Ryzodeg

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

insulin aspart, insulin degludec

Available from:

Novo Nordisk A/S

ATC code:

A10AD06

INN (International Name):

insulin degludec, insulin aspart

Therapeutic group:

Drugs used in diabetes

Therapeutic area:

Diabetes Mellitus

Therapeutic indications:

Treatment of diabetes mellitus in adults, adolescents and children from the age of 2 years.

Product summary:

Revision: 13

Authorization status:

Authorised

Authorization date:

2013-01-21

Patient Information leaflet

34
B. PACKAGE LEAFLET
35
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RYZODEG 100 UNITS/ML SOLUTION FOR INJECTION IN PRE-FILLED PEN
70% insulin degludec / 30% insulin aspart
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
–
Keep this leaflet. You may need to read it again.
–
If you have any further questions, ask your doctor, pharmacist or
nurse.
–
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
–
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Ryzodeg is and what it is used for
2.
What you need to know before you use Ryzodeg
3.
How to use Ryzodeg
4.
Possible side effects
5.
How to store Ryzodeg
6.
Contents of the pack and other information
1.
WHAT RYZODEG IS AND WHAT IT IS USED FOR
Ryzodeg is used to treat diabetes mellitus in adults, adolescents and
children from the age of 2 years. It
helps your body reduce your blood sugar level.
This medicine contains two types of insulin:
•
Basal insulin called insulin degludec, this has a long blood
sugar-lowering effect.
•
Rapid-acting insulin called insulin aspart, this lowers your blood
sugar soon after you inject it.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE RYZODEG
DO NOT USE RYZODEG
•
if you are allergic to insulin degludec, insulin aspart or any of the
other ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Ryzodeg. Be
especially aware of the following:
•
Low blood sugar (hypoglycaemia) – if your blood sugar is too low,
follow the guidance for low
blood sugar in section 4.
•
High blood sugar (hyperglycaemia) – if your blood sugar is too high,
follow the guidance for
high blood sugar in section 4.
•
Switching from other insulin medicines – the insulin dos

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
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).
Ryzodeg 100 units/mL solution for injection 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 (FlexTouch).
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, adolescents and children
from the age of 2 years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
This medicinal product is a soluble 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, 1 unit of
insulin glargine, 1 unit of insulin
detemir or 1 unit of biphasic 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 during concomitant illness.
_Patients with type 2 diabetes mellitus_
Ryzodeg can be administered once or twice daily with