Aminofluid

Number of 
stoppers

500 mL

Approx. 1700 mL

1

1000 mL

Approx. 2700 mL

1

INDICATIONS
Provision of amino acids, electrolytes, and water via a peripheral vein in following instances: mild hypoproteinemia or mild malnutrition due to inadequate oral intake, and before and after surgery.

DOSAGE AND ADMINISTRATION
Just before use, break the center seal between the chambers by pressing the lower chamber and mix the two solutions thoroughly.
The usual adult dose is 500 mL per dose, infused via a peripheral vein. The usual infusion rate in adults is 500 mL per 120 min and should be slowed in the elderly
and critically ill patients. The dosage may be adjusted according to the patients condition, body weight, and age. The maximum dosage is 2500 mL per day.

Method of mixing two solutions (Never fail to mix two solutions.)
Be sure to press the lower chamber to break the center seal between the two chambers. Peel off the red sticker at hanger after mixing two solutions.

CONTRAINDICATIONS
(AMINOFLUID® is contraindicated in the following patients.)

• Patients with hepatic coma or a risk of hepatic coma [Because of inadequate amino acid metabolism, the patients clinical condition may be worsened]
• Patients with severe renal disorder or azotemia [The amounts of water and electrolytes tend to be excessive and the patients clinical condition may be worsened. Urea and other amino acid metabolites may be retained, which may worsen the patients clinical condition.]
• Patients with congestive cardiac failure [An increase in the circulating blood volume may worsen the patients clinical condition.]
• Patients with severe acidosis (hyperlactacidemia etc.) [The patients clinical condition may be worsened.]
• Patients with abnormal electrolyte metabolism [Administration may worsen the patients clinical condition.]
  1. Patients with hyperpotassemia

(oliguria, Addison’s disease, etc.)

• Patients with hyperphosphatemia (hypoparathyroidism etc.)
• Patients with hypermagnesemia (hypothyroidism etc.)
• Patients with hypercalcemia
• Patients with reduced urine output due to obstructive uropathy [Overload of water and electrolytes may worsen the patients clinical condition.]
• Patients with abnormal amino acid metabolism [Since the infused amino acids are not adequately metabolized, the patients clinical condition may be worsened.]

PRECAUTIONS

cellspacing=”0″ >

1.

Careful Administration (AMINOFLUID® should be administered with care in the following patients.)

(1)

Patients with hepatic dysfunction
[Water and electrolyte metabolism may be worsened.]

(2)

Patients with renal dysfunction
[Since the patients have reduced water and electrolyte control, the solution should be administered with care.]

(3)

Patients with cardiovascular dysfunction
[An increase in the circulating blood volume may worsen the patients clinical condition.]

(4)

Patients with acidosis
[The patients clinical condition may be worsened.]

(5)

 Patients with diabetes mellitus
[Inhibited uptake of glucose into the tissues may cause hyperglycemia, which may worsen the patients clinical condition.]

2.

Important Precautions

(1)

AMINOFLUID® contains 15 g of amino acids (2.35 g nitrogen) and 150 kcal in 500 mL. However, daily calorie requirements cannot be met by only administering this solution as the sole source of nutrition.
Thus, this solution should be used for short-term nutrition therapy.

(2)

When used as a nutritional supplement in patients whose oral intake is inadequate, the solution should be used based on the overall assessment of the patients nutritional requirements and oral intake.

(3)

When this solution is used alone postoperatively, its use should be limited to 3-5 days and oral/enteral nutrition or other regimens should be started as soon as it is feasible to do so.

3.

Adverse Reactions
Reported incidence rates are based on data from 229 patients, and a total of 35 patients (15%) experienced 59 adverse reactions including abnormal laboratory values (data at the time of drug approval in 1996). If adverse reactions are observed, discontinue the administration, and institute appropriate treatment.

cellspacing=”0″ >

Reactions

≥ 5% or frequency unknown

0.1 % – ‹ 5 %

Hypersensitivity

[Rash etc.]

Gastrointestinal

Nausea, vomiting

Cardiovascular

[Chest discomfort, palpitation,etc.]

