HUMALOG

Israel - English - Ministry of Health

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Active ingredient:
INSULIN LISPRO
Available from:
ELI LILLY ISRAEL LTD
ATC code:
A10AB04
Pharmaceutical form:
SOLUTION FOR INJECTION
Composition:
INSULIN LISPRO 100 U/ML
Administration route:
S.C, I.V, I.M
Prescription type:
Required
Manufactured by:
LILLY FRANCE S.A.S., FRANCE
Therapeutic group:
INSULIN LISPRO
Therapeutic area:
INSULIN LISPRO
Therapeutic indications:
Humalog is indicated for the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Humalog is also indicated for the initial stabilization of diabetes mellitus.
Authorization number:
102 83 28580 00
Authorization date:
2011-07-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

25-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

26-03-2020

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PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS`

REGULATIONS (PREPARATIONS) - 1986

This medicine is dispensed by a physician`s prescription only

HUMALOG 100 U/ml

Solution for Injection

The active ingredient: Insulin Lispro 100 U/ml

For a list of the inactive ingredients, please see section 6.

Package: 5 x 3.0 ml cartridges.

Read this patient leaflet carefully in its entirety before using this medicine. This leaflet con-

tains concise information about this medicine. If you have any further questions, please con-

tact your doctor or pharmacist.

This medicine has been prescribed to treat your illness. Do not pass it on to others. It may

harm them, even if it seems to you that their illness is similar.

WHAT IS THIS MEDICINE INTENDED FOR?

Humalog is intended for the treatment of adults and children who suffer from diabetes and

need insulin in order to maintain a balance of blood sugar levels.

Therapeutic group: Rapid-acting insulins and insulin analogs.

Humalog is used to treat diabetes. Humalog works faster than normal

insulin.

Diabetes occurs when your pancreas does not make enough insulin to control the

level of glucose in your blood. Humalog is a substitute for your own insulin and is

used to control glucose in the long term. It works very quickly and lasts a shorter

time in the blood than soluble insulin (2-5 hours). You should normally use Humalog

within 15 minutes of a meal (either before or after).

Your doctor may instruct you to use Humalog as well as a longer-acting insulin.

Each kind of insulin comes with its own patient information leaflet. Do not change

your insulin without an explicit instruction from your doctor to do so. Be very careful if

you do decide to change your insulin.

Humalog is suitable for use in both children and adults. Humalog may be used in

children when an advantage is expected compared to soluble insulin, for example, in

the timing of injection in relation to meals.

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2. BEFORE USING THIS MEDICINE

Do not use this medicine if:

You are sensitive (allergic) to the active ingredient (insulin lispro) or any of the

other ingredients contained in this medicine (see section 6).

You think that you are developing a state of hypoglycemia (low blood sugar

levels).

See instructions for treating mild hypoglycemia further on in this leaflet (section

3 - If you have accidentally taken a higher dose).

Special warnings regarding the use of this medicine

If your blood sugar levels are well controlled by your current insulin therapy, you may

not feel the warning symptoms when your blood sugar level is falling too low. Warn-

ing signs are listed below, see "Common problems of diabetic patients". You should

pay particular attention to your mealtimes, how often to exercise and to what extent.

You must also keep a close watch on your blood sugar levels by testing your blood

glucose often.

A number of patients have reported that after switching to human insulin, the early

warning symptoms for hypoglycemia were less obvious or different than with animal

insulin. If you frequently suffer from hypoglycemia or have difficulty recognizing the

signs, consult your doctor.

Tell the doctor if:

- You have recently been ill

- You have kidney or liver problems

- You are exercising more than usual

The amount of insulin you need may change if you consume alcohol.

Tell your doctor or pharmacist if you are planning to go abroad. Due to the time

difference between countries, you may have to have your injections and meals at dif-

ferent times from when you are at home.

Some patients with long-standing type 2 diabetes who have also suffered from heart

disease or have experienced a stroke in the past, who were treated with insulin in

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combination with preparations containing pioglitazone (an oral medicine for treating

diabetes), developed heart failure.

Inform your doctor as soon as possible, if you experience signs of heart failure such

as unusual shortness of breath or rapid weight gain or localized swelling (oedema).

If you are taking or have recently taken any other medicines, including non-prescription med-

icines and nutritional supplements, tell the doctor or pharmacist.

