETATE (UNII: TTL6G7LIWZ) (LYSINE - UNII:K3Z4F929H6), ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77), VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7), HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E), PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R), THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S), METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL), TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX), TYROSINE (UNII: 42HK56048U) (TYROSINE - UNII:42HK56048U), ARGININE (UNII: 94ZLA3W45F) (ARGININE - UNII:94ZLA3W45F), PROLINE (UNII: 9DLQ4CIU6V) (PROLINE - UNII:9DLQ4CIU6V), ALANINE (UNII: OF5P57N2ZX) (ALANINE - UNII:OF5P57N2ZX), GLUTAMIC ACID (UNII: 3KX376GY7L) (GLUTAMIC ACID - UNII:3KX376GY7L), SERINE (UNII: 452VLY9402) (SERINE - UNII:452VLY9402), GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C), ASPARTIC ACID (UNII: 30KYC7MIAI) (ASPARTIC ACID - UNII:30KYC7MIAI), TAURINE (UNII: 1EQV5MLY3D) (TAURINE - UNII:1EQV5MLY3D), CYSTEINE HYDROCHLORIDE (UNII: ZT934N0X4W) (CYSTEINE - UNII:K848JZ4886)

Dostupné z:

Baxter Healthcare Corporation

INN (Medzinárodný Name):

LEUCINE

Zloženie:

LEUCINE 1.4 g in 100 mL

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

PREMASOL 10% injection is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with PREMASOL 10% injection is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where: (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutritional support, and vein tolerance (see DOSAGE AND ADMINISTRATION). Central venous infusion should be considered when amino acid solutions are to be admixed with hypertonic dextrose to promote protein synthesis in hypercatabolic or severely depleted infants, or those requiring long-term parenteral nutrition. For moderately catabolic or depleted patients in whom the central venous route is not indicated, diluted amino acid solutions mixed with 5-10% dextrose solutions may be infused by peripheral vein, supplemented, if desired, with fat emulsion. PREMASOL 10% injection is contraindicated in patients with untreated anuria, hepatic coma, inborn errors of amino acid metabolism, including those involving branched chain amino acid metabolism such as maple syrup urine disease and isovaleric acidemia, or hypersensitivity to one or more amino acids present in the solution.

Prehľad produktov:

PREMASOL 10% - sulfite-free (amino acids) injection is supplied in VIAFLEX plastic Pharmacy Bulk Package containers in the following sizes and concentrations: 500 mL 1000 mL 2000 mL 10% 2B0012 2B0009 2B0010 NDC 0338-1130-03 NDC 0338-1130-04 NDC 0338-1130-06 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended the product be stored at room temperature (25°C/77°F). Brief exposure up to 40°C/104°F does not adversely affect the product. Protect from light until immediately prior to use. Do not remove container from overpouch until ready to use. Do not use if overpouch has been previously opened or damaged.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

PREMASOL - SULFITE-FREE (AMINO ACID)- LEUCINE, LYSINE, ISOLEUCINE,
VALINE,
HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE,
N-
ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE,
GLYCINE,
ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
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PREMASOL 10% - SULFITE-FREE (AMINO ACIDS) INJECTION
IN VIAFLEX PLASTIC CONTAINER
RX ONLY
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
DESCRIPTION
PREMASOL 10% injection is a sterile, nonpyrogenic, hypertonic
solutions containing
crystalline amino acids provided in a Pharmacy Bulk Package. A
Pharmacy Bulk Package
is a container of a sterile preparation for parenteral use that
contains many single doses.
The contents are intended for use in a pharmacy admixture program and
are restricted
to the preparation of admixtures for intravenous infusion.
The VIAFLEX plastic container is fabricated from a specially
formulated polyvinyl chloride
(PL 146 Plastic). Exposure to temperatures above 25°C/77°F during
transport and
storage will lead to minor losses in moisture content. Higher
temperatures lead to
greater losses. It is unlikely that these minor losses will lead to
clinically significant
changes within the expiration period. The amount of water that can
permeate from
inside the container into the overwrap is insufficient to affect the
solution significantly.
Solutions in contact with the plastic container can leach out certain
of its chemical
components in very small amounts within the expiration period (e.g.,
di-2-ethylhexyl
phthalate, DEHP, at not more than 0.2 part per million); however, the
safety of the
plastic has been confirmed in tests in animals according to USP
biological tests for
plastic containers as well as by tissue culture toxicity studies.
Intravenous fat emulsion
should not be administered in polyvinyl chloride (PVC) containers that
use di-2-ethylhexyl
phthalate (DEHP) as a plasticizer, because the fat emulsion
facilitates the leaching of
DEHP from these containers.
Eac