Lantus Solostar

Lantus Solostar

insulin glargine

Manufacturer:

sanofi-aventis

Distributor:

DKSH
Full Prescribing Info
Contents
Insulin glargine.
Description
Each mL contains 100 units insulin glargine (equivalent to 3.64 mg). It also contains the following excipients: Zinc chloride, m-cresol, glycerol, hydrochloric acid, sodium hydroxide and water for injection. Each pen contains 3 mL of solution for injection, equivalent to 300 units.
Action
ATC Code: A10AE04.
Long-acting insulin.
Pharmacology: Pharmacodynamics: Mechanism of Action: Insulin glargine is a human insulin analogue designed to have a low solubility at neutral pH. It is completely soluble at the acidic pH of the Lantus injection solution (pH 4). After injection into the SC tissue, the acidic solution is neutralised leading to formation of microprecipitates from which small amounts of insulin glargine are continuously released, providing a smooth, peakless, predictable concentration/time profile with a prolonged duration of action.
Insulin glargine is metabolised into 2 active metabolites M1 and M2.
Insulin-Receptor Binding: In vitro studies indicate that the affinity of insulin glargine and its metabolites M1 and M2 for the human insulin receptor is similar to the one of human insulin.
IGF-1 Receptor Binding: The affinity of insulin glargine for the human IGF-1 receptor is approximately 5-8 fold greater than that of human insulin (but approximately 70-80 fold lower than the one of IGF-1), whereas M1 and M2 bind the IGF-1 receptor with slightly lower affinity compared to human insulin.
The total therapeutic insulin concentration (insulin glargine and its metabolites) found in type 1 diabetic patients was markedly lower than what would be required for a half maximal occupation of the IGF-1 receptor and the subsequent activation of the mitogenic-proliferative pathway initiated by the IGF-1 receptor. Physiological concentrations of endogenous IGF-1 may activate the mitogenic-proliferative pathway; however, the therapeutic concentrations found in insulin therapy, including in Lantus therapy, are considerably lower than the pharmacological concentrations required to activate the IGF-1 pathway.
The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogues lower blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis and enhances protein synthesis.
In clinical pharmacology studies, IV insulin glargine and human insulin have been shown to be equipotent when given at the same doses. As with all insulins, the time course of action of insulin glargine may be affected by physical activity and other variables.
In euglycaemic clamp studies in healthy subjects or in patients with type 1 diabetes, the onset of action of SC insulin glargine was slower than with human NPH insulin, its effect profile was smooth and peakless, and the duration of its effect was prolonged.
The figure shows the results from a study in patients:

