This information is intended for use by health professionals

Humalog 100 units/ml solution for injection in vial

Humalog 100 units/ml solution for injection in cartridge

Humalog 100 units/ml KwikPen solution for injection in a pre-filled pen

Humalog 100 units/ml Junior KwikPen solution for injection in a pre-filled pen

Humalog 100 units/ml Tempo Pen solution for injection in a pre-filled pen

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

Vial

Each vial contains g units insulin lispro in 10 ml solution.

Cartridge

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

KwikPen and Tempo Pen

Each pre-filled pen contains 300 units of insulin lispro in 3 ml solution.

Each pre-filled pen delivers one- threescore units in steps of 1 unit of measurement.

Inferior KwikPen

Each pre-filled pen contains 300 units of insulin lispro in iii ml solution.

Each Junior KwikPen delivers 0.v – 30 units in steps of 0.5 units.

*produced in E.coli by recombinant DNA engineering.

For a full listing of excipients, encounter department half dozen.1.

Solution for injection.

Clear, colourless, aqueous solution.

For the handling 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.

Posology

The dose should be determined past the physician, according to the requirement of the patient.

Junior KwikPen

Humalog 100 units/ml Junior KwikPen is suitable for patients who may benefit from finer insulin dose adjustments.

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

Humalog takes issue rapidly and has a shorter elapsing of activity (2 to v hours) given subcutaneously equally compared with soluble insulin. This rapid onset of activeness allows a Humalog injection (or, in the case of assistants past 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 dissimilar individuals or at different times in the aforementioned individual. The faster onset of activity 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 concrete activity.

Humalog can be used in conjunction with a longer-interim insulin or oral sulphonylurea agents, on the advice of a physician.

Special populations

Renal harm

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

Hepatic impairment

Insulin requirements may be reduced in patients with hepatic impairment due to reduced chapters for gluconeogenesis and reduced insulin breakdown; all the same, in patients with chronic hepatic impairment, an increase in insulin resistance may lead to increased insulin requirements.

Paediatric population

Humalog can exist used in adolescents and children (meet department 5.1).

Method of administration

Subcutaneous utilise

Humalog preparations should be given by subcutaneous injection.

The KwikPen, Junior KwikPen and Tempo Pen are but suitable for subcutaneous injections. Humalog in cartridges is but 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 belly. Apply of injection sites should be rotated so that the same site is not used more than than approximately once a month, in society to reduce the risk of lipodystrophy and cutaneous amyloidosis (encounter section 4.4 and 4.8).

When administered subcutaneously intendance should be taken when injecting Humalog to ensure that a claret vessel has not been entered. Later on injection, the site of injection should not be massaged. Patients must exist educated to use the proper injection techniques.

Humalog KwikPens

Humalog KwikPen is available in ii strengths. The Humalog 100 units/ml KwikPen (and Humalog 200 units/ml KwikPen, see divide SmPC) delivers i – lx units in steps of i unit in a single injection. The Humalog 100 units/ml Junior KwikPen delivers 0.5 – xxx units in steps of 0.5 units in a unmarried injection. The number of insulin units is shown in the dose window of the pen regardless of strength and no dose conversion should exist done when transferring a patient to a new strength or to a pen with a different dose step.

Humalog Tempo Pen

The Humalog 100 units/ml Tempo Pen delivers one – lx units in steps of ane unit of measurement in a single injection. The number of insulin units is shown in the dose window of the pen regardless of strength and no dose conversion should exist done when transferring a patient to a new strength or to a pen with a different dose footstep. The Tempo Pen tin be used with the optional transfer module Tempo Smart Button (see section 6.6).

Every bit with any insulin injection, when using the Tempo Pen, Smart Button and the mobile application, the patient should be instructed to check their blood sugar levels when considering or making decisions nearly some other injection if they are unsure how much they have injected.