Your insulin needs may change if you are taking:

Contraceptive pills

Steroids

Thyroid hormone replacement therapy

Oral hypoglycemic preparations

Aspirin and salicylates

Sulfa antibiotics

Octreotide

Beta

agonists (for example: ritodrine, salbutamol or terbutaline)

Beta-blockers, or

Some antidepressants (monoamine oxidase inhibitors or SSRI preparations)

Danazol

Some ACE inhibitors (for example: captopril, enalapril)

Angiotensin II receptor blockers

Use of this medicine and alcohol consumption

If you consume alcohol, your insulin requirement may change.

Pregnancy and breastfeeding

If you are pregnant, are planning a pregnancy, or breastfeeding, consult your doctor. The

amount of insulin you need usually decreases during the first trimester of pregnancy and in-

creases for the remaining six months.

If you are breastfeeding, there may be a need to change your insulin intake or diet.

Driving and using machines

Your ability to concentrate and react may be impaired if you have hypoglycemia. Bear this in

mind in situations where you might put yourself and others at risk (e.g. driving a car or oper-

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ating machines).

Consult your doctor about the advisability of driving if you experience:

Frequent episodes of hypoglycemia

Reduced or absent warning signs of hypoglycemia

3. HOW SHOULD YOU USE THE MEDICINE?

Always check the pack and cartridge label for the name and type of insulin when you get it

from your pharmacy. Make sure you get the Humalog that your doctor has told you to use.

Always use according to the doctor`s instructions. Check with the doctor or pharmacist if you

are not sure.

Only the doctor will determine the dosage and manner of treatment.

Do not exceed the recommended dose.

You should normally inject Humalog within 15 minutes of a meal. If

necessary, you can inject shortly after a meal. In any case, your doctor will instruct

you exactly how much to use, when and how often to use it. These instructions are

customized only for you and therefore you should follow them exactly.

If you change the type of insulin you use (for example from a human/animal insulin

to Humalog), you may have to inject a different amount than before. This change

might just be for the first injection or it may be a gradual change over several weeks

or months.

Inject Humalog under the skin. You should only inject it into a muscle if your doctor

has told you to.

Method of administration:

Humalog cartridge is intended for subcutaneous injection.

Do not inject Humalog into a vein. Inject Humalog according to the instructions of the

doctor or nurse. Only your doctor should administer Humalog into a vein. He will only

do this under special circumstances such as during surgery or if you are sick and

your glucose levels are too high.

Before using Humalog, it is very important to read the detailed instructions carefully

and follow them strictly. Failure to follow the instructions may result in an inaccurate

insulin dose.

The amount of insulin for injection is measured in units. It is important to recognize

the unit marks on the injector pen, because the volume of insulin that is injected is

calculated based on the number of units per ml. Use only an appropriate injector

pen. Using an inappropriate injector pen may result in an inaccurate insulin dose.

Below are general instructions for injection. For detailed instructions, please see the

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User Manual enclosed in the package of the pen.

Discarding of disposable needles after use must be strictly maintained according to

the instructions from the medical staff, in order to prevent infections. The pen and

needle must be used exclusively by you, even if you have changed the needle, in

order to prevent the possibility of transmission of diseases.

Preparing Humalog:

The medicine Humalog is already dissolved in water, therefore there is no need to mix it. It

may be used only if it looks like water – clear, colorless and without particles. Check the ap-

pearance of the insulin in the cartridge each time before the injection.

Instructions for injection:

Do not store the pen in use with the needle attached.

Use a new needle for each injection in order to prevent infections.

Wash your hands thoroughly. Disinfect the rubber stopper of the cartridge.

You must only use Humalog cartridges in injector pens supplied by Lilly. Make sure

that Humalog or Lilly cartridges are mentioned in the leaflet enclosed in the injector

pen package.

The 3 ml cartridge only fits the 3 ml injector pen.

Follow the instructions that appear in the leaflet enclosed in the injector pen pack-

age. Insert the cartridge into the injector pen.

Prime the injector pen before each use. Set the injector pen to a dose of 1 or 2 units.

Hold the injector pen with the needle pointing up and tap on the injector pen so that

air bubbles will rise to the top. While the injector pen is still pointing up, press the in-

jection button until a drop of Humalog comes out of the needle. There may still be

some small air bubbles left in the injector pen. This is harmless, but if the air bubble

is too big, the injected insulin dose may be less accurate.

