Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Vfend

VFEND 50 mg film-coated tablets VFEND 200 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 16–17

HOS-109484 · Präparat HOS-093201

16 Non-steroidal selective mineralocorticoid receptor (MR) antagonists Finerenone Although not studied, voriconazole Contraindicated (see section [CYP3A4 substrate] is likely to significantly increase 4.3) the plasma concentrations of finerenone. Eplerenone Although not studied, voriconazole Contraindicated (see section [CYP3A4 substrate] is likely to significantly increase 4.3) the plasma concentrations of eplerenone. Non-steroidal anti-inflammatory drugs (NSAIDs) [CYP2C9 substrates] Frequent monitoring for adverse S-Ibuprofen Cmax  20% reactions and toxicity related to Ibuprofen (400 mg single dose) S-Ibuprofen AUC0-  100% NSAIDs is recommended. Dose reduction of NSAIDs may be Diclofenac (50 mg single dose) Diclofenac Cmax  114% needed. Diclofenac AUC0-  78% Opioids Long-Acting Opiates In an independent published study, Dose reduction in oxycodone and [CYP3A4 substrates] Oxycodone Cmax  1.7-fold other long-acting opiates Oxycodone AUC0-  3.6-fold metabolised by CYP3A4 Oxycodone (10 mg single (e.g., hydrocodone) should be dose) considered. Frequent monitoring for opiate-associated adverse reactions may be necessary. Methadone (32-100 mg QD) R-methadone (active) Cmax  31% Frequent monitoring for adverse [CYP3A4 substrate] R-methadone (active) AUC  47% reactions and toxicity related to S-methadone Cmax  65% methadone, including QTc S-methadone AUC  103% prolongation, is recommended. Dose reduction of methadone may be needed. Short-acting Opiates Dose reduction of alfentanil, [CYP3A4 substrates] fentanyl and other short-acting opiates similar in structure to Alfentanil (20 μg/kg single In an independent published study, alfentanil and metabolised by dose, with concomitant Alfentanil AUC0-  6-fold CYP3A4 (e.g., sufentanil) should naloxone) be considered. Extended and frequent monitoring for Fentanyl (5 g/kg single dose) In an independent published study, respiratory depression and other Fentanyl AUC0-  1.34-fold opiate-associated adverse reactions is recommended. Opioid receptor antagonists Naloxegol Although not studied, voriconazole Contraindicated (see section [CYP3A4 substrate] is likely to significantly increase 4.3) the plasma concentrations of naloxegol. Oral contraceptives Oral Contraceptives* Ethinylestradiol Cmax  36% Monitoring for adverse reactions [CYP3A4 substrate; CYP2C19 Ethinylestradiol AUC  61% related to oral contraceptives, in inhibitor] Norethisterone Cmax  15% addition to those for Norethisterone/ethinylestradiol Norethisterone AUC  53% voriconazole, is recommended. (1 mg/0.035 mg QD) Voriconazole Cmax  14% Voriconazole AUC  46%

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): alfentanil (HOS-109375) diclofenac (HOS-085903) ibuprofen (HOS-087884) methadone (HOS-086198) eplerenone (HOS-089050) oxycodone (HOS-109487) finerenone (HOS-109430) naloxegol (HOS-109428) hydrocodone (HOS-109488) naloxone (HOS-109490) fentanyl (HOS-086196) sufentanil (HOS-109489)

