HUMALOG 100U / ml JUNIOR KWIKPEN injection for pre-filled pen medication leaflet

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 3.5mg).

Vial

Each vial contains 1000 units insulin lispro in 10 ml solution.

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 1-60 units in steps of 1 unit.

Junior KwikPen

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

Each Junior KwikPen delivers 0.5 - 30 units in steps of 0.5 units.

*produced in E.coli by recombinant DNA technology.

For a full list of excipients, see section 6.1.

Solution for injection.

Clear, colourless, aqueous solution.

For the treatment of adults and children with diabetes mellitus who require insulin for the maintenanceof normal glucose homeostasis. Humalog is also indicated for the initial stabilisation of diabetesmellitus.

The dose should be determined by 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 doseadjustments.

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 subcutaneouslyas compared with soluble insulin. This rapid onset of activity allows a Humalog injection (or, in thecase of administration by continuous subcutaneous infusion, a Humalog bolus) to be given very closeto mealtime. The time course of action of any insulin may vary considerably in different individuals orat different times in the same individual. The faster onset of action compared to soluble human insulinis 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 theadvice of a physician.

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

Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity forgluconeogenesis and reduced insulin breakdown; however, in patients with chronic hepaticimpairment, an increase in insulin resistance may lead to increased insulin requirements.

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

Subcutaneous use

Humalog preparations should be given by subcutaneous injection.

The KwikPen,Junior KwikPen and Tempo Pen are only suitable for subcutaneous injections. Humalogin cartridges is only suitable for subcutaneous injections from a Lilly reusable pen or compatible pumpsystems for continuous subcutaneous insulin infusion (CSII).

Subcutaneous administration should be in the upper arms, thighs, buttocks, or abdomen. Use ofinjection sites should be rotated so that the same site is not used more than approximately once amonth, in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see section 4.4 and4.8).

When administered subcutaneously care should be taken when injecting Humalog to ensure that ablood 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.

Humalog KwikPens

Humalog KwikPen is available in two strengths. The Humalog 100 units/ml KwikPen (and Humalog200 units/ml KwikPen, see separate SmPC) delivers 1 - 60 units in steps of 1 unit in a single injection.

The Humalog 100 units/ml Junior KwikPen delivers 0.5 - 30 units in steps of 0.5 units in a singleinjection. The number of insulin units is shown in the dose window of the pen regardless ofstrength and no dose conversion should be done when transferring a patient to a new strength or to apen with a different dose step.

Humalog Tempo Pen

The Humalog 100 units/ml Tempo Pen delivers 1 - 60 units in steps of 1 unit in a single injection. Thenumber of insulin units is shown in the dose window of the pen regardless of strength and no doseconversion should be done when transferring a patient to a new strength or to a pen with a differentdose step. The Tempo Pen can be used with the optional transfer module Tempo Smart Button (seesection 6.6).

As 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 makingdecisions about another 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 may fill the pumpreservoir from a Humalog 100 units/ml vial. Some pumps are compatible with cartridges that can beinserted intact into the pump.

Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro. Before infusinginsulin lispro, the pump manufacturer’s instructions should be studied to ascertain the suitability forthe particular pump. Use the correct reservoir and catheter for the pump. When filling the pumpreservoir avoid damaging it by using the correct needle length on the filling system. The infusion set(tubing and cannula) should be changed in accordance with the instructions in the product informationsupplied with the infusion set. In the event of a hypoglycaemic episode, the infusion should be stoppeduntil the episode is resolved. If repeated or severe low blood glucose levels occur consider the need toreduce or stop an insulin infusion. A pump malfunction or obstruction of the infusion set can result ina rapid rise in glucose levels. If an interruption to insulin flow is suspected, follow the instructions inthe pump product literature. When used with an insulin infusion pump, Humalog should not be mixedwith any other insulin.

Intravenous administration of insulin

If necessary, Humalog may also be administered intravenously, for example: for the control of bloodglucose 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 forintravenous injections, for example by an intravenous bolus or by an infusion system. Frequentmonitoring 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% sodiumchloride or 5% dextrose are stable at room temperature for 48 hours. It is recommended that thesystem is primed before starting the infusion to the patient.

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

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

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 medicalsupervision. Changes in strength, brand (manufacturer), type (regular/soluble, NPH/isophane, etc.),species (animal, human, human insulin analogue), and/or method of manufacture (recombinant DNAversus 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 acrossthe whole day, particularly nocturnal/fasting glucose control.

Vial

When mixing Humalog with a longer acting insulin, the shorter-acting Humalog should be drawn intothe syringe first, to prevent contamination of the vial by the longer-acting insulin. Mixing of theinsulins ahead of time or just before the injection should be on advice of the physician. However, aconsistent routine must be followed.