Before the injection, clean your skin at the injection site according to the instructions

you have received.

Inject the medicine under the skin according to the instructions you have received.

Do not inject directly into a vein.

After your injection, leave the needle in the skin for 5 seconds to make sure you

have received the whole dose. Do not rub the injection area.

Make sure you inject at least 1 cm from where you last injected and that you change

the injection site each time.

Consult the doctor or nurse about desirable injection sites.

It doesn’t matter where you inject, either in the upper arm, thigh, buttock or abdo-

men, your Humalog injection will still work quicker than soluble human insulin.

Immediately after injecting, remove the needle from the injector pen using the needle

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cap. This is to keep the Humalog sterile and prevent leakage of insulin from the in-

jector pen, and to prevent air going back into the pen and the needle clogging up. Do

not share your pen or needle with anyone else. Replace the cap on your pen. After

the injection, leave the cartridge in the injector pen.

Further injections:

Before every injection, set the injector pen to a dose of 1 or 2 units and press the in-

jection button until a drop of Humalog comes out of the needle. You can see how

much Humalog remains in the cartridge by looking at the gauge marked on it. The

distance between each mark on the gauge is about 20 units. If there is not enough

Humalog left for your dose, replace the cartridge.

Do not mix different types of insulin in the Humalog cartridge. Do not reuse the car-

tridge if it is empty.

Tests and Follow-up

During the course of treatment with this medicine, blood and urine tests should be carried

out.

If you have accidentally taken a higher dose

If you take more Humalog than you need, there may be a drop in blood sugar levels. Check

your blood sugar. If your blood sugar is low (mild hypoglycemia), eat glucose tablets, sugar

or drink a sugary drink. Then eat fruit, biscuits or a sandwich, as your doctor has advised

you, and have some rest. These steps will usually help you overcome mild hypoglycemia or

a minor insulin overdose.

If your condition gets worse, your breathing is shallow, and your skin becomes pale, tell your

doctor at once.

A glucagon injection can treat severe hypoglycemia. Eat glucose or sugar after the glucagon

injection. If you do not respond to glucagon, you will have to go to the hospital. Ask your doc-

tor about glucagon.

If a child has accidentally swallowed the medicine, proceed immediately to a doctor or hospi-

tal emergency room, and bring the package of the medicine with you.

If you forgot to take the medicine:

If you take less Humalog than you need, there may be an increase in blood sugar levels.

Check your blood sugar.

If hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar) is not treated, they

can be very serious and cause headaches, nausea, vomiting, dehydration, unconscious-

ness, coma or even death. See section 4 - side effects.

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Three simple steps to avoid hypoglycemia and hyperglycemia:

Always keep spare syringes and vials of Humalog, or a spare pen and cartridges, in

case you lose your pen and cartridges or they get damaged.

Always carry something with you to show you are diabetic.

Always carry sugar with you.

Treatment should be continued as recommended by the doctor.

Even if there is an improvement in your health condition, do not stop treatment with this med-

icine without consulting your doctor.

If you stop taking this medicine

If you take less Humalog than you need, there may be an increase in blood sugar levels. Do

not change your insulin without your doctor's instructions.

How can you contribute to the success of the treatment?

Do not take medicines in the dark! Check the label and dose each time you take

your medicine. Wear glasses if you need them.

If you have further questions regarding the use of this medicine, consult a doctor or

pharmacist.

4. SIDE EFFECTS

As with any medicine, using Humalog may cause side effects in some users. Do not be

alarmed while reading the list of side effects. You may not suffer from any of them.

Side effects requiring special attention:

Tell the doctor immediately if:

You suffer from systemic allergy (rare). The signs are: rash over the whole body, dif-

ficulty in breathing, wheezing, drop in blood pressure, rapid heartbeat, sweating.

Tell the doctor in the following cases:

Local allergy (common): Some patients have experienced redness, swelling or itch-

ing around the injection site. These side effects usually clear up in a short time (a

few days or a few weeks).

Lipodystrophy (uncommon): Thickening or pitting of the skin at the injection site.

Additional side effects:

Cases of oedema (e.g. swelling in the arms, ankles; fluid retention) have been reported, par-

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ticularly at the beginning of insulin therapy or during a change in therapy to improve control

of blood sugar levels.