Click on icon to see table/diagram/image

The longer duration of action of SC insulin glargine is directly related to its slower rate of absorption and supports once daily administration. The time course of action of insulin and insulin analogues eg, insulin glargine may vary considerably in different individuals or within the same individual.
In a clinical study, symptoms of hypoglycaemia or counter-regulatory hormone responses were similar after IV insulin glargine and human insulin both in healthy volunteers and patients with type 1 diabetes.
Effects of insulin glargine (once daily) on diabetic retinopathy were evaluated in an open-label 5 year NPH-controlled study (NPH given twice daily) in 1024 type 2 diabetic patients in which progression of retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study (ETDRS) scale was investigated by fundus photography. No significant difference was seen in the progression of diabetic retinopathy when insulin glargine was compared to NPH insulin.
The ORIGIN (Outcome Reduction with Initial Glargine INtervention) study was a multicenter, randomized, 2x2 factorial design study conducted in 12,537 participants at high cardiovascular (CV) risk with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) (12% of participants) or type 2 diabetes mellitus treated with ≤1 antidiabetic oral agent (88% of participants). Participants were randomized (1:1) to receive insulin glargine (n=6264), titrated to reach FPG ≤95 mg/dL (5.3 mM), or standard care (n=6273).
The 1st co-primary efficacy outcome was the time to the first occurrence of CV death, nonfatal myocardial infarction (MI), or nonfatal stroke, and the 2nd co-primary efficacy outcome was the time to the 1st occurrence of any of the first co-primary events, or revascularisation procedure (coronary, carotid, or peripheral), or hospitalisation for heart failure.
Secondary endpoints included all-cause mortality and a composite microvascular outcome.
Insulin glargine did not alter the relative risk for CV disease and CV mortality when compared to standard of care. There were no differences between insulin glargine and standard care for the two co-primary outcomes; for any component endpoint comprising these outcomes; for all-cause mortality; or for the composite microvascular outcome.
Mean dose of insulin glargine by study end was 0.42 U/kg. At baseline, participants had a median HbA1c value of 6.4% and median on-treatment HbA1c values ranged from 5.9-6.4% in the insulin glargine group, and 6.2-6.6% in the standard care group throughout the duration of follow-up. The rates of severe hypoglycaemia (affected participants per 100 participant years of exposure) were 1.05 for insulin glargine and 0.3 for standard care group and the rates of confirmed nonsevere hypoglycaemia were 7.71 for insulin glargine and 2.44 for standard care group. Over the course of this 6-year study, 42% of the insulin glargine group did not experience any hypoglycaemia.
At the last on-treatment visit, there was a mean increase in body weight from baseline of 1.4 kg in the insulin glargine group and a mean decrease of 0.8 kg in the standard care group.
Paediatric Population: In a randomized, controlled clinical study, paediatric patients (range 6-15 years) with type 1 diabetes (n=349) were treated for 28 weeks with a basal-bolus insulin regimen where regular human insulin was used before each meal. Insulin glargine was administered once daily at bedtime and NPH human insulin was administered once or twice daily. Similar effects on glycohemoglobin and the incidence of symptomatic hypoglycemia were observed in both treatment groups, however, fasting plasma glucose decreased more from baseline in the insulin glargine group than in the NPH group. There was less severe hypoglycaemia in the insulin glargine group as well. One hundred forty three (143) of the patients treated with insulin glargine in this study continued treatment with insulin glargine in an uncontrolled extension study with mean duration of follow-up of 2 years. No new safety signals were seen during this extended treatment with insulin glargine.
A crossover study comparing insulin glargine plus lispro insulin to NPH plus regular human insulin (each treatment administered for 16 weeks in random order) in 26 adolescent type 1 diabetic patients 12-18 years was also performed. As in the paediatric study described above, fasting plasma glucose reduction from baseline was greater in the insulin glargine group than in the NPH group. HbA1c changes from baseline were similar between treatment groups; however blood glucose values recorded overnight were significantly higher in the insulin glargine/ lispro group than the NPH/regular group, with a mean nadir of 5.4 mM vs 4.1 mM. Correspondingly, the incidences of nocturnal hypoglycaemia were 32% in the insulin glargine/lispro group vs 52% in the NPH / regular group.
A 24-week parallel group study was conducted in 125 children with type 1 diabetes mellitus 2-6 years, comparing insulin glargine given once daily in the morning to NPH insulin given once or twice daily as basal insulin. Both groups received bolus insulin before meals.
The primary aim of demonstrating non-inferiority of insulin glargine to NPH in all hypoglycaemia was not met and there was a trend to an increase of hypoglycemic events with insulin glargine [insulin glargine: NPH rate ratio (95% CI)=1.18 (0.97-1.44)].
Glycohaemoglobin and glucose variabilities were comparable in both treatment groups. No new safety signals were observed in this study.
Pharmacokinetics: In healthy subjects and diabetic patients, insulin serum concentrations indicated a slower and much more prolonged absorption and showed a lack of a peak after SC injection of insulin glargine in comparison to human NPH insulin. Concentrations were thus consistent with the time profile of the pharmacodynamic activity of insulin glargine. The previous figure shows the activity profiles over time of insulin glargine and NPH insulin.
Insulin glargine injected once daily will reach steady-state levels in 2-4 days after the 1st dose.
When given intravenously, the elimination half-life of insulin glargine and human insulin were comparable.
After SC injection of Lantus in diabetic patients, insulin glargine is rapidly metabolized at the carboxyl terminus of the Beta chain with formation of two active metabolites M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin). In plasma, the principal circulating compound is the metabolite M1.
The exposure to M1 increases with the administered dose of Lantus. The pharmacokinetic and pharmacodynamic findings indicate that the effect of the subcutaneous injection with Lantus is principally based on exposure to M1. Insulin glargine and the metabolite M2 were not detectable in the vast majority of subjects and, when they were detectable their concentration was independent of the administered dose of Lantus.
In clinical studies, subgroup analyses based on age and gender did not indicate any difference in safety and efficacy in insulin glargine-treated patients compared to the entire study population.
Paediatric Population: Pharmacokinetics in children 2 to <6 years with type 1 diabetes mellitus was assessed in 1 clinical study. Plasma "trough" levels of insulin glargine and its main M1 and M2 metabolites were measured in children treated with insulin glargine, revealing plasma concentration patterns similar to adults, and providing no evidence for accumulation of insulin glargine or its metabolites with chronic dosing.
Indications/Uses
Treatment of diabetes mellitus in adults, adolescents and children ≥2 years.
Dosage/Direction for Use
Lantus contains insulin glargine, an insulin analogue, and has a prolonged duration of action. Lantus should be administered once daily at any time but at the same time each day.
The Lantus dose regimen (dose and timing) should be individually adjusted. In patients with type 2 diabetes mellitus, Lantus can also be given together with orally active antidiabetic medicinal products. The potency of this medicinal product is stated in units. These units are exclusive to Lantus and are not the same as IU or the units used to express the potency of other insulin analogues.
