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Insuman Basal SoloStar 100 IU/ml suspension for injection in a pre filled pen

Last Updated on eMC 27-Jul-2017 View changes  | SANOFI Contact details

1. Name of the medicinal product

Insuman Basal 100 IU/ml suspension for injection in a vial

Insuman Basal 100 IU/ml suspension for injection in a cartridge

Insuman Basal SoloStar 100 IU/ml suspension for injection in a pre-filled pen

2. Qualitative and quantitative composition

Insuman Basal 100 IU/ml in a vial

Each ml contains 100 IU insulin human (equivalent to 3.5 mg).

Each vial contains 5 ml of suspension for injection, equivalent to 500 IU insulin, or 10 ml of suspension for injection, equivalent to 1000 IU insulin.

Insuman Basal 100 IU/ml in a cartridge, Insuman Basal SoloStar 100 IU/ml in a pre-filled pen

Each ml contains 100 IU insulin human (equivalent to 3.5 mg).

Each cartridge or pen contains 3 ml of suspension for injection, equivalent to 300 IU insulin.

One IU (International Unit) corresponds to 0.035 mg of anhydrous human insulin*.

Insuman Basal is an isophane insulin suspension.

*Human insulin is produced by recombinant DNA technology in Escherichia coli.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Suspension for injection.

After resuspension, milky-white suspension.

4. Clinical particulars
4.1 Therapeutic indications

Diabetes mellitus where treatment with insulin is required.

4.2 Posology and method of administration

Posology

The desired blood glucose levels, the insulin preparations to be used and the insulin dose regimen (doses and timings) must be determined individually and adjusted to suit the patient's diet, physical activity and life-style.

Daily doses and timing of administration

There are no fixed rules for insulin dose regimen. However, the average insulin requirement is often 0.5 to 1.0 IU per kg body weight per day. The basal metabolic requirement is 40% to 60% of the total daily requirement. Insuman Basal is injected subcutaneously 45 to 60 minutes before a meal.

Insuman Basal SoloStar 100 IU/ml in a pre-filled pen

SoloStar delivers insulin in doses from 1 to 80 units in steps of 1 unit. Each pen contains multiple doses.

Secondary dose adjustment

Improved metabolic control may result in increased insulin sensitivity, leading to a reduced insulin requirement. Dose adjustment may also be required, for example, if

- the patient's weight changes,

- the patient's life-style changes,

- other circumstances arise that may promote an increased susceptibility to hypo- or hyperglycaemia (see section 4.4).

Special populations

Elderly population (≧65 years old)

In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.

Renal impairment

In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.

Hepatic impairment

In patients with severe hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.

Method of administration

Insuman Basal must not be administered intravenously and must not be used in infusion pumps or external or implanted insulin pumps.

Insuman Basal is administered subcutaneously. Insuman Basal must never be injected intravenously.

Insulin absorption and hence the blood-glucose-lowering effect of a dose may vary from one injection area to another (e.g. the abdominal wall compared with the thigh). Injection sites within an injection area must be rotated from one injection to the next.

Insuman Basal 100 IU/ml in a vial

Only injection syringes designed for this strength of insulin (100 IU per ml) are to be used. The injection syringes must not contain any other medicinal product or residue (e.g. traces of heparin).

Insuman Basal SoloStar100 IU/ml in a pre-filled pen

Before using SoloStar, the Instructions for Use included in the Package Leaflet must be read carefully.

For further details on handling, see section 6.6.

4.3 Contraindications

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

4.4 Special warnings and precautions for use

Patients hypersensitive to Insuman Basal for whom no better tolerated preparation is available must only continue treatment under close medical supervision and – where necessary – in conjunction with anti-allergic treatment.

In patients with an allergy to animal insulin intradermal skin testing is recommended prior to a transfer to Insuman Basal, since they may experience immunological cross-reactions.

In case of insufficient glucose control or a tendency to hyper- or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.

Transfer to Insuman Basal

Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose.

The need to adjust (e.g. reduce) the dose may become evident immediately after transfer. Alternatively, it may emerge gradually over a period of several weeks.

Following transfer from an animal insulin to human insulin, dose regimen reduction may be required in particular in patients who

- were previously already controlled on rather low blood glucose levels,

- have a tendency to hypoglycaemia,

- previously required high insulin doses due to the presence of insulin antibodies.

Close metabolic monitoring is recommended during the transition and in the initial weeks thereafter. In patients who require high insulin doses because of the presence of insulin antibodies, transfer under medical supervision in a hospital or similar setting must be considered.

