Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Pedea

Pedea 5 mg/ml solution for injection · Abschnitt 4.3 · PDF-Seite 3

HOS-112954 · Präparat HOS-093805

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; - Life-threatening infection; - Active bleeding, especially intracranial or gastrointestinal haemorrhage; - Thrombocytopenia or coagulation defects; - Significant impairment of renal function; - Congenital heart disease in which patency of the ductus arteriosus is necessary for satisfactory pulmonary or systemic blood flow (e.g. pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta); - Known or suspected necrotising enterocolitis;

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

Wechselwirkungen · Pedea

Pedea 5 mg/ml solution for injection · Abschnitt 4.5 · PDF-Seite 4

HOS-112955 · Präparat HOS-093805

The concomitant use of Pedea with the following medicinal products is not recommended: - diuretics: ibuprofen may reduce the effect of diuretics; diuretics can increase the risk of nephrotoxicity of NSAIDs in dehydrated patients. - anticoagulants: ibuprofen may increase the effect of anticoagulants and enhance the risk of bleeding. - corticosteroids: ibuprofen may increase the risk of gastrointestinal bleeding. - nitric oxide: since both medicinal products inhibit platelet function, their combination may in theory increase the risk of bleeding. - other NSAIDs: the concomitant use of more than one NSAID should be avoided because of the increased risk of adverse reactions. - aminoglycosides: since ibuprofen may decrease the clearance of aminoglycosides, their co- administration may increase the risk of nephrotoxicity and ototoxicity (see section 4.4).

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): nitric oxide (HOS-088773)

Nebenwirkungen · Pedea

Pedea 5 mg/ml solution for injection · Abschnitt 4.8 · PDF-Seite 4

HOS-112956 · Präparat HOS-093805

Data are currently available on approximately 1,000 preterm newborn from both the literature concerning ibuprofen and clinical trials with Pedea. Causality of adverse events reported in the preterm newborn is difficult to assess since they may be related to the haemodynamic consequences of the patent ductus arteriosus as well as to direct effects of ibuprofen.

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

Nebenwirkungen · Pedea

Pedea 5 mg/ml solution for injection · Abschnitt 4.8 · PDF-Seite 4

HOS-112957 · Präparat HOS-093805

Reported adverse reactions are listed below, by system organ class and by frequency. Frequencies are defined as: very common (≥ 1/10), common (≥1/100, <1/10) and uncommon (≥1/1,000, <1/100). 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 · Pedea

Pedea 5 mg/ml solution for injection · Abschnitt 4.8 · PDF-Seite 4

HOS-112958 · Präparat HOS-093805

Blood and lymphatic system disorders Very common: Thrombocytopenia, Neutropenia Nervous system disorders Common: Intraventricular haemorrhage, Periventricular leukomalacia Respiratory, thoracic and mediastinal Very common: Bronchopulmonary dysplasia* disorders Common: Pulmonary haemorrhage Uncommon: Hypoxemia* Gastrointestinal disorders Common: Necrotizing enterocolitis, Intestinal perforation Uncommon: Gastrointestinal haemorrhage Unknown: Gastric perforation Renal and urinary disorders Common: Oliguria, Fluid retention, Haematuria Uncommon: Acute renal failure Investigations Very Common: Blood creatinine increased, Blood sodium decreased Skin and subcutaneous tissue disorders Not known: Acute generalised exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)

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

Nebenwirkungen · Pedea

Pedea 5 mg/ml solution for injection · Abschnitt 4.8 · PDF-Seite 4–5

HOS-112959 · Präparat HOS-093805

4 * see below

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

Nebenwirkungen · Pedea

Pedea 5 mg/ml solution for injection · Abschnitt 4.8 · PDF-Seite 5

HOS-112960 · Präparat HOS-093805

In a clinical curative trial involving 175 preterm newborn infants less than 35 weeks of gestational age, the incidence of bronchopulmonary dysplasia at 36 weeks post-conceptional age was 13/81 (16%) for indomethacin versus 23/94 (24%) for ibuprofen.

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

Nebenwirkungen · Pedea

Pedea 5 mg/ml solution for injection · Abschnitt 4.8 · PDF-Seite 5

HOS-112961 · Präparat HOS-093805

In a clinical trial where Pedea was administered prophylactically during the first 6 hours of life, severe hypoxemia with pulmonary hypertension was reported in 3 newborn infants less than 28 weeks of gestational age. This occurred within one hour of the first infusion and was reversed within 30 minutes after the inhalation of nitric oxide. There have also been post-marketing reports of pulmonary hypertension where Pedea was administered to premature neonates in the therapeutic setting.

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

Nebenwirkungen · Pedea

Pedea 5 mg/ml solution for injection · Abschnitt 4.8 · PDF-Seite 5

HOS-112962 · Präparat HOS-093805

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.