Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Somavert

SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection · Abschnitt 4.3 · PDF-Seite 4

HOS-110275 · Präparat HOS-093355

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 · Somavert

SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection · Abschnitt 4.5 · PDF-Seite 6

HOS-110276 · Präparat HOS-093355

No interaction studies have been performed. It should be considered whether to continue treatment with somatostatin analogues. The use of this medicine in combination with other medicinal products for the treatment of acromegaly has not been extensively investigated.

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): somatostatin (HOS-110277)

Wechselwirkungen · Somavert

SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection · Abschnitt 4.5 · PDF-Seite 6

HOS-110278 · Präparat HOS-093355

Patients receiving insulin or oral hypoglycaemic medicinal products may require dose reduction of these active substances due to the effect of pegvisomant on insulin sensitivity (see section 4.4).

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

Wechselwirkungen · Somavert

SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection · Abschnitt 4.5 · PDF-Seite 6

HOS-110279 · Präparat HOS-093355

Pegvisomant has significant structural similarity to growth hormone which causes it to cross-react in commercially available growth hormone assays. Since serum concentrations of therapeutically-effective doses of this medicine are generally 100 to 1 000 times higher than the actual serum growth hormone concentrations seen in acromegalics, measurements of serum growth hormone concentrations will be spuriously reported in commercially available growth hormone assays. Pegvisomant treatment should therefore not be monitored or adjusted based on serum growth hormone concentrations reported from these assays.

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

Nebenwirkungen · Somavert

SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-110280 · Präparat HOS-093355

Summary of the safety profile

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

Nebenwirkungen · Somavert

SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-110281 · Präparat HOS-093355

The list below contains adverse reactions seen in clinical trials with SOMAVERT.

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

Nebenwirkungen · Somavert

SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-110282 · Präparat HOS-093355

In clinical studies, for patients treated with pegvisomant (n = 550), the majority of adverse reactions to pegvisomant were of mild to moderate intensity, of limited duration and did not require discontinuation of treatment.

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

Nebenwirkungen · Somavert

SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-110283 · Präparat HOS-093355

The most commonly reported adverse reactions occurring in  10% of patients with acromegaly treated with pegvisomant during the clinical trials were headache 25%, arthralgia 16% and diarrhoea 13%.

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

Nebenwirkungen · Somavert

SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-110284 · Präparat HOS-093355

Tabulated list of adverse reactions

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

Nebenwirkungen · Somavert

SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-110285 · Präparat HOS-093355

The list below contains adverse reactions seen in clinical trials or that were spontaneously reported, classified by system organ class and frequency.

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

Nebenwirkungen · Somavert

SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-110286 · Präparat HOS-093355

Adverse reactions are listed according to the following categories: Very common:  1/10 Common:  1/100 to < 1/10 Uncommon:  1/1 000 to < 1/100 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 · Somavert

SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7

HOS-110287 · Präparat HOS-093355

System Organ Class Very Common Uncommon Frequency Common (≥ 1/100 to (≥ 1/1 000 to Not Known (≥ 1/10) < 1/10) < 1/100) (Cannot Be Estimated From Available Data) Blood and lymphatic thrombocytopenia, system disorders leukopenia, leukocytosis, haemorrhagic diathesis Immune system hypersensitivity anaphylactic disorders reactionsb reactionb, anaphylactoid reactionb

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

Nebenwirkungen · Somavert

SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 7–8

HOS-110288 · Präparat HOS-093355

7 System Organ Class Very Common Uncommon Frequency Common (≥ 1/100 to (≥ 1/1 000 to Not Known (≥ 1/10) < 1/10) < 1/100) (Cannot Be Estimated From Available Data) Metabolism and hypercholesterol hypertriglyceridemia nutrition disorders aemia, hyperglycaemia, hypoglycaemia, weight increased Psychiatric disorders abnormal panic attack, short anger dreams term memory loss, apathy, confusion, sleep disorder, libido increased Nervous system headache somnolence, narcolepsy, disorders tremor, migraine, dysgeusia dizziness, hypoaesthesia Eye disorders eye pain asthenopia Ear and labyrinth Meniere’s disease disorders Cardiac disorders oedema peripheral Vascular disorders hypertension Respiratory, thoracic dyspnoea laryngospasmb and mediastinal disorders Gastrointestinal diarrhoea vomiting, haemorrhoids, disorders constipation, salivary nausea, hypersecretion, dry abdominal mouth, tooth distension, disorder dyspepsia, flatulence Hepatobiliary abnormal liver disorders function tests (e.g. transaminase elevation) (see section 4.4) Skin and hyperhidrosis, face oedema, dry angioedemab subcutaneous tissue contusion, skin, increased disorders pruritusb, rashb tendency to bruise, night sweats, erythemab, urticariab Musculoskeletal and arthralgia myalgia, arthritis connective tissue disorders Renal and urinary haematuria proteinuria, disorders polyuria, renal impairment

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

Nebenwirkungen · Somavert

SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 8–9

HOS-110289 · Präparat HOS-093355

8  System Organ Class Very Common Uncommon Frequency Common (≥ 1/100 to (≥ 1/1 000 to Not Known (≥ 1/10) < 1/10) < 1/100) (Cannot Be Estimated From Available Data) General disorders and injection site feeling abnormal, administration site reaction impaired healing, conditions (including hunger injection site hypersensitivity) , injection site bruising or bleeding, injection site hypertrophy (e.g. lipohypertr ophy)a, influenza-like illness, fatigue, asthenia, pyrexia a see Description of selected adverse reactions below b ADR related to hypersensitivity reaction

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

Nebenwirkungen · Somavert

SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-110290 · Präparat HOS-093355

Description of selected adverse reactions

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

Nebenwirkungen · Somavert

SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-110291 · Präparat HOS-093355

Most injection site reactions characterised as localised erythemas and soreness, spontaneously resolved with local symptomatic treatment, while pegvisomant therapy continued. Occurrence of injection site hypertrophy has been observed, including lipohypertrophy.

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

Nebenwirkungen · Somavert

SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-110292 · Präparat HOS-093355

The development of isolated low-titre anti-growth hormone antibodies was observed in 16.9% of patients treated with pegvisomant. The clinical significance of these antibodies is unknown.

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

Nebenwirkungen · Somavert

SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-110293 · Präparat HOS-093355

Systemic hypersensitivity reactions including anaphylactic/anaphylactoid reactions, laryngospasm, angioedema, generalised skin reactions (rash, erythema, pruritus, urticaria) have been reported in post marketing use. Some patients required hospitalisation. Upon re-administration, symptoms did not re-occur in all patients.

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

Nebenwirkungen · Somavert

SOMAVERT 10 mg powder and solvent for solution for injection SOMAVERT 15 mg powder and solvent for solution for injection SOMAVERT 20 mg powder and solvent for solution for injection SOMAVERT 25 mg powder and solvent for solution for injection SOMAVERT 30 mg powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-110294 · Präparat HOS-093355

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.