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NOVOSEVEN 1 mg (50 KUI) POWDER AND SOLVENT FOR INJECTABLE SOLUTION

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About the medicine

How to use NOVOSEVEN 1 mg (50 KUI) POWDER AND SOLVENT FOR INJECTABLE SOLUTION

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

Show original

Contents of the leaflet

  1. Introduction
  2. What is NovoSeven and what is it used for
  3. What you need to know before you use NovoSeven
  4. How to use NovoSeven
  5. Possible side effects
  6. Storage of NovoSeven
  7. Container Contents and Additional Information

Introduction

Package Leaflet: Information for the User

NovoSeven 1mg (50KUI) powder and solvent for solution for injection

NovoSeven 2mg (100KUI) powder and solvent for solution for injection

NovoSeven 5mg (250KUI) powder and solvent for solution for injection

NovoSeven 8mg (400KUI) powder and solvent for solution for injection

eptacog alfa (activated)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

  1. What is NovoSeven and what is it used for
  2. What you need to know before you use NovoSeven
  3. How to use NovoSeven
  4. Possible side effects
  5. Storage of NovoSeven
  6. Contents of the pack and further information

On the back: Instructions for use of NovoSeven

1. What is NovoSeven and what is it used for

NovoSeven is a blood clotting factor. It works by activating the blood clotting system at the site of bleeding when the patient's own clotting factors are not working.

NovoSeven is used to treat bleeding and to prevent excessive bleeding after surgery or other major treatments. Early treatment with NovoSeven reduces the amount and duration of bleeding. It works in all types of bleeding, including joint bleeding. This reduces the need for hospitalization and days off work or school.

It is used in certain groups of people:

  • If you have congenital hemophilia and do not respond normally to treatment with factors VIII or IX
  • If you have acquired hemophilia
  • If you have Factor VII deficiency
  • If you have Glanzmann's thrombasthenia (a bleeding disorder) and your disease cannot be effectively treated with platelet transfusion, or if platelets are not readily available.

NovoSeven may also be given to you by a doctor to treat heavy bleeding after childbirth, even if you do not have a bleeding disorder.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you use NovoSeven

Do not use NovoSeven

  • If you are allergic to eptacog alfa (the active substance of NovoSeven) or to any of the other ingredients of this medicine (listed in section 6).
  • If you are allergic to mouse, hamster or bovine proteins (such as cow's milk).

If any of these apply to you, do not use NovoSeven. Talk to your doctor.

Warnings and precautions

Before starting treatment with NovoSeven, make sure your doctor knows:

  • If you have recently undergone surgery
  • If you have recently suffered a crush injury
  • If your arteries are narrower due to disease (atherosclerosis)
  • If you have a higher risk of blood clot formation (thrombosis)
  • If you have severe liver disease
  • If you have severe septicemia
  • If you are prone to disseminated intravascular coagulation (DIC, a condition in which blood clots form in the bloodstream) you should be closely monitored.

If any of these apply to you, tell your doctor before using this product.

Other medicines and NovoSeven

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Do not use NovoSeven at the same time as prothrombin complex concentratesor rFXIII. You should consult your doctor before using NovoSeven if you are also using factor VIII or IX.

There is limited experience with the use of NovoSeven together with other medicines called antifibrinolytics (such as aminocaproic acid or tranexamic acid) which are also used to control bleeding. You should consult your doctor before using NovoSeven with these medicines.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using NovoSeven.

Driving and using machines

There are no studies on the effects of NovoSeven on the ability to drive and use machines. However, there is no medical reason to think that it could affect your ability.

NovoSeven contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per injection, which is essentially "sodium-free".

3. How to use NovoSeven

NovoSeven powder must be reconstituted with the solvent and injected intravenously. See the detailed instructions on the back.

When to treat

Start treatment of a bleed as soon as possible, ideally within the first 2 hours.