Hypoglycaemia

Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement.

Particular caution should be exercised, and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance, such as in patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).

Patients should be aware of circumstances where warning symptoms of hypoglycaemia are diminished. The warning symptoms of hypoglycaemia may be changed, be less pronounced or be absent in certain risk groups. These include patients:

- in whom glycaemic control is markedly improved,

- in whom hypoglycaemia develops gradually,

- who are elderly,

- after transfer from animal insulin to human insulin,

- in whom an autonomic neuropathy is present,

- with a long history of diabetes,

- suffering from a psychiatric illness,

- receiving concurrent treatment with certain other medicinal products (see section 4.5).

Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia.

If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.

Adherence of the patient to the dose regimen and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia. Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment. These include:

- change in the injection area,

- improved insulin sensitivity (e.g. by removal of stress factors),

- unaccustomed, increased or prolonged physical activity,

- intercurrent illness (e.g. vomiting, diarrhoea),

- inadequate food intake,

- missed meals,

- alcohol consumption,

- certain uncompensated endocrine disorders (e.g. in hypothyroidism and in anterior pituitary or adrenocortical insufficiency),

- concomitant treatment with certain other medicinal products (see section 4.5).

Intercurrent illness

Intercurrent illness requires intensified metabolic monitoring. In many cases, urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose. The insulin requirement is often increased. Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even if they are able to eat only little or no food, or are vomiting etc. and they must never omit insulin entirely.

Insuman Basal 100 IU/ml in a cartridge

Pens to be used with Insuman Basal cartridges

The Insuman Basal cartridges should only be used with the following pens:

- JuniorSTAR which delivers Insuman Basal in 0.5 unit dose increments

- OptiPen, ClikSTAR, Tactipen, Autopen 24, and AllStar and AllStar PRO which all deliver Insuman Basal in 1 unit dose increments.

These cartridges should not be used with any other reusable pen as the dosing accuracy has only been established with the listed pens.

Not all of these pens may be marketed in your country.

Insuman Basal SoloStar100 IU/ml in a pre-filled pen

Handling of the pen

Before using SoloStar, the Instructions for Use included in the Package Leaflet must be read carefully. SoloStar has to be used as recommended in these Instructions for Use (see section 6.6).

Medication errors

Medication errors have been reported in which other Insuman formulations or other insulins have been accidentally administered. Insulin label must always be checked before each injection to avoid medication errors between insulin human and other insulins.

Combination of Insuman with pioglitazone

Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. This should be kept in mind if treatment with the combination of pioglitazone and Insuman is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.

4.5 Interaction with other medicinal products and other forms of interaction

A number of substances affect glucose metabolism and may require dose adjustment of human insulin.

Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics.

Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens (e.g. in oral contraceptives), phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, protease inhibitors and atypical antipsychotic medicinal products (e.g. olanzapine and clozapine).

Beta-blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood-glucose-lowering effect of insulin. Pentamidine may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.

In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.

4.6 Fertility, pregnancy and lactation

Pregnancy

For insulin human, no clinical data on exposed pregnancies are available. Insulin does not cross the placental barrier. Caution should be exercised when prescribing to pregnant women.

It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control throughout pregnancy. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential.

Breast-feeding

No effects on the suckling child are anticipated. Insuman Basal can be used during breast-feeding. Breast-feeding women may require adjustments in insulin dose and diet.

Fertility

No clinical or animal data with insulin human on male or female fertility are available.

4.7 Effects on ability to drive and use machines

The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).

Patients should be advised to take precautions to avoid hypoglycaemia whilst driving. This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycaemia or have frequent episodes of hypoglycaemia. It should be considered whether it is advisable to drive or use machines in these circumstances.

4.8 Undesirable effects

Summary of the safety profile

Hypoglycaemia, in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement. In clinical studies and during marketed use, the frequency varies with patient population and dose regimens. Therefore, no specific frequency can be presented.

Tabulated list of adverse reactions

The following related adverse reactions from clinical investigations are listed below 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 from the available data).

