Traceability
In
order to improve the traceability of biological medicinal products,
the name and the batch number of the administered product should be
clearly recorded.
Transferring
a patient to another type or brand of insulin
Transferring
a patient to another type or brand of insulin should be done under
strict medical supervision. Changes in strength, brand
(manufacturer), type (regular/soluble, NPH/isophane, etc.), species
(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. For fast-acting insulins, any patient also on
basal insulin must optimise dosage of both insulins to obtain glucose
control across the whole day, particularly nocturnal/fasting glucose
control.
Hypoglycaemia
and hyperglycaemia
Conditions
which may make the early warning symptoms of hypoglycaemia different
or less pronounced include long duration of diabetes, intensified
insulin therapy, diabetic nerve disease or medicinal products such as
beta-blockers.
A
few patients who have experienced hypoglycaemic reactions after
transfer from animal-source insulin to human insulin have reported
that the early warning symptoms of hypoglycaemia were less pronounced
or different from those experienced with their previous insulin.
Uncorrected hypoglycaemic or hyperglycaemic reactions can cause loss
of consciousness, coma, or death.
The
use of dosages which are inadequate or discontinuation of treatment,
especially in insulin-dependent diabetics, may lead to hyperglycaemia
and diabetic ketoacidosis; conditions which are potentially lethal.
Insulin
requirements and dosage adjustment
Insulin
requirements may be increased during illness or emotional
disturbances.
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. A
consequence of the pharmacodynamics of rapid-acting insulin analogues
is that if hypoglycaemia occurs, it may occur earlier after an
injection when compared with soluble human insulin.
Combination
of Humalog with pioglitazone
Cases
of cardiac failure have been reported when pioglitazone was used in
combination with insulin, especially in patients with risk factors
for development of cardiac heart failure. This should be kept in
mind, if treatment with the combination of pioglitazone and Humalog
is considered. If the combination is used, patients should be
observed for signs and symptoms of heart failure, weight gain and
oedema. Pioglitazone should be discontinued, if any deterioration in
cardiac symptoms occurs.
Avoidance
of medication errors when using insulin lispro (200 units/ml) in
pre-filled pen:
The
insulin lispro solution for injection containing 200 units/ml
must not be transferred from the pre-filled pen, the KwikPen, to a
syringe. The markings on the insulin syringe will not measure the
dose correctly. Overdose can result causing severe hypoglycemia. The
insulin lispro solution for injection containing 200 units/ml
must not be transferred from the KwikPen to any other insulin
delivery device, including insulin infusion pumps.
Patients
must be instructed to always check the insulin label before each
injection to avoid accidental mix-ups between the two different
strengths of Humalog as well as other insulin products.
Patients
must visually verify the dialled units on the dose counter of the
pen. Therefore, the requirement for patients to self-inject is that
they can read the dose counter on the pen. Patients who are blind or
have poor vision must be instructed to always get help/assistance
from another person who has good vision and is trained in using the
insulin device.
Excipients
This
medicinal product contains less than 1 mmol sodium (23 mg)
per dose, i.e., essentially “sodium‑free”.
Reference
Humalog
200 Units/ml [Summary of Product Characteristics]. Utrecht, The
Netherlands: Eli Lilly Nederland B.V.