Download HUMALOG KWIKPEN 100 U/ML

Patient leaflet in accordance with the Pharmacists' Regulations (Preparations) - 1986
This medicine is to be supplied by a physician’s prescription only
HUMALOG KWIKPEN 100 U/ML
Solution
Active ingredient and its quantity:
Each pen contains:
Insulin Lispro 100 U/ml
For a list of the inactive ingredients, please see section 6.
Read this patient leaflet carefully in its entirety before using this medicine. This leaflet contains concise
information regarding this medicine. If you have any further questions, please contact your physician 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.
1. WHAT IS THIS MEDICINE INTENDED FOR?
For the treatment of adults and children who have diabetes and need insulin to maintain a balance of blood sugar
levels.
In addition, Humalog KwikPen is indicated for initial diabetes control.
Therapeutic group:
Insulins and rapid-acting insulins analogs.
Insulin is a hormone secreted by the pancreas, a gland situated near the stomach. This hormone is needed by the
body for utilization of glucose from a food source. Diabetes occurs when the pancreas does not provide enough
insulin to meet the body’s needs. To balance the diabetes, the physician prescribed insulin injections for you.
Every case of diabetes is different. Therefore, your physician has told you what kind of insulin to use, the amount,
when, and with what frequency.
Insulin Lispro is a faster acting insulin than the regular insulin, and thus it can be injected close to mealtime, before or
a short time afterward.
2. BEFORE USING THIS MEDICINE
Do not use this medicine if:
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You have a known sensitivity to one of its ingredients.
Do not use in case of hypoglycemia (low blood sugar).
Special warnings regarding the use of this medicine:
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Do not inject Humalog KwikPen directly into the vein!
A change in the type of insulin usually requires a re-evaluation of dosage. Therefore, every change should be
made under the supervision of the attending physician.
Prior to treatment with Humalog KwikPen, tell the physician if:
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You suffer from fever and vomiting or if you have been ill recently
You suffer, or have suffered in the past, from dysfunction of the: liver, kidney/urinary system, thyroid gland (If
you suffer from these dysfunctions, adjustment of the medicine dosage may be required)
You exercise more than usual
Throughout treatment with this medicine, urine and blood tests should be carried out.
In certain cases, the usual dose may cause hypoglycemia, for example:
As a result of administering a dose of insulin that is too high
As a result of skipping a meal
As a result of more than usual physical activity
As a result of an illness (vomiting, diarrhea, fever)
As a result of a change in your body’s need for insulin
Due to worsening of kidney or liver function
Alcohol consumption and additional medicines can affect your blood sugar levels
If you are not sure whether you will recognize the warning symptoms of hypoglycemia, avoid situations such
as driving, which might be dangerous to you and others during a state of hypoglycemia.
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Initial symptoms of hypoglycemia can be identified as cold sweat, tachycardia, headache, irritability, fatigue,
apathy, confusion, vomiting and tremors. These symptoms can pass with the consumption of sugar or food
that contains sugar (it is therefore desirable to always carry around with you sugar cubes or sucking candies).
Several patients have reported that after switching to human insulin, the early warning symptoms of
hypoglycemia were less pronounced or different than when using insulin derived from an animal source. If you
experience frequent hypoglycemia events or find it difficult to identify the symptoms, discuss this with your
physician.
Your relatives and colleagues must know that you have diabetes and how they can help you in a case of
hypoglycemia. They must know that when a person is unconscious he/she should not be given food or drink
for fear of choking. They should roll the patient over on his/her side and call for immediate medical help.
Unconsciousness can be treated with an injection of glucagon. After regaining consciousness, the patient
should be instructed to take sugar orally.
Consult your physician if you have experienced repetitive reactions to insulin or another event that was
accompanied by unconsciousness, since in these cases changing the dose of insulin is necessary. If a
significant drop in blood sugar level is left untreated, it could cause loss of consciousness, and even death.
Diabetic-ketosis, ketoacidosis or loss of consciousness can result from very high sugar levels in the blood hyperglycemia. This condition can occur if there is an increased demand for insulin during an illness, infection,
changing the usual diet or injecting a smaller amount of insulin than that prescribed by the attending
physician.
Ketoacidosis can be diagnosed through a urine test that shows high levels of sugar and acetone. The
following symptoms can gradually develop within hours or days: thirst, loss of appetite, drowsiness, flushing,
acetone odour from the breath, nausea and vomiting. The severe symptoms are heavy breathing and rapid
pulse. If you feel any of these symptoms, consult your physician immediately. If these symptoms are left
untreated, they can cause diabetic coma and death.
You should tell your physician, pharmacist or diabetes nurse if you are planning to go abroad. Due to the time
difference between countries, you may have to change the times of your meals and injections.
Drug Interactions:
If you are taking or have recently taken other medicines, including nonprescription medications
and nutritional supplements, inform your physician or pharmacist.