Use of Humalog in an insulin infusion pump

For subcutaneous injection of Humalog using a continuous infusion pump, you lot may fill the pump reservoir from a Humalog 100 units/ml vial. Some pumps are compatible with cartridges that tin can exist 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'south 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 right needle length on the filling system. The infusion set (tubing and cannula) should exist inverse in accordance with the instructions in the product information supplied with the infusion ready. In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is resolved. If repeated or severe low claret glucose levels occur, consider the demand to reduce or stop an insulin infusion. A pump malfunction or obstruction of the infusion gear up can issue 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 exist mixed with any other insulin.

Intravenous administration of insulin

If necessary, Humalog may too be administered intravenously, for case: for the control of claret glucose levels during ketoacidosis, acute illnesses or during intra and post operative periods.

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

Intravenous injection of insulin lispro should be carried out following normal clinical practise for intravenous injections, for instance by an intravenous bolus or by an infusion arrangement. Frequent monitoring of the blood glucose levels is required.

Infusion systems at concentrations from 0.1 units/ml to one.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 organisation is primed earlier starting the infusion to the patient.

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

Hypoglycaemia.

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered medicinal production should be clearly recorded.

Transferring a patient to some other type or brand of insulin

Transferring a patient to another blazon or brand of insulin should exist done under strict medical supervision. Changes in strength, brand (manufacturer), blazon (regular/soluble, NPH/isophane, etc.), species (animal, man, homo insulin analogue), and/or method of manufacture (recombinant Dna versus beast-source insulin) may result in the need for a change in dosage. For fast-interim insulins, whatever patient also on basal insulin must optimise dosage of both insulins to obtain glucose control across the whole 24-hour interval, specially nocturnal/fasting glucose command.

Vial

When mixing Humalog with a longer acting insulin, the shorter-acting Humalog should be drawn into the syringe first, to forbid contagion of the vial by the longer-interim insulin. Mixing of the insulins ahead of fourth dimension or only earlier the injection should be on advice of the physician. However, a consistent routine must be followed.

Hypoglycaemia and hyperglycaemia

Conditions which may brand the early warning symptoms of hypoglycaemia different or less pronounced include long duration of diabetes, intensified insulin therapy, diabetic nerve illness or medications such as beta-blockers.

A few patients who have experienced hypoglycaemic reactions after transfer from creature-source insulin to man insulin accept 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, specially in insulin-dependent diabetics, may pb to hyperglycaemia and diabetic ketoacidosis; weather which are potentially lethal.

Injection technique

Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic command following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to event in hypoglycaemia. Blood glucose monitoring is recommended after the alter in the injection site, and dose adjustment of antidiabetic medications may be considered.

Insulin requirements and dosage adjustment

Insulin requirements may exist increased during illness or emotional disturbances.

Adjustment of dosage may too exist 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 event 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 accept been reported when pioglitazone was used in combination with insulin, especially in patients with adventure factors for development of cardiac centre failure. This should be kept in listen, 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 eye failure, weight gain and oedema. Pioglitazone should be discontinued, if any deterioration in cardiac symptoms occurs.

Avoidance of medication errors

Patients must exist instructed to always cheque the insulin label before each injection to avert accidental mix-ups betwixt the two dissimilar strengths of Humalog KwikPen likewise equally other 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 e'er get help/assistance from another person who has good vision and is trained in using the insulin device.

Tempo Pen

The Tempo Pen contains a magnet (run into section 6.five) that may interfere with the functions of an implantable electronic medical device, such as a pacemaker. The magnetic field extends to approximately 1.5 cm.

Excipients

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially "sodium-costless".

Insulin requirements may exist increased past medicinal products with hyperglycaemic activity, such as oral contraceptives, corticosteroids, or thyroid replacement therapy, danazol, beta2 stimulants (such as ritodrine, salbutamol, terbutaline).

Insulin requirements may be reduced in the presence of medicinal products with hypoglycaemic activity, such every bit 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 2 receptor blockers, beta-blockers, octreotide or alcohol.

The medico should be consulted when using other medications in add-on to Humalog (encounter section 4.iv).

Pregnancy

Data on a large number of exposed pregnancies do not betoken any adverse effect of insulin lispro on pregnancy or on the health of the foetus/newborn.

Information technology is essential to maintain good control of the insulin-treated (insulin-dependent or gestational diabetes) patient throughout pregnancy. Insulin requirements usually autumn during the first trimester and increase during the 2nd and tertiary 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.

