Addaven

Country: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

Chromium trichloride hexahydrate 5.33 µg/mL;  ; Copper chloride dihydrate 0.34 mg/mL;  ; Ferric chloride hexahydrate 0.54 mg/mL;  ; Manganese chloride tetrahydrate 99 µg/mL;  ; Potassium iodide 16.6 µg/mL; Sodium fluoride 0.21 mg/mL; Sodium molybdate dihydrate 4.85 µg/mL;  ; Sodium selenite 10.5 µg/mL;  ;  ; Zinc chloride 1.36 mg/mL;  ;  ; Chromium trichloride hexahydrate 5.33 µg/mL; Copper chloride dihydrate 102.3 µg/mL; Ferric chloride hexahydrate 540 µg/mL; Manganese chloride tetrahydrate 19.79 µg/mL; Potassium iodide 16.6 µg/mL; Sodium fluoride 210 µg/mL; Sodium molybdate dihydrate 4.85 µg/mL; Sodium selenite 17.29 µg/mL; Zinc chloride 1050 µg/mL

Доступно од:

Fresenius Kabi New Zealand Limited

INN (Међународно име):

Chromium trichloride hexahydrate 5.33 µg/mL

Фармацеутски облик:

Solution for infusion

Састав:

Active: Chromium trichloride hexahydrate 5.33 µg/mL   Copper chloride dihydrate 0.34 mg/mL   Ferric chloride hexahydrate 0.54 mg/mL   Manganese chloride tetrahydrate 99 µg/mL   Potassium iodide 16.6 µg/mL Sodium fluoride 0.21 mg/mL Sodium molybdate dihydrate 4.85 µg/mL   Sodium selenite 10.5 µg/mL     Zinc chloride 1.36 mg/mL     Excipient: Hydrochloric acid Water for injection Xylitol Active: Chromium trichloride hexahydrate 5.33 µg/mL Copper chloride dihydrate 102.3 µg/mL Ferric chloride hexahydrate 540 µg/mL Manganese chloride tetrahydrate 19.79 µg/mL Potassium iodide 16.6 µg/mL Sodium fluoride 210 µg/mL Sodium molybdate dihydrate 4.85 µg/mL Sodium selenite 17.29 µg/mL Zinc chloride 1050 µg/mL Excipient: Hydrochloric acid Water for injection Xylitol

Јединице у пакету:

Ampoule, plastic, 10ml polypropylene single dose amp, 20 dose units

Класа:

General sale

Тип рецептора:

General sale

Произведен од:

Merck KGaA

Терапеутске индикације:

To meet basal to moderately increased requirements of trace elements in parenteral nutrition in adults and children weighing 15 kg and over, when either oral or enteral nutrition is inappropriate

Резиме производа:

Package - Contents - Shelf Life: Ampoule, plastic, 10ml polypropylene single dose amp - 20 dose units - 36 months from date of manufacture stored at or below 30°C 24 hours opened stored at or below 25°C

Датум одобрења:

1990-08-27

Информативни летак

Addaven CMI – NEW ZEALAND
ADDAVEN
®
Infusion, solution concentrate
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
less
than
15
kg
body
weight.
_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,

Карактеристике производа

Page 1 of 6
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
ADDAVEN
®
(infusion, solution concentrate)
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)
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Addaven is a concentrated trace element solution for infusion which is
clear and colourless to slightly
yellow.
Osmolality:
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 parenteral nutrition in adults
and children weighing 15 kg and over, when either oral or enteral
nutrition is inappropriate
4.2 DOSE AND METHOD OF ADMINISTRATION
Dosage
_Adults:_
The recommended daily dosage 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.
Page 2 of 6
_Children ≥ 15kg:_
0.1 mL Addaven is given per kg body weight and day.
Method of administration
Addaven
must
not
be
given
undiluted.
Addaven
shall
be
diluted
in
a
parenteral
nutrition
solution/emulsion before being given as an intravenous infusion.
Information on admixtures is availabl