NOVOSEVEN RT (coagulation factor viia- recombinant kit

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

COAGULATION FACTOR VIIA RECOMBINANT HUMAN (UNII: AC71R787OV) (COAGULATION FACTOR VIIA RECOMBINANT HUMAN - UNII:AC71R787OV)

Verfügbar ab:

Novo Nordisk

INN (Internationale Bezeichnung):

COAGULATION FACTOR VIIA RECOMBINANT HUMAN

Zusammensetzung:

COAGULATION FACTOR VIIA RECOMBINANT HUMAN 1 mg in 1 mL

Anwendungsgebiete:

NOVOSEVEN RT, Coagulation Factor VIIa (Recombinant), is indicated for: None known. Risk Summary There are no adequate and well-controlled studies using NOVOSEVEN RT in pregnant women to determine whether there is a drug-associated risk. Treatment of rats and rabbits with NOVOSEVEN in reproduction studies has been associated with mortality at doses up to 6 mg per kg body weight and 5 mg per kg body weight respectively. At 6 mg per kg body weight in rats, the abortion rate was 0 out of 25 litters; in rabbits at 5 mg per kg body weight, the abortion rate was 2 out of 25 litters. Twenty-three out of 25 female rats given 6 mg per kg body weight of NOVOSEVEN gave birth successfully, however, two of the 23 litters died during the early period of lactation. No evidence of teratogenicity was observed after dosing with NOVOSEVEN. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Risk Summary There is

Produktbesonderheiten:

How Supplied NOVOSEVEN RT, Coagulation Factor VIIa (Recombinant), is supplied as a room temperature stable, white, lyophilized powder in single‑dose vials, one single-dose vial per carton. The diluent for reconstitution of NOVOSEVEN RT is a 10 mmol solution of L-histidine in water for injection and is supplied as a clear colorless solution, and referred to as the histidine diluent. The histidine diluent is provided in either a vial or pre-filled diluent syringe. The amount of rFVIIa in milligrams and in micrograms is stated on the label. NOVOSEVEN RT package containing 1 single-dose vial of NOVOSEVEN RT powder and 1 vial of histidine diluent: Presentation Carton NDC Number Components 1 mg per vial (1000 micrograms/vial) NDC 0169 7010 01 2 mg per vial (2000 micrograms/vial) NDC 0169 7020 01 5 mg per vial (5000 micrograms/vial) NDC 0169 7050 01 8 mg per vial (8000 micrograms/vial) NDC 0169 7040 01 NOVOSEVEN RT with MixPro® package containing 1 single-dose vial of NOVOSEVEN RT powder and 1 pre-filled histidine diluent syringe with sterile vial adapter which serves as an alternative needleless reconstitution system: Presentation Carton NDC Number Components 1 mg per vial (1000 micrograms/vial) NDC 0169 7201 01 2 mg per vial (2000 micrograms/vial) NDC 0169 7202 01 5 mg per vial (5000 micrograms/vial) NDC 0169 7205 01 8 mg per vial (8000 micrograms/vial) NDC 0169 7208 01 The NOVOSEVEN RT and histidine diluent vials are made of glass closed with a chlorobutyl rubber stopper not made with natural rubber latex, and covered with an aluminum cap. The pre-filled diluent syringes are made of glass, with a siliconised bromobutyl rubber plunger not made with natural rubber latex. The closed vials and pre-filled diluent syringes are equipped with a tamper-evident snap-off cap which is made of polypropylene. A vial adapter with 25 micrometer filter is provided with the pre-filled diluent syringe. Storage and Handling Prior to reconstitution, store NOVOSEVEN RT powder and histidine diluent between 2-25°C (36-77°F). Do not freeze. Store protected from light. Do not use past the expiration date. After reconstitution, store NOVOSEVEN RT either at room temperature or refrigerated for up to 3 hours. Do not freeze reconstituted NOVOSEVEN RT or store in syringes.

Berechtigungsstatus:

Biologic Licensing Application

Fachinformation

NOVOSEVEN RT- COAGULATION FACTOR VIIA (RECOMBINANT)
NOVO NORDISK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NOVOSEVEN RT SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR NOVOSEVEN RT.
NOVOSEVEN RT (COAGULATION FACTOR VIIA, RECOMBINANT)
LYOPHILIZED POWDER FOR SOLUTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1999
WARNING: THROMBOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
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INDICATIONS AND USAGE
NOVOSEVEN RT, Coagulation Factor VIIa (Recombinant) is indicated for:
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DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS INJECTION ONLY
BLEEDING EPISODES (2.1)
INDIC ATIO N
DOSING RECOMMENDATION
Congenital Hemophilia A or B with Inhibitors
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Acquired Hemophilia
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Congenital Factor VII Deficiency
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Glanzmann’s Thrombasthenia
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PERI-OPERATIVE MANAGEMENT (2.1)
INDIC ATIO N
DOSING RECOMMENDATION
Congenital Hemophilia A or B with Inhibitors
MINO R:
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Serious arterial and venous thrombotic events following administration
of NOVOSEVEN RT have been
reported. (5.1)
Discuss the risks and explain the signs and symptoms of thrombotic and
thromboembolic events to patients
who will receive NOVOSEVEN RT
Monitor patients for signs or symptoms of activation of the
coagulation system and for thrombosis. (5.1)
Treatment of bleeding episodes and perioperative management in adults
and children with hemophilia A or B with
inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s
thrombasthenia with refractoriness to platelet
transfusions, with or without antibodies to platelets (1)
Treatment of bleeding episodes and perioperative management in adults
with acquired hemophilia (1)
90 mcg/kg every 2 hours, adjustable based on severity of
bleeding until hemostasis is achieved
90 mcg/kg every 3-6 hours after hemostasis is achieved for
severe bleeds
70-90 mcg/kg every 2-3 hours until hemostasis is achieved
15-30 mcg/kg every 4-6 hours until hemostasis is achieved
90 mcg/kg every 2-6 hours until hemosta