NOVOMIX 30 FLEXPEN 3mL 30% soluble insulin aspart (rys) and 70% insulin aspart (rys) crystallised with protamine 300U/3mL injection syringe

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, suspension

Composition:

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

Administration route:

Subcutaneous

Units in package:

5 x 3mL syringes (cartridge fitted within a, disposable syringe - NOVOMIX 30 FLEXPEN)

Prescription type:

(S4) Prescription Only Medicine, Not scheduled. Not considered by committee

Therapeutic indications:

Treatment of diabetes mellitus.

Product summary:

Visual Identification: white and uniformly cloudy suspension; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2008-06-05

Patient Information leaflet

NovoMix® 30 FlexPen® v15.1
1
NOVOMIX® 30 FLEXPEN®
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 NOVOMIX® 30 FLEXPEN®?
NovoMix® 30 FlexPen® contains the active ingredient insulin aspart
in a rapid and longer acting form. NovoMix® 30 FlexPen® is
used to treat diabetes mellitus in adults and children.
For more information, see Section 1. Why am I using NovoMix® 30
FlexPen®?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NOVOMIX® 30 FLEXPEN®?
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
NovoMix® 30 FlexPen®? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with NovoMix® 30 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 NOVOMIX® 30 FLEXPEN®?
•
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.
More instructions can be found in Section 4. How do I use NovoMix®
30? and 8. Instructions for use
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NOVOMIX® 30 FLEXPEN®?
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

Summary of Product characteristics

Product Information
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
NOVORAPID
® (INSULIN ASPART (RYS))
NOVOMIX
® (SOLUBLE INSULIN ASPART (RYS)/INSULIN ASPART (RYS) 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
®
InnoLet
®
(insulin aspart (rys)) 100 U/mL solution for injection 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 Penfill
®
(50% soluble insulin aspart (rys) and 50% insulin aspart (rys)
crystallised with
protamine) 100 U/mL suspension for inejction 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
NovoMix
®
70 Penfill
®
(70% soluble insulin aspart (rys) and 30% insulin aspart (rys)
crystallised with
protamine) 100 U/mL suspension for injection 3mL cartridge
NovoMix
®
70 FlexPen
®
(70% soluble insulin aspart (rys) and 30% insulin aspart (rys)
crystallised with
protamine) 100 U/mL suspension for inejction 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 inje