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HUMULIN S KWIKPEN (SOLUBLE) 100 IU/ML SOLUTION FOR INJECTION

Active substance(s): HUMAN INSULIN (PRB)

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Humulin S KwikPen (Soluble) 100 IU/ml solution for injection

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 100 IU human insulin (produced in E. coli by recombinant DNA
technology).
One pre-filled pen contains 3 ml equivalent to 300 IU of soluble insulin.
For a full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
A solution for injection in a pre-filled pen.
Humulin S is a sterile, clear, colourless, aqueous solution of human insulin.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the treatment of patients with diabetes mellitus who require insulin for the
maintenance of glucose homeostasis.

4.2

Posology and method of administration
The dosage should be determined by the physician, according to the requirement of
the patient.
Humulin S should be given by subcutaneous injection but may, although not
recommended, also be given by intramuscular injection. It may also be administered
intravenously.
Subcutaneous administration should be in the upper arms, thighs, buttocks or
abdomen. Use of injection sites should be rotated so that the same site is not used
more than approximately once a month.
Care should be taken when injecting any Humulin insulin preparations to ensure that
a blood vessel has not been entered. After any insulin injection, the injection site
should not be massaged. Patients must be educated to use proper injection techniques.
Each pack contains a patient information leaflet with instructions on how to inject
insulin.

4.3

Contraindications
Hypoglycaemia.
Hypersensitivity to Humulin or to the formulation excipients, unless used as part of a
desensitisation programme.
Under no circumstances should any Humulin formulation other than Humulin S
(Soluble) be given intravenously.

4.4

Special warnings and precautions for use

Transferring a patient to another type or brand of insulin should be done under strict medical
supervision. Changes in strength, brand (manufacturer), type (soluble, isophane, mixture),
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.
Some patients taking human insulin may require a change in dosage from that used with
animal-source insulins. If an adjustment is needed, it may occur with the first dose or during
the first several weeks or months.

A few patients who experienced hypoglycaemic reactions after transfer to human insulin have
reported that the early warning symptoms were less pronounced or different from those
experienced with their previous animal insulin. Patients whose blood glucose is greatly
improved, e.g. by intensified insulin therapy, may lose some or all of the warning symptoms of
hypoglycaemia and should be advised accordingly. Other conditions which may make the
early warning symptoms of hypoglycaemia different or less pronounced include long duration
of diabetes, diabetic nerve disease, or medications such as beta blockers. Uncorrected
hypoglycaemic and hyperglycaemic reactions can cause loss of consciousness, coma or death.
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.
Treatment with human insulin may cause formation of antibodies, but titres of antibodies are
lower than those to purified animal insulin.
Insulin requirements may change significantly in diseases of the adrenal, pituitary or thyroid
glands and in the presence of renal or hepatic impairment.
Insulin requirements may be increased during illness or emotional disturbances.
Adjustment of insulin dosage may also be necessary if patients change their level of physical
activity or change their usual diet.
Combination of human insulin 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 human insulin
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.

4.5

Interactions with other medicinal products and other forms of interaction

A number of medicinal products are known to interact with glucose metabolism and therefore
the physician should be consulted when using other medications in addition to human insulin
(see section 4.4). The physician must therefore take possible interactions into account and
should always ask his patients about any medicinal products they take.
Insulin requirements may be increased by substances with hyperglycaemic activity, such as
glucocorticoids, thyroid hormones, growth hormone, danazol, beta2- sympatomimetics (such
as ritodrine, salbutamol, terbutaline), thiazides.
Insulin requirements may be reduced in the presence of substances with hypoglycaemic
activity, such as oral hypoglycaemics (OHA), salicylates (for example, acetylsalicylic acid),
certain antidepressants (monoamine oxidase inhibitors), certain angiotensin converting enzyme
(ACE) inhibitors (captopril, enalapril), angiotensin II receptor blockers, non-selective betablocking agents and alcohol.
Somatostatin analogues (octreotide, lanreotide) may both decrease or increase insulin dose
requirements.

4.6

Fertility, pregnancy and lactation
It is essential to maintain good control of the insulin treated (insulin-dependent or
gestational diabetes) patient throughout pregnancy. Insulin requirements usually fall
during the first trimester and increase during the second and third trimesters. Patients
with diabetes should be advised to inform their doctors if they are pregnant or are
contemplating pregnancy.
Careful monitoring of glucose control, as well as general health, is essential in
pregnant patients with diabetes.
Patients with diabetes who are lactating may require adjustments in insulin dose
and/or diet.

4.7

Effects on ability to drive and use machines
The patient’s ability to concentrate and react may be impaired as a result of
hypoglycaemia. This may constitute a risk in situations where these abilities are of
special importance (e.g. driving a car or operating machinery).
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving,
this is particularly important in those who have reduced or absent awareness of the
warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The
advisability of driving should be considered in these circumstances.

