諾和密斯50諾芯管

Pays: Taïwan

Langue: chinois

Source: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

Ingrédients actifs:

INSULIN ASPART

Disponible depuis:

台灣諾和諾德藥品股份有限公司 台北市敦化南路二段２１６號７樓－１ (23528693)

Code ATC:

A10AD05

forme pharmaceutique:

注射劑

Composition:

INSULIN ASPART (6820800109) approx.MG

Unités en paquet:

支裝

classe:

菌　疫

Type d'ordonnance:

限由醫師使用

Fabriqué par:

NOVO NORDISK A/S HALLAS ALLE, DK-4400 KALUNDBORG, DENMARK DK

Domaine thérapeutique:

insulin aspart

indications thérapeutiques:

糖尿病

Descriptif du produit:

註銷日期: 2016/03/01; 註銷理由: 自請註銷; 有效日期: 2016/01/12; 英文品名: NovoMix 50 Penfill

Statut de autorisation:

已註銷

Date de l'autorisation:

2011-01-12

Notice patient

1
1.
NAME OF THE MEDICINAL PRODUCT
NovoMix 50 Penfill
100 U/ml suspension for injection in cartridge
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of the suspension contains 100 U soluble insulin
aspart*/protamine-crystallised insulin aspart* in
the ratio 50/50 (equivalent to 3.5 mg). 1 cartridge contains 3 ml
equivalent to 300 U.
*Insulin aspart is produced by recombinant DNA technology in
_Saccharomyces cerevisiae_
.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection in cartridge. Penfill.
White suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The potency of insulin analogues, including insulin aspart, is
expressed in units (U), whereas the
potency of human insulin is expressed in international units (IU).
NovoMix 50 dosing is individual and determined in accordance with the
needs of the patient. Blood
glucose monitoring and insulin dose adjustments are recommended to
archive optimal glycaemic
control.
The individual insulin requirement is usually between 0.5 and 1.0
U/kg/day
_ _
in adult patients and this
may be fully or partially supplied with NovoMix 50. The daily insulin
requirement may be higher in
patients with insulin resistance (e.g. due to obesity), and lower in
patients with residual endogenous
insulin production.
In patients with type 2 diabetes,
_ _
NovoMix 50 can be given as monotherapy or in combination with
metformin, when the blood glucose is inadequately controlled with
metformin alone.
_ _
Adjustment of dose may be necessary if patients undertake increased
physical activity, change their
usual diet or during concomitant illness.
In patients with diabetes mellitus optimised metabolic control
effectively delays the onset and slows
the progression of diabetic late complications. Optimised metabolic
control, including glucose
monitoring, is therefore recommended.
Special populations
As with all insulin medicinal products, in elderly patients (