Primene 10% Solution for Infusion

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

L-isoleucine; L-leucine; L-valine; L-lysine; L-methionine; L-threonine; L-tryptophan; L-arginine; L-histidine; L-alanine; L-aspartic acid; Cysteine; L-glutamic acid; Glycine; L-proline; L-serine; L-tyrosine; Ornithine hydrochloride; Taurine; L-phenylalanine

可用日期:

Baxter Healthcare Limited

ATC代码:

B05BA; B05BA01

INN（国际名称）:

L-isoleucine; L-leucine; L-valine; L-lysine; L-methionine; L-threonine; L-tryptophan; L-arginine; L-histidine; L-alanine; L-aspa

剂量:

10 percent

药物剂型:

Solution for infusion

处方类型:

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

治疗领域:

Solutions for parenteral nutrition; amino acids

授权状态:

Not marketed

授权日期:

1995-05-19

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PRIMENE 10% SOLUTION FOR INFUSION
Amino Acid Intravenous Infusion
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD IS GIVEN THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOUR CHILD
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask the doctor or nurse.
•
If your child gets any side effects talk to the doctor or nurse. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Primene is and what it is used for
2.
What you need to know before your child is given Primene
3.
How your child will be given Primene
4.
Possible side effects
5.
How Primene is stored
6.
Contents of the pack and other information
Throughout this leaflet Primene 10% Solution for Infusion will be
called Primene.
1.
WHAT PRIMENE IS AND WHAT IT IS USED FOR
Primene is a sterile solution which contains:
•
amino acids – these are the building blocks which your body uses to
make proteins. The
amino acids in Primene are listed in section 6.
Primene is used in Children, infants and the newborn at term or born
prematurely to give
your child food (nutrition) straight into the blood, when your child
cannot take enough food
by his or her mouth.
Your doctor will check your child has all the nutrition that they need
for good health. If
necessary, your child may also have vitamins (such as folic Acid),
minerals, fatty acids (the
building blocks of fats), electrolytes (salts) and sugar solutions
(such as glucose) at the same
time as PRIMENE.
2.
WHAT YOU NEED TO KNOW BEFORE YOUR CHILD IS GIVEN PRIMENE
PRIMENE MUST NOT BE GIVEN TO YOUR CHILD IF:
•
Your child is allergic (hypersensitive) to any of the ingredients of
this medicine (listed in
section 6).
•
Your child’s body has a problem s using the building blocks of
proteins.
Your child will not be given Primene if any of the above applies.
WARNINGS AND PRECAUTIONS
Talk to the doctor or nurse before Primene.
Your doctor will make sure t

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Primene 10% Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each litre of infusion solution contains:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
A clear, colourless solution.
Primene 10% has an osmolarity of 780 mOsmol/L
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the prophylaxis and therapy of protein deficiency in neonates,
infants and children, when adequate oral
administration is not possible.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Parenteral nutrition initiation and duration as well as dosage (dose
and rate of administration) depends on a patient’s
• age, weight, clinical condition,
L-Isoleucine
6.70 g
L-Leucine
10.00 g
L-Valine
7.60 g
L-Lysine
11.00 g
L-Methionine
2.40 g
L-Threonine
3.70 g
L-Tryptophan
2.00 g
L-Arginine
8.40 g
L-Histidine
3.80 g
L-Alanine
8.00 g
L-Aspartic Acid
6.00 g
L-Cysteine
1.89 g
L-Glutamic Acid
10.00 g
Glycine
4.00 g
L-Proline
3.00 g
L-Serine
4.00 g
L-Tyrosine
0.45 g
L-Ornithine Hydrochloride
3.18 g
Taurine
0.60 g
L-Phenylalanine
4.20 g
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• nitrogen requirements,
• ability to metabolize the constituents of Primene,
• additional nutrition that may be provided parenterally and/or
enterally.
The usual range is