Active ingredients: Insulin (insulin lispro)
Humalog 100 U / ml solution for injection in cartridge
Humalog package inserts are available for pack sizes:- Humalog 100 U / ml solution for injection in cartridge
- Humalog Mix25 100 U / ml suspension for injection in vial
- Humalog Mix25 100 U / ml suspension for injection in cartridge
- Humalog Mix50 100 U / ml suspension for injection in cartridge
- Humalog BASAL 100 U / ml suspension for injection in cartridge
- Humalog 100 U / ml KwikPen solution for injection
- Humalog Mix25 100 U / ml KwikPen suspension for injection
- Humalog Mix50 100 U / ml KwikPen suspension for injection
- Humalog BASAL 100 U / ml KwikPen suspension for injection
Why is Humalog used? What is it for?
Humalog is used for the treatment of diabetes. Humalog works faster than normal human insulin, thanks to a small modification of the insulin molecule.
His disease, diabetes, stems from the fact that his pancreas does not produce enough insulin to control the level of glucose in the blood. Humalog replaces the insulin your body makes and is used to control glucose over the long term. The drug works very quickly and lasts for a shorter period of time than soluble insulin (2 to 5 hours). You should normally inject Humalog within 15 minutes before a meal.
Your doctor may prescribe both Humalog and a long-acting insulin. Each type of insulin is packaged with its own leaflet containing information for its correct use. Do not change your insulin type unless prescribed by a doctor. Be very careful when changing the type of insulin.
Humalog is suitable for use in both adults and children. Humalog can be used in children when an advantage over soluble insulin is expected, such as administration time over meals.
Contraindications When Humalog should not be used
DO NOT use Humalog
- If you think hypoglycaemia (low blood sugar) is starting. Further on in this leaflet you will find instructions for dealing with mild hypoglycaemia (see section: If you take more Humalog than you should).
- If you are allergic (hypersensitive) to insulin lispro or any of the other ingredients of this medicine
Precautions for use What you need to know before taking Humalog
- If your blood glucose level is well controlled with your insulin therapy, you may not notice the warning symptoms when your blood sugar is getting too low. The warning signs are listed later in this leaflet. He must pay close attention to meal times, the frequency and commitment of physical exercise. He must also monitor his blood sugar level, measuring it frequently.
- Some people who have had hypoglycaemia after switching from animal insulin to human insulin have reported that the warning symptoms of the hypoglycemic reaction were less noticeable or different. If you frequently have hypoglycaemia, or have difficulty recognizing it, talk to your doctor.
- If the answer to any of the following questions is YES, please tell your doctor, pharmacist or diabetes nurse.
Have you been sick recently?
Do you have liver or kidney problems?
Are you exercising more than usual?
- Your insulin requirements may change if you take alcohol.
- Also warn your doctor, pharmacist or diabetes nurse if you are planning to travel abroad. The differences in time zones between countries can lead to a change in the time you take both insulin injections and meals. , compared to when he is at home.
- Some patients with long-standing type 2 diabetes and heart disease or a previous cerebrovascular event who were treated with pioglitazone and insulin have reported development of heart failure. Tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain or localized swelling (edema).
Interactions Which drugs or foods may change the effect of Humalog
Your insulin needs may change if you are taking
- the birth control pill,
- cortisone,
- thyroid hormone replacement therapy,
- oral hypoglycemic agents,
- acetylsalicylic acid,
- sulfonamide antibiotics,
- octreotide,
- beta2-agonists (e.g. ritodrine, salbutamol, terbutaline),
- beta blockers,
- some antidepressants (monoamine oxidase inhibitors, selective serotonin reuptake inhibitors),
- danazol,
- some angiotensin converting enzyme (ACE) inhibitors (eg captopril, enalapril) and
- angiotensin II receptor antagonists.
Tell your doctor if you are taking or have recently taken any other medicines, even those obtained without a prescription (see section "Warnings and precautions").
