Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Toujeo (previously Optisulin)

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen · Abschnitt 4.3 · PDF-Seite 5

HOS-091276 · Präparat HOS-084253

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

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Toujeo (previously Optisulin)

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen · Abschnitt 4.5 · PDF-Seite 7

HOS-091277 · Präparat HOS-084253

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

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): glucose (HOS-088412)

Wechselwirkungen · Toujeo (previously Optisulin)

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen · Abschnitt 4.5 · PDF-Seite 7

HOS-091278 · Präparat HOS-084253

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

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): pentoxifylline (HOS-088586) propoxyphene (HOS-086140) fluoxetine (HOS-085946) disopyramide (HOS-085595)

Wechselwirkungen · Toujeo (previously Optisulin)

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen · Abschnitt 4.5 · PDF-Seite 7

HOS-091279 · Präparat HOS-084253

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

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): danazol (HOS-085473) diazoxide (HOS-088588) glucagon (HOS-088589) isoniazid (HOS-088590) somatropin (HOS-088591) epinephrine (HOS-088592) terbutaline (HOS-085475) clozapine (HOS-086149) olanzapine (HOS-085937) protease (HOS-085623)

Wechselwirkungen · Toujeo (previously Optisulin)

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen · Abschnitt 4.5 · PDF-Seite 7

HOS-091280 · Präparat HOS-084253

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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): clonidine (HOS-088594) lithium (HOS-085952) pentamidine (HOS-085605) guanethidine (HOS-088596) reserpine (HOS-088597)

Nebenwirkungen · Toujeo (previously Optisulin)

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 8

HOS-091281 · Präparat HOS-084253

Summary of the safety profile The following adverse reactions were observed during clinical studies conducted with Toujeo (see section 5.1) and during clinical experience with insulin glargine 100 units/ml. 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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Toujeo (previously Optisulin)

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 8

HOS-091282 · Präparat HOS-084253

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).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Toujeo (previously Optisulin)

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 8

HOS-091283 · Präparat HOS-084253

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

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Toujeo (previously Optisulin)

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 8

HOS-091284 · Präparat HOS-084253

MedDRA Very common Common Uncommon Rare Very Not known system organ rare classes Immune system Allergic disorders reactions Metabolism and Hypoglycaemia nutrition disorders Nervous system Dysgeusia disorders Eyes disorders Visual impairment

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Toujeo (previously Optisulin)

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 8

HOS-091285 · Präparat HOS-084253

Retinopathy Skin and Lipohypertrophy Lipoatrophy Cutaneous subcutaneous amyloidosis tissue disorders Musculoskeletal Myalgia and connective tissue disorders General Injection site Oedema disorders and reactions administration site conditions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Toujeo (previously Optisulin)

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 8–9

HOS-091286 · Präparat HOS-084253

8 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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Toujeo (previously Optisulin)

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 9

HOS-091287 · Präparat HOS-084253

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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Toujeo (previously Optisulin)

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 9

HOS-091288 · Präparat HOS-084253

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, angio-oedema, bronchospasm, hypotension and shock, and may be life-threatening. In Toujeo clinical studies in adult patients, the incidence of allergic reactions was similar in Toujeo-treated patients (5.3%) and insulin glargine 100 units/ml-treated patients (4.5%).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Toujeo (previously Optisulin)

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 9

HOS-091289 · Präparat HOS-084253

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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Toujeo (previously Optisulin)

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 9

HOS-091290 · Präparat HOS-084253

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.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Toujeo (previously Optisulin)

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 9

HOS-091291 · Präparat HOS-084253

Skin and subcutaneous tissue disorders Lipodystrophy and cutaneous amyloidosis 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 (see section 4.4).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Toujeo (previously Optisulin)

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 9

HOS-091292 · Präparat HOS-084253

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. In Toujeo clinical studies in adult patients, the incidence of injection site reactions was similar in Toujeo-treated patients (2.5%) and insulin glargine 100 units/ml-treated patients (2.8%).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Toujeo (previously Optisulin)

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 9

HOS-091293 · Präparat HOS-084253

Rarely, insulin may cause oedema particularly if previously poor metabolic control is improved by intensified insulin therapy.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Toujeo (previously Optisulin)

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 9

HOS-091294 · Präparat HOS-084253

Paediatric population Safety and efficacy of Toujeo have been demonstrated in a study in children aged 6 to less than 18 years. The frequency, type and severity of adverse reactions in the paediatric population do not indicate differences to the experience in the general diabetes population (see section 5.1). Clinical study safety data are not available for children under 6 years.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Toujeo (previously Optisulin)

Toujeo 300 units/ml SoloStar, solution for injection in a pre-filled pen Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen · Abschnitt 4.8 · PDF-Seite 9

HOS-091295 · Präparat HOS-084253

Other special populations Based on the results from clinical studies, the safety profile of Toujeo in elderly patients and in patients with renal impairment was similar to that of the overall population (see section 5.1).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.