  • In case of a mild or moderate bleed, you should treat yourself as soon as possible, preferably at home.
  • In case of a severe bleed, you should contact your doctor. Normally, severe bleeds are treated in hospital and you can give yourself the first dose of NovoSeven on the way there.

You should not treat for more than 24 hours without consulting your doctor.

  • Each time you use NovoSeven, you should inform your doctor or hospital as soon as possible.
  • If the bleed is not controlled within the first 24 hours, contact your doctor immediately. You will usually need hospital attention.

Dose

The first dose should be given as soon as possible after the start of the bleed. Ask your doctor when injections should be given and how long you should continue using them.

Your doctor will decide your dose, based on your body weight, condition and type of bleed.

To get the best result, follow the prescribed dose carefully. Your doctor may change the dose.

If you have hemophilia:

The normal dose is 90 micrograms per kilogram of body weight; you can repeat the injection every 2-3 hours until the bleed is controlled.

Your doctor may recommend a single dose of 270 micrograms per kilogram of body weight. There is no clinical experience with this single dose in people over 65 years of age.

If you have Factor VII deficiency:

The normal dose range is 15-30 micrograms per kilogram of body weight, for each injection.

If you have Glanzmann's thrombasthenia:

The usual dose is 90 micrograms (range 80 to 120 micrograms) per kilogram of body weight, for each injection.

If you inject more NovoSeven than you should

If you inject too much NovoSeven, talk to a doctor immediately.

If you forget to inject a dose of NovoSeven

If you forget to inject a dose of NovoSeven or want to stop treatment, talk to a doctor immediately.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Rare (may affect up to 1 in 1,000 people treated)

  • Allergic reactions, hypersensitivity or anaphylactic reactions. Symptoms may include skin rash, itching, redness and hives; chest tightness or difficulty breathing; dizziness or lightheadedness, and severe swelling of the lips or throat, or at the injection site.
  • Blood clots in the arteries of the heart (which could lead to a heart attack or angina), in the brain (which could lead to a stroke), or in the intestine and kidneys. Symptoms may include severe chest pain, difficulty breathing, confusion, difficulty with speech or movement (paralysis), or abdominal pain.

Uncommon (may affect up to 1 in 100 people treated)

  • Blood clots in the veins of the lungs, legs, liver, kidneys, or at the injection site. Symptoms may include difficulty breathing, red and painful swelling of the leg, and abdominal pain.
  • Lack of efficacy or reduced response to treatment.

If you experience any of these serious side effects, seek medical help immediately. Tell your doctor that you have been using NovoSeven.

Remember to tell your doctor if you have a history of allergic reactions, as you may need closer monitoring. In the vast majority of reported cases of thrombosis, patients had a predisposition to thrombotic disorders.

Other rare side effects

(may affect up to 1 in 1,000 people treated)

  • Nausea (feeling sick)
  • Headache
  • Changes in some blood test and liver results.

Other uncommon side effects

(may affect up to 1 in 100 people treated)

  • Skin rash, including rash, itching, and hives
  • Fever.

Reporting of side effects

If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of NovoSeven

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.
  • Store the powder and solvent below 25°C.
  • Store the powder and solvent protected from light.
  • Do not freeze.
  • Use NovoSeven immediately after mixing the powder with the solvent to avoid infections. If you cannot use it immediately, after mixing, you should store it in the vial with the vial adapter and with the syringe still in place, in the refrigerator between 2°C and 8°C, for a maximum of 24 hours. Do not freeze the reconstituted NovoSeven solution and keep it protected from light. Do not store the solution without consulting your doctor or nurse.
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Composition of NovoSeven

  • The active substance is recombinant coagulation factor VIIa (eptacog alfa activated).
  • The other components in the powder are sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, methionine, hydrochloric acid, and sodium hydroxide. The components of the solvent are histidine, hydrochloric acid, sodium hydroxide, and water for injections.

The powder for solution for injection contains: 1 mg/vial (which corresponds to 50 KUI/vial), 2 mg/vial (which corresponds to 100 KUI/vial), 5 mg/vial (which corresponds to 250 KUI/vial), or 8 mg/vial (which corresponds to 400 KUI/vial).

