ADDITRACE N

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

CHROMIC CHLORIDE HEXAHYDRATE; CUPRIC CHLORIDE DIHYDRATE ; FERRIC CHLORIDE HEXAHYDRATE ; MANGANESE CHLORIDE TETRAHYDRATE ; POTASSIUM IODIDE ; SODIUM FLUORIDE; SODIUM MOLYBDATE DIHYDRATE ; SODIUM SELENITE ANHYDROUS ; ZINC CHLORIDE

Доступно од:

Fresenius Kabi Limited

АТЦ код:

B05XA31

INN (Међународно име):

CHROMIC CHLORIDE HEXAHYDRATE; CUPRIC CHLORIDE DIHYDRATE ; FERRIC CHLORIDE HEXAHYDRATE ; MANGANESE CHLORIDE TETRAHYDRATE ; POTASSIUM IODIDE ; SODIUM FLUORIDE; SODIUM MOLYBDATE DIHYDRATE ; SODIUM SELENITE ANHYDROUS ; ZINC CHLORIDE

Дозирање:

N/A

Фармацеутски облик:

Concentrate for Soln for Inf

Пут администрације:

Intravenous infusion

Јединице у пакету:

Ampoule (polypropylene) 20 x 10 ml

Тип рецептора:

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

Произведен од:

Fresenius Kabi Norge AS

Терапеутска група:

Electrolytes in combination with other drugs

Терапеутска област:

electrolytes in combination with other drugs

Терапеутске индикације:

To meet basal to moderately increased requirements of trace elements in intravenous nutrition

Статус ауторизације:

Not Marketed

Датум одобрења:

2015-03-27

Информативни летак

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ADDITRACE N CONCENTRATE FOR 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 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.
WHAT IS IN THIS LEAFLET
1.
What Additrace N is and what it is used for
2.
What you need to know before you receive Additrace N
3.
How you are given Additrace N
4.
Possible side effects
5.
How to store Additrace N
6.
Contents of the pack and other information
1.
WHAT ADDITRACE N IS AND WHAT IT IS USED FOR
Additrace N is a medicine that contains trace elements. Trace elements
are tiny amounts of chemicals that
your body needs to work normally. Additrace N is given intravenously
(into a vein) when you can not eat
normally. This medicine is usually used as part of a balanced
intravenous diet, together with proteins, fat,
carbohydrates, salts and vitamins.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE ADDITRACE N
_ _
YOU SHOULD NOT RECEIVE ADDITRACE N:
-
if you are allergic (hypersensitive) to any of the ingredients of this
medicine (listed in section 6).
IF
YOU DEVELOP A RASH OR OTHER ALLERGIC REACTIONS (LIKE ITCHING, SWOLLEN
LIPS OR FACE, OR SHORTNESS OF
BREATH), INFORM YOUR DOCTOR IMMEDIATELY.
WARNINGS AND PRECAUTIONS
Talk to your doctor if you have problems with the way your liver
and/or kidney work.
Your doctor may want to do regular blood tests to check your
condition.
OTHER MEDICINES AND ADDITRACE N
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
PREGNANCY AND BREAST-FEEDING
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your
doctor for advice before taking this medicine.
DRIVING AND USING MACHINES
Additrace N has no effect on driving or usin

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Additrace N concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear solution, almost colourless.
Osmolality: approx. 3100 mosm/kg water
pH: 2.5
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
To meet basal to moderately increased requirements of trace elements
in intravenous nutrition.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dosage is dependent on age, weight and any degree of deficiency of the
patient and must be decided on an individual
basis.
1 ampoule of 10 ml contains:
Chromic chloride hexahydrate
53.3 microgram
Copper chloride dihydrate
1.02 milligram
Ferric chloride hexahydrate
5.40 milligram
Manganese chloride tetrahydrate
198 microgram
Potassium iodide
166 microgram
Sodium fluoride
2.10 milligram
Sodium molybdate dihydrate
48.5 microgram
Sodium selenite anhydrous
173 microgram
Zinc chloride
10.5 milligram
_The active ingredients in 10 ml of Additrace N correspond to:_
Cr
0.2 µmol
10 µg
Cu
6 µmol
380 µg
Fe
20 µmol
1.1 mg
Mn
1 µmol
55 µg
I
1 µmol
130 µg
F
50 µmol
950 µg
Mo
0.2 µmol
19 µg (as Mo
6+
)
Se
1 µmol
79 µg (as Se
4+
)
Zn
77 µmol
5 mg
The content of sodium and potassium in 10 ml corresponds to:
Sodium
1.0 mg
52 µmol
Potassium
39 µg
1 µmol
For the full list of excipients, see section 6.1.
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