Sevenfact (intravenous)

Sevenfact (intravenous)

Intravenous route (powder for solution)

Serious arterial and venous thrombotic events are associated with the use of coagulation factor VIIa. Patients should be informed of the risks and aware of the signs and symptoms of thrombotic and thromboembolic events. Monitor for signs/symptoms of thrombosis and activation of the coagulation cascade.

Intravenous route (powder for solution)

thrombosis

Serious arterial and venous thrombotic events may occur following administration of coagulation factor VIIa recombinant-jncw.

Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events in patients receiving coagulation factor VIIa (recombinant)-JNCW.

Monitor patients for signs or symptoms of coagulation system activation and thrombosis.

Used for Sevenfact

Factor VIIa is an artificial protein made to reproduce naturally occurring activated factor VII (Factor VIIa) in the body. It is used to stop bleeding from injuries in patients with hemophilia by helping blood clot.

Factor VIIa should only be administered by or under your doctor's direct supervision.

Before using Sevenfact

When deciding whether to use a medicine, the risks of taking the medicine must be weighed against the benefits it produces. This is a decision that you and your doctor will make. The following should be noted with this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor if you have other allergies, such as to foods, dyes, preservatives or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatrics

Studies conducted to date have not shown any pediatric problems that would limit the benefit of factor VIIa in children.

geriatrics

There have been no adequate and well-controlled studies on the association of age with the effects of factor VIIa in geriatric patients.

Breastfeeding

There are insufficient studies in women to determine the risk to infants when using this drug while breast-feeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. If you are receiving this medicine, it is particularly important that your doctor knows whether you are taking any of the medicines listed below. The following interactions were selected for their potential significance and are not necessarily exhaustive.

Using this medicine with any of the following medicines is not usually recommended but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Anti-Inhibitor-Gerinnungskomplex
• Faktor XIII
• Prothrombin-Komplex

Interactions with food/tobacco/alcohol

Certain medicines should not be taken during or near food or consumption of certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. Discuss using your medicine with food, alcohol or tobacco with your doctor.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Blutgerinnsel oder eine Vorgeschichte von medizinischen Problemen, die durch Blutgerinnsel verursacht wurden oder
• Herzerkrankung (z. B. koronare Herzkrankheit), Vorgeschichte von oder
• Infektion bzw
• Verletzung (Quetschung) bzw
• Lebererkrankung – Diese Erkrankungen können das Risiko der Bildung von Blutgerinnseln erhöhen.

Proper use of Sevenfact

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle into one of your veins.

Precautions when using Sevenfact

It is very important that your doctor closely monitors your progress while you are receiving this medicine to make sure it is working properly. Blood tests may be needed to check for adverse effects.

This medicine can cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you experience rash, itching, difficulty breathing, difficulty swallowing, or swelling of your hands, face, or mouth while taking this medication.

This medicine may increase your risk of blood clotting problems. The risk is higher if you have a condition such as disseminated intravascular coagulation (DIC) or severe artery disease, or if you take certain blood clotting medications. Tell your doctor right away if you experience sudden or severe headache, vision or speech problems, chest pain, shortness of breath, or numbness or weakness while taking this medication.

Side effects of Sevenfact

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

Contact your doctor or nurse immediately if any of the following side effects occur:

More common

• Blutungsprobleme
• Fieber
• Bluthochdruck
• Gelenk- oder Muskelschmerzen oder Steifheit

Less common or rare

• Blähungen oder Schwellungen im Gesicht, an den Händen, Unterschenkeln oder Füßen
• bläuliche Farbe der Hände oder Füße
• verschwommene Sicht
• Veränderungen der Gesichtsfarbe
• Brustschmerzen
• Schüttelfrost
• kalter Schweiß
• Verwirrung
• anhaltender Durst
• Husten
• Schwindel
• starkes Schwitzen
• Schwäche
• schneller Herzschlag
• Nesselsucht, Juckreiz oder Hautausschlag
• große flache blaue oder violette Flecken auf der Haut
• Benommenheit beim plötzlichen Aufstehen aus dem Liegen oder Sitzen
• anhaltende Blutung oder Nässen aus Einstichstellen oder Schleimhäuten (Darm, Mund, Nase oder Harnblase)
• Schwellungen oder Schwellungen der Augenlider oder um die Augen herum
• Zittern
• langsamer oder unregelmäßiger Herzschlag (weniger als 50 Schläge pro Minute)
• undeutliches Sprechen
• niesen
• Halsentzündung
• plötzliche Abnahme der Urinmenge
• Schwellung von Gesicht, Fingern, Füßen oder Unterschenkeln
• Atembeschwerden, Engegefühl in der Brust
• ungewöhnliche Müdigkeit oder Schwäche
• ungewöhnliche Gewichtszunahme

Some side effects may occur that usually do not require medical attention. These side effects may disappear during treatment as your body gets used to the medicine. Your doctor may also be able to give you ways to prevent or reduce some of these side effects. If any of the following side effects persist or are bothersome, or if you have any questions, contact your doctor:

Less common or rare

• Brennen oder Stechen an der Injektionsstelle
• Schläfrigkeit
• Gefühl von Wärme
• Kopfschmerzen
• Übelkeit oder Erbrechen
• Punktförmige rote oder violette Flecken auf der Haut
• Rötung des Gesichts, des Halses, der Arme und gelegentlich der oberen Brust

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Commonly used brand names

In the USA

• Novoseven
• NovoSeven RT
• Sevenfact

Available dosage forms:

• Pulver zur Lösung

Therapeutic Class: Hemostatic

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