order to improve the traceability of biological medicinal products,
the name and the batch number of the administered medicinal product
should be clearly recorded.
a patient to another type or brand of insulin
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.
mixing Humalog with a longer acting insulin, the shorter-acting
Humalog should be drawn into the syringe first, to prevent
contamination of the vial by the longer-acting insulin. Mixing of the
insulins ahead of time or just before the injection should be on
advice of the physician. However, a consistent routine must be
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 medications such as
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.
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.
must be instructed to perform continuous rotation of the injection
site to reduce the risk of developing lipodystrophy and cutaneous
amyloidosis. There is a potential risk of delayed insulin absorption
and worsened glycaemic control following insulin injections at sites
with these reactions. A sudden change in the injection site to an
unaffected area has been reported to result in hypoglycaemia. Blood
glucose monitoring is recommended after the change in the injection
site, and dose adjustment of antidiabetic medications may be
requirements and dosage adjustment
requirements may be increased during illness or emotional
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.
of Humalog with pioglitazone:
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.
of medication errors
must be instructed to always check the insulin label before each
injection to avoid accidental mix-ups between the two different
strengths of Humalog KwikPen as well as other insulin products.
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
Tempo Pen contains a magnet that may interfere with the functions of
an implantable electronic medical device, such as a pacemaker. The
magnetic field extends to approximately 1.5 cm.
medicinal product contains less than 1 mmol sodium (23 mg)
per dose, i.e., essentially “sodium‑free”.
100 Units/ml [Summary of Product Characteristics]. Utrecht, The
Netherlands: Eli Lilly Nederland B.V.