MIXTARD 30/70 PENFILL human insulin (rys) 100IU/mL injection multidose cartridge

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

insulin, Quantity: 70 IU/mL; insulin, Quantity: 30 IU/mL

Dostępny od:

Novo Nordisk Pharmaceuticals Pty Ltd

INN (International Nazwa):

insulin

Forma farmaceutyczna:

Injection, suspension

Skład:

Excipient Ingredients: Protamine sulfate; dibasic sodium phosphate dihydrate; hydrochloric acid; glycerol; zinc chloride; sodium hydroxide; metacresol; water for injections; phenol

Droga podania:

Intramuscular, Subcutaneous

Sztuk w opakowaniu:

5 x 3mL Cartridges.

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

The treatment of insulin-requiring diabetes.

Podsumowanie produktu:

Visual Identification: White, cloudy suspension. Resuspends on shaking.; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Status autoryzacji:

Licence status A

Data autoryzacji:

2011-04-28

Ulotka dla pacjenta

Novo Nordisk Insulin Penfill
®
Page 1 of 7
Insulin Penfill cmi 12.docx
ACTRAPID
® PENFILL
®
PROTAPHANE
® PENFILL
®
MIXTARD
® 30/70 PENFILL
®
MIXTARD
® 50/50 PENFILL
®
_insulin (rys) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
WHAT IS IN THIS LEAFLET ................ 1
WHAT INSULIN IS USED FOR ............ 1
BEFORE YOU USE INSULIN PENFILL
® . 1
HOW TO USE INSULIN PENFILL
® ....... 2
WHILE
YOU
ARE
USING
INSULIN
PENFILL
® ........................................ 5
SIDE EFFECTS .................................. 5
AFTER USING INSULIN PENFILL
® ....... 6
PRODUCT DESCRIPTION ................... 6
FURTHER INFORMATION .................. 7
This leaflet answers some common
questions about insulin Penfill
®
. It
does not contain all the available
information. It does not take the
place
of
talking
to
your
doctor,
diabetes
education
nurse
or
pharmacist.
All
medicines
have
risks
and
benefits. Your doctor has weighed
the
risks
of
you
using
insulin
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING
THIS
MEDICINE,
ASK
YOUR
DOCTOR, DIABETES EDUCATION NURSE
OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT
INSULIN
IS
USED
FOR
Insulin
is
used
to
treat
diabetes
mellitus.
Diabetes
mellitus
is
a
condition where your pancreas does
not
produce
enough
insulin
to
control your blood sugar (glucose)
level.
Extra
insulin
is
therefore
needed.
There
are
two
types
of
diabetes
mellitus:
Type
1
diabetes
–
also
called
juvenile onset diabetes
Type
2
diabetes
–
also
called
maturity onset diabetes
Patients
with
type
1
diabetes
always
require
insulin
to
control
their blood sugar levels.
Some patients with type 2 diabetes
may also require insulin after initial
treatment
with
diet,
exercise
and
tablets.
Insulin
lowers
your
blood
sugar
level after injection. Each of the
following
insulins
is
available
in
Penfill
®
,
a
3
mL
glass
cartridge
designed
to
be
used
with
Novo
Nordisk
insulin
delivery
devices
such as NovoPen
®
.
_Actrapid_
_®_
_ _
is
Neu

Charakterystyka produktu

AUSTRALIAN PRODUCT INFORMATION
Actrapid
®
insulin (rys) 100 IU/mL injection multidose vial
Actrapid
®
Penfill
®
insulin (rys) 100 IU/mL injection multidose cartridge
Mixtard
®
30/70 InnoLet
®
insulin (rys) 100 IU/mL injection multidose cartridge
Mixtard
®
30/70 Penfill
®
insulin (rys) 100 IU/mL injection multidose cartridge
Mixtard
®
50/50 Penfill
®
insulin (rys) 100 IU/mL injection multidose cartridge
Protaphane
®
insulin (rys) 100 IU/mL injection multidose vial
Protaphane
®
InnoLet
®
insulin (rys) 100 IU/mL injection multidose cartridge
Protaphane
®
Penfill
®
insulin (rys) 100 IU/mL injection multidose cartridge
1.
NAME OF THE MEDICINE
insulin (rys)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Actrapid

: 1 mL solution contains 100 international units insulin (rys). Also
contains:
glycerol, metacresol, zinc chloride, water for injections.
Hydrochloric acid and sodium
hydroxide are used to adjust the pH.
Protaphane

: 1 mL suspension contains 100 international units isophane insulin
(rys). Also
contains: glycerol, metacresol, phenol, dibasic sodium phosphate
dihydrate, zinc chloride,
protamine sulfate (a fish product), water for injections. Hydrochloric
acid and sodium
hydroxide are used to adjust the pH.
Mixtard

30/70:
1
mL
suspension
contains
100
international
units
soluble
insulin
(rys)/isophane insulin (rys) in the ratio 30/70. Also contains:
glycerol, metacresol, phenol,
dibasic sodium phosphate dihydrate, zinc chloride, protamine sulfate
(a fish product), water
for injections. Hydrochloric acid and sodium hydroxide are used to
adjust the pH.
Mixtard

50/50:
1
mL
suspension
contains
100
international
units
soluble
insulin
(rys)/isophane insulin (rys) in the ratio 50/50. Also contains:
glycerol, metacresol, phenol,
dibasic sodium phosphate dihydrate, zinc chloride, protamine sulfate
(a fish product), water
for injections. Hydrochloric acid and sodium hydroxide are used to
adjust the pH.
One IU (International Unit) of insulin corresponds to 0.035 mg of
anhydrous insulin (rys).
Insuli