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NovoSeven® 1 mg powder and solvent for solution for injection – recombinant coagulation factor VIIa
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- Stock: Zabrana online prodaje
- Brand: NOVO NORDISK
- Model: BR-6057662165
NovoSeven® contains eptacog alfa (activated), a recombinant coagulation factor VIIa. It enables the blood to clot at the site of bleeding when the body's own clotting factors do not work.
It is used to treat bleeding episodes and to prevent bleeding during surgery and other major procedures. Early treatment reduces the extent and duration of bleeding. The manufacturer is Novo Nordisk A/S (Denmark), and the marketing authorisation holder is Novo Nordisk Pharma d.o.o. Beograd.
Important warning
- Dispensing status: in an inpatient healthcare institution; exceptionally on a doctor's prescription to continue treatment at home.
- It must not be used in people allergic to eptacog alfa, to any of the excipients, or to mouse, hamster or bovine proteins (e.g. cow's milk).
- Do not use the medicine on your own for longer than 24 hours without a doctor's advice.
- It is not used at the same time as prothrombin complex concentrates or rFXIII.
What NovoSeven is used for and how it is given
Key facts about the medicine
| Name of the medicine | NovoSeven®, 1 mg, powder and solvent for solution for injection |
|---|---|
| Active substance | eptacog alfa (activated) – recombinant factor VIIa, 1 mg per vial (50 KIU) |
| Pharmaceutical form | powder and solvent for solution for injection, intravenous |
| Pack | a vial of powder and a pre-filled syringe with 1 mL of solvent |
| Marketing authorisation holder | Novo Nordisk Pharma d.o.o. Beograd |
| Manufacturer | Novo Nordisk A/S, Denmark |
| Dispensing status | inpatient institution; exceptionally on prescription for home treatment |
Indications
According to the leaflet, NovoSeven is used to treat and prevent bleeding in people:
- born with haemophilia who do not respond normally to factor VIII or IX;
- with acquired haemophilia;
- with factor VII deficiency;
- with Glanzmann's thrombasthenia, when platelet transfusion is not effective or platelets are not readily available.
Dosage and method of administration
The powder is dissolved in the supplied solvent and injected intravenously. Treatment of a bleed should start as early as possible, ideally within 2 hours. Patients can start treating mild and moderate bleeds themselves at home; in the case of a severe bleed they should contact a doctor immediately, and the first dose may be given on the way to hospital. The dose is determined by the doctor according to body weight, condition and the type of bleeding:
- haemophilia: usually 90 micrograms/kg, repeated every 2–3 hours until the bleeding is under control; the doctor may also recommend a single dose of 270 micrograms/kg;
- factor VII deficiency: 15–30 micrograms/kg per injection;
- Glanzmann's thrombasthenia: 90 micrograms/kg (80–120) per injection.
Report every administration to your doctor or hospital as soon as possible. If the bleeding is not under control within 24 hours, contact a doctor immediately.
Contraindications – when the medicine must not be used
- allergy to eptacog alfa or to any of the excipients;
- allergy to mouse, hamster or bovine proteins (e.g. cow's milk).
Warnings and precautions
Talk to your doctor before use if you have recently had surgery or a crush injury, if you have narrowing of the arteries (atherosclerosis), an increased risk of thrombosis, severe liver disease, a serious blood infection or a tendency to disseminated intravascular coagulation (DIC) – careful monitoring is then required.
Interactions with other medicines
It is not used at the same time as prothrombin complex concentrates or rFXIII. Talk to your doctor if you are already using factor VIII or IX, and before using it together with antifibrinolytics (aminocaproic or tranexamic acid), because experience is limited.
Pregnancy and breast-feeding
If you are pregnant, breast-feeding or planning a pregnancy, ask your doctor for advice before use.
Driving and using machines
No studies have been performed, but there are no medical reasons to suggest an effect on these abilities.
Possible side effects
Serious, rare: allergic reactions (hypersensitivity); blood clots in the arteries of the heart, brain, intestine or kidneys. A severe allergic (anaphylactic) reaction has been reported, but its frequency is not known. Serious, uncommon: blood clots in the veins of the lungs, legs, liver, kidneys or at the injection site; lack of or reduced response to treatment.
Other: rarely nausea, headache and changes in some liver and blood tests; uncommonly fever, rash, itching and hives.
When to seek medical help immediately
- rash, itching, wheezing or difficulty breathing, feeling faint, swelling of the lips or throat;
- severe chest pain, shortness of breath, confusion, difficulty speaking or paralysis;
- red, painful swellings in the legs or abdominal pain;
- bleeding that is not under control within 24 hours.
Pharmacist's advice
NovoSeven works best when it is given early – for a mild or moderate bleed, start treatment at home as soon as possible, ideally within 2 hours, and inform your haemophilia (haematology) centre about every administration. Do not use the medicine for longer than 24 hours without a doctor's advice.
Use the prepared solution immediately. If this is not possible, it may be kept in the refrigerator (2–8 °C) for no longer than 24 hours, with the adapter and syringe attached to the vial, and only on prior advice from your doctor or nurse.
Availability and price
NovoSeven is used in a healthcare institution and, exceptionally, is dispensed on a doctor's prescription to continue treatment at home. This page is for information purposes only and is not an offer to sell the medicine online.
For questions about your treatment, please speak to your haematologist.
Composition, pack and manufacturer
- Active substance: eptacog alfa (activated), 1 mg per vial (50 KIU); after reconstitution 1 mg/mL.
- Excipients (powder): sodium chloride; calcium chloride dihydrate; glycylglycine; polysorbate 80; mannitol; sucrose; methionine; hydrochloric acid; sodium hydroxide.
- Solvent: histidine, hydrochloric acid, sodium hydroxide, water for injections.
- Appearance: white freeze-dried (lyophilised) powder; the solvent and the prepared solution are clear and colourless.
- Marketing authorisation holder: Novo Nordisk Pharma d.o.o. Beograd; manufacturer: Novo Nordisk A/S, Bagsvaerd, Denmark.
Storing the medicine
- Keep out of the sight and reach of children.
- Store the powder and solvent at a temperature up to 25 °C, protected from light. Do not freeze.
- Use the prepared solution immediately; exceptionally, store it in the refrigerator (2–8 °C) for no longer than 24 hours.
- Do not use a solution that contains particles or has changed colour.
Frequently asked questions
Which disorders is NovoSeven used for?
Congenital haemophilia with a poor response to factor VIII or IX, acquired haemophilia, factor VII deficiency and Glanzmann's thrombasthenia.
How soon after a bleed starts should NovoSeven be given?
As early as possible, ideally within 2 hours of the start of the bleed.
What is the usual dose in haemophilia?
Usually 90 micrograms per kilogram of body weight, repeated every 2–3 hours until the bleeding is under control, or a single dose of 270 micrograms/kg as recommended by the doctor.
Why does an allergy to cow's milk matter?
The leaflet lists allergy to mouse, hamster or bovine proteins (e.g. cow's milk) as a contraindication.
Sources
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Additional information
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Shipping cost
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For international delivery:
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