NovoRapid Penfill

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Insulin aspart 100 U/mL;  

Disponible depuis:

Novo Nordisk Pharmaceuticals Ltd

DCI (Dénomination commune internationale):

Insulin aspart 100 U/mL

Dosage:

100 U/mL

forme pharmaceutique:

Solution for injection

Composition:

Active: Insulin aspart 100 U/mL   Excipient: Dibasic sodium phosphate dihydrate Glycerol Hydrochloric acid Metacresol Phenol Sodium chloride Sodium hydroxide Water for injection Zinc as the choloride

Unités en paquet:

Cartridge, glass, 3 mL

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Novo Nordisk A/S

indications thérapeutiques:

The treatment of diabetes mellitus.

Descriptif du produit:

Package - Contents - Shelf Life: Cartridge, glass, - 3 mL - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 1 months opened stored at or below 30°C - Cartridge, glass, 3mL X 5 - 5 mL - 30 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 1 months opened stored at or below 30°C

Date de l'autorisation:

1998-09-18

Notice patient

NovoRapid® Penfill®
1
NOVORAPID® PENFILL®
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.
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 tells you to.
•
Do not

Résumé des caractéristiques du produit

1 of 15
NEW ZEALAND DATASHEET
1 PRODUCT NAME
NovoRapid
®
10ml Vial
NovoRapid
®
Penfill
®
3ml
NovoRapid
®
FlexPen
®
3ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Insulin Aspart 100 Units/ml
Recombinant DNA origin: _Saccharomyces cerevisiae_
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.
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.
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.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Treatment of diabetes mellitus.
4.2 Dose and method of administration
NovoRapid has a faster onset and a shorter duration of action than
soluble human insulin. Due
to the faster onset of action, NovoRapid should generally be given
immediately before a meal
or when necessary, soon after the start of a meal.
The dosage of insulin aspart is determined by the physician according
to the patient’s individual
needs. The individual insulin requirement is usually between 0.5 and
1.0 Units/kg/day in adults
and children. In a meal-related treatment 50-70% of this requirement
may be provided by
NovoRapid and the remainder provided by an intermediate-acting or
long-acting insulin given
at least once a day.
The daily insulin requirement may be higher in patients with insulin
resistance (e.g. due to
obesity), and low