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

MedDRA system organ classes

Common

Uncommon

Not known

Immune system disorders

Shock

Immediate type allergic reactions (hypotension, angioneurotic oedema, bronchospasm, generalised skin reactions);

Anti-insulin antibodies

Metabolism and nutrition disorders

Oedema

Hypoglycaemia;

Sodium retention

Eye disorders

Proliferative retinopathy;

Diabetic retinopathy;

Visual impairment

Skin and subcutaneous tissue disorders

Lipodystrophy

General disorders and administration site conditions

Injection site reactions

Injection site urticaria

Injection site inflammation;

Injection site pain;

Injection site pruritus;

Injection site erythema;

Injection site swelling

Description of selected adverse reactions

Immune system disorders

Immediate type allergic reactions to insulin or to the excipients may be life-threatening.

Insulin administration may cause anti-insulin antibodies to form. In rare cases, the presence of such anti-insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia.

Metabolism and nutrition disorders

Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage.

Prolonged or severe hypoglycaemic episodes may be life-threatening.

In many patients, the signs and symptoms of neuroglycopenia are preceded by signs of adrenergic counter-regulation. Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter-regulation and its symptoms.

Insulin may cause sodium retention and oedema, particularly if previously poor metabolic control is improved by intensified insulin therapy.

Eyes disorders

A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens.

Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy. However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy.

Skin and subcutaneous tissue disorders

Lipodystrophy may occur at the injection site and delay local insulin absorption. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions.

General disorders and administration site conditions

Most minor reactions to insulins at the injection site usually resolve in a few days to a few weeks.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9 Overdose

Symptoms

Insulin overdose may lead to severe and sometimes long-term and life-threatening hypoglycaemia.

Management

Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates. Adjustments in dose regimen of the medicinal product, meal patterns, or physical activity may be needed.

More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, intermediate-acting, ATC Code: A10AC01.

Mechanism of action

Insulin

- lowers blood glucose and promotes anabolic effects as well as decreasing catabolic effects,

- increases the transport of glucose into cells as well as the formation of glycogen in the muscles and the liver, and improves pyruvate utilisation. It inhibits glycogenolysis and gluconeogenesis,

- increases lipogenesis in the liver and adipose tissue and inhibits lipolysis,

- promotes the uptake of amino acids into cells and promotes protein synthesis,

- enhances the uptake of potassium into cells.

Pharmacodynamic effects

Insuman Basal (an isophane insulin suspension) is an insulin with gradual onset and long duration of action. Following subcutaneous injection, onset of action is within 60 minutes, the phase of maximum action is between 3 and 4 hours after injection and the duration of action is 11 to 20 hours.

5.2 Pharmacokinetic properties

In healthy subjects, the serum half-life of insulin is approximately 4 to 6 minutes. It is longer in patients with severe renal insufficiency. However, it must be noted that the pharmacokinetics of insulin do not reflect its metabolic action.

5.3 Preclinical safety data

The acute toxicity was studied following subcutaneous administration in rats. No evidence of toxic effects was found. Studies of pharmacodynamic effects following subcutaneous administration in rabbits and dogs revealed the expected hypoglycaemic reactions.

6. Pharmaceutical particulars
6.1 List of excipients

Protamine sulphate,

metacresol,

phenol,

zinc chloride,

sodium dihydrogen phosphate dihydrate,

glycerol,

sodium hydroxide,

hydrochloric acid (for pH adjustment),

water for injections.

6.2 Incompatibilities

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

Insuman Basal must not be mixed with solutions containing reducing substances such as thioles and sulphites.

Mixing of insulins

Insuman Basal 100 IU/ml in a vial

Insuman Basal must not be mixed with insulin human formulations designed specifically for use in insulin pumps.

Insuman Basal must also not be mixed with insulins of animal origin or with insulin analogues.

Insulins of different concentration (e.g. 100 IU per ml and 40 IU per ml) must not be mixed.

Care must be taken to ensure that no alcohol or other disinfectants enter the insulin suspension.

Insuman Basal 100 IU/ml in a cartridge

Insuman Basal must not be mixed with insulin human formulations designed specifically for use in insulin pumps.

Insuman Basal must also not be mixed with insulins of animal origin or with insulin analogues.

Care must be taken to ensure that no alcohol or other disinfectants enter the insulin suspension.

Insuman Basal SoloStar 100 IU/ml in a pre-filled pen

Insuman Basal must not be mixed with any other insulin or with insulin analogues.

Care must be taken to ensure that no alcohol or other disinfectants enter the insulin suspension.

6.3 Shelf life

2 years.

Shelf life after first use of the vial

The product may be stored for a maximum of 4 weeks not above 25°C and away from direct heat or direct light.

Keep the vial in the outer carton in order to protect from light.

