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 NovoMix
30 FlexPen
Suspension for injection in a pre-filled pen
Qualitative and quantitative composition
Soluble insulin aspart*/protamine-crystallised
insulin aspart* 100 U/ml in the ratio of 30/70 * produced by recombinant DNA
technology in Saccharomyces cerevisiae.
One unit of insulin aspart corresponds to 6 nmol, 0.035 mg salt-free
anhydrous insulin aspart.
1 pre-filled pen contains 3 ml equivalent to 300 U.
Pharmaceutical form
Suspension for injection.
NovoMix 30 is a white suspension.
Clinical particulars Therapeutic indications
Treatment of diabetes mellitus.
Posology and method of administration
NovoMix 30 has a faster onset of
action than biphasic human insulin and should generally be given immediately
before a meal. When necessary, NovoMix 30 can be given soon after a meal.
Transfer to NovoMix 30 from other insulin preparations may require
adjustment of dose and timing of administration. As with all insulins, close
glucose monitoring is recommended during transition and the initial weeks
thereafter.
Administration
NovoMix 30 is administered subcutaneously in the thigh or in the abdominal
wall. If convenient, the gluteal or deltoid region may be used. Injection
sites should be rotated within the same region. As with all insulins the
duration of action will vary according to the dose, injection site, blood
flow, temperature and level of physical activity. The influence of different
injection sites on the absorption of NovoMix 30 has not been investigated.
NovoMix 30 should never be administered intravenously.
Renal or hepatic impairment may reduce the patient's insulin requirements.
NovoMix 30 can be used in children and adolescents aged 10 years and above
when premixed insulin is preferred. For children 6-9 years limited clinical
data exists.
No studies have been performed in children under the age of 6
years.
Dose recommendation:
Dosage of NovoMix 30 is individual and determined in accordance with the
needs of the patient.
In patients with type 2 diabetes, NovoMix 30 can be given in monotherapy or
in combination with, oral antidiabetic drugs when the blood glucose is
inadequately controlled with those oral antidiabetic drugs alone. For
patients with type 2 diabetes, the recommended starting dose of NovoMix 30
is 6 U at breakfast and 6 U at dinner (evening meal). NovoMix 30 can also be
initiated once daily with 12 U at dinner (evening meal). When using NovoMix
30 once daily, it is generally recommended to move to twicedaily when
reaching 30 units by splitting the dose into equal breakfast and dinner
doses. A NovoMix 30 thricedaily regimen can be safely initiated from a
twice-daily regimen by splitting the morning dose into morning and lunch
doses.
The following titration guideline is recommended for dose adjustment:
| Pre-meal blood glucose level |
NovoMix 30 dose adjustment |
| < 4.4 mmol/l |
< 80 mg/dL |
-2U |
| 4.4 - 6.1 mmol/l |
80 - 110 mg/dL |
0 |
| 6.2 - 7.8 mmol/l |
111 - 140 mg/dL |
+2U |
| 7.9 - 10 mmol/l |
141 - 180 mg/dL |
+4U |
| > 10 mmol/l |
> 180 mg/dL |
+6U |
The lowest of three previous days' pre-meal levels should be used. The dose
should not be increased if hypoglycaemia occurred within these days. Dose
adjustment can be made once a week until target HbA1c, is reached. Pre-meal
blood glucose levels should be used to evaluate the adequacy of the
preceding dose.
In patients with type 1 diabetes the individual insulin requirement is
usually between 0.5 and 1.0 Units/kg/day. NovoMix 30 may fully or partially
meet this requirement. The daily insulin requirement may be higher in
patients with insulin resistance (e.g due to obesity), and lower in patients
with residual endogenous insulin production. NovoMix 30 can be used in
elderly patients; however there is limited experience with the use of
NovoMix 30 in combination with OADs in patients older than 75 years.
Contraindications
• Hypersensitivity to the active substance or to any of the
excipients
• Hypoglycaemia.
Special warnings and precautions for use
The use of dosages which are inadequate or discontinuation of treatment,
especially in insulindependent diabetics, may lead to hyperglycaemia and
diabetic ketoacidosis, conditions which are potentially lethal.
Omission of a meal or unplanned, strenuous physical exercise may lead to
hypoglycaemia. Compared with biphasic human insulin, NovoMix 30 may have a
more pronounced glucose lowering effect up to 6 hours after injection. This
may have to be compensated for in the individual patient, through adjustment
of insulin dose and/or food intake.
Patients, whose blood glucose control is greatly improved, e.g. by
intensified insulin therapy, may experience a change in their usual warning
symptoms of hypoglycaemia, and should be advised accordingly.
Tighter
control of glucose levels can increase the potential for hypoglycaemic
episodes and therefore require special attention during dose
intensification.
NovoMix 30 should be administered in immediate relation to
a meal. The rapid onset of action should therefore be considered in patients
with concomitant diseases or treatment with other medicinal products where a
delayed absorption of food might be expected. Concomitant illness,
especially infections, usually increases the patient's insulin requirements.
When patients are transferred between different types of insulin products,
the early warning symptoms of hypoglycaemia may change or become less
pronounced than those experienced with their previous insulin.
Transferring
a patient to a new type or brand of insulin should be done under strict
medical supervision Changes in strength, brand (manufacturer), type, origin
(animal, human, human insulin analogue), and/or method of manufacture
(recombinant DNA versus animal source insulin) may result in the need for a
change in dosage.
Patients taking NovoMix 30 may need a change in dosage
from that used with their usual insulins. If dosage adjustment is needed, it
may be done with the first dose or during the first few weeks or months.
Adjustment of dosage may also be necessary if patients undertake increased
physical activity or change their usual diet. Exercise taken immediately
after a meal may increase the risk of hypoglycaemia.
Insulin suspensions are not to be used in insulin infusion pumps.
As with any insulin therapy, injection site reactions may occur and include
pain, itching, hives, swelling and inflammation. Continuous rotation of the
injection site within a given area may help to reduce or prevent these
reactions. Reactions usually resolve in a few days to a few weeks. On rare
occasions, injection site reactions may require discontinuation of NovoMix
30.
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