NOVORAPID insulin aspart (rys) 100U/mL injection multidose vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Insulin aspart, Quantity: 100 U/mL

Available from:

Novo Nordisk Pharmaceuticals Pty Ltd

INN (International Name):

Insulin aspart

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Subcutaneous, Intravenous

Units in package:

1 X 10mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of diabetes mellitus.

Product summary:

Visual Identification: A clear colourless solution in 10mL vials closed with a cream septa.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2006-12-21

Patient Information leaflet

NovoRapid® 10mL vial
1
NOVORAPID® 10ML VIAL
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor, diabetes
education nurse, or pharmacist.
1.
WHY AM I USING NOVORAPID®?
NovoRapid® contains the active ingredient insulin aspart. Insulin
aspart is a rapid-acting insulin used to treat diabetes mellitus
in adults and children.
For more information, see Section 1. Why am I using NovoRapid®? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NOVORAPID®?
Do not use if you have ever had an allergic reaction to insulin aspart
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY OTHER MEDICAL
CONDITIONS (ESPECIALLY KIDNEY, LIVER OR GLAND PROBLEMS), TAKE
ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE
BREAST-FEEDING.
For more information, see Section 2. What should I know before I use
NovoRapid®? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with NovoRapid® and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE NOVORAPID®?
•
Use immediately (up to 10 minutes) before your meal or carbohydrate
snack. Inject into the abdomen, thighs, buttocks or
upper arms.
•
Change your injection site regularly. Carefully follow the advice on
how to inject under the skin, or using an insulin pump.
Detailed instructions can be found in Section 4. How do I use
NovoRapid®? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NOVORAPID®?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist, pharmacist or diabetes education nurse you
visit that you have diabetes
and are using insulin.
•
Measure your blood sugar levels regularly.
•
Tell your doctor if you often have hypos (low blood sugar levels).
•
Always carry some sugary food or fruit juice with you.
THINGS YOU
SHOULD NOT DO
•
Do not stop using your medicine unless your doctor

Summary of Product characteristics

_NovoRapid_NovoMix_pi9 _
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_Page 1 of 19 _
AUSTRALIAN PRODUCT INFORMATION
NOVORAPID
® (INSULIN ASPART)
NOVOMIX
® (SOLUBLE INSULIN ASPART/INSULIN ASPART CRYSTALISED WITH PROTAMINE)
1.
NAME OF THE MEDICINE
NovoRapid
®
(insulin aspart (rys)) 100 U/mL solution for injection 10mL Vial
NovoRapid
®
Penfill
®
(insulin aspart (rys)) 100 U/mL solution for inejction 3mL cartridge
NovoRapid
®
FlexPen
®
(insulin aspart (rys)) 100 U/mL solution for injection 3mL cartridge
NovoRapid
®
FlexTouch
®
(insulin aspart (rys)) 100 U/mL solution for inejction 3mL cartridge
NovoMix
®
30 Penfill
®
(30% soluble insulin aspart (rys) and 70% insulin aspart (rys)
crystallised with
protamine) 100 U/mL suspension for inejction 3mL cartridge
NovoMix
®
30 FlexPen
®
(30% soluble insulin aspart (rys) and 70% insulin aspart (rys)
crystallised with
protamine) 100 U/mL suspension for injection 3mL cartridge
NovoMix
®
50 FlexPen
®
(50% soluble insulin aspart (rys) and 50% insulin aspart (rys)
crystallised with
protamine)100 U/mL suspension for injection 3mL cartridge
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Insulin aspart is a rapid-acting analogue of human insulin that
rapidly lowers blood glucose. Insulin
aspart is homologous with human insulin with the exception of a
substitution of the amino acid proline
by aspartic acid at position 28 on the B-chain. The unique structure
of insulin aspart increases the rate
of absorption from a subcutaneous injection site, giving a faster
onset of action, an earlier peak effect
and a shorter duration of action than soluble human insulin. Insulin
aspart should be given immediately
before a meal or, when necessary, after the start of a meal.
Insulin aspart is produced by recombinant DNA technology using
Saccharomyces cerevisiae. One unit
of insulin aspart corresponds to 6 nmol, 0.035 mg salt-free anhydrous
insulin aspart.
3.
PHARMACEUTICAL FORM
NovoRapid is a sterile, clear, colourless, aqueous, neutral solution
of insulin aspart (B28 Asp) 100
U/mL. NovoRapid is a solution for injection.
NovoMix