It is recommended that the date of the first use be noted on the label.

Shelf life after first use of the cartridge, pen

The cartridge in-use (in the insulin pen) or carried as a spare, the pen in-use or carried as a spare may be stored for a maximum of 4 weeks not above 25°C and away from direct heat or direct light.

The pen containing a cartridge or pens in-use must not be stored in the refrigerator.

The pen cap must be put back on the pen after each injection in order to protect from light.

6.4 Special precautions for storage

Unopened vials, unopened cartridges, not in-use pens

Store in a refrigerator (2°C - 8°C).

Do not freeze.

Do not put Insuman Basal next to the freezer compartment or a freezer pack.

Keep the vial, cartridge or pre-filled pen in the outer carton in order to protect from light.

Opened vials, in-use cartridges, in-use pens

For storage conditions after first opening of the medicinal product, see section 6.3.

6.5 Nature and contents of container

Insuman Basal 100 IU/ml in a vial

5 ml suspension in a vial and 10 ml suspension in a vial (type 1 colourless glass) with a flanged cap (aluminium), a stopper (chlorobutyl rubber (type 1)) and a tear-off cap (polypropylene).

Packs of 1 and 5 vials are available.

Not all pack sizes may be marketed.

Insuman Basal 100 IU/ml in a cartridge, Insuman Basal SoloStar 100 IU/ml in a pre-filled pen

3 ml suspension in a cartridge (type 1 colourless glass) with a plunger (bromobutyl rubber (type 1)) and a flanged cap (aluminium) with a stopper (bromobutyl or laminate of polyisoprene and bromobutyl rubber (type 1)).

Each cartridge contains 3 balls (stainless steel).

Pre-filled pen

The cartridges are sealed in a disposable pen injector.

Injection needles are not included in the pack.

Pack size

Packs of 3, 4, 5, 6, 9 or 10 cartridges are available.

Packs of 3, 4, 5, 6, 9 or 10 pens are available.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Insuman Basal 100 IU/ml in a vial

Before withdrawing insulin from the vial for the first time, remove the plastic protective cap.

Immediately before withdrawal from the vial into the injection syringe, the insulin must be resuspended. This is best done by rolling the vial at an oblique angle between the palms of the hands. Do not shake the vial vigorously as this may lead to changes in the suspension (giving the vial a frosted appearance; see below) and cause frothing. Froth may interfere with the correct measurement of the dose.

After resuspension, the fluid must have a uniformly milky appearance. Insuman Basal must not be used if this cannot be achieved, i.e. if the suspension remains clear, for example, or if clumps, particles or flocculation appear in the insulin or stick to the wall or bottom of the vial. These changes sometimes give the vial a frosted appearance. In such cases, a new vial yielding a uniform suspension must be used. It is also necessary to change to a new vial if the insulin requirement changes substantially.

Insuman Basal must not be administered intravenously and must not be used in infusion pumps or external or implanted insulin pumps.

It must be remembered that insulin protamine crystals dissolve in an acid pH range.

Insulin label must always be checked before each injection to avoid medication errors between insulin human and other insulins (see section 4.4).

Mixing of insulins

Insuman Basal may be mixed with all insulin human formulations, but not with those designed specifically for use in insulin pumps. Concerning incompatibility with other insulins, see section 6.2.

If two different insulins have to be drawn into one single injection syringe, it is recommended that the shorter-acting insulin be drawn first to prevent contamination of the vial by the longer-acting preparation. It is advisable to inject immediately after mixing.

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

Insuman Basal 100 IU/ml in a cartridge

Insulin pen

The Insuman Basal cartridges are to be used only in conjunction with the pens: OptiPen, ClikSTAR, Autopen 24, Tactipen, AllStar , AllStar PRO or JuniorSTAR (see section 4.4). Not all of these pens may be marketed in your country.

The pen should be used as recommended in the information provided by the device manufacturer.

The manufacturer's instructions for using the pen must be followed carefully for loading the cartridge, attaching the injection needle, and administering the insulin injection.

If the insulin pen is damaged or not working properly (due to mechanical defects) it has to be discarded, and a new insulin pen has to be used.

If the pen malfunctions (see instructions for using the pen), the suspension may be drawn from the cartridge into an injection syringe (suitable for an insulin with 100 IU/ml) and injected.

