Actrapid Penfill solution for injection

Riik: Armeenia

keel: inglise

Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Toimeaine:

insulin human

Saadav alates:

Novo Nordisk A/S

ATC kood:

A10AB01

INN (Rahvusvaheline Nimetus):

insulin human

Annus:

100IU/ml

Ravimvorm:

solution for injection

Ühikuid pakis:

(5) glass cartridges 3ml

Retsepti tüüp:

Prescription

Volitamisolek:

Registered

Loa andmise kuupäev:

2019-02-12

Infovoldik

Regulatory Operations
Insert: 2010-501,65x150-001
Current 5
Professionel
COLOUR: PMS 280C
Actrapid®
Penfill®
100 IU/ml
Solution for injection in cartridge.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Insulin human, rDNA (produced by recombinant DNA
technology in _Saccharomyces cerevisiae_).
1 ml contains 100 IU of insulin human.
1 cartridge contains 3 ml equivalent to 300 IU.
One IU (International Unit) corresponds to 0.035 mg of
anhydrous human insulin.
PHARMACEUTICAL FORM
Solution for injection in cartridge.
Clear, colourless, aqueous solution.
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus.
POSOLOGY AND METHOD OF ADMINISTRATION
Actrapid® is a fast-acting insulin and may be used in
combination with long-acting insulin products.
DOSAGE
Dosage is individual and determined in accordance with
the needs of the patient. The individual insulin
requirement is usually between 0.3 and 1.0 IU/kg/day.
The daily insulin requirement may be higher in patients
with insulin resistance (e.g. during puberty or due to
obesity) and lower in patients with residual, endogenous
insulin production.
An injection should be followed within 30 minutes by a
meal or snack containing carbohydrates.
DOSAGE ADJUSTMENT
Concomitant illness, especially infections and feverish
conditions, usually increases the patient’s insulin
requirement. Concomitant diseases in the kidney, liver or
affecting the adrenal, pituitary or thyroid gland can require
changes in the insulin dose. Adjustment of dosage may also
be necessary if patients change physical activity or their usual
diet. Dosage adjustment may be necessary when transferring
patients from one insulin preparation to another.
ADMINISTRATION
For subcutaneous or intravenous use.
Actrapid® is administered subcutaneously in the abdominal
wall. If convenient, the thigh, the gluteal region or the
deltoid region may also be used.
Subcutaneous injection into the abdominal wall ensures a
faster absorption than from other injection sites.
Injection into a lifted skin fold minimises the risk of unint