Swissmedic Nr.: 58475002
Index: 07.99.00

Pharmacode: 4483260
GTIN/EAN: 7680584750022
Markteintritt: 12.10.2009

Kategorie: B Mehrmalige Abgabe auf eine ärztliche Verschreibung hin.


Kuvan® (100 mg)

Sapropterin (A16AX07)

120 Stk

(0/5 , 704)

Um Kuvan® (100 mg) kaufen zu können, benötigen Sie zunächst ein Rezept. Bei Deindoktor.ch können Sie im Rahmen einer Online-Sprechstunde per Webcam, mit dem Artz Ihrer Wahl, ein elektronische Rezept erhalten.

Das mit DeinDoktor.ch erhaltene Rezept kann in einer der 1400 Schweizer Apotheken verwendet werden. Wir organisieren mit einer unserer Partner-Apotheken eine Sendung Ihres Kuvan® (100 mg)'s gegen Unterschrift (24h) oder dem Medikamenten-Taxi nach einer Online Sprechstunde, falls gewünscht.

You can get more infos with the following doctors during an online consultation. They might prescribe you this medicament.
Dr. David Herren, Einigen (BE)
Generalist
Internist


Tariff:
First 10 minutes: CHF 32.91
Next 5 minutes: CHF 15.28
Day tarif
Dr. Ueli Krebs, Thun (BE)
Generalist
Internist


Tariff:
First 10 minutes: CHF 32.91
Next 5 minutes: CHF 15.28
Day tarif
Dr. Carla Bonomo Coradi, Männedorf (ZH)
Generalist
Internist


Tariff:
First 10 minutes: CHF 33.71
Next 5 minutes: CHF 15.81
Day tarif
Your received prescription through DeinDoktor.ch is usable to get your medicaments in any of the 1400 Swiss pharmacies or in the Swiss online pharmacies. We can arrange with one of our pharmacy-partners a delivery against signature (24h) or medicament-taxi after an online-consultation.

Kuvan ist eine synthetisch hergestellte Kopie einer körpereigenen Substanz, die Tetrahydrobiopterin (BH4) genannt wird. BH4 wird im Körper gebraucht, um eine Aminosäure namens Phenylalanin nutzen zu können, um daraus eine andere Aminosäure herstellen zu können, die Tyrosin heisst.

Kuvan wird zur Behandlung der Hyperphenylalaninämie (HPA) oder der Phenylketonurie (PKU) angewandt. Diese Erkrankungen führen zu abnorm hohen Phenylalaninblutspiegeln, was schädlich sein kann. Kuvan senkt den Phenylalaninblutspiegel bei einigen Patienten, die auf BH4 ansprechen und kann dazu beitragen, dass die Menge an Phenylalanin, die mit der Nahrung zugeführt werden kann, gesteigert werden kann.

Kuvan wird ausserdem zur Behandlung einer angeborenen Erkrankung, des sog. BH4-Mangels, eingesetzt, dabei ist der Körper nicht in der Lage, genügend BH4 herzustellen. Aufgrund der sehr niedrigen BH4-Spiegel kann Phenylalanin nicht richtig verwertet werden, und es kommt zum Anstieg der Phenylalaninkonzentration, was schädliche Effekte nach sich zieht. Durch Ersatz von BH4, das der Körper nicht produzieren kann, mindert Kuvan den schädlichen Überschuss an Phenylalanin im Blut und steigert die Toleranz gegenüber mit der Nahrung zugeführtem Phenylalanin.

Kuvan darf im Falle einer Überempfindlichkeit (Allergie) gegen den Wirkstoff Sapropterin oder einen der Hilfsstoffe nicht angewendet werden.

Vorsicht wird empfohlen bei gleichzeitiger Anwendung von Methotrexat, Trimethoprim, gefässerweiternden Arzneimitteln, Arzneimittel zur Behandlung der Impotenz des Mannes (z.B. Sildenafil, Tadalafil, Vardenafil), Minoxidil oder Levodopa.

Halten Sie Rücksprache mit Ihrem Arzt bzw. Ihrer Ärztin wenn Sie krank sind, da die Phenylalaninblutspiegel dann ansteigen können.

Informieren Sie Ihren Arzt bzw. Ihre Ärztin, falls Sie zu Krampfanfällen neigen.