4.8

Undesirable effects

Hypoglycaemia is the most frequent undesirable effect of insulin therapy that a patient with
diabetes may suffer. Severe hypoglycaemia may lead to loss of consciousness, and in extreme
cases, death. No specific frequency for hypoglycaemia is presented, since hypoglycaemia is a
result of both the insulin dose and other factors e.g. a patient`s level of diet and exercise.
Local allergy in patients is common (1/100 to < 1/10). Redness, swelling, and itching can
occur at the site of insulin injection. This condition usually resolves in a few days to a few
weeks. In some instances, local reactions may be related to factors other than insulin, such as
irritants in the skin cleansing agent or poor injection technique.
Systemic allergy, which is very rare (< 1/10,000) but potentially more serious, is a generalised
allergy to insulin. It may cause rash over the whole body, shortness of breath, wheezing,
reduction in blood pressure, fast pulse, or sweating. Severe cases of generalised allergy may be
life-threatening.
In the rare event of a severe allergy to Humulin, treatment is required immediately. A change
of insulin or desensitisation may be required.
Lipodystrophy at the injection site is uncommon (1/1,000 to < 1/100).
Cases of oedema have been reported with insulin therapy, particularly if previous poor
metabolic control is improved by intensified insulin therapy.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions via the
United Kingdom: Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard

4.9

Overdose
Insulin has no specific overdose definitions, because serum glucose concentrations
are a result of complex interactions between insulin levels, glucose availability and
other metabolic processes. Hypoglycaemia may occur as a result of an excess of
insulin relative to food intake and energy expenditure.
Hypoglycaemia may be associated with listlessness, confusion, palpitations,
headache, sweating and vomiting.
Mild hypoglycaemic episodes will respond to oral administration of glucose or sugar
products.
Correction of moderately severe hypoglycaemia can be accomplished by
intramuscular or subcutaneous administration of glucagon, followed by oral
carbohydrate when the patient recovers sufficiently. Patients who fail to respond to
glucagon must be given glucose solution intravenously.
If the patient is comatose, glucagon should be administered intramuscularly or
subcutaneously. However, glucose solution must be given intravenously, if glucagon
is not available or if the patient fails to respond to glucagon. The patient should be
given a meal as soon as consciousness is recovered.
Sustained carbonhydrate intake and observation may be necessary because
hypoglycaemia
may occur after apparent clinical recovery.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmaco-therapeutic group: Humulin S: ATC code A10A B01.
Humulin S is a rapidly acting insulin preparation.

The prime activity of insulin is the regulation of glucose metabolism.
In addition insulin has several anabolic and anti-catabolic actions on a variety of
different tissues. Within muscle tissue this includes increasing glycogen, fatty acid,
glycerol and protein synthesis and amino acid uptake, while decreasing
glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein catabolism and
amino acid output.
The typical activity profile (glucose utilisation curve) following subcutaneous
injection is illustrated below by the heavy line. Variations that a patient may
experience in timing and/or intensity of insulin activity are illustrated by the shaded
area. Individual variability will depend on factors such as size of dose, site of
injection temperature and physical activity of the patient.
Humulin S

Time (hours)

5.2

Pharmacokinetic properties
The pharmacokinetics of insulin do not reflect the metabolic action of that hormone.
Therefore, it is more appropriate to examine glucose utilisation curves (as discussed
above) when considering the activity of insulin.

5.3

Preclinical safety data
Humulin is human insulin produced by recombinant technology. No serious events
have been reported in subchronic toxicology studies. Human insulin was not
mutagenic in a series of in vitro and in vivo genetic toxicity assays.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
m-cresol
glycerol
water for injections
The following may be used to adjust pH; hydrochloric acid and/or sodium hydroxide.

6.2

Incompatibilities
Humulin preparations should not be mixed with insulins produced by other
manufacturers or with animal insulin preparations.

6.3

Shelf life

Unused pre-filled pens
3 years.
After first use
28 days.

6.4

Special precautions for storage

Unused pre-filled pens
Store in a refrigerator (2 °C – 8 °C). Do not freeze. Do not expose to excessive heat or direct
sunlight.
After first use
Store below 30°C. Do not refrigerate. The pre-filled pen should not be stored with the needle
attached

6.5

Nature and content of container

3 ml solution in a cartridge (type I glass) with a plunger head at the bottom (rubber) and disc
seal at the top (rubber) in a pre-filled pen.
Pack sizes of 5.

6.6

Special precautions for disposal and other handling
Do not reuse needles. Dispose of the needle in a responsible manner. Needles and
pens must not be shared. Humulin S KwikPen can be used until empty, then properly
discard. Any unused product or waste material should be disposed of in accordance
with local requirements.
Instructions for use and handling
A solution for injection in a pre-filled / disposable pen injector containing a 3ml
cartridge. Humulin S KwikPen delivers up to 60 units per dose in single unit
increments.
a) Preparing a dose
Humulin KwikPen containing Humulin S formulation does not require resuspension
and should only be used if it is clear, colourless, with no solid particles visible and if
it is of water-like appearance.
The cartridges are not designed to allow any other insulin to be mixed in the
cartridge. Cartridges are not designed to be refilled.
Follow the instructions with Humulin S KwikPen for attaching the needle and
administering the insulin injection.
For Humulin S KwikPen, a needle must always be attached before priming, dialing
and injecting an insulin dose. Humulin S KwikPen should always be primed before
each injection. Failure to prime Humulin S KwikPen may result in an inaccurate dose.
b) Injecting a dose
Inject the correct dose of insulin, as directed by your doctor or diabetes specialist
nurse.
Use of the injection sites should be rotated so that the same is not used more than
approximately once a month.
Each pack contains a patient information leaflet with instructions on how to inject
insulin.

7

MARKETING AUTHORISATION HOLDER
Eli Lilly and Company Limited, Lilly House, Priestley Road, Basingstoke, Hampshire
RG24 9NL
Trading style: Lilly Industries Limited

8

MARKETING AUTHORISATION NUMBER(S)
PL 00006/0337

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
19 September 1997 / 24 April 2006

10

DATE OF REVISION OF THE TEXT
07/08/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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