Wechselwirkungen · Vfend

VFEND 200 mg powder for solution for infusion · Abschnitt 4.5 · PDF-Seite 48–49

HOS-109554 · Präparat HOS-093201

48 Non-steroidal selective mineralocorticoid receptor (MR) antagonists Finerenone Although not studied, voriconazole Contraindicated (see section [CYP3A4 substrate] is likely to significantly increase 4.3) the plasma concentrations of finerenone. Eplerenone Although not studied, voriconazole Contraindicated (see section [CYP3A4 substrate] is likely to significantly increase 4.3) the plasma concentrations of eplerenone. Non-steroidal anti-inflammatory drugs (NSAIDs) [CYP2C9 substrates] Frequent monitoring for adverse S-Ibuprofen Cmax  20% reactions and toxicity related to Ibuprofen (400 mg single dose) S-Ibuprofen AUC0-  100% NSAIDs is recommended. Dose reduction of NSAIDs may be Diclofenac (50 mg single dose) Diclofenac Cmax  114% needed. Diclofenac AUC0-  78% Opioids Long-Acting Opiates In an independent published study, Dose reduction in oxycodone and [CYP3A4 substrates] Oxycodone Cmax  1.7-fold other long-acting opiates Oxycodone AUC0-  3.6-fold metabolised by CYP3A4 Oxycodone (10 mg single (e.g., hydrocodone) should be dose) considered. Frequent monitoring for opiate-associated adverse reactions may be necessary. Methadone (32-100 mg QD) R-methadone (active) Cmax  31% Frequent monitoring for adverse [CYP3A4 substrate] R-methadone (active) AUC  47% reactions and toxicity related to S-methadone Cmax  65% methadone, including QTc S-methadone AUC  103% prolongation, is recommended. Dose reduction of methadone may be needed. Short-acting Opiates Dose reduction of alfentanil, [CYP3A4 substrates] fentanyl and other short-acting opiates similar in structure to Alfentanil (20 μg/kg single In an independent published study, alfentanil and metabolised by dose, with concomitant Alfentanil AUC0-  6-fold CYP3A4 (e.g., sufentanil) should naloxone) be considered. Extended and frequent monitoring for Fentanyl (5 g/kg single dose) In an independent published study, respiratory depression and other Fentanyl AUC0-  1.34-fold opiate-associated adverse reactions is recommended. Opioid receptor antagonists Naloxegol Although not studied, voriconazole Contraindicated (see section [CYP3A4 substrate] is likely to significantly increase 4.3) the plasma concentrations of naloxegol. Oral contraceptives Oral Contraceptives* Ethinylestradiol Cmax  36% Monitoring for adverse reactions [CYP3A4 substrate; CYP2C19 Ethinylestradiol AUC  61% related to oral contraceptives, in inhibitor] Norethisterone Cmax  15% addition to those for Norethisterone/ethinylestradiol Norethisterone AUC  53% voriconazole, is recommended. (1 mg/0.035 mg QD) Voriconazole Cmax  14% Voriconazole AUC  46%

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): alfentanil (HOS-109375) diclofenac (HOS-085903) ibuprofen (HOS-087884) methadone (HOS-086198) eplerenone (HOS-089050) oxycodone (HOS-109487) finerenone (HOS-109430) naloxegol (HOS-109428) hydrocodone (HOS-109488) naloxone (HOS-109490) fentanyl (HOS-086196) sufentanil (HOS-109489)