Wenn Sie mit Kuvan behandelt werden, wird Ihr Arzt bzw. Ihre Ärztin Ihr Blut untersuchen, um festzustellen, wie viel Phenylalanin es enthält. Sofern erforderlich, wird er bzw. sie beschliessen, Ihre Kuvandosis oder Ihre Diät anzupassen.

Sie müssen, wie von Ihrem Arzt bzw. Ihrer Ärztin empfohlen, Ihre Diät fortführen. Verändern Sie Ihre Diät nicht ohne Rücksprache mit Ihrem Arzt bzw. Ihrer Ärztin.

Informieren Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin, wenn Sie an anderen Krankheiten leiden, Allergien haben oder andere Arzneimittel (auch selbstgekaufte!) einnehmen oder äusserlich anwenden (Externa!).

Die Sicherheit der Anwendung von Kuvan in der Schwangerschaft und Stillzeit ist nicht nachgewiesen. Deshalb soll Kuvan während der Schwangerschaft und Stillzeit nicht angewendet werden.

Bitte informieren Sie Ihren Arzt bzw. Ihre Ärztin, falls Sie schwanger sind oder stillen, falls Sie vermuten schwanger zu sein oder falls Sie eine Schwangerschaft planen oder anfangen möchten zu stillen.

Wenn Sie schwanger sind, wird Ihnen Ihr Arzt sagen, wie Sie Ihre Phenylalaninspiegel angemessen kontrollieren. Wenn der Phenylalaninspiegel vor oder nach Beginn der Schwangerschaft nicht strikt überwacht wird, kann dies schädlich für Sie und Ihr Kind sein. Ihr Arzt wird die diätetische Beschränkung der Phenylalaninaufnahme vor und während der Schwangerschaft überwachen.

Nehmen Sie Kuvan immer genau nach Anweisung Ihres Arztes bzw. Ihrer Ärztin ein. Bitte fragen Sie bei Ihrem Arzt oder Apotheker bzw. bei Ihrer Ärztin oder Apothekerin nach, wenn Sie sich nicht ganz sicher sind.

Allgemeine Dosierungsanweisungen

Die verordnete Anzahl Tabletten ist für Erwachsene in 120 bis 240 ml Wasser, für Kinder in maximal 120 ml Wasser unter leichtem Rühren aufzulösen.

Bei Dosierungen unter 100 mg ist eine Tablette in 100 ml Wasser aufzulösen. Ihr Arzt bzw. Ihre Ärztin wird Sie anweisen, nur eine bestimmte Menge der Lösung zu geben, die der richtigen Dosis entspricht. Dazu muss ein genaues Messgefäss mit entsprechender Graduierung benutzt werden.

Es kann wenige Minuten dauern, bis sich die Tabletten aufgelöst haben. Um die Lösung der Tabletten zu beschleunigen, können sie zerkleinert werden. In der Lösung können kleine Teilchen sichtbar sein, die jedoch nicht die Wirksamkeit des Arzneimittels beeinträchtigen. Die zubereitete Lösung sollte zusammen mit einer Mahlzeit, immer zur gleichen Tageszeit, vorzugsweise morgens, innerhalb von 15 bis 20 Minuten getrunken werden.

Spezielle Dosierungsanweisungen

PKU

Die übliche Anfangsdosis von Kuvan bei Erwachsenen und Kindern ab 4 Jahren mit PKU beträgt 10 mg/kg Körpergewicht/Tag. Die Tabletten zur Herstellung einer Lösung werden einmal täglich, am besten immer zur gleichen Tageszeit (vorzugsweise morgens), mit einer Mahlzeit eingenommen. Die Dosis kann nach Ermessen des Arztes bzw. der Ärztin angepasst werden, üblicherweise zwischen 5 und 20 mg/kg/Tag.

BH4-Mangel

Die übliche Anfangsdosis von Kuvan bei Erwachsenen und Kindern mit BH4-Mangel beträgt 2 bis 5 mg/kg Körpergewicht/Tag. Die Tabletten zur Herstellung einer Lösung werden einmal täglich, am besten immer zur gleichen Tageszeit (vorzugsweise morgens), mit einer Mahlzeit eingenommen. Die Dosis kann auf bis zu 20 mg/kg/Tag erhöht werden. Gegebenenfalls muss die Tagesdosis auf 2 oder 3 Dosen über den Tag verteilt werden, um den besten therapeutischen Effekt zu erreichen.