Warnings It is important to know that:
Pregnancy and breastfeeding
Are you pregnant, or planning to become pregnant, or are you breastfeeding? Insulin requirements generally decrease during the first trimester of pregnancy and increase over the following six months. If you are breastfeeding, you may need to adjust the amount of insulin you are taking or your diet. Ask your doctor for advice.
Driving and using machines
Your ability to concentrate and react may be impaired if you have a hypoglycemic reaction. Keep this possible problem in mind in all situations where you could put yourself or others at risk (for example by driving a car or using machinery). You should consult your doctor about the advisability of driving if you have:
- frequent episodes of hypoglycemia
- reduced or absent warning signs of hypoglycemia
Dosage and method of use How to use Humalog: Dosage
The 3ml cartridge should only be used with 3ml pens. Do not use with 1.5ml pens.
Always check the box and cartridge label for the name and type of insulin your pharmacist gives you. Make sure your Humalog pack matches the one your doctor has prescribed for you.
Always use Humalog exactly as your doctor has told you. If in doubt, you should consult your doctor.
Dosage
- As a rule, you should inject Humalog within 15 minutes before a meal. If necessary, you can also give the injection immediately after a meal. As for the quantity, time and frequency of administration, follow your doctor's instructions exactly: they apply exclusively to you. Follow them exactly and have them checked regularly in the diabetes center .
- If you change the type of insulin you are using (for example from animal or human insulin to a Humalog product), you may need a different (more or less) amount of the medicine than before. The change could occur with the first injection, or it could be done gradually over a period of a few weeks or months.
- Inject Humalog under the skin. You should only inject into a muscle when directed by your doctor.
Humalog preparation
- Humalog is already dissolved in water, so you should not mix it. However, take care to use it only if its appearance is the same as that of water. The solution should be clear, colorless and free from solid particles. Check this before each injection.
Preparing the pen
- First, wash your hands. Disinfect the rubber membrane of the cartridge.
- You should use Humalog cartridges only with compatible CE marked pens. Make sure the words Humalog or Lilly cartridges are mentioned in the leaflet that accompanies your pen. The 3 ml cartridge can only be used with the 3 ml pen.
- Follow the instructions that came with the pen. Put the cartridge into the pen.
- Set the dose to 1 or 2 units. Then hold the pen with the inserted needle pointing upwards and tap the side of the pen to cause air bubbles to escape. With the pen still pointing upwards, press the injection button until until a drop of Humalog comes out of the needle. Some small air bubbles may be left in the pen; they are not dangerous, but if they are too large they could make the dose to inject less precise.
Humalog injection
- Before giving the injection, disinfect your skin according to the instructions you have received. Inject the medicine under the skin, as you have been taught. Do not inject it directly into a vein. After injection, leave the needle in the skin for 5 seconds to make sure you have injected the full dose. Do not rub the skin where you injected. Make sure the injection site is at least one centimeter away from the previous time and remember to rotate the injection site as you were told. It doesn't matter which Injection site use, be it the upper arms, thighs, buttocks or abdomen, the injection of Humalog will have an even faster action than soluble human insulin.
- You must not be given Humalog intravenously. Inject Humalog as your doctor or nurse has taught you. Only your doctor can give you Humalog intravenously. You will only do this in special circumstances such as surgery or if you are sick and your blood sugar levels are too high.
After the injection
- As soon as you have finished injecting, remove the needle from the pen using the outer needle cap. This will allow you to keep Humalog sterile, prevent drug spillage, stop air from flowing into the pen and prevent clogging of the needle. Do not share your needles with others. Do not share your pen with others. Put the cap back on the pen. Leave the cartridge in the pen.
Subsequent injections
- Before each subsequent injection, select 1 or 2 units and activate the injection mechanism with the pen pointing upwards until a drop of Humalog comes out of the needle. You can gauge how much Humalog is left in the cartridge by looking at the level on the side of the cartridge. The distance between each line is approximately 20 units. If there is not enough left for the next dose, change the cartridge.