If a side effect occurs, if one of the side effects gets worse, or if you suffer from a side effect

not mentioned in this leaflet, consult your doctor.

Side effects can be reported to the Ministry of Health by clicking on the link "Reporting side

effects due to drug treatment" found on the Ministry of Health Home Page

(www.health.gov.il

), that directs you to the online form for reporting side effects.

Or by entering the link:

https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic

@moh.gov.il

Common problems of diabetic patients:

A. Hypoglycemia (low blood sugar) means there is not enough sugar in the blood. This can

be caused if:

You take too much Humalog or other insulin

You miss or delay meals or change your diet

You exercise or work too hard just before or after a meal

You have an infection or illness (especially diarrhea or vomiting)

There is a change in your need for insulin or

You have trouble with your kidneys or liver which gets worse

Alcohol and some medicines can affect your blood sugar levels.

The first symptoms of low blood sugar usually come on quickly and include the following:

Tiredness

Rapid heartbeat

Nervousness or shakiness

Nausea

Headache

Cold sweat

If you are not confident about recognizing your warning symptoms, avoid certain situations

such as driving, which may put yourself or others at risk as a result of hypoglycemia. See the

section "Driving and using machines".

B. Hyperglycemia and diabetic ketoacidosis

Hyperglycemia (high blood sugar level) means that your body does not have enough insulin.

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Hyperglycemia can be caused by:

Not taking your Humalog or other insulin

Taking less insulin than your doctor has prescribed

Eating a lot more than your diet allows

Fever, infection or emotional stress

Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over

many hours or days. The symptoms include the following:

Feeling sleepy

No appetite

Flushed face

Fruity smell on the breath

Thirst

Nausea or vomiting

Severe symptoms are heavy breathing and a rapid pulse. Get medical assistance immedi-

ately.

C. Illness

If you are ill, especially in cases of nausea and vomiting, the amount of insulin you need may

change. Even when you are not eating normally, you still need insulin. Test your urine or

blood, proceed as you would normally do when sick, and tell your doctor.

5. HOW TO STORE THIS MEDICINE?

Before opening, store in the refrigerator at a temperature of 2°C - 8°C. Do not

freeze.

During use, do not store in the refrigerator, but in a place as cool as possible (below

30°C). Do not freeze. The pen in use should not be stored with the needle attached.

The insulin can be used for up to 28 days from first opening. Do not expose to

sunlight or heat.

Avoid poisoning! This medicine, and all other medicines, must be stored in a closed

place out of the reach and sight of children and/or infants in order to avoid poisoning.

Do not induce vomiting unless explicitly instructed to do so by the doctor.

Do not use the medicine after the expiry date (exp. date) which is stated on the car-

ton. The expiry date refers to the last day of that month.

Do not store different medicines in the same package.

Do not use the medicine if the solution is colored or has particles in it. You must use

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it only if it looks like water. Check the solution in the cartridge each time before the

injection.

Medicines should not be disposed of via wastewater or household waste. Ask your

pharmacist how to dispose of medicines no longer required. These measures will

help to protect the environment.

6. ADDITIONAL INFORMATION

In addition to the active ingredient, the medicine also contains:

Metacresol, glycerol, dibasic sodium phosphate, zinc oxide, water for injections, hydrochloric

acid, sodium hydroxide.

What the medicine looks like and contents of the package

Humalog is a sterile, clear, colorless aqueous solution for injection and contains 100 units of

insulin lispro in each milliliter of solution.

Package: 5 cartridges for the injector pen. Each cartridge contains 3.0 ml.

Registration holder and address:

Eli Lilly Israel Ltd., P.O.Box 2160, Herzliya Pituach 46120.

Manufacturer and address:

Lilly France S.A.S., Fegersheim, France

Manufacturing site: Eli Lilly Italia S.p.A., Sesto Fiorentino, Italy

Registration number of the medicine in the National Drug Registry of the Ministry of Health:

102-83-28580-00

This leaflet was reviewed and approved by the Ministry of Health in April 2017.

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HUMALOG

1.

NAME OF THE MEDICINAL PRODUCT

Humalog 100 units/ml, solution for injection in vial

Humalog 100 units/ml, solution for injection in cartridge.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains 100 units of insulin lispro* (equivalent to 3.5mg).

