Vaminolact solution for infusion, 500 ml bottle

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

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

Saatavilla:

Fresenius Kabi Deutschland GmbH

ATC-koodi:

B05BA; B05BA01

INN (Kansainvälinen yleisnimi):

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

Annos:

500 millilitre(s)

Lääkemuoto:

Solution for infusion

Terapeuttinen alue:

Solutions for parenteral nutrition; amino acids

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

1991-06-10

Pakkausseloste

_ _
_ _
_ _
_ _
_ _
_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 possible 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 recieves 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.
When used in neonates and children below 2 years, the solution (inbags
and administration sets) should be
protected from light exposure

Valmisteyhteenveto

Health Products Regulatory Authority
20 April 2023
CRN009W3X
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vaminolact solution for infusion, 500 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 paediatric patients when enteral supply of
protein is insufficient, undesirable or impossible.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Neonates, infant, children and adolescents:
AGE GROUPS (AGE RANGE)
DOSAGE RANGE
​
​
ML/KG BW/D
G AA/KG BW/D
NEONATES (BIRTH TO <1 MONTH OF AGE)
​
​
Health Products Regulatory Authority
20 April 2023
CRN009W3X
Page 2 of 5
PRETERM NEONATES
​
​
1st Day
23 to 38 mL/kg/d
1.5 to 2.5 g AA/kg/d
≥2nd Day
38 to 54 mL/kg/d
2.5 to 3.5 g AA/kg/d
Gradual dose increase during the first days of infusion should be
used, starting with
a dose such as 23 to 38 mL/kg/d (corresponding to 1.5 to 2.5 g amino
acids/kg/d)
on the first day and increasing to 38 to 54 (corresponding to 2.5 to
3.5 g amino
acids/kg/d) on the second day onwards.
​
​
TERM NEONATES
23 to 46 mL/kg/d
1.5 to 3.0 g AA/kg/d
Gradual dose increase to the target dose should be used during the
first days of
infusion.
​
​
INFANTS
(≥1 MONTH TO <2 YEARS OF AGE)
15 to 38 mL/kg/d
1.0 to 2.5 g AA/kg/d
CHILDREN
(≥2 YEARS TO <12 YEARS OF AGE)
15 to 31 mL/kg/d
1.0 to 2.0 g AA/kg/d
ADOLESCENTS
(≥12 YEAR