Vaminolact solution for infusion, 100 ml bottle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cysteine; Tryptophan; Glutamic acid; Tyrosine; Histidine; Alanine; Phenylalanine; Leucine; Aspartic acid; Lysine; Arginine; Threonine; Serine; Taurine; Valine; Proline; Methionine; Glycine; Isoleucine

Available from:

Fresenius Kabi Limited

ATC code:

B05BA; B05BA01

INN (International Name):

Cysteine; Tryptophan; Glutamic acid; Tyrosine; Histidine; Alanine; Phenylalanine; Leucine; Aspartic acid; Lysine; Arginine; Threonine; Serine; Taurine; Valine; Proline; Methionine; Glycine; Isoleucine

Dosage:

100 millilitre(s)

Pharmaceutical form:

Solution for infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Solutions for parenteral nutrition; amino acids

Authorization status:

Marketed

Authorization date:

1991-06-10

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
VAMINOLACT
® SOLUTION FOR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 or pharmacist.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET:
1. What Vaminolact is and what it is used for
2. What you need to know before your child receives Vaminolact
3. How your child will be given Vaminolact
4. Possible side effects
5. How to store Vaminolact
6. Contents of the pack and other information
1.
WHAT VAMINOLACT IS AND WHAT IT IS USED FOR
Vaminolact is especially designed for new born babies and infants.
It provides nourishment into your child’s blood stream when they
cannot eat normally. It provides amino acids, which the body
will use to make proteins (to build and repair muscles, organs, and
other body structures).
Vaminolact is typically mixed with glucose, salts, fats, carbohydrates
and vitamins, which together provide complete nutritional
needs.
In this leaflet this solution will be referred to as Vaminolact.
2.
WHAT YOU NEED TO KNOW BEFORE YOUR CHILD IS GIVEN VAMINOLACT
YOUR CHILD SHOULD NOT USE VAMINOLACT IF:
•
a known allergy (hypersensitivity) to Vaminolact or any of the
ingredients of Vaminolact mentioned in section 6 (for symptoms
of an allergic reaction please refer to section 4).
•
seriously reduced liver function
•
reduced kidney function (ureamia) and is not on dialysis or another
form of blood filtration treatment
Inform your doctor if any of the above conditions apply to your child
before treatment with Vaminolact.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Vaminolact
Before giving this medicine to your child your doctor should know if
he/she suffers from:
•
cardiac insufficiency - where the heart can’t pump enough blo

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vaminolact solution for infusion, 100 ml bottle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Alanine
6.3 g
Arginine
4.1 g
Aspartic Acid
4.1 g
Cysteine
1.0 g
Glutamic Acid
7.1 g
Glycine
2.1 g
Histidine
2.1 g
Isoleucine
3.1 g
Leucine
7.0 g
Lysine (as monohydrate)
5.6 g
Methionine
1.3 g
Phenylalanine
2.7 g
Proline
5.6 g
Serine
3.8 g
Taurine
0.3 g
Threonine
3.6 g
Tryptophan
1.4 g
Tyrosine
0.5 g
Valine
3.6 g
in each 1000 ml
For a full list of excipients, see section 6.1.
Product Properties
Amino acids
65.3 g/l
Total Nitrogen
9.3 g/l corresponding to 58 g/l protein
Energy
240 kcal (1.0MJ)/l
Osmolality
510 mosmol/kg water
pH
5.2
3 PHARMACEUTICAL FORM
Solution for infusion
A clear, colourless to slightly yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clinical conditions in children when enteral supply of protein is
insufficient, undesirable or impossible.
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4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Infants and children
Body weight
Dosage
(kg)
ml/kg bw/24 hours
Neonates (including LBW)
Up to 10
8 - 35
and infants (up to 10 kg)
(To be increased gradually
during the first week of life)
Solution should be administered as a continuous infusion over 24 hours
using a suitable pump.
Body weight
Dosage
(kg)
ml/kg bw/24 hours
Childr