Hypoglycaemia and hyperglycaemia

Conditions which may make the early warning symptoms of hypoglycaemia different or lesspronounced include long duration of diabetes, intensified insulin therapy, diabetic nerve disease ormedications such as beta-blockers.

A few patients who have experienced hypoglycaemic reactions after transfer from animal-sourceinsulin to human insulin have reported that the early warning symptoms of hypoglycaemia were lesspronounced or different from those experienced with their previous insulin. Uncorrectedhypoglycaemic 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 arepotentially lethal.

Patients must be instructed to perform continuous rotation of the injection site to reduce the risk ofdeveloping lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulinabsorption and worsened glycaemic control following insulin injections at sites with these reactions. Asudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia.

Blood glucose monitoring is recommended after the change in the injection site, and dose adjustmentof antidiabetic medications may be considered.

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 orchange their usual diet. Exercise taken immediately after a meal may increase the risk ofhypoglycaemia. A consequence of the pharmacodynamics of rapid-acting insulin analogues is that ifhypoglycaemia occurs, it may occur earlier after an injection when compared with soluble humaninsulin.

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 inmind, if treatment with the combination of pioglitazone and Humalog is considered. If thecombination is used, patients should be observed for signs and symptoms of heart failure, weight gainand 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 accidentalmix-ups between the two different strengths of Humalog KwikPen as well as other insulin products.

Patients must visually verify the dialled units on the dose counter of the pen. Therefore, therequirement for patients to self-inject is that they can read the dose counter on the pen. Patients whoare blind or have poor vision must be instructed to always get help/assistance from another person whohas good vision and is trained in using the insulin device.

Tempo Pen

The Tempo Pen contains a magnet (see section 6.5) that may interfere with the functions of animplantable electronic medical device, such as a pacemaker. The magnetic field extends toapproximately 1.5 cm.

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

Insulin requirements may be increased by medicinal products with hyperglycaemic activity, such asoral contraceptives, corticosteroids, or thyroid replacement therapy, danazol, beta2 stimulants (such asritodrine, salbutamol, terbutaline).

Insulin requirements may be reduced in the presence of medicinal products with hypoglycaemicactivity, such as oral hypoglycaemics, salicylates (for example, acetylsalicylic acid), sulphaantibiotics, certain antidepressants (monoamine oxidase inhibitors, selective serotonin reuptakeinhibitors), certain angiotensin converting enzyme inhibitors (captopril, enalapril), angiotensin IIreceptor blockers, beta-blockers, octreotide or alcohol.

The physician should be consulted when using other medications in addition to Humalog (see section4.4).

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

It is essential to maintain good control of the insulin-treated (insulin-dependent or gestationaldiabetes) patient throughout pregnancy. Insulin requirements usually fall during the first trimester andincrease during the second and third trimesters. Patients with diabetes should be advised to informtheir doctor if they are pregnant or are contemplating pregnancy. Careful monitoring of glucosecontrol, as well as general health, is essential in pregnant patients with diabetes.

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

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

The patient’s ability to concentrate and react may be impaired as a result of hypoglycaemia. This mayconstitute a risk in situations where these abilities are of special importance (e.g. driving a car oroperating machinery).

Patients should be advised to take precautions to avoid hypoglycaemia whilst driving, this isparticularly important in those who have reduced or absent awareness of the warning signs ofhypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should beconsidered in these circumstances.

Hypoglycaemia is the most frequent undesirable effect of insulin therapy that a patient with diabetesmay suffer. Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, death. Nospecific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the insulindose and other factors e.g. a patient`s level of diet and exercise.

The following related adverse reactions from clinical trials are listed below as MedDRA preferredterm 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) ;not known (cannot be estimated form the available data).

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

MedDRA system Very Common Uncommon Rare Very Notorgan classes common rare known

Local allergy X

Systemic allergy X

Lipodystrophy X

Cutaneous

Xamyloidosis

Local allergy

Local allergy in patients is common. Redness, swelling, and itching can occur at the site of insulininjection. This condition usually resolves in a few days to a few weeks. In some instances, thiscondition may be related to factors other than insulin, such as irritants in the skin cleansing agent orpoor injection technique.

Systemic allergy

Systemic allergy, which is rare but potentially more serious, is a generalised allergy to insulin. It maycause a rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fastpulse, or sweating. Severe cases of generalised allergy may be life-threatening.

Lipodystrophy and cutaneous amyloidosis may occur at the injection site and delay local insulinabsorption. Continuous rotation of the injection site within the given injection area may help to reduceor prevent these reactions (see section 4.4).