Vial

Each

vial

contains 1000 units insulin lispro in 10 ml solution.

Cartridge

Each cartridge contains 300 units of insulin lispro in 3 ml solution.

*produced in

E.coli

by recombinant DNA technology.

For a full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Solution for injection.

Clear, colourless, aqueous solution.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of

normal glucose homeostasis. Humalog is also indicated for the initial stabilisation of diabetes mellitus.

4.2

Posology and method of administration

Posology

The dosage should be determined by the physician, according to the requirement of the patient.

Humalog may be given shortly before meals. When necessary Humalog can be given soon after meals.

Humalog takes effect rapidly and has a shorter duration of activity (2 to 5 hours) given subcutaneously as

compared with soluble insulin. This rapid onset of activity allows a Humalog injection (or, in the case of

administration by continuous subcutaneous infusion, a Humalog bolus) to be given very close to mealtime.

The time course of action of any insulin may vary considerably in different individuals or at different times

in the same individual. The faster onset of action compared to soluble human insulin is maintained

regardless of injection site. As with all insulin preparations, the duration of action of Humalog is dependent

on dose, site of injection, blood supply, temperature, and physical activity.

Humalog can be used in conjunction with a longer-acting insulin or oral sulphonylurea agents, on the

advice of a physician.

Special populations

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Renal impairment

Insulin requirements may be reduced in the presence of renal impairment.

Hepatic impairment

Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for

gluconeogenesis and reduced insulin breakdown; however, in patients with chronic hepatic impairment, an

increase in insulin resistance may lead to increased insulin requirements.

Paediatric population

Humalog can be used in adolescents and children (see section 5.1).

Method of administration

Humalog preparations should be given by subcutaneous injection and may, although not recommended,

also be given by intramuscular injection.

Humalog in cartridges is only suitable for subcutaneous injections from a Lilly reusable pen or compatible

pump systems for continuous subcutaneous insulin infusion (CSII).

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.

When administered subcutaneously care should be taken when injecting Humalog to ensure that a blood

vessel has not been entered. After injection, the site of injection should not be massaged. Patients must be

educated to use the proper injection techniques.

Use of Humalog in an insulin infusion pump

For subcutaneous injection of Humalog using a continuous infusion pump, you may fill the pump reservoir

from a Humalog 100 units/ml vial. Some pumps are compatible with cartridges that can be inserted intact

into the pump.

Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro. Before infusing

insulin lispro, the pump manufacturer's instructions should be studied to ascertain the suitability for the

particular pump. Use the correct reservoir and catheter for the pump. When filling the pump reservoir

avoid damaging it by using the correct needle length on the filling system Change the infusion set every

48 hours. Change the Humalog in the reservoir at least every 7 days. Humalog should not be exposed to

temperatures greater than 37

C. Use aseptic technique when inserting the infusion set. In the event of a

hypoglycaemic episode, the infusion should be stopped until the episode is resolved. If repeated or severe

low blood glucose levels occur consider the need to reduce or stop an insulin infusion. A pump malfunction

or obstruction of the infusion set can result in a rapid rise in glucose levels. If an interruption to insulin

flow is suspected, follow the instructions in the pump product literature. When used with an insulin

infusion pump, Humalog should not be mixed with any other insulin.

Intravenous administration of insulin

If necessary, Humalog may also be administered intravenously, for example: for the control of blood

glucose levels during ketoacidosis, acute illnesses or during intra and post operative periods.

Humalog 100 units /ml is available in vials if administration of intravenous injection is necessary.

Intravenous injection of insulin lispro should be carried out following normal clinical practise for

intravenous injections, for example by an intravenous bolus or by an infusion system. Frequent monitoring

of the blood glucose levels is required.

Infusion systems at concentrations from 0.1 units/ml to 1.0 units/ml insulin lispro in 0.9% sodium chloride

or 5% dextrose are stable at room temperature for 48 hours. It is recommended that the system is primed

before starting the infusion to the patient.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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Hypoglycaemia.

4.4

Special warnings and precautions for use

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.

Vial

When 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 followed.

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 medications 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

Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-

ups between the 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”.