Wechselwirkungen · Vfend

VFEND 40 mg/ml powder for oral suspension · Abschnitt 4.5 · PDF-Seite 80–81

HOS-109619 · Präparat HOS-093201

80 Non-steroidal selective mineralocorticoid receptor (MR) antagonists Finerenone Although not studied, voriconazole Contraindicated (see section [CYP3A4 substrate] is likely to significantly increase 4.3) the plasma concentrations of finerenone. Eplerenone Although not studied, voriconazole Contraindicated (see section [CYP3A4 substrate] is likely to significantly increase 4.3) the plasma concentrations of eplerenone. Non-steroidal anti-inflammatory drugs (NSAIDs) [CYP2C9 substrates] Frequent monitoring for adverse S-Ibuprofen Cmax  20% reactions and toxicity related to Ibuprofen (400 mg single dose) S-Ibuprofen AUC0-  100% NSAIDs is recommended. Dose reduction of NSAIDs may be Diclofenac (50 mg single dose) Diclofenac Cmax  114% needed. Diclofenac AUC0-  78% Opioids Long-Acting Opiates In an independent published study, Dose reduction in oxycodone and [CYP3A4 substrates] Oxycodone Cmax  1.7-fold other long-acting opiates Oxycodone AUC0-  3.6-fold metabolised by CYP3A4 Oxycodone (10 mg single (e.g., hydrocodone) should be dose) considered. Frequent monitoring for opiate-associated adverse reactions may be necessary. Methadone (32-100 mg QD) R-methadone (active) Cmax  31% Frequent monitoring for adverse [CYP3A4 substrate] R-methadone (active) AUC  47% reactions and toxicity related to S-methadone Cmax  65% methadone, including QTc S-methadone AUC  103% prolongation, is recommended. Dose reduction of methadone may be needed. Short-acting Opiates Dose reduction of alfentanil, [CYP3A4 substrates] fentanyl and other short-acting opiates similar in structure to Alfentanil (20 μg/kg single In an independent published study, alfentanil and metabolised by dose, with concomitant Alfentanil AUC0-  6-fold CYP3A4 (e.g., sufentanil) should naloxone) be considered. Extended and frequent monitoring for Fentanyl (5 g/kg single dose) In an independent published study, respiratory depression and other Fentanyl AUC0-  1.34-fold opiate-associated adverse reactions is recommended. Opioid receptor antagonists Naloxegol Although not studied, voriconazole Contraindicated (see section [CYP3A4 substrate] is likely to significantly increase 4.3) the plasma concentrations of naloxegol. Oral contraceptives Oral Contraceptives* Ethinylestradiol Cmax  36% Monitoring for adverse reactions [CYP3A4 substrate; CYP2C19 Ethinylestradiol AUC  61% related to oral contraceptives, in inhibitor] Norethisterone Cmax  15% addition to those for Norethisterone/ethinylestradiol Norethisterone AUC  53% voriconazole, is recommended. (1 mg/0.035 mg QD) Voriconazole Cmax  14% Voriconazole AUC  46%

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): alfentanil (HOS-109375) diclofenac (HOS-085903) ibuprofen (HOS-087884) methadone (HOS-086198) eplerenone (HOS-089050) oxycodone (HOS-109487) finerenone (HOS-109430) naloxegol (HOS-109428) hydrocodone (HOS-109488) naloxone (HOS-109490) fentanyl (HOS-086196) sufentanil (HOS-109489)

Wechselwirkungen · Voriconazole Hikma (previously Voriconazole Hospira)

Voriconazole Hikma 200 mg powder for solution for infusion · Abschnitt 4.5 · PDF-Seite 17–18

HOS-130968 · Präparat HOS-096981

17 Finerenone Although not studied, voriconazole Contraindicated (see section [CYP3A4 substrate] is likely to significantly increase 4.3) the plasma concentrations of finerenone. Eplerenone Although not studied, voriconazole Contraindicated (see section [CYP3A4 substrate] is likely to significantly increase 4.3) the plasma concentrations of eplerenone. Non-steroidal anti-inflammatory drugs (NSAIDs) [CYP2C9 substrates] Frequent monitoring for adverse S-Ibuprofen Cmax ↑ 20% reactions and toxicity related to Ibuprofen (400 mg single dose) S-Ibuprofen AUC0-∞ ↑ 100% NSAIDs is recommended. Dose reduction of NSAIDs may be Diclofenac (50 mg single dose) Diclofenac Cmax ↑ 114% needed. Diclofenac AUC0-∞ ↑ 78% Opioids Long-Acting Opiates In an independent published study, Dose reduction in oxycodone and [CYP3A4 substrates] Oxycodone Cmax ↑ 1.7-fold other long-acting opiates Oxycodone AUC0-∞ ↑ 3.6-fold metabolised by CYP3A4 Oxycodone (10 mg single (e.g., hydrocodone) should be dose) considered. Frequent monitoring for opiate-associated adverse reactions may be necessary. Methadone (32-100 mg QD) R-methadone (active) Cmax ↑ 31% Frequent monitoring for adverse [CYP3A4 substrate] R-methadone (active) AUCτ ↑ 47% reactions and toxicity related to S-methadone Cmax ↑ 65% methadone, including QTc S-methadone AUCτ ↑ 103% prolongation, is recommended. Dose reduction of methadone may be needed. Short-acting Opiates Dose reduction of alfentanil, [CYP3A4 substrates] fentanyl and other short-acting opiates similar in structure to Alfentanil (20 μg/kg single In an independent published study, alfentanil and metabolised by dose, with concomitant Alfentanil AUC0-∞ ↑ 6-fold CYP3A4 (e.g., sufentanil) should naloxone) be considered. Extended and frequent monitoring for Fentanyl (5 µg/kg single dose) In an independent published study, respiratory depression and other Fentanyl AUC0-∞ ↑ 1.34-fold opiate-associated adverse reactions is recommended. Opioid receptor antagonists Naloxegol Although not studied, voriconazole Contraindicated (see section [CYP3A4 substrate] is likely to significantly increase 4.3) the plasma concentrations of naloxegol. Oral contraceptives Oral Contraceptives* Ethinylestradiol Cmax ↑ 36% Monitoring for adverse reactions [CYP3A4 substrate; CYP2C19 Ethinylestradiol AUCτ ↑ 61% related to oral contraceptives, in inhibitor] Norethisterone Cmax ↑ 15% addition to those for Norethisterone/ethinylestradiol Norethisterone AUCτ ↑ 53% voriconazole, is recommended. (1 mg/0.035 mg QD) Voriconazole Cmax ↑ 14% Voriconazole AUCτ ↑ 46%