After reconstitution, 1 ml of the solution contains 1 mg of eptacog alfa (activated).

1 KUI is equal to 1,000 IU (International Units).

Appearance of NovoSeven and Container Contents

The vial of powder contains white powder and the pre-filled syringe contains a clear and colorless solution. The reconstituted solution is colorless. Do not use the reconstituted solution if particles appear or if it is discolored.

Each NovoSeven container contains:

  • 1 vial with white powder for solution for injection
  • 1 vial adapter
  • 1 pre-filled syringe with solvent for reconstitution
  • 1 plunger

Presentation: 1 mg (50 KUI), 2 mg (100 KUI), 5 mg (250 KUI), and 8 mg (400 KUI).

The current presentation is indicated on the outer packaging.

Marketing Authorization Holder and Manufacturer

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd, Denmark

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

Instructions for Use of NovoSeven

READ THESE INSTRUCTIONS CAREFULLY BEFORE USING NOVOSEVEN

NovoSeven is presented as a powder. Before injection (administration), it must be reconstituted with the solvent that accompanies it in the syringe. The solvent is a histidine solution. The reconstitution of NovoSeven must be injected into a vein (intravenous injection). The equipment in this container is designed to reconstitute and inject NovoSeven.

You will also need administration equipment (catheter and butterfly needle, sterile alcohol-impregnated swabs, gauze pads, and adhesive strips). These materials are not included in the NovoSeven container.

Do not use the equipment without proper training by your doctor or nurse.

Always wash your hands and ensure the area around you is clean.

When preparing and injecting a medication directly into a vein, it is essential to use a clean and germ-free technique (aseptic technique).An inappropriate technique can introduce germs capable of infecting the blood.

Do not open the equipment until you are ready to use it.

Do not use the equipment if it has been dropped or is damaged.In that case, use a new container.

Do not use the equipment if it has expired.In that case, use a new container. The expiration date is printed after EXP on the carton, vial, vial adapter, and pre-filled syringe.

Do not use the equipment if you suspect it is contaminated.In that case, use a new container.

Do not discard any of the materials until the reconstituted solution has been injected.

The equipment is for single use.

Contents

The container contains:

  • 1 vial with NovoSeven powder
  • 1 vial adapter
  • 1 pre-filled syringe with solvent
  • 1 plunger (located under the syringe)

Glass vial with white powder, rubber stopper covered by a light blue plastic cap

Vial adapter with transparent protective cap and visible spike under paper protector

Pre-filled syringe with solvent showing cap, tip, piston, and graduated scale on cylindrical body

Diagram of a plunger with thread on one end and wide opposite end, arrows indicate parts

  1. Prepare the vial and syringe
  • Remove the number of NovoSeven containers you will need.
  • Check the expiration date.
  • Check the name, concentration, and color of the container to ensure it contains the correct product.
  • Wash your hands and dry them well with a clean towel or dry air.
  • Remove the vial, vial adapter, and pre-filled syringe from the container. Leave the plunger untouched in the container.
  • Bring the vial and pre-filled syringe to room temperature (not above 37°C). You can do this by holding them in your hands until you feel they are at the same temperature as your hands.
  • Do not use any other system to heat the vial and pre-filled syringe.

Two hands holding ends of a white and purple medical device for connection

  • Remove the plastic cap from the vial.

If the plastic cap is loose or missing, do not use the vial.

  • Clean the rubber stopper with an alcohol-impregnated swab and let it air dry for a few seconds before use to ensure it is as germ-free as possible.
  • Do not touch the rubber stopper with your fingers, as this can transfer germs.

Hand holding a blue medicine vial with a silver cap about to be removed by a blue arrow

  1. Place the vial adapter
  • Remove the paper seal from the vial adapter.

If the paper seal is not completely sealed or is broken, do not use the vial adapter.