Do not mix any other insulin into the Humalog cartridge. Once the cartridge is empty, do not use it again.
Use of Humalog in an infusion pump
- Only certain CE marked insulin infusion pumps can be used to administer insulin lispro. Before administering insulin lispro, the manufacturer's instructions should be read carefully to determine whether or not it is suitable for that particular pump. Read and follow the instructions in the documentation supplied with the infusion pump.
- Be sure to use the appropriate reservoir and catheter for your pump.
- The infusion set (tube and needle) must be changed following the instructions attached to the infusion set.
- In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is resolved. If repeated or severe episodes of low blood glucose levels occur, please inform your doctor and consider reducing or stopping. the insulin infusion.
- A malfunction of the pump or an obstruction of the infusion set can result in a rapid rise in blood glucose levels. report to doctor.
- When used with an insulin infusion pump, Humalog must not be mixed with any other insulin.
Overdose What to do if you have taken too much Humalog
If you take more Humalog than you should
If you take more Humalog than you should, a decrease in your blood sugar may occur.
Check your blood sugar level. If your blood sugar is low (mild hypoglycemia), eat glucose tablets, some sugar or have a sugary drink. Then eat fruit, biscuits or a sandwich, as your doctor has suggested, and rest. Often this is enough to counteract a mild "hypoglycemia, or a minor insulin overdose. If you notice that it is getting worse and you are short of breath and your skin turns pale, tell your doctor right away. A glucagon injection can treat fairly severe hypoglycemia. Take glucose or sugar after the glucagon injection. If he does not get a positive response with glucagon, he must be hospitalized. Ask your doctor about the use of glucagon.
If you forget to use Humalog
If you take less Humalog than you need, your blood sugar may rise. Check your blood sugar level.
Hypoglycaemia (low blood sugar level) or hyperglycaemia (high blood sugar level) not properly treated can become very serious and cause headache, nausea, vomiting, dehydration, unconsciousness, coma and even death (see paragraphs A and B of section 4 "Possible side effects").
Three simple steps to avoid situations of hypoglycemia or hyperglycemia:
- Always keep spare syringes and a spare vial of Humalog, or a spare pen and cartridges, in case you lose your pen or cartridges or they get damaged.
- Always carry a document indicating that you are diabetic.
- Always carry sugar with you.
If you stop using Humalog
If you take less Humalog than you need, your blood sugar may rise. Do not change your insulin type unless prescribed by a doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Side Effects What are the side effects of Humalog
Like all medicines, Humalog can cause side effects, although not everybody gets them.
Local allergy is common (≥ 1/100 to <1/10). In some people, the skin at the injection site may be red, swollen and itchy. This reaction usually disappears within a few days to a few weeks. If this happens, tell your doctor.
Systemic allergy is rare (≥ 1 / 10,000 to <1 / 1,000). Symptoms are:
- rash all over the body
- difficulty breathing
- dyspnea
- lowering of blood pressure
- rapid heartbeat
- sweating
If you think Humalog is causing you this type of insulin allergy, tell your doctor right away.
Lipodystrophy (thickening or mild depression of the skin) is uncommon (≥ 1 / 1,000 to <1/100). If you feel that your skin is thickening or that there is mild depression at the injection site, please tell your doctor.
Edema (eg swelling of the arms, ankles; fluid retention) has been reported, particularly at the start of insulin therapy or during a change in therapy to improve glycemic control.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Common Diabetes Problems
A. Hypoglycemia
Hypoglycemia (low blood sugar) means there is not enough sugar in the blood. Hypoglycemia can be caused by:
- an overdose of Humalog or an "other insulin;
- a delay or missed meal, or a change in diet;
- excessive exercise or physical work done immediately before or after eating a meal;
- an "infection or some other disorder (especially diarrhea or vomiting);
- a change in insulin requirement;
- a worsening of a pre-existing kidney or liver disorder.