Hepatic

Increases in AST (GOT), ALT (GPT), Al-P, or total bilirubin

Large dose and rapid administration

‹Cerebral, pulmonary and peripheral edema, hyperpotassemia, water intoxication›, [acidosis]

Other

Vascular pain, phlebitis, [chills, fever, feeling of warmth, headache]

>

[ ]

common adverse reactions in amino acid injeksis (Drug Efficacy Reevaluation, Part 15, 1979, Japan.

‹ ›

common adverse reactions in maintenance solutions (Drug Efficacy Reevaluation, Part 14, 1978, Japan.

4.

Use in the Elderly
Since elderly patients often have reduced physiological function and associated hepatic, renal or cardiac dysfunction, it is advisable to take such measures as reducing the dose by decreasing the infusion rate under careful supervision.

5.

Use during Pregnancy, Delivery, or Lactation
The safety in pregnant women has not been established. AMINOFLUID® should be used in pregnant women and women who may possibly be pregnant only if the therapeutic benefits outweigh the possible risks associated with treatment.

6.

Pediatric Use
The safety in children has not been established (no clinical experience).

7.

Precautions Concerning Use

(1)

Admixture
Open the outer wrap just before use, break the center seal between the two chambers, and mix the two solutions thoroughly. The solution in one chamber should not be administered alone without mixing with the solution in the other chamber.

(2)

At the time of preparation

• Physical changes of the solution such as precipitation may occur when AMINOFLUID® is combined with the following drugs. Changes should be observed.
  1. drugs which are stable in alkaline or acidic conditions
  2. drugs which are not soluble in water

The solution should not be mixed with drugs containing calcium salt or       phosphate, since this will cause the solution to precipitate

Since the solution contains calcium salt, blood clotting may occur when mixed with citrated blood

After opening the outer wrap and mixing the two solutions, the mixed solution should be used promptly

(3)

Before administration

• When administering AMINOFLUID®, it is recommended to maintain urine output of more than 500 mL per day or more than 20 mL per hari
• To prevent infection, carry out all procedures under aseptic conditions
• Use the solution after warming to near body temperature during cold     environmental conditions
• Use the solution immediately after opening the container. After use, discard all unused solution

(4)

During administration

• The usual adult dose is 500 mL per 120 min. The administration rate should be slowed in the elderly and seriously ill patients
• When vascular pain occurs, use an alternate site or discontinue the       administration
• Extravasation of the solution may result in skin necrosis and ulceration
• Discontinue the administration promptly after confirming clinical signs of extravasation (ex. redness, infiltration or swelling) at injeksi site

PRECAUTIONS FOR HANDLING

• Since an oxygen absorbent is enclosed between the bag and the outer wrap to maintain stability of the product, do not remove the outer wrap until immediately before use
• A crystalline precipitate may form in the upper chamber solution (amino acid solution) due to changes in environmental temperature. Shake the solution at temperatures of 15-25°C to dissolve precipitates before use
• Do not use the solution if the outer wrap covering the product has been damaged, the solution is discolored, or a precipitate that cannot be dissolved by shaking has formed
• If the two solutions packaged in the chambers have already been mixed for any reason or if the center seal between the two chambers looks white in color (the sealed area>appears white in color when it is peeled off), do not use the product
• Puncture the rubber stopper vertically with a needle in the marked circle. If the stopper is not pierced vertically, the needle may pass through the neck of the container and cause leakage of the contents
• Soft bag products may not be infused in tandem using a connection tube
• If droplets of water or leakage of the contents is noted inside the outer wrap or if the solution is discolored or cloudy, do not use the solution
• Volume markings on the container may not be accurate. Use only as a guide

STORAGE:
below 30°C, protect from light

HOW SUPPLY
Box, 1 soft double bag of 1000 mL, REG. NO.: DKL 0918707849A1
Box, 1 soft double bag of 500 mL, REG. NO.: DKL 0918707849A1

➲ Caution

• Open the outer wrap just before use, break the center seal between the two chambers, and mix the two solutions thoroughly
• After opening the outer wrap and mixing the two solutions, the mixed solution should be used promptly
• Do not use if bag is leaking, solution cloudy or contains foreign matters
• Do not use if the oxygen indicator tablet became blue

ON MEDICAL PRESCRIPTION ONLY
HARUS DENGAN RESEP DOKTER

Manufactured by:
PT. Otsuka Indonesia
Jl. Sumber Waras No. 25
Lawang, Malang 65216, Indonesia