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): alfentanil (HOS-109375) diclofenac (HOS-085903) ibuprofen (HOS-087884) methadone (HOS-086198) eplerenone (HOS-089050) oxycodone (HOS-109487) finerenone (HOS-109430) naloxegol (HOS-109428) hydrocodone (HOS-109488) naloxone (HOS-109490) fentanyl (HOS-086196) sufentanil (HOS-109489)

Gegenanzeigen · Dzuveo

Dzuveo 30 micrograms sublingual tablet · Abschnitt 4.3 · PDF-Seite 3

HOS-137924 · Präparat HOS-098113

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Significant respiratory depression or pulmonary compromise.

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

Wechselwirkungen · Dzuveo

Dzuveo 30 micrograms sublingual tablet · Abschnitt 4.5 · PDF-Seite 4

HOS-137925 · Präparat HOS-098113

Interaction with cytochrome P450-3A4 enzyme

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

Wechselwirkungen · Dzuveo

Dzuveo 30 micrograms sublingual tablet · Abschnitt 4.5 · PDF-Seite 4

HOS-137926 · Präparat HOS-098113

Sufentanil is primarily metabolised by the human cytochrome P450-3A4 enzyme. Ketoconazole, a potent CYP3A4 inhibitor, can significantly increase the systemic exposure to sublingual sufentanil (maximal plasma levels (Cmax) increase of 19%, overall exposure to the active substance (AUC) increase of 77% and prolong the time to reach maximum concentration by 41%. Similar effects with other potent CYP3A4 inhibitors (e. g. itraconazole, ritonavir) cannot be excluded. Any change in efficacy/tolerability associated with the increased exposure would be compensated in practice by an increase in the amount of time between doses (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): ketoconazole (HOS-084513) itraconazole (HOS-084516) ritonavir (HOS-084521)

Wechselwirkungen · Dzuveo

Dzuveo 30 micrograms sublingual tablet · Abschnitt 4.5 · PDF-Seite 4

HOS-137927 · Präparat HOS-098113

Interaction with calcium channel and/or beta blockers

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): calcium (HOS-085615)

Wechselwirkungen · Dzuveo

Dzuveo 30 micrograms sublingual tablet · Abschnitt 4.5 · PDF-Seite 4–5

HOS-137928 · Präparat HOS-098113

4 The incidence and degree of bradycardia and hypotension with sufentanil may be greater in patients on chronic calcium channel and/or beta blocker therapy.