Alcohol and some medications can interfere with your blood sugar level.
Usually, the first symptoms of hypoglycemia come on quickly and include:
- tiredness
- nervousness or agitation
- headache
- rapid heartbeat
- malaise
- cold sweat
If you are unable to recognize the warning symptoms of hypoglycaemia, avoid situations, such as driving a car, in which the hypoglycemia could put you or others at risk.
B. Hyperglycemia and diabetic ketoacidosis
Hyperglycaemia (too much sugar in the blood) means there is not enough insulin in your body. Hyperglycaemia can be caused by:
- not taking Humalog or another insulin;
- taking less insulin than prescribed by your doctor;
- intake of food in quantities much higher than that allowed by the diet;
- fever, infection, or a strong emotion.
Hyperglycemia can lead to diabetic ketoacidosis. The first symptoms begin slowly, over many hours or days. They understand:
- feeling sleepy
- redness of the face
- thirst
- lack of appetite
- fruit-smelling breath
- feeling unwell
Heavy breathing and rapid pulse are serious symptoms. Seek medical help immediately.
C. Diseases
If you have a disease, particularly if you feel or are sick, your insulin requirements may vary. Even when he's not eating normally, he still needs insulin. Have your urine and blood tests tested; when you are ill, follow the precautions you are already familiar with and tell your doctor.
Expiry and Retention
Before use, store Humalog in a refrigerator (2 ° C - 8 ° C). Do not freeze.
During use, store the vial in the refrigerator (2 ° C - 8 ° C) or at room temperature up to 30 ° C and discard after 28 days. Do not keep it near a heat source or in direct sunlight.
Keep out of the reach and sight of children.
Do not use Humalog after the expiry date which is stated on the label and carton. The expiry date refers to the last day of the month.
Do not use Humalog if it appears colored or contains solid particles. You should only use it if it looks the same as water. Check this before each injection.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What Humalog 100 U / ml solution for injection in cartridge contains
- The active substance is insulin lispro. Insulin lispro is made in the laboratory using a technology called 'recombinant DNA'. It is a modified form of human insulin, and is therefore different from other insulins of human or animal origin. Insulin lispro is structurally similar to human insulin, which is a naturally occurring hormone produced by the pancreas.
- The other ingredients are m-cresol, glycerol, dibasic sodium phosphate 7H2O, zinc oxide and water for injections. Sodium hydroxide or hydrochloric acid can be added to adjust the pH.
What Humalog looks like and contents of the pack
Humalog 100 U / ml solution for injection is a sterile, clear and colorless aqueous solution and contains 100 units of insulin lispro for each milliliter (100 U / ml) of solution for injection. Each cartridge contains 300 units (3 milliliters). The cartridges are available in a pack of 5 cartridges or in a multipack of 2 packs of 5 cartridges. Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
HUMALOG 100 U / ML
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Humalog is a sterile, clear and colorless aqueous solution.
One ml contains 100 U (equivalent to 3.5 mg) of insulin lispro (originating from recombinant DNA produced in E. coli). Each pack contains 3 ml equivalent to 300 U of insulin lispro.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Injectable solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Treatment of adults and children with diabetes mellitus who require insulin to maintain normal glucose homeostasis. Humalog is also indicated in the initial stabilization of diabetes mellitus.
04.2 Posology and method of administration
The dosage should be determined by the physician according to the patient's needs.
Humalog can be given just before meals. If needed, Humalog can also be given immediately after meals. Humalog must be administered by subcutaneous injection or by continuous subcutaneous infusion by pump (see section 4.2) and, although not recommended, it can also be administered by intramuscular injection. If necessary, Humalog can also be administered intravenously, for example for the control of blood glucose levels in ketoacidosis, acute illnesses, during intra or postoperative periods.
