ADDAVEN concentrated injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

chromic chloride hexahydrate, Quantity: 5.33 microgram/mL; ferric chloride hexahydrate, Quantity: 540 microgram/mL; sodium selenite, Quantity: 17.29 microgram/mL; sodium fluoride, Quantity: 210 microgram/mL; cupric chloride dihydrate, Quantity: 102.3 microgram/mL; potassium iodide, Quantity: 16.6 microgram/mL; sodium molybdate dihydrate, Quantity: 4.85 microgram/mL; manganese chloride tetrahydrate, Quantity: 19.79 microgram/mL; zinc chloride, Quantity: 1.05 mg/mL

Available from:

Fresenius Kabi Australia Pty Ltd

INN (International Name):

chromic chloride hexahydrate,cupric chloride dihydrate,Ferric chloride hexahydrate,manganese chloride tetrahydrate,Potassium iod

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: water for injections; hydrochloric acid; xylitol

Administration route:

Intravenous Infusion

Units in package:

20

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

To meet basal to moderately increased requirements of trace elements in parenteral nutrition in adults, when either oral or enteral nutrition is inappropriate

Product summary:

Visual Identification: Clear and colourless to slightly yellow solution.; Container Type: Ampoule; Container Material: PP; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2016-07-29

Patient Information leaflet

ADDAVEN
®
Concentrated solution for injection
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Addaven. It does
not
contain
all
the
available
information. It does not take the
place of talking to your doctor or
pharmacist.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the
risks
of
you
taking
Addaven
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. You may need to
read it again.
WHAT ADDAVEN IS USED
FOR
Addaven
is
a
medicine
that
contains
trace
elements.
Trace
elements
are
tiny
amounts
of
chemicals that your body needs to
function normally. Addaven is given
intravenously (as a drip 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.
BEFORE
YOU
ARE
GIVEN
ADDAVEN
_WHEN YOU MUST NOT TAKE IT _

if you are allergic to any of
the
ingredients
of
this
medicine. 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 under 12 years of age.
_BEFORE YOU START TO TAKE IT _
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
parallel
with
the
infusion
your
doctor will check that iron is not
accumulating in your body.
Iron and iodine may cause allergic
reactions on rare occasions when
given as a drip. Tell your doctor or
nurse
if
you
get
any
allergic
reaction when receiving Addaven.
_PREGNANCY AND BREAST-FEEDING _
If
you
are
pregnant
or
breast-
feeding, think you may be pregnant
or

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - ADDAVEN
® (CHROMIUM,
COPPER, IRON, MANGANESE, IODINE, FLUORIDE, MOLYBDENUM,
SELENIUM, ZINC)
Page 1 of 7
1 NAME OF MEDICINE
Chromic chloride hexahydrate
Cupric chloride dihydrate
Ferric chloride hexahydrate
Manganese chloride tetrahydrate
Potassium iodide
Sodium fluoride
Sodium molybdate dihydrate
Sodium selenite
Zinc chloride
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mL ampoule of Addaven contains:
Chromic chloride hexahydrate
53.33 µg
Cupric chloride dihydrate
1.02 mg
Ferric chloride hexahydrate
5.40 mg
Manganese chloride tetrahydrate
198 µg
Potassium iodide
166 µg
Sodium fluoride
2.10 mg
Sodium molybdate dihydrate
48.5 µg
Sodium selenite
173 µg
Zinc chloride
10.5 mg
The active ingredients per 10 mL of Addaven correspond to the
following electrolyte profile:
Chromium (Cr
3+
)
0.20 µmol (10 µg)
Copper (Cu
2+
)
6.0 µmol (380 µg)
Iron (Fe
3+
)
20 µmol (1.10 mg)
Manganese (Mn
2+
)
1.0 µmol (55 µg)
Iodine (I
-
)
1.0 µmol (130 µg)
Fluoride (F
-
)
50 µmol (950 µg)
Molybdenum (Mo
6+
)
0.20 µmol (19 µg)
Selenium (Se
4+
)
1.0 µmol (79 µg)
Zinc (Zn
2+
)
77 µmol (5.0 mg)
The content of sodium and potassium correspond to:
Sodium content:
52 µmol (1.20 mg)
Potassium content:
1 µmol (39 µg)
Excipients with known effect: Xylitol
For the full list of excipients, see section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Addaven is a concentrated trace element solution for intravenous
infusion which is clear and
colourless to slightly yellow.
Osmolality:
3100 mOsm/kg water
pH:
2.5
Page 2 of 7
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
To meet basal to moderately increased requirements of trace elements
in parenteral nutrition
in adults, when either oral or enteral nutrition is inappropriate.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dosage
The recommended daily dosage of Addaven in patients over 12 years of
age with basal to
moderately increased requirements is 10 mL (one ampoule).
In patients with renal or hepatic impairments, or mild cholestasis the
dose shou