NOVOSEVEN Powder and solvent for solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
NovoSeven 1 mg (50 KIU) powder and solvent for solution for injection. NovoSeven 2 mg (100 KIU) powder and solvent for solution for injection. NovoSeven 5 mg (250 KIU) powder and solvent for solution for ...
Qualitative and quantitative composition
NovoSeven 1 mg (50 KIU): NovoSeven is presented as powder and solvent for solution for injection containing 1 mg eptacog alfa (activated) per vial (corresponds to 50 KIU/vial). NovoSeven 2 mg (100 KIU): ...
Pharmaceutical form
Powder and solvent for solution for injection. White lyophilised powder. Solvent: clear colourless solution. The reconstituted solution has a pH of approximately 6.0.
Therapeutic indications
NovoSeven is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: in patients with congenital ...
Posology and method of administration
Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and/or bleeding disorders. Posology Haemophilia A or B with inhibitors or expected to have ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to mouse, hamster or bovine protein.
Special warnings and precautions for use
In pathological conditions in which tissue factor may be expressed more extensively than considered normal, there may be a potential risk of development of thrombotic events or induction of Disseminated ...
Interaction with other medicinal products and other forms of interaction
The risk of a potential interaction between NovoSeven and coagulation factor concentrates is unknown. Simultaneous use of prothrombin complex concentrates, activated or not, should be avoided. Anti-fibrinolytics ...
Pregnancy and lactation
Pregnancy As a precautionary measure, it is preferable to avoid use of NovoSeven during pregnancy. Data on a limited number of exposed pregnancies within approved indications indicate no adverse effects ...
Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.
Undesirable effects
Summary of the safety profile The most frequently reported adverse drug reactions are decreased therapeutic response, pyrexia, rash, venous thromboembolic events, pruritus and urticaria. These reactions ...
Overdose
Dose limiting toxicities of NovoSeven have not been investigated in clinical trials. Four cases of overdose have been reported in patients with haemophilia in 16 years. The only complication reported in ...
Pharmacodynamic properties
Pharmacotherapeutic group: Blood coagulation factors ATC code: B02BD08 Mechanism of action NovoSeven contains activated recombinant coagulation factor VII. The mechanism of action includes the binding ...
Pharmacokinetic properties
Healthy subjects Distribution, elimination and linearity Using the FVII clotting assay, the pharmacokinetics of rFVIIa were investigated in 35 healthy Caucasian and Japanese subjects in a dose-escalation ...
Preclinical safety data
All findings in the preclinical safety programme were related to the pharmacological effect of rFVIIa. A potential synergistic effect of combined treatment with rFXIII and rFVIIa in an advanced cardiovascular ...
List of excipients
Powder: Sodium chloride Calcium chloride dihydrate Glycylglycine Polysorbate 80 Mannitol Sucrose Methionine Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment) Solvent: Histidine ...
Incompatibilities
NovoSeven must not be mixed with infusion solutions or be given in a drip.
Shelf life
Shelf life: The shelf life for the product packed for sale is 3 years when the product is stored below 25°C. In vial: After reconstitution, chemical and physical stability has been demonstrated for 6 hours ...
Special precautions for storage
Store powder and solvent below 25°C. Store powder and solvent protected from light. Do not freeze. For storage conditions of the reconstituted medicinal product, see section 6.3.
Nature and contents of container
The solvent of NovoSeven is provided in either a vial or in a pre-filled syringe. Not all presentations may be marketed. The NovoSeven 1 mg (50 KIU)/NovoSeven 2 mg (100 KIU) package contains either: 1 ...
Special precautions for disposal and other handling
The solvent of NovoSeven is provided in either a vial or in a pre-filled syringe. Not all presentations may be marketed. Handling procedures for both presentations are described below. Powder in vial and ...
Marketing authorization holder
Novo Nordisk A/S, Novo Allé, DK-2880, Bagsværd, Denmark
Marketing authorization number(s)
NovoSeven 1 mg (50 KIU): EU/1/96/006/004 EU/1/96/006/008 NovoSeven 2 mg (100 KIU): EU/1/96/006/005 EU/1/96/006/009 NovoSeven 5 mg (250 KIU): EU/1/96/006/006 EU/1/96/006/010 NovoSeven 8 mg (400 KIU): EU/1/96/006/007 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 23 February 1996 Date of latest renewal: 23 February 2006
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