Chest-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 department 5.3).

The patient'due south ability to concentrate and react may be impaired as a result of hypoglycaemia. This may institute a run a risk in situations where these abilities are of special importance (e.1000. driving a automobile or operating machinery).

Patients should be advised to take precautions to avoid hypoglycaemia whilst driving, this is specially 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 exist considered in these circumstances.

Summary of safety profile

Hypoglycaemia is the near frequent undesirable consequence of insulin therapy that a patient with diabetes may suffer. Astringent hypoglycaemia may atomic number 82 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.m. a patient`s level of diet and practice.

Tabulated listing of adverse reactions

The following related adverse reactions from clinical trials are listed below as MedDRA preferred term by system organ class and in gild of decreasing incidence (very mutual: ≥ 1/10; common: ≥ ane/100 to < 1/10; uncommon: ≥ i/1,000 to < ane/100; rare: ≥ 1/ten,000 to < 1/1,000; very rare: < 1/10,000); not known (cannot exist estimated grade the available data).

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

MedDRA system organ classes

Very common

Common

Uncommon

Rare

Very rare

Non known

Immune arrangement disorders

Local allergy

X

Systemic allergy

10

Skin and subcutaneous tissue disorders

Lipodystrophy

10

Cutaneous amyloidosis

X

Clarification of selected adverse reactions

Local allergy

Local allergy in patients is common. Redness, swelling, and itching tin 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 every bit irritants in the skin cleansing agent or poor injection technique.

Systemic allergy

Systemic allergy, which is rare merely potentially more than serious, is a generalized allergy to insulin. It may crusade a rash over the whole body, shortness of breath, wheezing, reduction in blood pressure level, fast pulse, or sweating. Astringent cases of generalized allergy may exist life-threatening.

Peel and subcutaneous tissue disorders

Lipodystrophy and cutaneous amyloidosis may occur at the injection site and filibuster local insulin absorption. Continuous rotation of the injection site within the given injection surface area may help to reduce or prevent these reactions (encounter section 4.4).

Oedema

Cases of oedema have been reported with insulin therapy, peculiarly if previous poor metabolic control is improved by intensified insulin therapy.

Reporting of suspected adverse reactions

Reporting suspected agin reactions after say-so of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal production. Healthcare professionals are asked to report any suspected adverse reactions via Ireland: HPRA Pharmacovigilance, Website: www.hpra.ie, or United kingdom of great britain and northern ireland: Yellow Bill of fare Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Insulins take 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 every bit a result of an excess of insulin activity relative to food intake and free energy expenditure.

Hypoglycaemia may exist associated with listlessness, confusion, palpitations, headache, sweating and airsickness.

Balmy hypoglycaemic episodes volition respond to oral administration of glucose or other sugar or saccharated products.

Correction of moderately severe hypoglycaemia can be accomplished by intramuscular or subcutaneous administration of glucagon, followed by oral carbohydrate when the patient recovers sufficiently. Patients who neglect to answer to glucagon must exist given glucose solution intravenously.

If the patient is comatose, glucagon should exist administered intramuscularly or subcutaneously. However, glucose solution must be given intravenously if glucagon is non bachelor or if the patient fails to respond to glucagon. The patient should be given a repast as shortly as consciousness is recovered.

Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after credible clinical recovery.

Pharmacotherapeutic group : Drugs used in diabetes, insulins and analogues for injection, fast-acting, ATC code: A10AB04

The principal action of insulin lispro is the regulation of glucose metabolism.

In improver, insulins have several anabolic and anti-catabolic deportment on a variety of different tissues. Inside muscle tissue this includes increasing glycogen, fat acrid, glycerol and protein synthesis and amino acid uptake, while decreasing glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein catabolism and amino acrid output.

Insulin lispro has a rapid onset of activity (approximately 15 minutes), thus assuasive 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 event rapidly and has a shorter duration of activity (2 to 5 hours) when compared to soluble insulin.

Clinical trials in patients with type i and type two diabetes have demonstrated reduced postprandial hyperglycaemia with insulin lispro compared to soluble human insulin.