The insulin requirement of the body may change upon concomitant administration with medicines such as:
Oral contraceptives
Steroids
Thyroid hormones
Oral hypoglycemic preparations for treatment of diabetes
Salicylates (such as acetylsalicylic acid – aspirin)
Sulfa antibiotics
Octreotide (for the treatment of pulmonary hypertension)
Beta-2 agonists (for example salbutamol, terbutaline)
Beta blockers (for blood pressure or the heart)
Certain antidepressants (MAOIs or SSRIs)
Danazol
Certain ACE inhibitors (for blood pressure or the heart), for example: captopril and enalapril
Angiotensin II receptor blockers
Cases of heart failure were reported in type 2 diabetes patients who also suffer from a heart disease or have
experienced a stroke in the past, who were treated with insulin in combination with preparations containing
pioglitazone (an oral medicine for treating diabetes). Therefore, inform your physician as soon as possible if you
experience symptoms such as: unusual shortness of breath, rapid increase in weight or localised swelling (oedema).
Use of this medicine and food
Consult a physician.
Use of this medicine and alcohol consumption
The insulin requirement may change upon concomitant consumption with alcohol. Adjustment of the medicine dosage
may be needed.
Pregnancy and breastfeeding
Consult a physician or pharmacist prior to using the medicine.
Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on the pregnancy
or on the health of the fetus or newborn.
Nonetheless, during pregnancy it is particularly important to maintain balanced blood sugar levels.
Insulin requirements usually decrease during the first trimester and increase during the second and third trimesters.
If you are breastfeeding there may be a need to change your insulin dosage or your diet. Consult your physician.
Driving and using machines
The ability to concentrate and react may be impaired as a result of hypoglycemia, which can be dangerous in certain
situations such as driving a car or operating heavy machinery. If you experience frequent episodes of hypoglycemia
or have reduced or absent awareness of the warning signs of hypoglycemia, consult your physician on whether you
should drive.
3. HOW SHOULD YOU USE THE MEDICINE?
Always use according to the physician's instructions. You must check with the physician or pharmacist if you are
unsure. The dosage and manner of treatment will be determined only by the physician.
Do not exceed the recommended dose.
Always check the name of the medicine and the insulin type indicated on the package and label of the product
dispensed to you at the pharmacy. Ensure that you received the Humalog KwikPen as prescribed to you by the
physician.
Humalog KwikPen may be administered a short time before a meal. In case of need, Humalog KwikPen may be
administered immediately after a meal (up to 15 minutes after the meal).
Humalog KwikPen is intended for subcutaneous injection. Never inject intravenously.
Below are general instructions for injection. For detailed instructions for use of Humalog KwikPen see the user
manual enclosed in the package of the pen.
Before using Humalog KwikPen it is very important to read the detailed instructions carefully and to follow them
strictly. Failure to follow the instructions may result in an inaccurate insulin dose.
The amount of insulin to be injected is measured in units. It is important to recognize the unit signs on the injector
pen, since the volume of insulin that is injected is calculated based on the number of units per ml.
Inspect the Humalog solution in the pen. The solution should be clear and transparent. Do not use if the solution is
cloudy, thick, slightly colored or has particles.
Discarding of disposable needles after use must be strictly maintained according to instructions from the healthcare
professionals, in order to prevent contamination. The injector pen and needle are to be used by one person only and
must not be transferred from one person to another.
Pens in use should not be stored with the needle attached.
General Instructions for Injection:
1.
Wash your hands thoroughly.
2.
Read the instructions for use and follow them carefully.
3.
Use a new needle for each injection in order to prevent infections.
4.
Prime the KwikPen before each use of the pen to remove air bubbles. There may still be some small air
bubbles left in the injector pen. This is harmless, but if the air bubble is too big, it may make the dose of your
injection less accurate.
5.
Set the injector pen to the desired dose according to the injector pen instructions for use.
6.
Clean the injection site according to the instructions provided to you.
7.
"Pinch up” a wide area of skin and lift it.
8.
Insert the injector pen needle under the skin.
9.
Inject the insulin by pushing the injection button to the end and wait 5 seconds prior to removing the needle
from the skin.
10. Remove the needle. Do not rub the injection site.
11. Replace the external cover of the needle and discard the disposable items in accordance with the
instructions provided to you by the medical staff.
12. Immediately after injecting, remove the needle from the injector pen to ensure sterility, prevent leakage of
insulin from the pen, entry of air and needle clogging. Do not reuse the needle. Destroy the needle according
to the instructions received from the healthcare professionals. Replace the pen cover.
13. Ensure injecting at a distance of at least 1 cm from the previous injection site. Change the injection site each
time.
Consult your physician or nurse about desirable injection sites.
14. Do not mix different insulin types in the Humalog KwikPen cartridge. Do not re- use an empty injector pen.
Throughout treatment with this medicine, urine and blood tests should be carried out.
Complete the full course of treatment as instructed by your physician.
If you have accidentally taken an overdose, you may experience low blood sugar levels. Check your sugar level.
If you experience mild hypoglycemia, eat sugar or drink a sweet beverage. Afterwards eat a fruit, a biscuit or a
sandwich, in accordance with the physician’s instructions. You should rest after a mild hypoglycemia event.