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4.5

Interaction with other medicinal products and other forms of interaction

Insulin requirements may be increased by medicinal products with hyperglycaemic activity, such as oral

contraceptives, corticosteroids, or thyroid replacement therapy, danazol, beta

stimulants (such as ritodrine,

salbutamol, terbutaline).

Insulin requirements may be reduced in the presence of medicinal products with hypoglycaemic activity,

such as oral hypoglycaemics, salicylates (for example, acetylsalicylic acid), sulpha antibiotics, certain

antidepressants (monoamine oxidase inhibitors, selective serotonin reuptake inhibitors), certain angiotensin

converting enzyme inhibitors (captopril, enalapril), angiotensin II receptor blockers, beta-blockers,

octreotide or alcohol.

The physician should be consulted when using other medications in addition to Humalog (see section 4.4).

4.6

Fertility, pregnancy and lactation

Pregnancy

Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on

pregnancy or on the health of the foetus/newborn.

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 doctor 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.

Breast-feeding

Patients with diabetes who are breast-feeding may require adjustments in insulin dose, diet or both.

Fertility

Insulin lispro did not induce fertility impairment in animal studies (see section 5.3).

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

Summary of safety profile

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.

Tabulated list of adverse reactions

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The following related adverse reactions from clinical trials are listed below as MedDRA preferred term by

system organ class and in order of decreasing incidence (very common: ≥1/10; common: ≥1/100 to <1/10;

uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

MedDRA system

organ classes

Very

common

Common

Uncommon

Rare

Very

rare

Immune system disorders

Local allergy

Systemic allergy

Skin and subcutaneous tissue disorders

Lipodystrophy

Description of selected adverse reactions

Local allergy

Local allergy in patients is common. 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, this condition

may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection

technique.

Systemic allergy

Systemic allergy, which is rare but potentially more serious, is a generalised allergy to insulin. It may cause

a 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.

Lipodystrophy

Lipodystrophy at the injection site is uncommon.

Oedema

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 authorization of the medicinal product is important. It allows

continued monitoring of the benefit/risk balance of the medicinal product.

Any suspected adverse events should be reported to the Ministry of Health according to the National

Regulation by using an online form

https://sideeffects.health.gov.il

4.9

Overdose

Insulins have 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 activity 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 other sugar or saccharated

products.

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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 carbohydrate intake and observation may be necessary because hypoglycaemia may recur after

apparent clinical recovery.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, fast-acting, ATC

code: A10AB04

The primary activity of insulin lispro is the regulation of glucose metabolism.

In addition, insulins have 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.

Insulin lispro has a rapid onset of action (approximately 15 minutes), thus allowing it to be given closer to

a meal (within zero to 15 minutes of the meal) when compared to soluble insulin (30 to 45 minutes before).

Insulin lispro takes effect rapidly and has a shorter duration of activity (2 to 5 hours) when compared to

soluble insulin.

Clinical trials in patients with type 1 and type 2 diabetes have demonstrated reduced postprandial

hyperglycaemia with insulin lispro compared to soluble human insulin.

As with all insulin preparations, the time course of insulin lispro action may vary in different individuals or

at different times in the same individual and is dependent on dose, site of injection, blood supply,

temperature and physical activity. The typical activity profile following subcutaneous injection is

illustrated below.

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The above representation reflects the relative amount of glucose over time required to maintain the

subject's whole blood glucose concentrations near fasting levels and is an indicator of the effect of these

insulins on glucose metabolism over time.

Clinical trials have been performed in children (61 patients aged 2 to 11) and children and adolescents (481

patients aged 9 to 19 years), comparing insulin lispro to human soluble insulin. The pharmacodynamic

profile of insulin lispro in children is similar to that seen in adults.

When used in subcutaneous infusion pumps, treatment with insulin lispro has been shown to result in lower

glycosylated haemoglobin levels compared to soluble insulin. In a double-blind, crossover study, the

reduction in glycosylated haemoglobin levels after 12 weeks dosing was 0.37 percentage points with

insulin lispro, compared to 0.03 percentage points for soluble insulin (p = 0.004).

In patients with type 2 diabetes on maximum doses of sulphonyl urea agents, studies have shown that the

addition of insulin lispro significantly reduces HbA

compared to sulphonyl urea alone. The reduction of

would also be expected with other insulin products e.g. soluble or isophane insulins.

