Aminoven 25, solution for infusion, bottle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Isoleucine; Leucine ; Lysine acetate; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine ; Histidine; Alanine; Glycine; Proline; Serine; Tyrosine; Taurine

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

B05BA; B05BA01

INN (International Name):

Isoleucine; Leucine ; Lysine acetate; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine ; Histidine; Alanine; Glycine; Proline; Serine; Tyrosine; Taurine

Dosage:

15 percent

Pharmaceutical form:

Solution for infusion

Therapeutic area:

Solutions for parenteral nutrition; amino acids

Authorization status:

Marketed

Authorization date:

1999-09-07

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMINOVEN
® 8 SOLUTION FOR INFUSION
AMINOVEN
® 16 SOLUTION FOR INFUSION
AMINOVEN
® 25 SOLUTION FOR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any of the side effects, talk to your doctor, pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Aminoven is and what it is used for
2. What you need to know before you receive Aminoven
3. How to use Aminoven
4. Possible side effects
5. How to store Aminoven
6. Contents of the pack and other information
1. WHAT AMINOVEN IS AND WHAT IT IS USED FOR
Aminoven provides nourishment straight into your blood stream when you
cannot eat normally. It provides
amino acids which your body will use to make proteins (to build and
repair muscles, organs, and other body
structures).
Aminoven is typically mixed in a pharmacy with fat, carbohydrates,
salts and vitamins, which together
provide your complete nutritional needs.
This leaflet covers 3 products:
• Aminoven 8 Solution for Infusion
• Aminoven 16 Solution for Infusion
• Aminoven 25 Solution for Infusion
In this leaflet the three solutions are collectively referred to as
Aminoven.
2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE AMINOVEN
YOU SHOULD NOT RECEIVE AMINOVEN IF YOU ARE SUFFERING FROM, OR HAVE
SUFFERED FROM THE FOLLOWING.:
DO NOT USE AMINOVEN:
• if you have a condition where your BODY HAS PROBLEMS USING
PROTEINS OR AMINO ACIDS
• if you have METABOLIC ACIDOSIS (the acid levels of your body
fluids and tissues become too high)
• if you have reduced KIDNEY function and are not on dialysis or
another form of blood filtration treatment
• if you have seriously reduced LIVER FUNCTION
• inf you have FLUID RETENTION
• if you suffer from SHOCK
• if you have HYPOXIA (low

Summary of Product characteristics

Health Products Regulatory Authority
05 April 2019
CRN008RPQ
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aminoven 25, solution for infusion, bottle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml solution for infusion contains:
Isoleucine 5.20 g
Leucine 8.90 g
Lysine acetate 15.66 g
= Lysine 11.1 g
Methionine 3.80 g
Phenylalanine 5.50 g
Threonine 8.60 g
Tryptophan 1.60 g
Valine 5.50 g
Arginine 20.00 g
Histidine 7.30 g
Alanine 25.00 g
Glycine 18.50 g
Proline 17.00 g
Serine 9.60 g
Tyrosine 0.40 g
Taurine 2.00 g
Total amino acids: 150.00 g/l
Total nitrogen: 25.7 g/l
Total energy: 2520 kJ/l (= 600 kcal/l)
Titratable acidity: 44 mmol NaOH/l
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
The solution is clear and colourless to slightly yellow
pH: 5.5 – 6.3
Theoretical osmolarity: 1505 mosm/l
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For supply of amino acids as part of a parenteral nutrition regimen.
Aminoven 25 is mainly indicated if during parenteral nutrition therapy
the fluid volume has to be restricted.
Amino acid solutions should be administered generally in combination
with adequate amounts of energy supplements.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The daily requirement of amino acids depends on the body weight and
the metabolic conditions of the patient.
Health Products Regulatory Authority
05 April 2019
CRN008RPQ
Page 2 of 5
The maximum daily dose varies with the clinical condition of the
patient and may even change from day to day.
The recommended infusion period is to provide a continuous infusion
for at least 14 hours up to 24 hours, depending on the
clinical situation. Bolus administration is not recommended.
The solution is administered as long as a parenteral nutrition is
required.
Adults
_Dosage: _
6.7 – 13.3 ml of Aminoven 25 per kg body weight/day (equivalent to
1.0 - 2.0 g amino acids per kg body weight/day) e.g.
corresponding to 470 - 930 ml Aminoven 25 at 70 kg body weight/day.
_Maximum in