If your condition worsens, your breathing becomes superficial and your skin becomes pale, notify the physician
immediately. You can use a glucagon injection in situations of severe hypoglycemia. Following the injection, eat
sugar or glucose.
If you do not respond to the glucagon injection, you should be transported to a hospital.
If you have taken an overdose, or if a child has accidentally swallowed the medicine, go immediately to a hospital
emergency room and bring the medicine package with you.
If you forgot to inject Humalog, you may experience high blood sugar levels.
If hypoglycemia or hyperglycemia are left untreated, you may experience: headaches, nausea, vomiting, dehydration,
loss of consciousness, coma and even death.
In order to avoid hypoglycemia or hyperglycemia, you should:
1. Keep a spare Humalog Kwikpen, in case you lose your Humalog Kwikpen or it gets damaged.
2. Keep glucose within reach.
3. Carry something to show people around you that you have diabetes.
If you are ill, you may need to adjust your insulin dosage. Even if you do not eat normally, you still need insulin! Test
your blood and urine and notify your physician.
Even if there is an improvement in your health, do not stop treatment with this medicine without consulting the
physician.
Do not take medicines in the dark! Check the label and the dose each time you take the medicine. Wear glasses if
you need them.
If you have any further questions regarding the use of this medicine, consult the physician or pharmacist.
4. SIDE EFFECTS
As with any medicine, Humalog Kwikpen may cause side effects in some users. Do not be alarmed by reading the
list of side effects. You may not experience any of them.
Hypoglycemia is the most common side effect which may be experienced by patients treated with insulin. Severe
hypoglycemia may lead to loss of consciousness and in extreme cases, even death. Hypoglycemia may occur if:
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You take too much Humalog or other insulin
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You miss or delay meals or change your diet
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You exercise or work too hard just before or after a meal
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You have an infection or illness (especially diarrhea or vomiting)
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There is a change in your need for insulin
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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 levels usually come on quickly and include: tiredness, nervousness,
shakiness, headache, rapid heartbeat, feeling sick and cold sweat.
Hyperglycemia means that your body does not have enough insulin.
Hyperglycemia can occur if:
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You are not taking your Humalog or other insulin
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You are taking less insulin than your physician tells you to
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You are eating a lot more than your diet allows
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You suffer from fever, infection or emotional stress
Hyperglycemia can lead to diabetic ketoacidosis.
The first symptoms come on slowly over hours or days. The symptoms include:
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Feeling sleepy
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Flushed face
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Thirst
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Loss of appetite
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Fruity smell on the breath
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Nausea or vomiting
Severe symptoms are heavy breathing and a rapid pulse. Get medical help immediately.
Oedema - swelling of the arms, ankles, fluid retention, especially at the beginning of treatment with insulin or during a
change in dosage in order to improve blood sugar level control.
Common side effects:
Local allergy: redness, swelling, itching in the injection site. This side effect usually clears up in several days or
weeks. Notify the physician.
Uncommon side effects:
Lipodystrophy (thickening of the skin at the injection site) - refer to a physician immediately!
Rare side effects:
Systemic allergy: rash over the whole body, difficulty in breathing, wheezing, blood pressure decrease, fast heart
beating or sweating. Severe cases of systemic allergy may be life threatening. Notify the physician immediately!
If any side effect gets worse, or if you suffer from a side effect not mentioned in the leaflet, you should consult the
physician.
Side effects may be reported to the Ministry of Health by using the on-line form in the following link:
http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic%40moh.health.gov.il
5. HOW TO STORE THE MEDICINE?
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Before opening, store refrigerated at 2 C-8 C. Do not freeze.
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When in use, should not be refrigerated, but should be kept in a place as cool as possible (below 30 C).
Do not expose to direct sunlight or excessive heat.
The insulin may be used for up to 28 days from the first use.
Do not use the medicine after the expiry date (exp. date) appearing on the package. The expiry date refers to the last
day of that month.
In case of any doubt, you must consult the pharmacist who supplied the medicine to you.
Avoid poisoning! This medicine and any other medicine should be kept in a closed place out of the reach of children
and/or infants in order to avoid poisoning. Do not induce vomiting without an explicit instruction from the physician.
Do not store different medicines in the same package.
Medicines should not be disposed of via wastewater or household waste. Consult the 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 Humalog Kwikpen also contains:
Metacresol, glycerol, dibasic sodium phosphate, zinc oxide, water for injections, HCL solution 10%, NaOH solution
10%, water for injection.
What does the medicine look like and what are the contents of the package:
Humalog KwikPen is a transparent and clear solution. Each injector pen contains a cartridge of 300 units (3 ml).
Each pack contains 5 prefilled injector pens.
Manufacturer: Eli Lilly & Company Ltd., Indianapolis, Indiana, USA
Manufacturing site: Eli Lilly Italia S.p.A, Sesto Fiorentino, Italy
Registration holder name and address: Eli Lilly Israel Ltd., P.O.Box 2160, Herzliya Pituach 4672511
This leaflet was checked and approved by the Ministry of Health in: June 2015.
Registration number of the medicine in the National Drug Registry of the Ministry of Health: 143-44-33216-00