Addaven concentrate for solution for infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CHROMIC CHLORIDE, COPPER CHLORIDE, FERRIC CHLORIDE, MANGANESE CHLORIDE, POTASSIUM IODIDE, SODIUM FLUORIDE, SODIUM MOLYBDATE, DIHYDRATE, SODIUM SELENITE, ZINC CHLORIDE

Available from:

Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy

ATC code:

B05XA31

INN (International Name):

CHROMIC CHLORIDE 5.33 µg/ml COPPER CHLORIDE 0.102 mg/ml FERRIC CHLORIDE 0.54 mg/ml MANGANESE CHLORIDE 19.8 µg/ml POTASSIUM IODIDE 16.6 µg/ml SODIUM FLUORIDE 0.21 mg/ml SODIUM MOLYBDATE DIHYDRATE 4.85 µg/ml SODIUM SELENITE 17.3 µg/ml ZINC CHLORIDE 1.05 mg/ml

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

CHROMIC CHLORIDE 5.33 µg/ml COPPER CHLORIDE 0.102 mg/ml FERRIC CHLORIDE 0.54 mg/ml MANGANESE CHLORIDE 19.8 µg/ml POTASSIUM IODIDE 16.6 µg/ml SODIUM FLUORIDE 0.21 mg/ml SODIUM MOLYBDATE DIHYDRATE 4.85 µg/ml SODIUM SELENITE 17.3 µg/ml ZINC CHLORIDE 1.05 mg/ml

Prescription type:

POM

Therapeutic area:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Authorization status:

Authorised

Authorization date:

2016-03-15

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ADDAVEN 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 Addaven is and what it is used for
2.
What you need to know before you receive Addaven
3.
How you are given Addaven
4.
Possible side effects
5.
How to store Addaven
6.
Contents of the pack and other information
1.
WHAT ADDAVEN IS AND WHAT IT IS USED FOR
Addaven is a medicine that contains trace elements. Trace elements are
tiny amounts of chemicals that your
body needs to work normally. Addaven 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 ADDAVEN
_ _
YOU SHOULD NOT RECEIVE ADDAVEN:
-
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.
-
if your bile excretion is blocked;
-
if you have Wilson’s disease (a genetic disorder in which copper
builds up in the body) or
hemochromatosis (accumulation of iron in the body).
Addaven must not be given to children less than 40 kg body weight
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. If you are taking iron orally in
parallell with the infusion your doctor will check that iron is not
accumulating in your body.
Iron and iodine may cause allergic reactions on rare

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Addaven 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 Addaven correspond to: _
_ _
Cr
Cu
Fe
Mn
0.2 μmol
6 μmol
20 μmol
1 μmol
10 μg
380 μg
1.1 mg
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.
2
•
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.
_Adults_
: The recommended daily dosage of Addaven in adult patients with basal
to
moderately increased requirements is 10 ml (one ampoule).
_Children: _
Addaven is not recommended for use in children weighing under 40 kg
body weight. The trace element Peditrace should be used.
Method of administration
Addaven must not be given undiluted.
For instructions on dilution of the medicinal product before
administration, see
section 6.6.
4.3
CONTRAINDICATIONS
-
Hypersensitivity to the active substances or to any of the excipients
listed in section
6.1.
-
Conditions with total biliary obstruction
-
Wilson’s disease, he