Special Population: Elderly (≥65 years): 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 hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.
Paediatric Population: Safety and efficacy of Lantus have been established in adolescents and children ≥2 years. Lantus has not been studied in children <2 years.
Transition from Other Insulins to Lantus: When changing from a treatment regimen with an intermediate or long-acting insulin to a regimen with Lantus, a change of the dose of the basal insulin may be required and the concomitant antidiabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fast-acting insulin analogues or the dose of oral antidiabetic medicinal products).
To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from a twice daily NPH insulin to a once daily regimen with Lantus should reduce their 2 daily dose of basal insulin by 20-30% during the 1st weeks of treatment.
During the 1st weeks the reduction should, at least partially, be compensated by an increase in mealtime insulin, after this period the regimen should be adjusted individually.
As with other insulin analogues, patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with Lantus.
Close metabolic monitoring is recommended during the transition and in the initial weeks thereafter.
With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dose regimen may become necessary. Dose adjustment may also be required, ie, if the patient's weight or life-style changes, change of timing of insulin dose or other circumstances arise that increase susceptibility to hypo-or hyperglycaemia.
Administration: Lantus is administered SC. Lantus should not be administered IV. The prolonged duration of action of Lantus is dependent on its injection into SC tissue. IV administration of the usual SC dose could result in severe hypoglycaemia. There are no clinically relevant differences in serum insulin or glucose levels after abdominal, deltoid or thigh administration of Lantus. Injection sites must be rotated within a given injection area from 1 injection to the next. Lantus must not be mixed with any other insulin or diluted. Mixing or diluting can change its time/action profile and mixing can cause precipitation. Before using Solostar, the Instructions for Use included in the package insert must be read carefully.
Overdosage
Insulin overdose may lead to severe and sometimes, long-term and life-threatening hypoglycaemia. Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates. Adjustments in dosage, meal patterns or physical activity may be necessary. More severe episodes with coma, seizure or neurologic impairment may be treated with glucagon (IM or SC) or concentrated glucose solution (IV). Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.
Contraindications
Hypersensitivity to insulin glargine or to any of the excipients of Lantus.
Special Precautions
Lantus is not the insulin of choice for the treatment of diabetic ketoacidosis. Instead, regular insulin administered IV is recommended in such cases.
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.
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.
Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia.
Hypoglycaemia: The time of occurrence of hypoglycaemia depends on the action profile of the insulins used and may, therefore, change when the treatment regimen is changed. Due to more sustained basal insulin supply with Lantus Solostar, less nocturnal but early morning hypoglycaemia can be expected.
Particular caution should be exercised and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance eg, 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 the 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 product (see Interactions).
Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia.
The prolonged effect of SC insulin glargine may delay recovery from hypoglycaemia.
If normal or deceased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognized (especially nocturnal) episodes of hypoglycaemia must be considered.
Adherence of the patient to the dosage and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycemia. 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 (by eg, removal of stress factors); unaccustomed, increased or prolonged physical activity; intercurrent illness (eg, vomiting, diarrhea); inadequate food intake; missed meals; alcohol consumption; certain uncompensated endocrine disorders (eg, in hypothyroidism and in anterior pituitary or adrenocortical insufficiency) and concomitant treatment with certain other medicinal products.
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.
Handling of the Pen: Before using Solostar, the Instructions for Use included in the package insert must be read carefully. Solostar has to be used as recommended in these Instructions for Use.
Medication Errors: Medication errors have been reported in which other insulins, particularly short-acting insulins, have been accidentally administered instead of insulin glargine. Insulin label must always be checked before each injection to avoid medication errors between insulin glargine and other insulins.
Effects on the Ability to Drive or Operate Machinery: The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or ie, as a result of visual impairment. This may constitute a risk in situations where these abilities are of special importance (eg, driving a car or operating 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 operate machines in these circumstances.
Impairment of Fertility: Animal studies do not indicate direct harmful effects with respect to fertility.
Use in pregnancy: For insulin glargine, no clinical data on exposed pregnancies from controlled clinical trials are available.
A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicate no specific adverse effects of insulin glargine on pregnancy and no specific malformative nor feto/neonatal toxicity of insulin glargine.
Animal data do not indicate reproductive toxicity.
The use of Lantus may be considered during pregnancy, if necessary.
It is essential for patients with preexisting or gestational diabetes to maintain good metabolic control throughout pregnancy. Insulin requirements may decrease during the 1st trimester and generally increase during the 2nd and 3rd trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential.
Use in lactation: It is unknown whether insulin glargine is excreted in human milk. No metabolic effects of ingested insulin glargine on the breastfed newborn/infant are anticipated since insulin glargine as a peptide is digested into aminoacids in the human gastrointestinal tract.
Breastfeeding women may require adjustments in insulin dose and diet.
Use In Pregnancy & Lactation
Use in pregnancy: For insulin glargine, no clinical data on exposed pregnancies from controlled clinical trials are available.
A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicate no specific adverse effects of insulin glargine on pregnancy and no specific malformative nor feto/neonatal toxicity of insulin glargine.
Animal data do not indicate reproductive toxicity.
The use of Lantus may be considered during pregnancy, if necessary.
It is essential for patients with preexisting or gestational diabetes to maintain good metabolic control throughout pregnancy. Insulin requirements may decrease during the 1st trimester and generally increase during the 2nd and 3rd trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential.
Use in lactation: It is unknown whether insulin glargine is excreted in human milk. No metabolic effects of ingested insulin glargine on the breastfed newborn/infant are anticipated since insulin glargine as a peptide is digested into aminoacids in the human gastrointestinal tract.
Breastfeeding women may require adjustments in insulin dose and diet.
Adverse Reactions
Hypoglycaemia, in general, the most frequent undesirable effect of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
The following related adverse reactions from clinical investigations were listed as follows by system organ class and in order of decreasing incidence (Very Common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1000 to <1/100; rare: ≥1/10,000 to <1/1000; very rare: <1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Click on icon to see table/diagram/image