The subcutaneous injection should be given in the upper arms, thighs, buttocks or abdomen. The injection site should be rotated so that the same site is affected approximately once a month.
When injecting Humalog subcutaneously, it must be ensured that the needle does not enter a blood vessel. After injection, the skin site should not be massaged. Patients should be instructed to use appropriate injection techniques.
Humalog administered subcutaneously works faster and has a shorter duration of action (2-5 hours) than regular insulin. This rapid onset of activity means that the Humalog injection (or, in the case of continuous subcutaneous infusion, the Humalog bolus) can be given very close to meals. The duration of action of any insulin can vary greatly in different individuals or, in the same individual, on different occasions. Regardless of the injection site, a faster onset of activity remains than with soluble human insulin.As with all insulin preparations, the duration of action of Humalog depends on several factors such as the dose, injection site, blood flow, body temperature and the patient's physical activity.
Humalog can be used in combination with a "long-acting" insulin or oral sulphonylureas, according to the doctor's advice.
Use of Humalog in insulin infusion pumps
Only certain CE marked insulin infusion pumps may be used to administer insulin lispro. Before administering insulin lispro, the manufacturer's instructions should be carefully read to determine whether or not it is suitable for that particular pump. Read and follow the instructions accompanying the infusion pump. Use the appropriate reservoir and catheter for the pump. The infusion set (tube and cannula) must be changed according to the instructions enclosed with the infusion set. In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is resolved. If repeated or severe episodes of low blood glucose levels occur, notify your doctor and consider reducing or stopping. the insulin infusion. A malfunction of the pump or an obstruction of the infusion set can result in a rapid rise in blood glucose levels. If an interruption in the flow of insulin is suspected, follow the instructions in the documentation accompanying the product and, if you believe advisable, report it to your doctor. When used with an insulin infusion pump, Humalog must not be mixed with any other insulin.
Intravenous administration of insulin
Intravenous injection of insulin lispro should be done following normal clinical practice for intravenous administration, for example by intravenous bolus or via an infusion device. Frequent monitoring of blood glucose levels is required.
Infusion devices with insulin lispro concentrations of 0.1 U / mL to 1.0 U / mL in 0.9% sodium chloride or 5% dextrose solutions are stable at room temperature for 48 hours. It is recommended to adjust the device before starting the infusion to the patient.
04.3 Contraindications
Hypersensitivity to insulin lispro or to any of the excipients.
Hypoglycemia.
04.4 Special warnings and appropriate precautions for use
Transferring a patient on insulin therapy to another type or brand of insulin should be done under strict medical supervision. Changes in concentration, brand (manufacturer), type (regular, isophane, slow, etc.), species (animal, human, human insulin analogue) and / or production method (recombinant DNA versus animal insulin ) may result in the need to change the dosage. For fast-acting insulins, any patient who is also being treated with basal insulin should optimize the dosage of both insulins to achieve full-day glucose control, particularly at night and on an empty stomach.
Conditions that may cause different or less obvious early warning symptoms of hypoglycemia include long-lasting diabetes, intensification of insulin therapy, diabetic neuropathy, or the use of drugs such as beta-blockers.
Some patients who have experienced hypoglycaemic reactions after transfer from insulin of animal origin to human insulin have reported that the warning symptoms of the event were less evident or different from those experienced during treatment with the previously used insulin. Uncontrolled hypo- and hyperglycemic reactions can cause unconsciousness, coma or death.
The use of inadequate dosages or discontinuation of treatment, especially in patients with insulin-dependent diabetes mellitus, can lead to hyperglycemia or diabetic ketoacidosis, two life-threatening conditions.
Insulin requirements may decrease in the presence of renal insufficiency. Insulin requirements may decrease in patients with hepatic insufficiency due to reduced gluconeogenesis and decreased insulin catabolism; however, in patients with chronic hepatic insufficiency, an increase in insulin resistance may lead to an increase in insulin requirement.