Oedema

Cases of oedema have been reported with insulin therapy, particularly if previous poor metaboliccontrol is improved by intensified insulin therapy.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. Itallows continued monitoring of the benefit/risk balance of the medicinal product. Healthcareprofessionals are asked to report any suspected adverse reactions via the national reporting systemlisted in Appendix V.

Insulins have no specific overdose definitions because serum glucose concentrations are a result ofcomplex 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 energyexpenditure.

Hypoglycaemia may be associated with listlessness, confusion, palpitations, headache, sweating andvomiting.

Mild hypoglycaemic episodes will respond to oral administration of glucose or other sugar orsaccharated products.

Correction of moderately severe hypoglycaemia can be accomplished by intramuscular orsubcutaneous administration of glucagon, followed by oral carbohydrate when the patient recoverssufficiently. 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 patientfails to respond to glucagon. The patient should be given a meal as soon as consciousness isrecovered.

Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recurafter apparent clinical recovery.

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 andamino acid uptake, while decreasing glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, proteincatabolism and amino acid output.

Insulin lispro has a rapid onset of action (approximately 15 minutes), thus allowing it to be givencloser to a meal (within zero to 15 minutes of the meal) when compared to soluble insulin (30 to45 minutes before). Insulin lispro takes effect rapidly and has a shorter duration of activity (2 to5 hours) when compared to soluble insulin.

Clinical trials in patients with type 1 and type 2 diabetes have demonstrated reduced postprandialhyperglycaemia with insulin lispro compared to soluble human insulin.

As with all insulin preparations, the time course of insulin lispro action may vary in differentindividuals 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 subcutaneousinjection is illustrated below.

The above representation reflects the relative amount of glucose over time required to maintain thesubject’s whole blood glucose concentrations near fasting levels and is an indicator of the effect ofthese 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. Thepharmacodynamic 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 inlower glycosylated haemoglobin levels compared to soluble insulin. In a double-blind, crossoverstudy, the reduction in glycosylated haemoglobin levels after 12 weeks dosing was 0.37 percentagepoints 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 thatthe addition of insulin lispro significantly reduces HbA1c compared to sulphonyl urea alone. Thereduction of HbA1c would also be expected with other insulin products e.g. soluble or isophaneinsulins.

Clinical trials in patients with type 1 and type 2 diabetes have demonstrated a reduced number ofepisodes of nocturnal hypoglycaemia with insulin lispro compared to soluble human insulin. In somestudies, reduction of nocturnal hypoglycaemia was associated with increased episodes of daytimehypoglycaemia.

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 aglucose 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 morerapid and of a shorter duration.

The pharmacokinetics of insulin lispro reflect a compound that is rapidly absorbed, and achieves peakblood levels 30 to 70 minutes following subcutaneous injection. When considering the clinicalrelevance of these kinetics, it is more appropriate to examine the glucose utilisation curves (asdiscussed in 5.1).

Insulin lispro maintains more rapid absorption when compared to soluble human insulin in patientswith renal impairment. In patients with type 2 diabetes over a wide range of renal function thepharmacokinetic differences between insulin lispro and soluble human insulin were generallymaintained and shown to be independent of renal function. Insulin lispro maintains more rapidabsorption and elimination when compared to soluble human insulin in patients with hepaticimpairment.

In in vitro tests, including binding to insulin receptor sites and effects on growing cells, insulin lisprobehaved in a manner that closely resembled human insulin. Studies also demonstrate that thedissociation 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.

m-Cresol

Glycerol

Dibasic sodium phosphate. 7H2O

Zinc oxide

Water for injections

Hydrochloric acid and sodium hydroxide maybe used to adjust pH.

Vial

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

Cartridge, KwikPen, Junior KwikPen and Tempo Pen

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

Before use3 years.

After first use/after cartridge insertion28 days.

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

Store in a refrigerator (2°C - 8°C).

After first use/after cartridge insertion

Vial

Store in a refrigerator (2°C - 8°C) or below 30°C.

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

KwikPen,Junior KwikPen and Tempo Pen

Store below 30°C. Do not refrigerate. The pre-filled pen should not be stored with the needle attached.

Vial

The solution is contained in type I flint glass vials, sealed with butyl or halobutyl stoppers and securedwith aluminium seals. Dimeticone or silicone emulsion may be used to treat the vial stoppers.

10 ml vial: Packs of 1 or 2 or a multipack of 5 (5 packs of 1). Not all packs may be marketed.

The solution is contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals andplunger heads, and are secured with aluminium seals. Dimeticone or silicone emulsion may be used totreat 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 contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals andplunger heads and are secured with aluminium seals. Dimeticone or silicone emulsion may be used totreat the cartridge plunger, and/or the glass cartridge. The 3 ml cartridges are sealed in a disposablepen injector, called the “KwikPen”. Needles are not included.