Cartridges

Before insertion into the pen, Insuman Basal must be kept at room temperature for 1 to 2 hours and then resuspended to check the contents. This is best done by gently tilting the cartridge back and forth (at least ten times). Each cartridge contains three small metal balls to facilitate quick and thorough mixing of the contents.

Later on, when the cartridge has been inserted into the pen, the insulin must be resuspended again prior to each injection. This is best done by gently tilting the pen back and forth (at least ten times).

After resuspension, the fluid must have a uniformly milky appearance. Insuman Basal must not be used if this cannot be achieved, i.e. if the suspension remains clear, for example, or if clumps, particles or flocculation appear in the insulin or stick to the wall or bottom of the cartridge. These changes sometimes give the cartridge a frosted appearance. In such cases, a new cartridge yielding a uniform suspension must be used. It is also necessary to change to a new cartridge if the insulin requirement changes substantially.

Air bubbles must be removed from the cartridge before injection (see instructions for using the pen). Empty cartridges must not be refilled.

Insuman Basal must not be administered intravenously and must not be used in infusion pumps or external or implanted insulin pumps.

It must be remembered that insulin protamine crystals dissolve in an acid pH range.

Insulin label must always be checked before each injection to avoid medication errors between insulin human and other insulins (see section 4.4).

Mixing of insulins

Insuman Basal may be mixed with all insulin human formulations, but not with those designed specifically for use in insulin pumps. Concerning incompatibility with other insulins, see section 6.2.

Insuman Basal cartridges are not designed to allow any other insulin to be mixed in the cartridge.

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

Insuman Basal SoloStar 100 IU/ml in a pre-filled pen

Before first use, Insuman Basal must be kept at room temperature for 1 to 2 hours and then resuspended to check the contents. This is best done by gently tilting the pen back and forth (at least ten times). Each cartridge contains three small metal balls to facilitate quick and thorough mixing of the contents. Later on, the insulin must be resuspended again prior to each injection.

After resuspension, the fluid must have a uniformly milky appearance. Insuman Basal must not be used if this cannot be achieved, i.e. if the suspension remains clear, for example, or if clumps, particles or flocculation appear in the insulin or stick to the wall or bottom of the cartridge. These changes sometimes give the cartridge a frosted appearance. In such cases, a new pen yielding a uniform suspension must be used. It is also necessary to change to a new pen if the insulin requirement changes substantially.

Empty pens must never be re-used and must be properly discarded.

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

It must be remembered that insulin protamine crystals dissolve in an acid pH range.

Insulin label must always be checked before each injection to avoid medication errors between insulin human and other insulins (see section 4.4).

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

Before using the SoloStar pre-filled pen, the Instructions for Use included in the package leaflet must be read carefully.

7. Marketing authorisation holder

Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany

8. Marketing authorisation number(s)

EU/1/97/030/033

EU/1/97/030/035

EU/1/97/030/148

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 21 February 1997

Date of latest renewal: 21 February 2007

10. Date of revision of the text

29 June 2017

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

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Risk Materials
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Educational Risk Minimisation Materials to help reduce the risk associated with using this medicine.

Insuman HCP risk minimisation educational leaflet

HCP risk minimisation educational leaflet for
Insuman® Basal 100 IU/mL suspension for injection in a cartridge
Insuman® Comb 25 100 IU/mL suspension for injection in a cartridge
Insuman® Basal Solostar® 100 IU/mL suspension for injection in a pre-filled pen
Insuman® Comb 25 Solostar® 100 IU/mL suspension for injection in a pre-filled pen

For hard copies please contact our medical information department at 0845 372 7101 or email uk-medicalinformation@sanofi.com .

For Healthcare Professionals

Insuman Patient Organisation Letter

Patient Organisation Letter for
Insuman® Basal 100 IU/mL suspension for injection in a cartridge
Insuman® Comb 25 100 IU/mL suspension for injection in a cartridge
Insuman® Basal Solostar® 100 IU/mL suspension for injection in a pre-filled pen
Insuman® Comb 25 Solostar® 100 IU/mL suspension for injection in a pre-filled pen

For hard copies please contact our medical information department at 0845 372 7101 or email uk-medicalinformation@sanofi.com .

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Company contact details

SANOFI

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Address

1 Onslow Street, Guildford, Surrey, GU1 4YS, UK

Fax

+44 (0)1483 535 432

Medical Information e-mail
Telephone

+44 (0)1483 505 515

Medical Information Direct Line

+44 (0)845 372 7101

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Active ingredients

human insulin

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POM - Prescription Only Medicine

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