AMINOSYN II 8.5% INJECTION SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

L-ISOLEUCINE; L-LEUCINE; L-LYSINE (L-LYSINE ACETATE); METHIONINE; L-PHENYLALANINE; L-THREONINE; TRYPTOPHAN; L-VALINE; L-ALANINE; L-ARGININE; L-ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; L-PROLINE; SERINE; N-ACETYL-L-TYROSINE

Mevcut itibaren:

HOSPIRA HEALTHCARE ULC

ATC kodu:

B05BA01

INN (International Adı):

AMINO ACIDS

Doz:

561MG; 850MG; 893MG; 146MG; 253MG; 340MG; 170MG; 425MG; 844MG; 865MG; 595MG; 627MG; 425MG; 255MG; 614MG; 450MG; 230MG

Farmasötik formu:

SOLUTION

Kompozisyon:

L-ISOLEUCINE 561MG; L-LEUCINE 850MG; L-LYSINE (L-LYSINE ACETATE) 893MG; METHIONINE 146MG; L-PHENYLALANINE 253MG; L-THREONINE 340MG; TRYPTOPHAN 170MG; L-VALINE 425MG; L-ALANINE 844MG; L-ARGININE 865MG; L-ASPARTIC ACID 595MG; GLUTAMIC ACID 627MG; GLYCINE 425MG; HISTIDINE 255MG; L-PROLINE 614MG; SERINE 450MG; N-ACETYL-L-TYROSINE 230MG

Uygulama yolu:

INTRAVENOUS

Paketteki üniteler:

500ML

Reçete türü:

Ethical

Terapötik alanı:

CALORIC AGENTS

Ürün özeti:

Active ingredient group (AIG) number: 1750888003; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2016-07-29

Ürün özellikleri

PRESCRIBING INFORMATION
AMINOSYN
TM II 7%
AMINOSYN
TM II 8.5%
AMINOSYN
TM II 10%
AMINOSYN
TM II 15%
(amino acids for injection 7%, 8.5%, 10% and 15% w/v)
SULFITE-FREE
NUTRITIVE SUPPLEMENT FOR INTRAVENOUS INFUSION
Hospira Healthcare Corporation
DATE OF PREPARATION:
1111 Dr. Frederik-Philips
June 1, 2012
St-Laurent, Quebec
H4M 2X6
Control # 151223
_PRESCRIBING INFORMATION; Aminosyn_
_TM_
_ II 7%, 8.5%, 10 % and 15% _
_Page 2 of 16 _
PRESCRIBING INFORMATION
NAME OF DRUGS
AMINOSYN
TM
II 7%
AMINOSYN
TM
II 8.5%
AMINOSYN
TM
II 10%
AMINOSYN
TM
II 15%
(amino acids for injection 7%, 8.5%, 10% and 15% w/v)
Sulfite-Free
THERAPEUTIC OR PHARMACOLOGICAL CLASSIFICATION
Nutritive Supplement for Intravenous Infusion
ACTIONS AND CLINICAL PHARMACOLOGY
AMINOSYN
7
II 7%, 8.5%, 10% and 15% (amino acids for injection 7%, 8.5%, 10% and
15%)
provides crystalline amino acids which, when administered with
appropriate source of energy,
promote protein synthesis and wound healing and prevent endogenous
protein catabolism.
AMINOSYN
7
II, when given by peripheral or central venous infusion in combination
with
dextrose, electrolytes, vitamins, trace metals and/or ancillary fat
supplements, constitutes Total
Parenteral Nutrition (TPN).
INDICATIONS AND CLINICAL USE
Parenteral nutrition with AMINOSYN
7
II 7%, 8.5%, 10% and 15% is indicated to prevent
nitrogen loss or treat negative nitrogen balance in adults and
children where:
1.
the alimentary tract, by the oral, gastrotomy, 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
for additional information).
_PRESCRIBING INFORMATION; A