MULTRYS- trace elements injection 4 injection, solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37), CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L), MANGANESE SULFATE (UNII: W00LYS4T26) (MANGANESE CATION (2+) - UNII:H6EP7W5457), SELENIOUS ACID (UNII: F6A27P4Q4R) (SELENIOUS ACID - UNII:F6A27P4Q4R)

Inapatikana kutoka:

American Regent, Inc.

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Multrys is indicated in neonatal and pediatric patients weighing less than 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Multrys is contraindicated in patients with hypersensitivity to zinc or copper [see Warnings and Precautions  (5.7 )]. Multrys is approved for use in neonatal and pediatric patients weighing less than 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.  Safety and dosing recommendations in pediatric patients less than 10 kg are based on published literature describing controlled studies of products containing zinc, copper, manganese, and selenium [see Dosage and Administration (2.5)] . Copper is primarily excreted in the bile.  Excretion is decreased in patients with cholestasis and/or cirrhosis.  Manganese is presumed to be excreted in bile [see Clinical Pharm

Bidhaa muhtasari:

Multrys (trace elements injection 4*, USP) is a clear, colorless to slightly blue solution supplied in: *Each mL of Multrys contains zinc 1,000 mcg, copper 60 mcg, manganese 3 mcg, and selenium 6 mcg. Vial closure is not made with natural rubber latex. Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Store admixed solution at 2ºC to 8ºC (36ºF to 46ºF) [see Dosage and Administration (2.3)] .

Idhini hali ya:

New Drug Application

Tabia za bidhaa

MULTRYS- TRACE ELEMENTS INJECTION 4 INJECTION, SOLUTION
AMERICAN REGENT, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MULTRYS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MULTRYS
.
MULTRYS (TRACE ELEMENTS INJECTION 4*) FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2020
INDICATIONS AND USAGE
Multrys is a combination of trace elements (zinc sulfate, cupric
sulfate, manganese sulfate, and selenious
acid) indicated in neonatal and pediatric patients weighing less than
10 kg as a source of zinc, copper,
manganese, and selenium for parenteral nutrition when oral or enteral
nutrition is not possible, insufficient,
or contraindicated. (1)
DOSAGE AND ADMINISTRATION
_Single-dose vial, for admixture use only._ (2.1)
See full prescribing information for information on preparation,
administration and general dosing
considerations. (2.1, 2.2, 2.3, 2.4)
Recommended Dosage
Each mL of Multrys provides zinc 1,000 mcg, copper 60 mcg, manganese 3
mcg, and selenium 6 mcg.
(2.5)
Multrys is recommended only for pediatric patients who require
supplementation with all four of the
individual trace elements (i.e., zinc, copper, manganese, and
selenium) to meet daily requirements.
(2.5)
_Pediatric Patients 0.4 kg to 0.59 kg_: The total recommended dosage
of Multrys is 0.2 mL EVERY OTHER
DAY.Daily supplementation of Zinc Sulfate, Cupric Chloride and
Selenious Acid will be needed to meet
daily requirements. (2.5)
_Pediatric Patients 0.6 kg to 10 kg_: The recommended dosage of
Multrys is 0.3 mL/kg/day rounded to
the nearest 0.1 mL for up to a maximum of 1 mL per day. The
recommended volume of Multrys to be
added to parenteral nutrition ranges from 0.2 mL per day to 1 mL per
day based on body weight. (2.5)
Multrys is not recommended for patients who may require a lower dosage
of one or more of the
individual trace elements. (2.5)
Monitor trace element concentrations in blood during long-term
administration of parenteral nutrition.
(2.5)
DOSAGE FORMS AND STRE