Expiration date: 04/2025

The composition and form of issue:

Suspension for subcutaneous injection. 1 ml contains:

active substance: insulin aspart biphasic soluble insulin aspart (30%) and crystals of insulin aspart Protamine (70%) — 100 UNITS 

1 IU corresponds to 0,035 mg or 6 nmol of anhydrous insulin aspart 

excipients: glycerol, phenol, metacresol zinc chloride sodium chloride sodium hydrogen phosphate dihydrate Protamine sulphate sodium hydroxide hydrochloric acid water for injections 

1 cartridge (3 ml) contains 300 UNITS 

for 3 ml glass cartridges Penfill in blister packs of 5 cartridges in cardboard pack 1 blister.

Method of application and dose:

NovoMix 30 Penfill is designed for p/to the introduction. Never should be administered I/V. the Dose is determined individually in each case on the basis of the concentration of glucose in the blood.

The average daily dose of the drug in patients with type 1 diabetes ranges from 0.5 to 1 U/kg/day (depends on the individual characteristics of the patient and the concentration of glucose in the blood). In patients with insulin resistance (such as obesity), daily insulin requirements may be increased in patients with residual endogenous insulin secretion — is reduced.

Patients suffering from diabetes type 2, NovoMix 30 Penfill can be prescribed both as monotherapy and in combination with oral hypoglycemic drugs in cases when the content of glucose in the blood is insufficiently regulated only oral hypoglycemic agents. For patients with diabetes type 2 diabetes the recommended starting dose NovoMix 30 Penfill is 6 UNITS morning and 6 evening MEALS (with Breakfast and dinner respectively). Also allowed the introduction of 12 UNITS NovoMix 30 Penfill 1 time per day in the evening. In the latter case, it is recommended that after reaching the dose of 30 IU of the preparation to switch to the application NovoMix 30 Penfill 2 times a day, dividing the dose into two equal parts — morning and evening. Safe transition to the use of NovoMix 30 Penfill 3 times a day with splitting the morning dose into two equal parts and the introduction of these two parts morning and afternoon.

For dose adjustment it is recommended to use the following table:

The concentration of glucose in blood before a meal	Dose adjustment Novomiks 30 Penfill, ED
<4.4 mmol/l (<80 mg/DL)	-2
4.4–6.1 mmol/l (80-110 mg/DL)	0 (not required)
6.2–7.8 mmol/l (111-140 mg/DL)	+2
7.9–10 mmol/l (141-180 mg/DL)	+4
>10 mmol/l (>180 mg/DL)	+6

For adjustment use the lowest value of the concentration of glucose in the blood before eating in the last three days. Should not increase the dose, if in this period, there was hypoglycemia. Dose adjustment can be carried out 1 time per week until reaching the target value of glycosylated hemoglobin (?b?1C). To assess the adequacy of previous dose using the concentration value of glucose in blood before a meal. When transferring a patient from biphasic human insulin NovoMix 30 Penfill should start with the same dose and mode of administration. Then adjust the dose according to the individual needs of the patient (see the above table). NovoMix 30 Penfill may be used in elderly patients, but experience of its application in combination with oral hypoglycemic drugs in patients over 75 years of age is limited.

NovoMix 30 Penfill should be administered immediately before eating. If necessary, you can enter NovoMix 30 Penfill shortly after the start of the meal.

Temperature of insulin must correspond to room. NovoMix 30 Penfill you should enter n/a in the thigh or the anterior abdominal wall. If desired, the drug can be administered into the upper arm or buttocks.

It is necessary to change the injection site within the anatomical region to prevent the development of lipodystrophy. As with any other insulin preparations, the duration of the NovoMix 30 Penfill is dependent on dose, site of injection, intensity of flow, temperature and level of physical activity. The dependence of the absorption NovoMix 30 Penfill from the site of injection has not been studied. In patients with renal or hepatic impairment, insulin requirements may be reduced.

NovoMix 30 Penfill may be used to treat children and adolescents aged 10 years in those cases where it is preferable the use of pre-mixed insulin.

There are limited clinical data for children aged 6-9 years. For children under 6 years of clinical studies have not been conducted.

Storage conditions:

Do not freeze. The exposed cartridges are to be used within 4 weeks do not store at temperatures above 30 °C, do not store in the refrigerator.