HEPATAMINE- isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alani injection, solu

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77), LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C), LYSINE ACETATE (UNII: TTL6G7LIWZ) (LYSINE - UNII:K3Z4F929H6), METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL), PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R), THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S), TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX), VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7), ALANINE (UNII: OF5

Available from:

B. Braun Medical Inc.

INN (International Name):

ISOLEUCINE

Composition:

ISOLEUCINE 0.9 g in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

HepatAmine® is indicated for the treatment of hepatic encephalopathy in patients with cirrhosis or hepatitis. HepatAmine® provides nutritional support for patients with these diseases of the liver who require parenteral nutrition and are intolerant of general purpose amino acid injections, which are contraindicated in patients with hepatic coma. HepatAmine® is contraindicated in patients with anuria, inborn errors of amino acid metabolism, especially 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.

Product summary:

HepatAmine® (8% Amino Acid Injection) is supplied sterile and nonpyrogenic in glass containers with solid stoppers packaged 6 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Protect from light until use.

Authorization status:

New Drug Application

Patient Information leaflet

ALANI INJECTION, SOLUTION
B. Braun Medical Inc.
----------
DIRECTIONS FOR USE OF B. BRAUN GLASS
CONTAINERS WITH SOLID STOPPERS
Designed for use with a vented set. Use 18 to 22 gauge needle size for
admixing or withdrawing solutions
from the glass bottle.
1.
Before use, perform the following checks:
•
Inspect each container. Read the label. Ensure solution is the one
ordered and is within the
expiration date.
•
Invert container and carefully inspect the solution in good light for
cloudiness, haze, or particulate
matter; check the bottle for cracks or other damage. In checking for
cracks, do not be confused by
normal surface marks and seams on the bottom and sides of the bottle.
These are not flaws. Look
for bright reflections that have depth and penetrate into the wall of
the bottle. Reject any such
bottle.
2. Remove plastic cap (See Figure 1).
3. Swab exposed stopper surface with a suitable disinfectant.
Warning: Some additives may be incompatible. Consult with pharmacist.
When introducing additives, use
aseptic techniques. Mix thoroughly. Do not store.
4. When adding medication to the container prior to administration,
swab the target area of the rubber
stopper, inject medication and mix thoroughly by gentle agitation.
5. Refer to Directions for Use of the set being used. Insert the set
spike into the bottle through the target
area of the rubber stopper. Allow the fluid to flow and remove air
from the tubing before administration
begins. Hang the container.
6. After admixture and during administration, re-inspect the solution
frequently. If any evidence of
solution contamination or instability is found or if the patient
exhibits any signs of fever, chills or other
reactions not readily explainable, discontinue administration
immediately and notify the physician.
7. Spiking, additions, or transfers should be made immediately after
swabbing stopper surface. Check for
vacuum at first puncture of stopper. Admixture by needle or syringe
should be made through the target
area of the rubber stopper; contents should

Summary of Product characteristics

HEPATAMINE- ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE,
PHENYLALANINE, THREONINE,
TRYPTOPHAN, VALINE, ALANI INJECTION, SOLUTION
B. BRAUN MEDICAL INC.
----------
HEPATAMINE
(8% AMINO ACID INJECTION)
PROTECT FROM LIGHT UNTIL USE.
DESCRIPTION
HepatAmine® (8% Amino Acid Injection) is a sterile, nonpyrogenic,
hypertonic solution containing
crystalline amino acids. A 500 mL unit provides a total of 40 g of
amino acids and 6 g of nitrogen (38 g
of protein equivalent).
Each 100 mL contains:
_ESSENTIAL AMINO ACIDS_
Isoleucine USP..............................................0.90 g
Leucine USP.................................................1.10 g
Lysine...........................................................0.61
g
(added as Lysine Acetate USP....................0.86 g)
Methionine USP............................................0.10 g
Phenylalanine USP.........................................0.10 g
Threonine USP..............................................0.45 g
Tryptophan USP.........................................0.066 g
Valine USP...................................................0.84 g
_NONESSENTIAL AMINO ACIDS_
Alanine USP..................................................0.77 g
Arginine USP.................................................0.60 g
Histidine USP.................................................0.24 g
Proline USP...................................................0.80 g
Serine USP....................................................0.50 g
Glycine USP..................................................0.90 g
Cysteine....................................................<0.014 g
(as Cysteine HCl•H O USP....................<0.020 g)
Phosphoric Acid NF....................................0.115 g
Sodium Bisulfite (as an antioxidant)................<0.1 g
Water for Injection USP......................................qs
pH adjusted with Glacial Acetic Acid USP
pH: 6.5 (6.0–6.8)
®
2
Calculated Osmolarity: 785 mOsmol/liter
Concentration of Electrolytes (mEq/liter): Sodium 10; Chloride <3
Phosphate (HPO ) 20 (