As with all insulin preparations, the fourth dimension course of insulin lispro action may vary in different individuals or at different times in the aforementioned 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.

The above representation reflects the relative amount of glucose over time required to maintain the subject area'due south whole blood glucose concentrations most 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 anile ii to 11) and children and adolescents (481 patients anile nine to nineteen 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 effect in lower glycosylated haemoglobin levels compared to soluble insulin. In a double-bullheaded, crossover written report, the reduction in glycosylated haemoglobin levels after 12 weeks dosing was 0.37 pct points with insulin lispro, compared to 0.03 percentage points for soluble insulin (p = 0.004).

In patients with blazon 2 diabetes on maximum doses of sulphonyl urea agents, studies take shown that the addition of insulin lispro significantly reduces HbA1c compared to sulphonyl urea lonely. The reduction of HbA1c would also be expected with other insulin products east.thousand. soluble or isophane insulins.

Clinical trials in patients with type one and blazon two diabetes accept 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 afflicted by renal or hepatic function impairment. Glucodynamic differences between insulin lispro and soluble homo insulin, equally 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 ground but its effect is more rapid and of a shorter duration.

The pharmacokinetics of insulin lispro reflect a compound that is speedily captivated, and achieves peak blood levels thirty to 70 minutes following subcutaneous injection. When considering the clinical relevance of these kinetics, it is more than advisable to examine the glucose utilisation curves (as discussed in 5.1).

Insulin lispro maintains more than rapid assimilation when compared to soluble human insulin in patients with renal damage. In patients with type two diabetes over a wide range of renal part the pharmacokinetic differences between insulin lispro and soluble man insulin were generally maintained and shown to be independent of renal role. Insulin lispro maintains more rapid absorption and emptying when compared to soluble human insulin in patients with hepatic impairment.

In in vitro tests, including binding to insulin receptor sites and furnishings on growing cells, insulin lispro behaved in a style that closely resembled human insulin. Studies also demonstrate that the dissociation of bounden to the insulin receptor of insulin lispro is equivalent to human insulin. Acute, i month and twelve month toxicology studies produced no meaning toxicity findings.

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

g-Cresol

Glycerol

Dibasic sodium phosphate.7HiiO

Zinc oxide

Water for injections

Muriatic acid and sodium hydroxide maybe used to arrange pH.

Vial

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Cartridge, KwikPen, Junior KwikPen and Tempo Pen

These medicinal products should not exist mixed with any other insulin or any other medicinal product.

Before use

three years.

After kickoff use / after cartridge insertion

28 days.

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

Before use

Store in a refrigerator (2°C - 8°C).

Afterwards first use / later cartridge insertion

Vial

Shop in a fridge (2°C - eight°C) or below 30°C.

Cartridge

Store below thirty°C. Do not refrigerate. The pen with the inserted cartridge should not exist stored with the needle attached.

KwikPen, Inferior KwikPen and Tempo Pen

Store below thirty°C. Do not refrigerate. The pre-filled pen should not be stored with the needle attached.

Vial

The solution is contained in type I flintstone 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: Packs of 1 or two or a multipack of 5 (5 packs of 1). Not all packs may exist marketed.

Cartridge

The solution is contained in type I flintstone drinking 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: Packs of 5 or 10. Not all packs may be marketed.

KwikPen

The solution is independent 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 care for the cartridge plunger, and/or the glass cartridge. The 3 ml cartridges are sealed in a disposable pen injector, called the "KwikPen". Needles are non included.

3 ml KwikPen: Packs of 5 or a multipack of 10 (2 packs of 5). Not all packs may be marketed.

Junior KwikPen

Blazon I glass cartridges, sealed with halobutyl disc seals secured with aluminium seals and bromobutyl plunger heads. Dimeticone or silicone emulsion may be used to treat the cartridge plunger. The 3 ml cartridges are sealed in a disposable pen injector, chosen the "Junior KwikPen". Needles are not included.

3 ml Inferior KwikPen: Packs of ane pre-filled pen, 5 pre-filled pens or a multipack of 10 (2 packs of v) pre-filled pens. Not all packs may exist marketed.

