NOVOEIGHT 250 IU Порошок и раствор для инъекционного раствора

Содержание инструкции

1. NovoEight 250 IU powder and solvent for injectable solution, 500 IU powder and solvent for injectable solution, 1000 IU powder and solvent for injectable solution, 1500 IU powder and solvent for injectable solution, 2000 IU powder and solvent for injectable solution, 3000 IU powder and solvent for injectable solution
   1. What is NovoEight and what is it used for
   2. What you need to know before using NovoEight
   3. How to use NovoEight
   4. Possible side effects
   5. How to store NovoEight
   6. Package Contents and Other Information

NovoEight 250 IU powder and solvent for injectable solution, 500 IU powder and solvent for injectable solution, 1000 IU powder and solvent for injectable solution, 1500 IU powder and solvent for injectable solution, 2000 IU powder and solvent for injectable solution, 3000 IU powder and solvent for injectable solution

turoctocog alfa (human coagulation factor VIII (rDNA))

Read this leaflet carefully before you start using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you personally. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If you notice any side effects, tell your doctor. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What is NovoEight and what is it used for

NovoEight contains the active substance turoctocog alfa, which is human coagulation factor VIII. The
factor VIII is a protein naturally present in the blood that helps the blood to coagulate.
NovoEight is used in patients with haemophilia A (congenital factor VIII deficiency) for the treatment or
prevention of bleeding events (haemorrhages) and can be used in patients of all ages.
In subjects with haemophilia A, factor VIII is missing or does not function correctly. NovoEight replaces
this dysfunction or this deficiency of factor VIII and helps the blood to coagulate at the point where the
bleeding (haemorrhage) occurs.

2. What you need to know before using NovoEight

Do not use NovoEight:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to hamster proteins.

Do not use NovoEight if you experience any of these conditions. If you are not sure, contact your doctor before using
this medicine.

Warnings and precautions
Consult your doctor before using NovoEight.
There is a possibility, although rare, that you may develop an anaphylactic reaction (a severe and sudden allergic
reaction) to NovoEight. The first signs of this type of allergic reactions are skin rashes, urticaria,
hives, widespread itching, swelling of the lips and tongue, difficulty breathing, wheezing,
a feeling of tightness in the chest, a general feeling of illness and dizziness.
If any of these symptoms occur, stop the injection immediately and contact your doctor.
Consult your doctor if you believe that the bleeding has not been controlled with the dose taken, as the
causes may be multiple. Some people using this medicine may develop antibodies
against factor VIII (also known as factor VIII inhibitors). Factor VIII inhibitors can
make NovoEight less effective in preventing or controlling bleeding. If this happens you may
need a higher dose of NovoEight or another medicine to control the bleeding.
Do not increase the total dose of NovoEight to control bleeding without first talking to your
doctor. You must inform your doctor if you have been previously treated with factor VIII, especially if
you have developed inhibitors, as their formation may recur.
The formation of inhibitors (antibodies) is a known complication that can occur during treatment with
all factor VIII-based medicines. Inhibitors, especially at high levels, prevent treatment from
acting correctly and you or your child will be closely monitored to check for the development
of these inhibitors. If your bleeding or your child's bleeding has not been controlled with NovoEight,
inform your doctor immediately.

Taking other medicines with NovoEight
Tell your doctor if you are taking, have recently taken or are planning to take any other medicines.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you are pregnant or are planning a pregnancy, ask
your doctor for advice before taking this medicine.

Driving and using machines
NovoEight does not affect the ability to drive or use machines.

NovoEight contains sodium
This medicine contains 30.5 mg of sodium (the main component of table salt) per reconstituted vial.
This is equivalent to 1.5% of the maximum recommended daily intake of sodium for an adult.
Consult your doctor if you are on a low-sodium diet.

3. How to use NovoEight

Treatment with NovoEight must be initiated by a physician experienced in the treatment of patients with
hemophilia A. Always use this medicine exactly as your doctor has told you. If you are not sure, check with
your doctor.
The doctor will determine the necessary dose for you, based on body weight and the medicines you are using.

Prevention of bleeding
The usual dose of NovoEight is between 20 and 50 International Units (IU) per kg of body weight, injected every 2-3
days. In some cases, especially for younger patients, more frequent injections
or higher doses may be necessary.

Treatment of bleeding
The dose of NovoEight is calculated based on body weight and the factor VIII levels that need to be
achieved. Optimal factor VIII levels will depend on the severity and location of the bleeding.