Do not remove the vial adapter from the protective cap with your fingers.If you touch the spike of the vial adapter, you can transfer germs from your fingers.

Hands holding a pre-filled syringe with needle pointing up and arrow indicating injection direction

  • Place the vial on a flat and solid surface.
  • Turn the protective cap over and fit the vial adapter onto the vial.

Once joined, do not remove the vial adapter from the vial.

Hand pressing an auto-injector device onto the skin with a medicine vial underneath

  • Gently press the protective cap between your thumb and index finger as shown in the drawing.

Remove the protective capfrom the vial adapter.

Do not remove the vial adapter from the vialwhen removing the protective cap.

Hand holding an application device with a blue arrow indicating direction and small vial in the lower right corner

  1. Place the plunger on the syringe.
  • Hold the plunger by the wide end and remove it from the container. Do not touch the sides or thread of the plunger. If you touch the sides or thread, you can transfer germs from your fingers.

Connect the plunger immediatelyto the syringe by turning it clockwise in the piston inside the pre-filled syringe until you feel resistance.

Hands holding a pre-filled injection device with an arrow indicating activation direction

  • Remove the syringe cap from the pre-filled syringe by folding it down until the perforation breaks.

Do not touch the tip of the syringe under the syringe cap.If you touch the tip of the syringe, you can transfer germs from your fingers.

If the syringe cap is loose or missing, do not use the pre-filled syringe.

Hands holding an insulin applicator and a puncture needle with an arrow indicating connection

  • Tightly screw the pre-filled syringe onto the vial adapter until you feel resistance.

Hands holding an auto-injector with an arrow indicating device removal direction

  1. Reconstitute the powder with the solvent
  • Hold the pre-filled syringe slightly inclined with the vial facing down.
  • Press the plunger to inject all the solvent into the vial.

Hand holding a syringe with a needle inserted into the skin, blue arrow indicates subcutaneous injection direction

  • Keep the plunger pressed and make gentle circular movements with the vial until all the powder is dissolved.

Do not shake the vial, as this can produce foam.

  • Check the reconstituted solution. It should be colorless. If you see particles or a color change, do not use it. In that case, use a new container.

Hand holding an auto-injector with a small vial attached, turning clockwise with an arrow indicating direction

Use the reconstituted NovoSeven immediatelyto avoid infections.

If you cannot use it immediately,see section 5Storage of NovoSevenon the other side of this leaflet. Do not store the reconstituted solution without consulting your doctor or nurse.

(I)

If your dose requires more than one vial, repeat steps Ato Jwith additional vials, vial adapters, and pre-filled syringes until you reach the required dose.

  • Keep the plunger fully pressed.
  • Turn the syringe over with the vial facing down.
  • Release the pressure on the plunger and let it slide down by itself while the reconstituted solution passes into the syringe.
  • Pull the plunger down slightly to transfer all the reconstituted solution to the syringe.
  • If you do not need the full dose, use the scale on the syringe to see how much reconstituted solution to extract, as your doctor or nurse has taught you.
  • If there is too much air in the syringe at any time, reinject the air into the vial.
  • While holding the vial upside down, gently tap the syringe to make the air bubbles rise.
  • Slowly press the plunger until no air bubbles remain.

Hand holding a pre-filled syringe with transparent medication and black plunger, arrow indicates downward pressure

  • Unscrew the vial adapter with the vial.
  • Do not touch the tip of the syringe. If you touch the tip of the syringe, you can transfer germs from your fingers.

Hand holding an auto-injector with a removed needle protector showing the connection mechanism to a transparent ampoule

Injection of NovoSeven with pre-filled syringe through needle-free connectors for intravenous (IV) catheters

Precaution:The pre-filled syringe is made of glass and is designed to be compatible with standard luer-lock connections. Some needle-free connectors with an internal spike are incompatible with the pre-filled syringe. This incompatibility can prevent medication administration and/or damage the needle-free connector.

Follow the instructions for use of the needle-free connector. Administration through a needle-free connector may require extracting the reconstituted solution with a standard 10 ml sterile luer-lock plastic syringe. This should be done immediately after step J.

