Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Tresiba

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 100 units/mL FlexPen solution for injection in pre-filled pen Tresiba 100 units/mL Penfill solution for injection in cartridge · Abschnitt 4.3 · PDF-Seite 5

HOS-126562 · Präparat HOS-096277

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 · Tresiba

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 100 units/mL FlexPen solution for injection in pre-filled pen Tresiba 100 units/mL Penfill solution for injection in cartridge · Abschnitt 4.5 · PDF-Seite 6

HOS-126563 · Präparat HOS-096277

A number of medicinal products are known to interact with glucose metabolism.

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 · Tresiba

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 100 units/mL FlexPen solution for injection in pre-filled pen Tresiba 100 units/mL Penfill solution for injection in cartridge · Abschnitt 4.5 · PDF-Seite 6

HOS-126564 · Präparat HOS-096277

The following substances may reduce the insulin requirement Oral antidiabetic medicinal products, GLP-1 receptor agonists, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulfonamides.

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

Wechselwirkungen · Tresiba

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 100 units/mL FlexPen solution for injection in pre-filled pen Tresiba 100 units/mL Penfill solution for injection in cartridge · Abschnitt 4.5 · PDF-Seite 6–7

HOS-126565 · Präparat HOS-096277

6 The following substances may increase the insulin requirement Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.

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)

Wechselwirkungen · Tresiba

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 100 units/mL FlexPen solution for injection in pre-filled pen Tresiba 100 units/mL Penfill solution for injection in cartridge · Abschnitt 4.5 · PDF-Seite 7

HOS-126566 · Präparat HOS-096277

Beta-blockers may mask the symptoms of hypoglycaemia.

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

Wechselwirkungen · Tresiba

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 100 units/mL FlexPen solution for injection in pre-filled pen Tresiba 100 units/mL Penfill solution for injection in cartridge · Abschnitt 4.5 · PDF-Seite 7

HOS-126567 · Präparat HOS-096277

Octreotide/lanreotide may either increase or decrease the insulin requirement.

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): lanreotide (HOS-090210) octreotide (HOS-085481)

Wechselwirkungen · Tresiba

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 100 units/mL FlexPen solution for injection in pre-filled pen Tresiba 100 units/mL Penfill solution for injection in cartridge · Abschnitt 4.5 · PDF-Seite 7

HOS-126570 · Präparat HOS-096277

Alcohol may intensify or reduce the hypoglycaemic effect of insulin.

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

Nebenwirkungen · Tresiba

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 100 units/mL FlexPen solution for injection in pre-filled pen Tresiba 100 units/mL Penfill solution for injection in cartridge · Abschnitt 4.8 · PDF-Seite 7

HOS-126571 · Präparat HOS-096277

Summary of the safety profile The most frequently reported adverse reaction during treatment is hypoglycaemia (see section ‘Description of selected adverse reactions’ below).

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

Nebenwirkungen · Tresiba

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 100 units/mL FlexPen solution for injection in pre-filled pen Tresiba 100 units/mL Penfill solution for injection in cartridge · Abschnitt 4.8 · PDF-Seite 7

HOS-126572 · Präparat HOS-096277

Tabulated list of adverse reactions Adverse reactions listed below are based on clinical trial data and classified according to MedDRA

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

Nebenwirkungen · Tresiba

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 100 units/mL FlexPen solution for injection in pre-filled pen Tresiba 100 units/mL Penfill solution for injection in cartridge · Abschnitt 4.8 · PDF-Seite 7–8

HOS-126573 · Präparat HOS-096277

7 System Organ Class. Frequency categories are defined according to the following convention: 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) and 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 · Tresiba

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 100 units/mL FlexPen solution for injection in pre-filled pen Tresiba 100 units/mL Penfill solution for injection in cartridge · Abschnitt 4.8 · PDF-Seite 8

HOS-126574 · Präparat HOS-096277

System organ class Frequency Adverse reaction Immune system disorders Rare Hypersensitivity Urticaria Metabolism and nutrition disorders Very common Hypoglycaemia Skin and subcutaneous tissue disorders Uncommon Lipodystrophy Not known Cutaneous amyloidosis† General disorders and administration site conditions Common Injection site reactions Uncommon Peripheral oedema † ADR from postmarketing sources.

