FIASP PENFILL insulin aspart (rys) 100 units/mL solution for injection 3 mL cartridge

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

Insulin aspart, Quantity: 100 U/mL

제공처:

Novo Nordisk Pharmaceuticals Pty Ltd

INN (International Name):

Insulin aspart

약제 형태:

Injection, solution

구성:

Excipient Ingredients: glycerol; phenol; metacresol; zinc; dibasic sodium phosphate dihydrate; arginine; hydrochloric acid; sodium hydroxide; water for injections; nicotinamide

관리 경로:

Subcutaneous, Intravenous

패키지 단위:

5 x 3 mL

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

제품 요약:

Visual Identification: Clear, colourless solution; Container Type: Cartridge; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius

승인 상태:

Licence status A

승인 날짜:

2017-07-27

환자 정보 전단

Fiasp
®
Penfill
®
Page 1 of 5
Fiasp Pf cmi1.docx
FIASP
® PENFILL
®
_Insulin aspart (rys) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
WHAT FIASP
® PENFILL
®
IS USED FOR
1
BEFORE YOU USE FIASP
®
PENFILL
® . 1
HOW TO USE FIASP
®
PENFILL
® ....... 2
WHILE YOU ARE USING FIASP
®
PENFILL
® ..................................................... 4
THINGS TO BE CAREFUL OF .............. 4
SIDE EFFECTS .................................. 4
AFTER USING FIASP
®
PENFILL
® ....... 5
PRODUCT DESCRIPTION .................. 5
FURTHER INFORMATION ................. 5
This
leaflet
answers
some
common
questions
about
Fiasp
®
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 Fiasp
®
Penfill
®
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 FIASP
® PENFILL
®
IS
USED FOR
The
insulin
aspart,
or
“Fiasp
®
”,
in
Fiasp
®
Penfill
®
is a fast-acting insulin
used
to
treat
diabetes
mellitus
in
adults.
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

type 2 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.
Fiasp
®
lowers your blood sugar level
after
injection. When injected under
your skin, Fiasp
®
has a faster onset of
action than NovoRapid
®
. Fiasp
®
can be
injected at the start of a meal, with an
option to inject up to 20 minutes after
starting
a
meal.
A
maximum
effect
occurs between 1 a

제품 특성 요약

_Fiasp_pi2.docx_
Page
1
of
22
AUSTRALIAN PRODUCT INFORMATION
FIASP
® FLEXTOUCH
®
(insulin aspart (rys)) solution for injection
FIASP
®
(insulin aspart (rys)) solution for injection
FIASP
® PENFILL
®
(insulin aspart (rys)) solution for injection
1.
NAME OF THE MEDICINE
Insulin aspart (rys)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Insulin aspart is an analogue of human insulin, differing by the
substitution of the amino acid
proline by aspartic acid at position 28 on the B-chain. Insulin aspart
is produced by
recombinant DNA technology in
_Saccharomyces cerevisiae_
.
1 mL of the solution contains 100 units of insulin aspart (equivalent
to 3.5 mg).
FIASP FLEXTOUCH:
Each pre-filled pen contains 3 mL equivalent to 300 units.
FIASP VIAL:
Each vial contains 10 mL equivalent to 1,000 units.
FIASP PENFILL:
Each cartridge contains 3 mL equivalent to 300 units.
For the full list of excipients, see Section 6.1 ‘List of
Excipients.’
3.
PHARMACEUTICAL FORM
Sterile, clear, colourless, aqueous solution for subcutaneous
injection, subcutaneous infusion
or intravenous injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus in adults.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dosage
Fiasp is an ultra-fast acting insulin for subcutaneous administration.
Fiasp administered 0-2
minutes before the start of a meal produced a significantly greater
postmeal glucose lowering
effect after a standardised meal test compared to NovoRapid.
Administration of Fiasp up to
20 minutes after starting a meal was as efficacious as NovoRapid given
before a meal (see
Section 5.1 ‘Pharmacodynamic Properties’ – ‘Clinical
trials’)
_._
Fiasp can be used for continuous subcutaneous insulin infusion (CSII)
in pumps or be
administrated intravenously by healthcare professionals.
The potency of insulin analogues, including Fiasp, is expressed in
units. One (1) unit of Fiasp
corresponds to 1 international unit of human insulin or 1 unit of
other fast-acting insulin
analogues.
_Fiasp_pi2.docx_
Page
2
of
22
Dos