The need for insulin can increase in the course of illness or emotional disturbances.
An adjustment in insulin dosage may also be necessary if the patient increases his physical activity or changes his usual diet. Exercise immediately after eating a meal may increase the risk of hypoglycaemia. A consequence of pharmacodynamics. One of the fast-acting insulin analogues is that if hypoglycaemia occurs, it may occur earlier after injection than soluble human insulin.
If you are routinely prescribed to use the product in 40 U / mL vials, do not withdraw insulin from a 100 U / mL cartridge using the same type of syringe you use with the 40 U / mL vial.
Humalog should be used in children preferably to soluble insulin only when rapid insulin action would be of benefit. For example, as regards the timing of administration compared to meals.
Use of Humalog in combination with pioglitazone
Cases of heart failure have been reported when pioglitazone was used in combination with insulin, particularly in patients with risk factors for developing heart failure. This should be borne in mind if treatment with the combination of pioglitazone and Humalog is considered. If this combination is used, patients should be observed for signs and symptoms of heart failure, increased blood pressure. body weight and edema If any worsening of cardiac symptoms occurs, pioglitazone should be discontinued.
04.5 Interactions with other medicinal products and other forms of interaction
The need for insulin may increase due to the simultaneous administration of medicinal products with hyperglycemic activity such as oral contraceptives, corticosteroids or during replacement therapy with thyroid hormones, danazol, beta2-agonists (such as ritodrine, salbutamol, terbutaline).
The need for insulin may decrease due to the simultaneous administration of medicinal products with hypoglycemic activity such as oral hypoglycemic agents, salicylates (such as acetylsalicylic acid), sulfonamide antibiotics, some antidepressants (monoamine oxidase inhibitors, selective inhibitors of the reuptake of serotonin), some angiotensin converting enzyme inhibitors (captopril, enalapril), angiotensin II receptor antagonists, beta blockers, octreotide or alcohol.
The patient should warn the treating physician if he is using other drugs in addition to Humalog (see section 4.4).
04.6 Pregnancy and lactation
Data on a large number of pregnant women exposed to the drug show no adverse effects of insulin lispro on pregnancy or on the health of the fetus / newborn.
During pregnancy, it is essential to maintain good control of insulin-treated patients, both those with gestational diabetes and those with insulin-dependent diabetes mellitus.
Insulin requirements generally decrease during the first trimester and increase in the second and third trimesters. Diabetic patients should inform their doctor in case they are pregnant or planning it. A careful check of glucose control, as well as general health status, is an essential requirement in pregnant women who have diabetes.
Diabetic patients who are breastfeeding may require adjustment of insulin dose and / or diet.
04.7 Effects on ability to drive and use machines
The patient's ability to concentrate and react may be reduced as a result of hypoglycaemia. This fact can constitute a risk in situations where these skills are of particular importance (for example driving a car or operating machinery).
Patients should be advised to take necessary precautions to avoid a hypoglycemic reaction while they are driving, and this is particularly important in those who have little or no awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycemia. In such circumstances the opportunity to drive must be evaluated.
04.8 Undesirable effects
Hypoglycemia is the most frequent side effect resulting from insulin therapy that the diabetic patient can experience. Severe hypoglycemia can lead to loss of consciousness and, in extreme cases, to death. No specific frequency is reported for hypoglycaemia, as hypoglycemia is the result of both insulin dose and other factors, such as the patient's diet and physical activity.
Local allergy in patients is common (1/100 to itching can occur at the site of the insulin injection. These manifestations generally disappear after a few days or after a few weeks. In some cases, these manifestations may be attributable to factors other than "insulin as irritants present in the product used to disinfect the skin or to an incorrect injection technique." Systemic allergy which is rare (1 / 10,000 to dyspnoea, shallow breathing, decreased blood pressure, tachycardia, sweating Severe cases of generalized allergy can be life-threatening.