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

Nebenwirkungen · Tresiba

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 100 units/mL FlexPen solution for injection in pre-filled pen Tresiba 100 units/mL Penfill solution for injection in cartridge · Abschnitt 4.8 · PDF-Seite 8

HOS-126575 · Präparat HOS-096277

Description of selected adverse reactions Immune system disorders With insulin preparations, allergic reactions may occur. Immediate-type allergic reactions to either insulin itself or the excipients may potentially be life-threatening.

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

Nebenwirkungen · Tresiba

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 100 units/mL FlexPen solution for injection in pre-filled pen Tresiba 100 units/mL Penfill solution for injection in cartridge · Abschnitt 4.8 · PDF-Seite 8

HOS-126576 · Präparat HOS-096277

With Tresiba, hypersensitivity (manifested with swelling of tongue and lips, diarrhoea, nausea, tiredness and itching) and urticaria were reported rarely.

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

Nebenwirkungen · Tresiba

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 100 units/mL FlexPen solution for injection in pre-filled pen Tresiba 100 units/mL Penfill solution for injection in cartridge · Abschnitt 4.8 · PDF-Seite 8

HOS-126577 · Präparat HOS-096277

Hypoglycaemia Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. Severe hypoglycaemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death. The symptoms of hypoglycaemia usually occur suddenly. They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.

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

Nebenwirkungen · Tresiba

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 100 units/mL FlexPen solution for injection in pre-filled pen Tresiba 100 units/mL Penfill solution for injection in cartridge · Abschnitt 4.8 · PDF-Seite 8

HOS-126578 · Präparat HOS-096277

Skin and subcutaneous tissue disorders Lipodystrophy (including lipohypertrophy, lipoatrophy) 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 · Tresiba

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 100 units/mL FlexPen solution for injection in pre-filled pen Tresiba 100 units/mL Penfill solution for injection in cartridge · Abschnitt 4.8 · PDF-Seite 8

HOS-126579 · Präparat HOS-096277

Injection site reactions Injection site reactions (including injection site haematoma, pain, haemorrhage, erythema, nodules, swelling, discolouration, pruritus, warmth and injection site mass) occurred in patients treated with Tresiba. These reactions are usually mild and transitory and they normally disappear during continued treatment.

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

Nebenwirkungen · Tresiba

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 100 units/mL FlexPen solution for injection in pre-filled pen Tresiba 100 units/mL Penfill solution for injection in cartridge · Abschnitt 4.8 · PDF-Seite 8

HOS-126580 · Präparat HOS-096277

Paediatric population Tresiba has been administered to children and adolescents up to 18 years of age for the investigation of pharmacokinetic properties (see section 5.2). Safety and efficacy have been demonstrated in a long term trial in children aged 1 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).

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

Nebenwirkungen · Tresiba

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 100 units/mL FlexPen solution for injection in pre-filled pen Tresiba 100 units/mL Penfill solution for injection in cartridge · Abschnitt 4.8 · PDF-Seite 8

HOS-126581 · Präparat HOS-096277

Other special populations Based on results from clinical trials, the frequency, type and severity of adverse reactions observed in elderly and in patients with renal or hepatic impairment do not indicate any differences to the broader experience in the general population.

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

Nebenwirkungen · Tresiba

Tresiba 100 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 200 units/mL FlexTouch solution for injection in pre-filled pen Tresiba 100 units/mL FlexPen solution for injection in pre-filled pen Tresiba 100 units/mL Penfill solution for injection in cartridge · Abschnitt 4.8 · PDF-Seite 8–9

HOS-126582 · Präparat HOS-096277

8 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 listed in Appendix V.

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