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): calcium (HOS-085615)

Wechselwirkungen · Dzuveo

Dzuveo 30 micrograms sublingual tablet · Abschnitt 4.5 · PDF-Seite 5

HOS-137929 · Präparat HOS-098113

Caution should be exercised in patients on these concomitant medicinal products and they should be closely monitored.

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

Wechselwirkungen · Dzuveo

Dzuveo 30 micrograms sublingual tablet · Abschnitt 4.5 · PDF-Seite 5

HOS-137930 · Präparat HOS-098113

Central nervous system (CNS) depressants

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

Wechselwirkungen · Dzuveo

Dzuveo 30 micrograms sublingual tablet · Abschnitt 4.5 · PDF-Seite 5

HOS-137931 · Präparat HOS-098113

The concomitant use of CNS depressants including barbiturates, benzodiazepines, neuroleptics or other opioids, halogen gases or other non-selective CNS depressants (e.g. alcohol) may enhance respiratory depression. The concomitant use of opioids and gabapentinoids (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression and death.

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): pregabalin (HOS-112893) gabapentin (HOS-090745)

Wechselwirkungen · Dzuveo

Dzuveo 30 micrograms sublingual tablet · Abschnitt 4.5 · PDF-Seite 5

HOS-137932 · Präparat HOS-098113

When considering the use of sufentanil in a patient taking a CNS depressant, the duration of use of the CNS depressant and the patient’s response should be assessed, including the degree of tolerance that has developed to CNS depression. If the decision to begin sufentanil is made, the patient should be closely monitored and a lower dose of the concomitant CNS depressant should be considered.

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

Wechselwirkungen · Dzuveo

Dzuveo 30 micrograms sublingual tablet · Abschnitt 4.5 · PDF-Seite 5

HOS-137933 · Präparat HOS-098113

Co-administration of sufentanil with a serotonergic agent, such as Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), or Monoamine Oxidase Inhibitors (MAOIs), may increase the risk of serotonin syndrome, a potentially life threatening condition. Monoamine Oxidase Inhibitors must not be taken in the 2 weeks before or at the same time as Dzuveo is given.

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): norepinephrine (HOS-090547) serotonin (HOS-085477)

Wechselwirkungen · Dzuveo

Dzuveo 30 micrograms sublingual tablet · Abschnitt 4.5 · PDF-Seite 5

HOS-137935 · Präparat HOS-098113

Interaction with other sublingually administered products or products intended to dilute/establish an effect in the oral cavity were not evaluated and simultaneous administration should be avoided.

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

Nebenwirkungen · Dzuveo

Dzuveo 30 micrograms sublingual tablet · Abschnitt 4.8 · PDF-Seite 6

HOS-137936 · Präparat HOS-098113

Summary of the safety profile

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

Nebenwirkungen · Dzuveo

Dzuveo 30 micrograms sublingual tablet · Abschnitt 4.8 · PDF-Seite 6

HOS-137937 · Präparat HOS-098113

The most serious adverse reaction of sufentanil is respiratory depression, which occurred at a rate of 0.6% in sufentanil clinical trials.

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

Nebenwirkungen · Dzuveo

Dzuveo 30 micrograms sublingual tablet · Abschnitt 4.8 · PDF-Seite 6

HOS-137938 · Präparat HOS-098113

The most commonly reported adverse reactions seen in clinical trials and from post marketing experience with sufentanil containing products were nausea, vomiting and pyrexia (≥1/10 patients) (see section 4.4).

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

Nebenwirkungen · Dzuveo

Dzuveo 30 micrograms sublingual tablet · Abschnitt 4.8 · PDF-Seite 6

HOS-137939 · Präparat HOS-098113

Tabulated list of adverse reactions

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

Nebenwirkungen · Dzuveo

Dzuveo 30 micrograms sublingual tablet · Abschnitt 4.8 · PDF-Seite 6

HOS-137940 · Präparat HOS-098113

Adverse reactions identified either from clinical studies or from post marketing experience with other medicinal products containing sufentanil are summarised in the table below. The frequencies are defined as:

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