国家: 亚美尼亚
语言: 英文
来源: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
insulin degludec (70%), insulin aspart (30%)
Novo Nordisk A/S
A10AD06
insulin degludec (70%), insulin aspart (30%)
100U/ml
solution for injection
(5) pre-filled pens 3ml
Prescription
Registered
2018-06-27
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 阅读完整的文件
tl - . ,, " " ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 0 t-to 1dls ,\ .. . \ .,;. -+ f, i _""1,, _ j 0 0,., . ...... &" _:_ ' _,_ _ _ _tl _ () 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 阅读完整的文件