Wirkstoffe & Arzneimittelsicherheit

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.

Wechselwirkungen · Controloc Control

CONTROLOC Control 20 mg gastro-resistant tablets · Abschnitt 4.5 · PDF-Seite 5

HOS-121772 · Präparat HOS-095429

Pantoprazole is metabolised in the liver via the cytochrome P450 enzyme system. Interaction studies with carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline and an oral contraceptive containing levonorgestrel and ethinyl oestradiol did not reveal clinically significant interactions. However, an interaction of pantoprazole with other substances which are metabolised by the same enzyme system cannot be excluded.

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): nifedipine (HOS-086289) piroxicam (HOS-110101) diclofenac (HOS-085903) carbamazepine (HOS-085618) levonorgestrel (HOS-089677) digoxin (HOS-086172) caffeine (HOS-085902) theophylline (HOS-085910) diazepam (HOS-085904) ethanol (HOS-089988) metoprolol (HOS-090094) phenytoin (HOS-084531) naproxen (HOS-087936)

Wechselwirkungen · Somac Control

SOMAC Control 20 mg gastro-resistant tablets · Abschnitt 4.5 · PDF-Seite 5

HOS-211882 · Präparat HOS-154776

Pantoprazole is metabolised in the liver via the cytochrome P450 enzyme system. Interaction studies with carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline and an oral contraceptive containing levonorgestrel and ethinyl oestradiol did not reveal clinically significant interactions. However, an interaction of pantoprazole with other substances which are metabolised by the same enzyme system cannot be excluded.

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): nifedipine (HOS-086289) piroxicam (HOS-110101) diclofenac (HOS-085903) carbamazepine (HOS-085618) levonorgestrel (HOS-089677) digoxin (HOS-086172) caffeine (HOS-085902) theophylline (HOS-085910) diazepam (HOS-085904) ethanol (HOS-089988) metoprolol (HOS-090094) phenytoin (HOS-084531) naproxen (HOS-087936)

Wechselwirkungen · Revolade

Revolade 12.5 mg film-coated tablets Revolade 25 mg film-coated tablets Revolade 50 mg film-coated tablets Revolade 75 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 12

HOS-122070 · Präparat HOS-095473

In studies utilising human liver microsomes, eltrombopag (up to 100 M) showed no in vitro inhibition of the CYP450 enzymes 1A2, 2A6, 2C19, 2D6, 2E1, 3A4/5, and 4A9/11 and was an inhibitor of CYP2C8 and CYP2C9 as measured using paclitaxel and diclofenac as the probe substrates. Administration of eltrombopag 75 mg once daily for 7 days to 24 healthy male subjects did not inhibit or induce the metabolism of probe substrates for 1A2 (caffeine), 2C19 (omeprazole), 2C9 (flurbiprofen), or 3A4 (midazolam) in humans. No clinically significant interactions are expected when eltrombopag and CYP450 substrates are co-administered (see section 5.2).

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): diclofenac (HOS-085903) caffeine (HOS-085902) flurbiprofen (HOS-122073) paclitaxel (HOS-087959) midazolam (HOS-086167) omeprazole (HOS-085912)

Wechselwirkungen · Revolade

Revolade 25 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 53

HOS-122159 · Präparat HOS-095473

In studies utilising human liver microsomes, eltrombopag (up to 100 M) showed no in vitro inhibition of the CYP450 enzymes 1A2, 2A6, 2C19, 2D6, 2E1, 3A4/5, and 4A9/11 and was an inhibitor of CYP2C8 and CYP2C9 as measured using paclitaxel and diclofenac as the probe substrates. Administration of eltrombopag 75 mg once daily for 7 days to 24 healthy male subjects did not inhibit or induce the metabolism of probe substrates for 1A2 (caffeine), 2C19 (omeprazole), 2C9 (flurbiprofen), or 3A4 (midazolam) in humans. No clinically significant interactions are expected when eltrombopag and CYP450 substrates are co-administered (see section 5.2).

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): diclofenac (HOS-085903) caffeine (HOS-085902) flurbiprofen (HOS-122073) paclitaxel (HOS-087959) midazolam (HOS-086167) omeprazole (HOS-085912)

Wechselwirkungen · Leflunomide Zentiva (previously Leflunomide Winthrop)

Leflunomide Zentiva 10 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 9

HOS-122360 · Präparat HOS-095511

Effect on caffeine (CYP1A2 substrate) Repeated doses of A771726 decreased mean Cmax and AUC of caffeine (CYP1A2 substrate) by 18% and 55%, respectively, suggesting that A771726 may be a weak inducer of CYP1A2 in vivo. Therefore, medicinal products metabolised by CYP1A2 (such as duloxetine, alosetron, theophylline and tizanidine) should be used with caution during treatment, as it could lead to the reduction of the efficacy of these products.

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): duloxetine (HOS-089666) tizanidine (HOS-089668) caffeine (HOS-085902) theophylline (HOS-085910) lead (HOS-085592) alosetron (HOS-089667)

Wechselwirkungen · Leflunomide Zentiva (previously Leflunomide Winthrop)

Leflunomide Zentiva 20 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 26

HOS-122433 · Präparat HOS-095511

Effect on caffeine (CYP1A2 substrate) Repeated doses of A771726 decreased mean Cmax and AUC of caffeine (CYP1A2 substrate) by 18% and 55%, respectively, suggesting that A771726 may be a weak inducer of CYP1A2 in vivo. Therefore, medicinal products metabolised by CYP1A2 (such as duloxetine, alosetron, theophylline and tizanidine) should be used with caution during treatment, as it could lead to the reduction of the efficacy of these products.

