Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.3 · PDF-Seite 4

HOS-121291 · Präparat HOS-095319

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 · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.5 · PDF-Seite 5

HOS-121292 · Präparat HOS-095319

Inter-conversion between caffeine and theophylline occurs in preterm newborn infants. These active substances should not be used concurrently.

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): theophylline (HOS-085910)

Wechselwirkungen · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.5 · PDF-Seite 5

HOS-121293 · Präparat HOS-095319

Cytochrome P450 1A2 (CYP1A2) is the major enzyme involved in the metabolism of caffeine in humans. Therefore, caffeine has the potential to interact with active substances that are substrates for CYP1A2, inhibit CYP1A2, or induce CYP1A2. However, caffeine metabolism in preterm newborn infants is limited due to their immature hepatic enzyme systems.

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

Wechselwirkungen · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.5 · PDF-Seite 5–6

HOS-121294 · Präparat HOS-095319

5 Although few data exist on interactions of caffeine with other active substances in preterm newborn infants, lower doses of caffeine citrate may be needed following co-administration of active substances which are reported to decrease caffeine elimination in adults (e.g., cimetidine and ketoconazole) and higher caffeine citrate doses may be needed following co-administration of active substances that increase caffeine elimination (e.g., phenobarbital and phenytoin). Where doubt exists about possible interactions, plasma caffeine concentrations should be measured. As bacterial overgrowth in the gut is associated with the development of necrotising enterocolitis, co- administration of caffeine citrate with medicinal products that suppress gastric acid secretion (antihistamine H2 receptor blockers or proton-pump inhibitors) may in theory increase the risk of necrotising enterocolitis (see section 4.4 and 4.8). Concurrent use of caffeine and doxapram might potentiate their stimulatory effects on the cardio- respiratory and central nervous system. If concurrent use is indicated, cardiac rhythm and blood pressure must be carefully monitored.

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): phenobarbital (HOS-085617) cimetidine (HOS-085835) ketoconazole (HOS-084513) doxapram (HOS-121295) phenytoin (HOS-084531)

Nebenwirkungen · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.8 · PDF-Seite 6

HOS-121296 · Präparat HOS-095319

Summary of the safety profile

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

Nebenwirkungen · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.8 · PDF-Seite 6

HOS-121297 · Präparat HOS-095319

The known pharmacology and toxicology of caffeine and other methylxanthines predict the likely adverse reactions to caffeine citrate. Effects described include central nervous system (CNS) stimulation such as convulsion, irritability, restlessness and jitteriness, cardiac effects such as tachycardia, arrhythmia, hypertension and increased stroke volume, metabolism and nutrition disorders such as hyperglycaemia. These effects are dose related and may necessitate measurement of plasma levels and dose reduction.

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

Nebenwirkungen · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.8 · PDF-Seite 6

HOS-121298 · Präparat HOS-095319

Tabulated list of adverse reactions

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

Nebenwirkungen · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.8 · PDF-Seite 6

HOS-121299 · Präparat HOS-095319

The adverse reactions described in the short- and long-term published literature and obtained from a post-authorisation safety study that can be associated with caffeine citrate are listed below by System Organ Class and Preferred Term (MedDRA).

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

Nebenwirkungen · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.8 · PDF-Seite 6–7

HOS-121300 · Präparat HOS-095319

6 Frequency is defined as: 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 · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.8 · PDF-Seite 7

HOS-121301 · Präparat HOS-095319

System Organ Class Adverse Reaction Frequency Infections and infestations Sepsis Not known Immune system disorders Hypersensitivity reaction Rare Metabolism and nutrition Hyperglycaemia Common disorders Hypoglycaemia, failure to thrive, Not known feeding intolerance Nervous system disorders Convulsion Uncommon Irritability, jitteriness, restlessness, Not known brain injury Ear and labyrinth disorders Deafness Not known

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

Nebenwirkungen · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.8 · PDF-Seite 7

HOS-121302 · Präparat HOS-095319

Cardiac disorders Tachycardia Common Arrhythmia Uncommon Increased left ventricular output and Not known increased stroke volume Gastrointestinal disorders Regurgitation, increased gastric Not known aspirate, necrotising enterocolitis General disorders and Infusion site phlebitis, infusion site Common administration site inflammation conditions Investigations Urine output increased, urine sodium Not known and calcium increased, haemoglobin decreased, thyroxine decreased

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

Nebenwirkungen · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.8 · PDF-Seite 7

HOS-121303 · Präparat HOS-095319

Description of selected adverse reactions

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

Nebenwirkungen · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.8 · PDF-Seite 7–8

HOS-121304 · Präparat HOS-095319

Necrotising enterocolitis is a common cause of morbidity and mortality in premature newborn infants. There are reports of a possible association between the use of methylxanthines and development of necrotising enterocolitis. However, a causal relationship between caffeine or other methylxanthine use and necrotising enterocolitis has not been established. In a double-blind placebo-controlled study of caffeine citrate in 85 preterm infants (see section 5.1), necrotising enterocolitis was diagnosed in the blinded phase of the study in two infants on active treatment and one on placebo, and in three infants on caffeine during the open-label phase of the study. Three of the infants who developed necrotising enterocolitis during the study died. A large multicentre study (n=2006) investigating long-term outcome of premature infants treated with caffeine citrate (see section 5.1) did not show an increased frequency of necrotising enterocolitis in the caffeine group when compared to placebo. As for all preterm infants, those treated with caffeine citrate should be carefully monitored for the development of necrotising enterocolitis (see section 4.4). Brain injury, convulsion and deafness were observed but they were more frequent in the placebo group. Caffeine may suppress erythropoietin synthesis and hence reduce haemoglobin concentration with prolonged treatment. Transient falls in thyroxine (T4) have been recorded in infants at the start of therapy but these are not sustained with maintained therapy. Available evidence does not indicate any adverse long-term reactions of neonatal caffeine therapy as regards neurodevelopmental outcome, failure to thrive or on the cardiovascular, gastrointestinal or 7 endocrine systems. Caffeine does not appear to aggravate cerebral hypoxia or to exacerbate any resulting damage, although the possibility cannot be ruled out.

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

Nebenwirkungen · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.8 · PDF-Seite 8

HOS-121305 · Präparat HOS-095319

Other special populations

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

Nebenwirkungen · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.8 · PDF-Seite 8

HOS-121306 · Präparat HOS-095319

In a post-authorisation safety study on 506 preterm infants treated with Peyona, safety data have been collected in 31 very premature infants with renal/hepatic impairment. Adverse reactions appeared to be more frequent in this subgroup with organ impairment than in other observed infants without organ impairment. Cardiac disorders (tachycardia, including one single case of arrhythmia) were mostly reported.

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

Nebenwirkungen · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.8 · PDF-Seite 8

HOS-121307 · Präparat HOS-095319

Reporting of suspected adverse reactions

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

Nebenwirkungen · Peyona (previously Nymusa)

Peyona 20 mg/mL solution for infusion and oral solution · Abschnitt 4.8 · PDF-Seite 8

HOS-121308 · Präparat HOS-095319

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.