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

Junior KwikPen

Type I glass cartridges, sealed with halobutyl disc seals secured with aluminium seals and bromobutylplunger heads. Dimeticone or silicone emulsion may be used to treat the cartridge plunger. The 3 mlcartridges are sealed in a disposable pen injector, called the “Junior KwikPen”. Needles are notincluded.

3 ml Junior KwikPen: Packs of 1 prefilled pen, 5 prefilled pens or a multipack of 10 (2 packs of 5)prefilled pens. Not all packs may be marketed.

Tempo Pen

Type I glass cartridges, sealed with halobutyl disc seals secured with aluminium seals and bromobutylplunger heads. Dimeticone or silicone emulsion may be used to treat the cartridge plunger. The 3 mlcartridges are sealed in a disposable pen injector, called the “Tempo Pen”. The Tempo Pen contains amagnet (see section 4.4). Needles are not included.

3 ml Tempo Pen: Packs of 5 prefilled pens or a multipack of 10 (2 packs of 5) prefilled pens. Not allpacks may be marketed.

Instructions for use and handling

To prevent the possible transmission of disease, each cartridge or pre-filled pen must be used by onepatient only, even if the needle on the delivery device is changed. Patients using vials must nevershare 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 appearscloudy, 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).

i) Humalog1. Wash your hands.

2. If using a new vial, flip off the plastic protective cap, but do not remove the stopper.

3. If the therapeutic regimen requires the injection of basal insulin and Humalog at the sametime, the two can be mixed in the syringe. If mixing insulins, refer to the instructions formixing that follow in Section (ii) and 6.2.

4. Draw air into the syringe equal to the prescribed Humalog dose. Wipe the top of the vialwith a swab. Put the needle through the rubber top of the Humalog vial and inject the airinto the vial.

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

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

7. Before removing the needle from the vial, check the syringe for air bubbles that reducethe amount of Humalog in it. If bubbles are present, hold the syringe straight up and tapits side until the bubbles float to the top. Push them out with the plunger and withdrawthe correct dose.

8. Remove the needle from the vial and lay the syringe down so that the needle does nottouch anything.

ii) Mixing Humalog with longer-acting Human Insulins (see section 6.2)1. Humalog should be mixed with longer-acting human insulins only on the advice of adoctor.

2. Draw air into the syringe equal to the amount of longer-acting insulin being taken. Insertthe 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 manner, but do not withdraw the needle.

4. Turn the vial and syringe upside down.

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

Humalog into the syringe.

6. Before removing the needle from the vial, check the syringe for air bubbles that reducethe amount of Humalog in it. If bubbles are present, hold the syringe straight up and tapits side until the bubbles float to the top. Push them out with the plunger and withdrawthe correct dose.

7. 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 inone hand and shake gently. Making sure the tip of the needle is in the insulin, withdrawthe dose of longer-acting insulin.

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

Humalog cartridges are to be used with a Lilly reusable insulin pen and should not be used with anyother 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 theneedle and administering the insulin injection.

KwikPen, Junior KwikPen and Tempo Pen

Before using the pre-filled pen the user manual included in the package leaflet must be read carefully.

The pre-filled pen has to be used as recommended in the user manual.

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 injectingthe dose, the following is a general description.

1. Wash your hands2. Choose a site for injection.

3. Clean the skin as instructed.

4. Stabilise the skin by spreading it or pinching up a large area. Insert the needle and injectas instructed.

5. Pull the needle out and apply gentle pressure over the injection site for several seconds.

Do not rub the area.

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

7. Use of the injection sites should be rotated so that the same is not used more thanapproximately once a month.

Humalog Tempo Pen

The Tempo Pen is designed to work with the Tempo Smart Button. The Tempo Smart Button is anoptional product that can be attached to the Tempo Pen dose knob and aids in transmitting Humalogdose information from the Tempo Pen to a compatible mobile application. The Tempo Pen injectsinsulin with or without the Tempo Smart Button attached. To transmit data to the mobile application,follow the instructions provided with the Tempo Smart Button and the instructions with the mobileapplication

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

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

EU/1/96/007/002

EU/1/96/007/004

EU/1/96/007/020

EU/1/96/007/021

EU/1/96/007/023

EU/1/96/007/031

EU/1/96/007/032

EU/1/96/007/043

EU/1/96/007/044

EU/1/96/007/045

EU/1/96/007/046

EU/1/96/007/047

Date of first authorisation: 30th April 1996

Date of last renewal: 30th April 2006

Detailed information on this medicinal product is available on the website of the European Medicines

Agency http://www.ema.europa.eu