Use in children and adolescents
NovoEight can be used in children of all ages. In younger children (under 12 years) higher doses or more frequent injections may
be necessary. Adolescents (over 12 years) can use the
same dose as adults.

How to administer NovoEight
NovoEight is administered with an injection into a vein. For more information see “Instructions on how
to use NovoEight”.

If you take more NovoEight than you should
If you take more NovoEight than you should, inform your doctor and go to hospital immediately.

If you forget to use NovoEight
If you have forgotten a dose of NovoEight and do not know how to make up for this, consult your doctor.

If you stop taking NovoEight
If you stop taking NovoEight you may no longer be protected against bleeding and subsequent bleeding may not stop.
Do not stop taking NovoEight without first consulting your doctor.
If you have any doubts about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With this medicine the following side effects may occur. If you experience severe and sudden allergic
reactions (anaphylactic reactions) (very rare), you should stop the injection immediately. If you
experience any of the following early symptoms, you should contact your doctor immediately:

• difficulty breathing, shortness of breath or wheezing
• chest tightness
• swelling of the lips and tongue
• skin rash, urticaria, wheals and generalized itching
• dizziness or loss of consciousness
• low blood pressure (pale and cold skin, rapid heartbeat).

Serious symptoms, including difficulty swallowing and breathing, redness or swelling of the face or
hands, require rapid emergency treatment. If you have a severe allergic reaction, your doctor may
change your medicine. In children previously not treated with Factor VIII, inhibitor antibodies may
form (see section 2) very commonly (more than 1 in 10 people); however, in patients who have
received previous treatment with Factor VIII (more than 150 days of treatment), the risk is uncommon
(less than 1 in 100 people). If this happens to you or your child, the medicine may not work properly
and you or your child may have persistent bleeding. If this happens, you should contact your doctor
immediately.

Common side effects (affecting up to 1 in 10 people)

• blood tests showing changes in liver function
• reactions (redness and itching) at the injection site.

Common side effects (affecting up to 1 in 10 people) in patients previously not treated with
Factor VIII

• skin redness
• inflammation of the veins (phlebitis)
• bleeding into the joints
• bleeding into muscle tissue
• cough
• redness of the site where the catheter is located
• vomiting.

Uncommon side effects (affecting up to 1 in 100 people)

• fatigue
• headache
• dizziness
• difficulty sleeping (insomnia)
• fast heartbeat
• increased blood pressure
• rash
• fever
• hot flashes
• muscle stiffness
• muscle pain
• pain in the legs and arms
• swelling of the legs and feet
• arthritis
• bruising
• heart attack.

Side effects in children and adolescents
The side effects observed in children and adolescents are the same as those observed in adults.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system listed in Annex V. By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store NovoEight

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated after ‘EXP.’ on the pack and
on the vial and pre-filled syringe label. The expiry date refers to the last day of the
month indicated.
Store in a refrigerator (2°C – 8 °C).
Do not freeze.
Keep the vial in the outer packaging to protect the medicine from light.
Before NovoEight powder is reconstituted, it can be stored:

• at room temperature (≤ 30 °C) for a single period of time not exceeding 9 months or
• above room temperature (from 30°C up to 40°C) for a single period of time not exceeding 3 months

Once the product has been taken from the refrigerator, it must not be returned to the refrigerator.
Record the start of the storage period and the storage temperature on the packaging.
Once NovoEight has been reconstituted it must be used immediately. If you cannot use it immediately
the reconstituted solution of NovoEight can be used within:

• 24 hours stored at 2°C - 8°C
• 4 hours stored at 30°C, for the product that has been kept for a single period of time not exceeding 9 months at room temperature (≤ 30°C)
• 4 hours stored up to 40°C, for the product that has been kept for a single period of time not exceeding 3 months above room temperature (from 30°C up to 40°C).

Store the reconstituted medicine in the vial. If you do not use the medicine immediately, it may not
be sterile anymore and could cause infections. Do not store the solution without medical advice.
The powder in the vial appears white or slightly yellow. Do not use the powder if the colour has
changed.
The reconstituted solution is clear or slightly opalescent. Do not use this medicine if you notice that the
solution is cloudy or contains visible particles.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What NovoEight contains

• The active substance is turoctocog alfa (human coagulation factor VIII (rDNA)). Each vial of NovoEight nominally contains 250, 500, 1000, 1500, 2000 or 3000 IU of turoctocog alfa.
• The other excipients are L-histidine, sucrose, polysorbate 80, sodium chloride, L-methionine, calcium chloride dihydrate, sodium hydroxide and hydrochloric acid.
• The excipients in the solvent are sodium chloride and water for injections.

