ADDAVEN

Country: Israel

Language: English

Source: Ministry of Health

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:

CURE MEDICAL & TECHNICAL SUPPLY

ATC code:

B05XA31

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

SODIUM FLUORIDE 210 MCG / 1 ML; CHROMIC CHLORIDE HEXAHYDRATE 5.330 MCG / 1 ML; POTASSIUM IODIDE 16.60 MCG / 1 ML; SODIUM MOLYBDATE DIHYDRATE 4.850 MCG / 1 ML; SODIUM SELENITE ANHYDROUS 17.29 MCG / 1 ML; COPPER CHLORIDE DIHYDRATE 102.3 MCG / 1 ML; MANGANESE CHLORIDE TETRAHYDRATE 19.79 MCG / 1 ML; ZINC CHLORIDE 1050 MCG / 1 ML; FERRIC CHLORIDE HEXAHYDRATE 540 MCG / 1 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

FRESENIUS KABI AB, SWEDEN

Therapeutic area:

ELECTROLYTES IN COMBINATION WITH OTHER DRUGS

Therapeutic indications:

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

Authorization date:

2019-10-07

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
Addaven
concentrate for solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Addaven contains:
1 ml
1 ampoule (10 ml)
Chromic chloride hexahydrate
5.33 microgram
53.3 microgram
Copper chloride dihydrate
102.3 microgram
1.02 mg
Ferric chloride hexahydrate
0.54 mg
5.40 mg
Manganese chloride tetrahydrate
19.79 microgram
197.9 microgram
Potassium iodide
16.6 microgram
166 microgram
Sodium fluoride
0.21 mg
2.10 mg
Sodium molybdate dihydrate
4.85 microgram
48.5 microgram
Sodium selenite anhydrous
17.29 microgram
172.9 microgram
Zinc chloride
1.05 mg
10.5 mg
_The active ingredients in 1 ml of Addaven correspond to:_
Cr
0.020 micromol
1.0 microgram
Cu
0.60 micromol
38 microgram
Fe
2.0 micromol
110 microgram
Mn
0.10 micromol
5.5 microgram
I
0.10 micromol
13 microgram
F
5.0 micromol
95 microgram
Mo
0.020 micromol
1.9 microgram (as Mo
6+
)
Se
0.10 micromol
7.9 microgram (as Se
4+
)
Zn
7.7 micromol
500 microgram
The content of sodium and potassium correspond to
Sodium
120 microgram
5.2 micromol
Potassium
3.9 microgram
0.1 micromol
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear solution, colourless to slightly yellow and essentially free
from
particles.
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
_Adults_: The recommended daily dose of Addaven in adult patients with
basal to moderately increased requirements is 10 ml (one ampoule).
In patients with renal or hepatic impairments, or mild cholestasis the
dose
should be adapted.
_Children ≥15 kg:_ 0.1 ml Addaven is given per kg body weight and
day.
Method of administration
Addaven must not be given undiluted. Addaven shall be given as an
intravenous infusion, diluted in a parenteral nutrition
solution/emulsion.
For instructions on dilution of the medicinal product before
administration,
see section 6.6.