Lipodystrophy at the injection site is uncommon (1 / 1,000 to
Cases of edema have been reported with insulin therapy, particularly when previous poor metabolic control was improved by intensified insulin therapy.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. in "Annex V.
04.9 Overdose
Insulin does not have an appropriate definition for overdose, as serum glucose concentrations are the result of complex interactions between insulin levels, glucose availability and other metabolic processes. Hypoglycemia can occur as a result of a excess of insulin activity in relation to food intake and energy expenditure.
Hypoglycemia may be associated with fatigue, confusion, palpitations, headache, cold sweats and vomiting.
Episodes of mild hypoglycemia respond to oral administration of glucose, sugar, or sugary products.
Correction of moderate hypoglycemia can be achieved by intramuscular or subcutaneous administration of glucagon, followed by oral carbohydrate ingestion as soon as the patient's condition permits. Individuals who do not respond to glucagon should receive an intravenous glucose solution.
If the patient is in a hypoglycemic coma, glucagon should be administered intramuscularly or subcutaneously. However, if glucagon is not available or if the patient does not respond to glucagon administration, intravenous glucose solutions should be administered. The patient should have a meal as soon as he regains consciousness.
Since hypoglycemia can recur after apparent clinical recovery, it may be necessary to observe the patient and get a lot of carbohydrates.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: fast-acting human insulin analog.
ATC code: A10AB04.
The main activity of insulin lispro is the regulation of glucose metabolism.
Furthermore, insulin exerts various anticatabolic and anabolic activities on different tissues. In muscle tissue it increases the synthesis of glycogen, fatty acids, glycerol, proteins and the uptake of amino acids, while reducing glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein catabolism and amino acid output.
Insulin lispro is fast-acting (onset within approximately 15 minutes), which allows administration closer to meals (within 0-15 minutes) than regular insulin which must be administered 30-45 minutes before a meal. Insulin lispro works faster and has a shorter duration of action (2-5 hours) than regular insulin.
Clinical studies with insulin lispro in patients with type 1 and type 2 diabetes have shown reduced postprandial hyperglycaemia compared to the use of soluble human insulin.
As with all insulin preparations, the time course of the action of insulin lispro may vary from one individual to another or, at different times, within the same individual and depends on the dose, injection site, blood flow, body temperature and physical activity.
Clinical studies were performed in children (61 patients aged 2 to 11 years) and in children and adolescents (481 patients aged 9 to 19 years), comparing insulin lispro with soluble human insulin. The pharmacodynamic profile of insulin lispro in children is similar to that seen in adults.
Treatment with insulin lispro administered by subcutaneous infusion pumps has been shown to produce lower glycosylated hemoglobin levels than soluble insulin. In a double-blind crossover study, the reduction in glycosylated hemoglobin levels after 12 weeks of treatment was of 0.37 percentage points with lispro insulin compared to 0.03 percentage points with soluble insulin (p = 0.004).
Clinical studies in patients with type 2 diabetes treated with sulphonylureas at maximum doses have shown that the addition of insulin lispro significantly reduces HbA1c compared to the use of sulphonylurea alone. Reduction in HbA1c should also be expected with other insulin products, such as soluble or isophane insulin.
Clinical studies with insulin lispro in patients with type 1 and type 2 diabetes have shown fewer episodes of nocturnal hypoglycaemia compared to the use of soluble human insulin. In some studies, reduction of nocturnal hypoglycaemia was associated with an increase in episodes of hypoglycemia during the day.
The glucodynamic response to insulin lispro is not affected by insufficient renal or hepatic function. The glucodynamic differences between insulin lispro and soluble human insulin, evaluated during a glycemic clamp procedure, were maintained within a wide variation in renal function.
Insulin lispro has been shown to be equipotent to human insulin based on molarity, but its effect is faster and of shorter duration.