Tempo Pen

Blazon I glass cartridges, sealed with halobutyl disc seals secured with aluminium seals and bromobutyl plunger heads. Dimeticone or silicone emulsion may be used to treat the cartridge plunger. The iii ml cartridges are sealed in a dispensable pen injector, called the "Tempo Pen". The Tempo Pen contains a magnet (see section 4.4). Needles are non included.

3 ml Tempo Pen: Packs of 5 pre-filled pens or a multipack of 10 (2 packs of 5) pre-filled pens. Not all packs may be marketed.

Instructions for use and treatment

To prevent the possible transmission of disease, each cartridge or pre-filled pen must be used by one patient only, even if the needle on the delivery device is inverse. Patients using vials must never share needles or syringes. The patient should discard the needle subsequently every injection.

The Humalog solution should be clear and colourless. Humalog should non 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 half dozen.2.

Preparing a dose

Vial

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

i) Humalog

1. Wash your easily.

2. If using a new vial, flip off the plastic protective cap, but practise non remove the stopper.

three. If the therapeutic regimen requires the injection of basal insulin and Humalog at the aforementioned time, the 2 can be mixed in the syringe. If mixing insulins, refer to the instructions for mixing that follow in Department (ii) and six.two.

four. 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.

v. Turn the vial and syringe upside down. Agree the vial and syringe firmly in one paw.

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

7. 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 directly upward and tap its side until the bubbles float to the top. Push them out with the plunger and withdraw the correct dose.

8. Remove the needle from the vial and lay the syringe down and then that the needle does not touch anything.

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

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

medico.

2. Depict air into the syringe equal to the amount of longer-interim insulin existence taken. Insert the needle into the longer-acting insulin vial and inject the air. Withdraw the needle.

3. Now inject air into the Humalog vial in the same mode, merely practice not withdraw the needle.

four. Plow the vial and syringe upside down.

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

six. Before removing the needle from the vial, check the syringe for air bubbling that reduce the amount of Humalog in it. If bubbling are nowadays, concord the syringe straight upwardly and tap its side until the bubbles float to the peak. Push them out with the plunger and withdraw the correct dose.

7. Remove the needle from the vial of Humalog and insert information technology into the vial of the longer-interim insulin. Plough the vial and syringe upside downwardly. 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-interim insulin.

8. Withdraw the needle and lay the syringe down then that the needle does not affect anything.

Cartridge

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

KwikPen, Junior KwikPen and Tempo Pen

Before using the pre-filled pen the user manual included in the parcel leaflet must exist read carefully. The pre-filled pen has to be used equally recommended in the user manual.

Pens should non exist 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 clarification.

one. Wash your easily

ii. Choose a site for injection.

3. Make clean the skin equally instructed.

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

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

six. Dispose of the syringe and needle safely. For an injection device utilize the outer needle cap, unscrew the needle and dispose of it safely.

7. Utilise of the injection sites should be rotated so that the same is not used more than than approximately in one case a month.

Humalog Tempo Pen

The Tempo Pen is designed to piece of work with the Tempo Smart Button. The Tempo Smart Button is an optional product that can be fastened to the Tempo Pen dose knob and aids in transmitting Humalog dose information from the Tempo Pen to a compatible mobile application. The Tempo Pen injects insulin with or without the Tempo Smart Push button fastened. To transmit data to the mobile application, follow the instructions provided with the Tempo Smart Button and the instructions with the mobile application.

Whatsoever unused product or waste material cloth should be disposed of in accord with local requirements.

Eli Lilly Nederland B.5., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

EU/1/96/007/002

EU/1/96/007/004

EU/one/96/007/020

EU/1/96/007/021

EU/i/96/007/023

EU/one/96/007/031

European union/ane/96/007/032

EU/one/96/007/043

EU/ane/96/007/044

Eu/1/96/007/045

EU/1/96/007/046

Eu/1/96/007/047

Appointment of beginning say-so: thirtyth April 1996

Date of last renewal: 30th Apr 2006

03 September 2020

Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu

LEGAL CATEGORY

POM