Description of Selected Adverse Reactions: 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 counterregulation. Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counterregulation and its symptoms.
Immune System Disorders: Immediate-type allergic reactions to insulin are rare. Such reactions to insulin (including insulin glargine) or the excipients may, for example, be associated with generalised skin reactions, angioedema, bronchospasm, hypotension and shock, and may be life-threatening.
Insulin administration may cause insulin antibodies to form. In clinical studies, antibodies that crossreact with human insulin and insulin glargine were observed with the same frequency in both NPH insulin and insulin glargine treatment groups. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia.
Eye 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. In patients with proliferative retinopathy, particularly if not treated with photocoagulation, severe hypoglycaemic episodes may result in transient amaurosis.
Skin and Subcutaneous Tissue Disorders: As with any insulin therapy, 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: Injection site reactions include redness, pain, itching, hives, swelling or inflammation. Most minor reactions to insulins at the injection site usually resolve in a few days to a few weeks.
Rarely, insulin may cause sodium retention and oedema particularly if previously poor metabolic control is improved by intensified insulin therapy.
Paediatric Population: In general, the safety profile for children and adolescents (≤18 years) is similar to the safety profile for adults.
The adverse reaction reports received from post-marketing surveillance included relatively more frequent injection site reactions (injection site pain, injection site reaction), and skin reactions (rash, urticaria) in children and adolescents (≤18 years) than in adults.
Clinical study safety data are not available for children <2 years.
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 the national reporting system.
Drug Interactions
A number of substances affect glucose metabolism and may require dose adjustment of insulin glargine.
Substances that may enhance the blood glucose-lowering agent and increase susceptibility to hypoglycaemia include oral antidiabetic agents, angiotensin-converting enzyme inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, propoxyphene, salicyclates and sulfonamide antibiotics.
Substances that may reduce the blood glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagons, isoniazid, oestrogens and progestogens, phhenothiazine derivatives, somatropin, sympathomimetic agents [eg, ephinephrine (adrenaline), salbutamol, terbutaline], thyroid hormones, atypical antipsychotic medicinal products (eg, clozapine and olanzapine) and protease inhibitors.
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 eg, β-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counterregulation may be reduced or absent.
Caution For Usage
Instructions for Use, Disposal and Other Handling: Before 1st use, the pen must be stored at room temperature for 1-2 hrs.
Inspect the cartridge before use. It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency. Since Lantus is a solution, it does not require resuspension before use.
Lantus must not be mixed with any other insulin or diluted. Mixing or diluting can change its time/action profile and mixing can cause precipitation.
Empty pens must never be reused and must be properly discarded.
To prevent the possible transmission of disease, each pen must be used by 1 patient only.
Insulin label must always be checked before each injection to avoid medication errors between insulin glargine and other insulins.
Storage
Unopened: Store in a refrigerator (2°-8°C). Do not freeze. Do not place Lantus next to the freezer compartment or a freezer pack. Keep the pre-filled pen in the outer carton in order to protect from light.
In Use Conditions: Shelf-Life after 1st Use: Lantus SoloStar may be stored for a maximum of 4 weeks not above 30°C away from direct heat or direct light. 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.
ATC Classification
A10AE04 - insulin glargine ; Belongs to the class of long-acting insulins and analogues for injection. Used in the treatment of diabetes.
Presentation/Packing
Soln for inj (pre-filled pen) 100 units/mL x 3 mL x 5's.
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