Wenn Sie eine grössere Menge von Kuvan eingenommen haben, als Sie sollten

Nehmen Sie Kuvan bitte immer gemäss Ihrer Verschreibung ein. Falls Sie mehr Kuvan eingenommen haben, als Ihnen verschrieben wurde, könnte dies zu Nebenwirkungen wie Kopfschmerzen oder Schwindel führen. Bitte informieren Sie umgehend Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin.

Wenn Sie die Einnahme von Kuvan vergessen haben

Nehmen Sie nicht die doppelte Dosis ein, um die vergessene Dosis auszugleichen.

Wenn Sie die Einnahme von Kuvan abbrechen

Ihr Arzt bzw. Ihre Ärztin wird Ihnen mitteilen, wie lange Ihre Behandlung dauern wird. Brechen Sie die Einnahme von Kuvan bitte nicht ohne Rücksprache mit Ihrem Arzt bzw. mit Ihrer Ärztin ab, da dadurch der Phenylalaninspiegel im Blut ansteigen kann.

Ändern Sie nicht von sich aus die verschriebene Dosierung. Wenn Sie glauben, das Arzneimittel wirke zu schwach oder zu stark, so sprechen Sie mit Ihrem Arzt oder Apotheker bzw. mit Ihrer Ärztin oder Apothekerin.

Als sehr häufige Nebenwirkungen, die bei mehr als 1 von 10 Behandelten festgestellt wurden, traten Kopfschmerzen oder laufende Nase (auch als Rhinorrhoe bekannt) auf.

Als häufige Nebenwirkungen, die bei 1-10 unter 100 Behandelten festgestellt wurden, traten Durchfall, Erbrechen, Bauchschmerzen, Halsschmerzen, Nasenschleimhautanschwellung bzw. verstopfte Nase, Husten und zu niedrige Phenylalaninspiegel im Blut auf. Um festzustellen, wie viel Phenylalanin Ihr Blut enthält, wird Ihr Arzt bzw. Ihre Ärztin Ihr Blut untersuchen.

Mit unbekannter Häufigkeit wurden Überempfindlichkeitsreaktionen, einschliesslich schwere allergische Reaktionen und Hautausschlag beobachtet.

Falls sich eine der Nebenwirkungen verschlimmert oder falls Sie Nebenwirkungen bemerken, die hier nicht beschrieben sind, sollten Sie Ihren Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin informieren.

Das Arzneimittel darf nur bis zu dem auf dem Behälter mit «EXP» bezeichneten Datum verwendet werden.

Das Arzneimittel nicht über 25 °C und ausser Reichweite von Kindern aufbewahren. Um die Tabletten vor Licht und Feuchtigkeit zu schützen, den Behälter fest verschlossen und in der Originalverpackung aufbewahren.

Allfällige nach Ende der Behandlung verbleibende Tabletten oder solche mit abgelaufenem Verfalldatum bitte zur fachgerechten Entsorgung Ihrer Verkaufsstelle (Arzt oder Apotheker) übergeben.

Jede Flasche enthält einen kleinen Plastikbehälter mit einem gesundheitlich unbedenklichen Trockenmittel (Silicagel), das nicht eingenommen werden darf. Das Trockenmittel kann ohne Bedenken mit dem normalen Hausmüll entsorgt werden.

Weitere Auskünfte erteilt Ihnen Ihr Arzt oder Apotheker bzw. Ihre Ärztin oder Apothekerin. Diese Personen verfügen über die ausführliche Fachinformation.

Eine Tablette zur Herstellung einer Lösung zum Einnehmen enthält 100 mg Sapropterin-Dihydrochlorid und als Hilfsstoffe Mannitol, Calciumhydrogenphosphat (wasserfrei), Crospovidon, Antioxidans E 300 (Ascorbinsäure), Natriumstearylfumarat und Riboflavin.

58475 (Swissmedic).

In Apotheken nur gegen ärztliche Verschreibung.

Polyäthylenflaschen zu 30 oder 120 Tabletten.

Merck (Schweiz) AG, Zug.

Diese Packungsbeilage wurde im März 2015 letztmals durch die Arzneimittelbehörde (Swissmedic) geprüft.

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How effective was the medicament? (1: not effective, 5: very effective)
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Would you recommend someone else to use this medicament? (1: would never recommend, 5: would definitely recommend)
How many effects caused the medicament? (1: lots of side effects, 5: no side effects)
How heavy were the side effects caused by the medicament? (1: very heavy, 5: not heavy)
I hereby certify that all information is true and accurate. My evaluation reflects my personal experience. My evaluation is appropriate and serves to benefit others before usage of the medicament.