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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Novo Nordisk Pharmaceuticals Pty Ltd

INN (International Name):

insulin

Pharmaceutical form:

Injection, suspension

Composition:

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

Administration route:

Intramuscular, Subcutaneous

Units in package:

5 x 3mL InnoLet

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

The treatment of insulin-requiring diabetes.

Product summary:

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

Authorization status:

Registered

Authorization date:

2011-04-28

Patient Information leaflet

Novo Nordisk Insulin InnoLet
®
Page 1 of 11
Insulin InnoLet cmi 12.docx
PROTAPHANE
® INNOLET
®
MIXTARD
® 30/70 INNOLET
®
_insulin (rys) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
WHAT INSULIN IS USED FOR ........... 1
BEFORE YOU USE INSULIN INNOLET
®
1
HOW TO USE INSULIN INNOLET
® .... 2
WHILE
YOU
ARE
USING
INSULIN
INNOLET
® .................................... 4
SIDE EFFECTS ................................. 4
AFTER USING INSULIN INNOLET
® .... 5
PRODUCT DESCRIPTION ................. 5
FURTHER INFORMATION ................. 6
INSTRUCTIONS FOR USE ................. 7
This leaflet answers some common
questions about insulin InnoLet
®
. 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 InnoLet
®
, a 3
mL
compact
pre-filled
insulin
pen
able
to
deliver
1-50
units
in
increments of 1 unit:
_ _
_Protaphane_
_®_
_ _
is
Isophane
Insulin
Injection,
an
intermediate-acting
insulin. This means that it will

Summary of Product characteristics

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