Ryzodeg FlexTouch solution for injection

Land: Armenien

Språk: engelska

Källa: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiva substanser:

insulin degludec (70%), insulin aspart (30%)

Tillgänglig från:

Novo Nordisk A/S

ATC-kod:

A10AD06

INN (International namn):

insulin degludec (70%), insulin aspart (30%)

Dos:

100U/ml

Läkemedelsform:

solution for injection

Enheter i paketet:

(5) pre-filled pens 3ml

Receptbelagda typ:

Prescription

Bemyndigande status:

Registered

Tillstånd datum:

2018-06-27

Bipacksedel

Ryzodeg
®
FlexTouch
®
100 U/ml Professional Leaflet STF-Apr-2019 8-9564-00-007-1_v.3.0
Based on EU text: 20180815_EN_05828_RYZ_10-3_hi.
1 of 21
RYZODEG
®
FlexTouch
®
100 units/ml
Solution for injection in pre-filled pen.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 100 units insulin degludec/insulin aspart* in
the ratio 70/30 (equivalent to 2.56 mg
insulin degludec and 1.05 mg insulin aspart).
One pre-filled pen contains 300 units of insulin degludec/insulin
aspart in 3 ml solution.
*Produced in _Saccharomyces cerevisiae _by recombinant DNA technology.
For the full list of excipients see _List of excipients._
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless, neutral solution.
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus in adults, adolescents and children
from the age of 2 years.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Ryzodeg
®
is a soluble insulin product consisting of the basal insulin degludec
and the rapid-acting prandial
insulin aspart.
Ryzodeg
®
can be administered once or twice daily with the main meal(s). When
needed, the patient can
change the time of administration as long as Ryzodeg
®
is dosed with the largest meal when taken once daily.
The potency of insulin analogues, including Ryzodeg
®
, is expressed in units (U). One (1) unit (U) of
Ryzodeg
®
corresponds to 1 international unit (IU) of human insulin, 1 unit of
insulin glargine, 1 unit of
insulin detemir or 1 unit of biphasic insulin aspart.
In patients with type 2 diabetes mellitus, Ryzodeg
®
can be administered alone, in combination with oral
antidiabetic medicinal products, and in combination with bolus insulin
(see _Pharmacodynamic properties_).
In type 1 diabetes mellitus, Ryzodeg
®
is combined with short-/rapid-acting insulin at the remaining meals.
Ryzodeg
®
is to be dosed in accordance with the individual patient’s needs.
Dose-adjustments are
recommended to be primarily based on fasting plasma glucose
measurements.
As with all insulin products adjustment of dose may be necessa

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ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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PODKOVSH
DI
A'LIA
1.
NAME OF THE MEDICINAL PRODUCT
Ryzodeg 100 units/mL solution for injection in pre-filled pen
Ryzodeg 100 units/mL solution for injection in cartridge
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
l mL solution contains 100 units insulin degludec/insulin aspart* in
the ratio 70/30 (equivalent to
2.56 mg insulin degludec and 1.05 mg insulin aspart).
Ryzodeg 100 units/mL solut ion for in ject ion in pre-filled pen
One pre-filled pen contains 300 units of insulin degludec/insulin
aspart in 3 mL solution.
Ryzodeg 100 units/mL solution for injection in cartridge
One cartridge contains 300 units of insulin degludec/insulin aspart in
3 mL solution.
*Produced in _Saccharomyces cerevisiae _by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ryzodeg 100 units/mL solution for injection in pre-filled pen
Solution for injection (FlexTouc h).
Ryzodeg 100 units/mL solution for injection in cartridge
Solution for injection (Penfill).
Clear, colourless, neutral solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of diabetes mellitus in adults , ado lescents and children
from the age of2 years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
This medicinal product is a solub le insulin product consisting of the
basal insulin degludec and the
rapid-acting prandial insulin aspart.
The potency of insulin analogues, including Ryzodeg, is expressed in
units. One (1) unit of this insulin
corresponds to 1 international unit of human insulin, l unit of insu
lin glargine, I unit of insulin
detemir or 1 unit ofbiphasic insulin aspart.
Ryzodeg is to be dosed in accordance with the individual patient's
needs. Dose-adjustments are
recommended to be based on fasting plasma glucose measurements.
Adjustment of dose may be necessary if patients undertake increased
physical activity, change their
usual diet or dur