05.2 Pharmacokinetic properties
The pharmacokinetics of insulin lispro indicate that the compound is rapidly absorbed and reaches maximum levels in the blood 30 to 70 minutes after subcutaneous injection. In evaluating the clinical significance of these kinetics, glucose utilization curves should be considered (see paragraph 5.1).
In patients with renal insufficiency, insulin lispro maintains faster absorption than soluble human insulin. In patients with type 2 diabetes, within a large change in renal function, the kinetic differences between insulin lispro and soluble human insulin were substantially maintained and were shown to be independent of renal function. In patients with hepatic insufficiency, insulin Lispro maintains faster absorption and elimination than soluble human insulin.
05.3 Preclinical safety data
In tests in vitro, including binding to insulin receptor sites and effects on developing cells, insulin lispro had a behavior very close to that of human insulin. Studies also show that the dissociation of insulin lispro from insulin receptors is equivalent to that of human insulin. Acute, one-month and twelve-month toxicology studies yielded no significant toxicity findings.
In animal studies, insulin lispro did not cause impaired fertility, embryotoxicity or teratogenicity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
m-cresol (3.15 mg / ml)
Glycerol
Dibasic sodium phosphate 7H2O
Zinc oxide
Water for injections
Hydrochloric acid and sodium hydroxide can be used to adjust the pH to 7.0-7.8.
06.2 Incompatibility
Humalog preparations must not be mixed with insulins from other manufacturers or with animal insulin preparations.
06.3 Period of validity
Unused cartridges
3 years.
After inserting the cartridge into the pen
28 days.
06.4 Special precautions for storage
Unused cartridges
Store in a refrigerator (2 ° C - 8 ° C). Do not freeze. Do not expose to excessive heat or direct sunlight.
After inserting the cartridge into the pen
Store below 30 ° C. Do not refrigerate. The pen and cartridge should not be stored with the needle attached.
06.5 Nature of the immediate packaging and contents of the package
The solution is contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals and plunger heads and tightly closed with aluminum seals.Dimethicone or silicone emulsion can be used to treat the cartridge plunger and / or the cartridge glass.
Not all pack sizes may be marketed.
5 cartridges of 3ml Humalog per 3ml pen.
2 x 5 cartridges of 3ml Humalog per 3ml pen.
06.6 Instructions for use and handling
Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.
Instructions for use and handling
Humalog cartridges should be used with a CE marked pen as recommended in the information provided by the device manufacturer.
to) Instructions for preparing a dose
Check Humalog solution. The product must be clear and colorless. Do not use Humalog if it appears cloudy, thickened, slightly colored or if solid particles are visible.
The general indications are given below. For cartridge loading, needle insertion and insulin administration, it is recommended that you follow the instructions of the injection pen manufacturer.
b) Instructions for injecting one dose
1. Wash your hands.
2. Choose the skin site where to inject.
3. Disinfect the skin following the instructions received.
4. Remove the needle cover.
5. Stabilize the skin by smoothing it or by pinching a large skin surface. Then insert the needle.
6. Press the plunger.
7. Pull the needle out of the skin and apply gentle pressure to the injection site for a few seconds. Do not rub the area.
8. Remove the needle using its protective cap and throw it away in a safe place.
9. The injection site should be rotated so that the same site is not used more often than about once a month.
c) Mixing of insulins
Do not mix the insulin contained in the vials with the insulin contained in the cartridges. See paragraph 6.2.
07.0 MARKETING AUTHORIZATION HOLDER
Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA Houten, The Netherlands
08.0 MARKETING AUTHORIZATION NUMBER
EU / 1/96/007/004 5 cartridges of Humalog of 3 ml per pen of 3 ml
033637051
EU / 1/96/007/023 2 x 5 cartridges of Humalog of 3 ml per pen of 3 ml
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 30 April 1996
Date of last renewal: 30 April 2006
10.0 DATE OF REVISION OF THE TEXT
D.CCE September 2014
