Additrace N concentrate for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Chromic chloride hexahydrate; Copper chloride dihydrate; Ferric chloride hexahydrate; Manganese chloride tetrahydrate; Potassium iodide; Sodium fluoride; Sodium molybdate dihydrate; Sodium selenite anhydrous; Zinc chloride

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

B05XA; B05XA31

INN (International Name):

Chromic chloride hexahydrate; Copper chloride dihydrate; Ferric chloride hexahydrate; Manganese chloride tetrahydrate; Potassium iodide; Sodium fluoride; Sodium molybdate dihydrate; Sodium selenite anhydrous; Zinc chloride

Pharmaceutical form:

Concentrate for solution for infusion

Therapeutic area:

Electrolyte solutions; electrolytes in combination with other drugs

Authorization status:

Not marketed

Authorization date:

2015-03-27

Patient Information leaflet

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, pharmacist or
nurse.
-
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 cannot 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

Summary of Product characteristics

Health Products Regulatory Authority
12 November 2021
CRN00CNMP
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Additrace N concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
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
Health Products Regulatory Authority
12 November 2021
CRN00CNMP
Page 2 of 5
Posology
Dosage is dependent on age, weight and any degree of deficiency of the
patient and must be decided on an individual basis.
_Adults_: The recommended daily dosage of Additrace N in adult
patients with basal to moderately increased requirements is 10
ml (one ampoule).
_Children: _Additrace N is not recommended for use in children
weighing under 40 kg body weight. The trace element Peditrace
should be used.
Method of administration
Additrace N must not be given undiluted.
For instructions on dilution of the medicinal product before
administration, see section 6.6.
4.3 CON