  1. Inject the reconstituted solution

NovoSeven is now ready to be injected into a vein.

  • Inject the reconstituted solution according to the instructions of your doctor or nurse.
  • Inject slowly over 2 to 5 minutes.

Injection through a central venous access device (CVAD) such as a central venous catheter or subcutaneous port:

  • Use a clean and germ-free technique (aseptic technique). Follow the instructions for the proper use of your connector and CVAD with the guidance of your doctor or nurse.
  • Injection into a CVAD may require using a 10 ml sterile plastic syringe to extract the reconstituted solution.
  • If it is necessary to flush the CVAD line before or after the injection of NovoSeven, use sodium chloride 9 mg/ml solution for injection.

Disposal

  • After injection, safely discard the syringe with the administration equipment, the vial with the vial adapter, the unused NovoSeven, and other waste according to the instructions of your doctor or nurse.
  • Do not throw it away with household waste.

Vial with gray cap, needle connected to a cylinder, and small vial with white powder, arrow indicates direction

Do not disassemble the equipment before discarding it.

Do not reuse the equipment.

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Jonathan Marshall Ben Ami

Family medicine 9 years exp.

Dr. Jonathan Marshall Ben Ami is a licensed family medicine doctor in Spain. He provides comprehensive care for adults and children, combining general medicine with emergency care expertise to address both acute and chronic health concerns.

Dr. Ben Ami offers expert diagnosis, treatment, and follow-up for:

  • Respiratory infections (cold, flu, bronchitis, pneumonia).
  • ENT conditions such as sinusitis, ear infections, and tonsillitis.
  • Digestive issues including gastritis, acid reflux, and irritable bowel syndrome (IBS).
  • Urinary tract infections and other common infections.
  • Management of chronic diseases: high blood pressure, diabetes, thyroid disorders.
  • Acute conditions requiring urgent medical attention.
  • Headaches, migraines, and minor injuries.
  • Wound care, health check-ups, and ongoing prescriptions.

With a patient-focused and evidence-based approach, Dr. Ben Ami supports individuals at all stages of life — offering clear medical guidance, timely interventions, and continuity of care.
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Frequently Asked Questions

Is a prescription required for NOVOSEVEN 1 mg (50 KUI) POWDER AND SOLVENT FOR INJECTABLE SOLUTION?
NOVOSEVEN 1 mg (50 KUI) POWDER AND SOLVENT FOR INJECTABLE SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in NOVOSEVEN 1 mg (50 KUI) POWDER AND SOLVENT FOR INJECTABLE SOLUTION?
The active ingredient in NOVOSEVEN 1 mg (50 KUI) POWDER AND SOLVENT FOR INJECTABLE SOLUTION is coagulation factor VIIa. This information helps identify medicines with the same composition but different brand names.
Who manufactures NOVOSEVEN 1 mg (50 KUI) POWDER AND SOLVENT FOR INJECTABLE SOLUTION?
NOVOSEVEN 1 mg (50 KUI) POWDER AND SOLVENT FOR INJECTABLE SOLUTION is manufactured by Novo Nordisk A/S. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of NOVOSEVEN 1 mg (50 KUI) POWDER AND SOLVENT FOR INJECTABLE SOLUTION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether NOVOSEVEN 1 mg (50 KUI) POWDER AND SOLVENT FOR INJECTABLE SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to NOVOSEVEN 1 mg (50 KUI) POWDER AND SOLVENT FOR INJECTABLE SOLUTION?
Other medicines with the same active substance (coagulation factor VIIa) include CEVENFACTA 1 mg (45 KIU) POWDER AND SOLVENT FOR INJECTABLE SOLUTION, CEVENFACTA 2 MG (90 KIU) POWDER AND SOLVENT FOR INJECTABLE SOLUTION, CEVENFACTA 5 MG (225 KIU) POWDER AND SOLVENT FOR INJECTABLE SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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