Clinical trials in patients with type 1 and type 2 diabetes have demonstrated a reduced number of episodes

of nocturnal hypoglycaemia with insulin lispro compared to soluble human insulin. In some studies,

reduction of nocturnal hypoglycaemia was associated with increased episodes of daytime hypoglycaemia.

The glucodynamic response to insulin lispro is not affected by renal or hepatic function impairment.

Glucodynamic differences between insulin lispro and soluble human insulin, as measured during a glucose

clamp procedure, were maintained over a wide range of renal function.

Insulin lispro has been shown to be equipotent to human insulin on a molar basis but its effect is more rapid

and of a shorter duration.

5.2

Pharmacokinetic properties

The pharmacokinetics of insulin lispro reflect a compound that is rapidly absorbed, and achieves peak

blood levels 30 to 70 minutes following subcutaneous injection. When considering the clinical relevance of

these kinetics, it is more appropriate to examine the glucose utilisation curves (as discussed in 5.1).

Insulin lispro maintains more rapid absorption when compared to soluble human insulin in patients with

renal impairment. In patients with type 2 diabetes over a wide range of renal function the pharmacokinetic

differences between insulin lispro and soluble human insulin were generally maintained and shown to be

independent of renal function. Insulin lispro maintains more rapid absorption and elimination when

compared to soluble human insulin in patients with hepatic impairment.

5.3

Preclinical safety data

in vitro

tests, including binding to insulin receptor sites and effects on growing cells, insulin lispro

behaved in a manner that closely resembled human insulin. Studies also demonstrate that the dissociation

of binding to the insulin receptor of insulin lispro is equivalent to human insulin. Acute, one month and

twelve month toxicology studies produced no significant toxicity findings.

Insulin lispro did not induce fertility impairment, embryotoxicity or teratogenicity in animal studies.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

MetaCresol Glycerol

Dibasic sodium phosphate. 7H

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Zinc oxide

Water for injections

Hydrochloric acid and sodium hydroxide maybe used to adjust pH.

6.2

Incompatibilities

Cartridge

This medicinal product should not be mixed with any other insulin or any other medicinal product.

Vial

This medicinal product must not be mixed with other medicinal products except those mentioned in section

6.6.

6.3

Shelf life

Before use

The expiry date of the product is indicated on the packaging materials.

After first use

of the vial/ after

cartridge insertion

28 days.

6.4

Special precautions for storage

Do not freeze. Do not expose to excessive heat or direct sunlight.

Vial

Before use

Store in a refrigerator (2°C - 8°C).

After first use

Store below 30°C.

Cartridge

Before use

Store in a refrigerator (2°C - 8°C).

After cartridge insertion

Store below 30°C. Do not refrigerate. The pen with the inserted cartridge should not be stored with the

needle attached.

Use in an External Insulin Pump

Change the Humalog in the reservoir at least every 7 days, change the infusion sets at least every 48 hours

or after exposure to temperatures that exceed 37

6.5

Nature and contents of container

Vial–

The solution is contained in type I flint glass vials, sealed with butyl or halobutyl stoppers and secured with

aluminium seals. Dimeticone or silicone emulsion may be used to treat the vial stoppers.

10 ml Vial: Pack of 1.

Cartridge–

The solution is contained in Type I flint glass cartridges, sealed with butyl or halobutyl disc seals and

plunger heads, and are secured with aluminium seals. Dimeticone or silicone emulsion may be used to treat

the cartridge plungers, and/or the glass cartridges.

3 ml Cartridge: Pack of 5.

6.6

Special precautions for disposal and other handling

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Instructions for use

and handling

To prevent the possible transmission of disease, each cartridge or pen must be used by one patient only,

even if the needle on the delivery device is changed. Patients using vials must never share needles or

syringes. The patient should discard the needle after every injection.

The Humalog solution should be clear and colourless. Humalog should not be used if it appears cloudy,

thickened, or slightly coloured or if solid particles are visible.

Do not mix insulin in vials with insulin in cartridges. See section 6.2.

Preparing a dose

Vial

The vial is to be used in conjunction with an appropriate syringe (100 unit markings).

Humalog

Wash your hands.

If using a new vial, flip off the plastic protective cap, but

do not

remove the stopper.

If the therapeutic regimen requires the injection of basal insulin and Humalog at the same time, the

two can be mixed in the syringe. If mixing insulins, refer to the instructions for mixing that follow

in Section (ii) and 6.2.