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): duloxetine (HOS-089666) tizanidine (HOS-089668) caffeine (HOS-085902) theophylline (HOS-085910) lead (HOS-085592) alosetron (HOS-089667)

Wechselwirkungen · Leflunomide Zentiva (previously Leflunomide Winthrop)

Leflunomide Zentiva 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 43

HOS-122493 · Präparat HOS-095511

Effect on caffeine (CYP1A2 substrate) Repeated doses of A771726 decreased mean Cmax and AUC of caffeine (CYP1A2 substrate) by 18% and 55%, respectively, suggesting that A771726 may be a weak inducer of CYP1A2 in vivo. Therefore, medicinal products metabolised by CYP1A2 (such as duloxetine, alosetron, theophylline and tizanidine) should be used with caution during treatment, as it could lead to the reduction of the efficacy of these products.

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): duloxetine (HOS-089666) tizanidine (HOS-089668) caffeine (HOS-085902) theophylline (HOS-085910) lead (HOS-085592) alosetron (HOS-089667)

Wechselwirkungen · Votrient

Votrient 200 mg film-coated tablets Votrient 400 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 9

HOS-122571 · Präparat HOS-095539

In vitro studies with human liver microsomes showed that pazopanib inhibited CYP enzymes 1A2, 3A4, 2B6, 2C8, 2C9, 2C19, and 2E1. Potential induction of human CYP3A4 was demonstrated in an in vitro human PXR assay. Clinical pharmacology studies, using pazopanib 800 mg once daily, have demonstrated that pazopanib does not have a clinically relevant effect on the pharmacokinetics of caffeine (CYP1A2 probe substrate), warfarin (CYP2C9 probe substrate), or omeprazole (CYP2C19 probe substrate) in cancer patients. Pazopanib resulted in an increase of approximately 30% in the mean AUC and Cmax of midazolam (CYP3A4 probe substrate) and increases of 33% to 64% in the ratio of dextrometrophan to dextrophan concentrations in the urine after oral administration of dextromethorphan (CYP2D6 probe substrate). Co-administration of pazopanib 800 mg once daily and paclitaxel 80 mg/m2 (CYP3A4 and CYP2C8 substrate) once weekly resulted in a mean increase of 26% and 31% in paclitaxel AUC and Cmax, respectively.

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): caffeine (HOS-085902) paclitaxel (HOS-087959) dextromethorphan (HOS-109265) warfarin (HOS-085950) midazolam (HOS-086167) omeprazole (HOS-085912)

Wechselwirkungen · Rapiscan

Rapiscan 400 microgram solution for injection · Abschnitt 4.5 · PDF-Seite 5

HOS-122804 · Präparat HOS-095579

Methylxanthines Methylxanthines (e.g., caffeine and theophylline) are non-specific adenosine receptor antagonists and may interfere with the vasodilation activity of regadenoson (see section 5.1). Patients should avoid consumption of any medicinal products containing methylxanthines as well as any medicinal products containing theophylline for at least 12 hours before regadenoson administration (see section 4.2).

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): caffeine (HOS-085902) theophylline (HOS-085910) adenosine (HOS-112292)

Wechselwirkungen · Leflunomide medac

Leflunomide medac 10 mg film-coated tablets Leflunomide medac 15 mg film-coated tablets Leflunomide medac 20 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 9

HOS-213053 · Präparat HOS-155028

Effect on caffeine (CYP1A2 substrate) Repeated doses of A771726 decreased mean Cmax and AUC of caffeine (CYP1A2 substrate) by 18 % and 55 %, respectively, suggesting that A771726 may be a weak inducer of CYP1A2 in vivo. Therefore, medicinal products metabolised by CYP1A2 (such as duloxetine, alosetron, theophylline and tizanidine) should be used with caution during treatment, as it could lead to the reduction of the efficacy of these products.

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): duloxetine (HOS-089666) tizanidine (HOS-089668) caffeine (HOS-085902) theophylline (HOS-085910) lead (HOS-085592) alosetron (HOS-089667)

Wechselwirkungen · Leflunomide ratiopharm

Leflunomide ratiopharm 10 mg film-coated tablets Leflunomide ratiopharm 20 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 9

HOS-213334 · Präparat HOS-155090

Effect on caffeine (CYP1A2 substrate) Repeated doses of A771726 decreased mean Cmax and AUC of caffeine (CYP1A2 substrate) by 18% and 55%, respectively, suggesting that A771726 may be a weak inducer of CYP1A2 in vivo. Therefore, medicinal products metabolised by CYP1A2 (such as duloxetine, alosetron, theophylline and tizanidine) should be used with caution during treatment, as it could lead to the reduction of the efficacy of these products.

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): duloxetine (HOS-089666) tizanidine (HOS-089668) caffeine (HOS-085902) theophylline (HOS-085910) lead (HOS-085592) alosetron (HOS-089667)