Draw air into the syringe equal to the prescribed Humalog dose. Wipe the top of the vial with a

swab. Put the needle through the rubber top of the Humalog vial and inject the air into the vial.

Turn the vial and syringe upside down. Hold the vial and syringe firmly in one hand.

Making sure the tip of the needle is in the Humalog, withdraw the correct dose into the syringe.

Before removing the needle from the vial, check the syringe for air bubbles that reduce the amount

of Humalog in it. If bubbles are present, hold the syringe straight up and tap its side until the bubbles

float to the top. Push them out with the plunger and withdraw the correct dose.

Remove the needle from the vial and lay the syringe down so that the needle does not touch

anything.

Mixing Humalog with longer-acting Human Insulins (see section 6.2)

Humalog should be mixed with longer-acting human insulins only on the advice of a doctor.

Draw air into the syringe equal to the amount of longer-acting insulin being taken. Insert the needle

into the longer-acting insulin vial and inject the air. Withdraw the needle.

Now inject air into the Humalog vial in the same manner, but

do not

withdraw the needle.

Turn the vial and syringe upside down.

Making sure the tip of the needle is in the Humalog, withdraw the correct dose of Humalog into the

syringe.

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Before removing the needle from the vial, check the syringe for air bubbles that reduce the amount

of Humalog in it. If bubbles are present, hold the syringe straight up and tap its side until the bubbles

float to the top. Push them out with the plunger and withdraw the correct dose.

Remove the needle from the vial of Humalog and insert it into the vial of the longer-acting insulin.

Turn the vial and syringe upside down. Hold the vial and syringe firmly in one hand and shake

gently. Making sure the tip of the needle is in the insulin, withdraw the dose of longer-acting insulin.

Withdraw the needle and lay the syringe down so that the needle does not touch anything.

Cartridge

Humalog cartridges are to be used with a Lilly reusable insulin pen and should not be used with any other

reusable pen as the dosing accuracy has not been established with other pens.

The instructions with each individual pen must be followed for loading the cartridge, attaching the needle

and administering the insulin injection.

Pens should not be used if any part looks broken or damaged.

Injecting a dose

If using a pre-filled or reusable pen refer to the detailed instructions for preparing the pen and injecting the

dose, the following is a general description.

Wash your hands

Choose a site for injection.

Clean the skin as instructed.

Stabilise the skin by spreading it or pinching up a large area. Insert the needle and inject as

instructed.

Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub

the area.

Dispose of the syringe and needle safely. For an injection device use the outer needle cap, unscrew

the needle and dispose of it safely.

Use of the injection sites should be rotated so that the same is not used more than approximately

once a month.

Any unused product or waste material should be disposed of in accordance with local requirements.

7.

MANUFACTURER

Vial: Lilly S.A, Alcobendas, Madrid, Spain

Cartridge: Lilly France S.A.S., Fegersheim, France

Eli Lilly Italia S.p.A, Sesto Fiorentino, Italy

8.

LICENSE HOLDER

Eli Lilly Israel Ltd., P.O.Box 2160 Herzliya 46120.

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Revised on June 2020.

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אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה

ןכרצלו ןכרצלו ןכרצלו

ןכדועמ( ןכדועמ( ןכדועמ(

.102.50

.102.50

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)

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6.1

םושירה לעב םש

:

לארשי יליל ילא

! דבלב תורמחהה טורפל דעוימ הז ספוט

:אפורל ןולע

ובמה תורמחהה תושק

ןולעב קרפ

יחכונ טסקט

שדח טסקט

Special Warnings and

Special Precautions for Use

Use

6.6

CARTRIDGE

Instruction

for

use

and handling

Humalog cartridges are to be

used with a CE marked

pen as recommended in

the information

provided by the device

manufacturer.

6.6

CARTRIDGE

Instruction

for use and handling

To prevent the possible transmission of

disease, each cartridge must be used by

one patient only, even if the needle on

the delivery device is changed.

Humalog cartridges are to be used with

a CE markedLilly pen. as

recommended in the

information provided by the

device manufacturer.

:ןכרצל ןולע

תושקובמה תורמחהה

ןולעב קרפ

יחכונ טסקט

שדח טסקט

שמתשת דציכ

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