After reconstitution with the provided solvent (sodium chloride 9 mg/ml (0.9%) injection solution), the
prepared injection solution contains 62.5, 125, 250, 375, 500 or 750 IU of turoctocog alfa
per ml (based on the dosage of turoctocog alfa, 250, 500, 1000, 1500, 2000 or 3000 IU).

Description of the appearance of NovoEight and package contents
NovoEight consists of powder and solvent for injection solution.
Each pack of NovoEight contains a vial with white or slightly yellow powder, a prefilled syringe with 4 ml of
clear and colourless solution, a plunger and a vial adapter.

Marketing Authorisation Holder:
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd, Denmark

This leaflet was last revised on
Further sources of information
More detailed information on this medicinal product is available on the European Medicines
Agency (EMA) website http://www.ema.europa.eu .

Instructions on how to use NovoEight
READ THESE INSTRUCTIONS CAREFULLY BEFORE USING NOVOEIGHT.
NovoEight is supplied as a powder. Before injection (administration) it must be reconstituted with the
solvent provided in the syringe. The solvent is a sodium chloride 9 mg/ml (0.9%) solution. Reconstituted
NovoEight must be injected into a vein (intravenous injection). The material contained in this
pack is designed to reconstitute and inject NovoEight.
You will also need an infusion set (tubing and butterfly needle), sterile alcohol swabs, gauze and
plasters. These devices are not included in the NovoEight pack.

Do not use the material without adequate training from your doctor or nurse.
Always wash your hands and make sure the area around you is clean.
When preparing and injecting a medicine directly into a vein, it is important to use an aseptic
technique and in the absence of germs.Improper technique can introduce germs that can infect the blood.

Do not open the material until you are ready to use it.
Do not use the material if it has been dropped or if it is damaged.Instead, use a new pack.

Do not use the material if it is expired.Instead, use a new pack. The expiry date is
printed after ‘EXP.’ on the outer packaging, on the vial, on the vial adapter and on the
prefilled syringe.

Do not use the material if you suspect it has been contaminated.Instead, use a new
pack.

Do not discard any of the items until you have injected the reconstituted solution.
The material is for single use only.
Contents
The package contains:

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

Overview o Vial with NovoEight powder Vial Adapter Cap c Plastic Cap Protective rubber stopper (under the plastic cap) m r Tip Seal a (under the protective seal)
F Pre-filled syringe with solvent l Plunger Syringe Tip Plunger and (under the cap Syringe Scale Threaded Tip a End n Syringe Cap
i 1. Prepare the vial and the syringe l a Remove the number of NovoEight packs you need. t I Check the expiration date. Check the name, dosage and color of the pack to make sure it contains the correct product. i z Wash your hands and dry them thoroughly with a clean towel or hand dryer. n e Remove the vial, vial adapter and pre-filled syringe from the packaging. Leave the plunger intact inside the packaging. g Bring the vial and syringe to room temperature. You can do this by holding them in your hands until they feel as warm as your hands.

Do not use other ways to warm the vial and pre-filled syringe.
Remove the plastic cap from the vial. If the plastic cap is loose or missing, do not use the vial. Clean the rubber stopper of the vial with a sterile swab moistened with alcohol and let it air dry for a few seconds before use to ensure it is germ-free. Do not touch the rubber stopper with your fingers as this may transfer germs.	a r m a c o
2. Attach the vial adapter Remove the protective seal from the vial adapter. If the protective seal is not hermetically sealed or is broken, do not use the adapter. Do not remove the adapter from the protective cap with your fingers. If you touch the tip of the vial adapter, germs from your fingers may be transferred. a	n a d e l F
i Place the vial on a flat, solid surface. l a Rotate the protective seal and attach the adapter to the vial. t I Once attached, do not remove the adapter from the vial.
a i Lightly press the protective cap with your thumb and index finger as shown. z Remove the protective cap from the adapter. n Do not lift the adapter from the vial when removing the protective cap. e	E
A 3. Attach the plunger and syringe Grasp the plunger by the end and pull it out of the packaging. Do not touch the parts or the thread of the plunger. If you touch them, germs from your fingers may be transferred.

Immediately attach the plunger to the syringe by screwing it clockwise onto the plunger inside the pre-filled syringe until you feel resistance.	a c o
Remove the syringe cap from the pre-filled syringe by bending it down until it breaks. Do not touch the tip of the syringe under the syringe cap. If you touch it, germs from your fingers may be transferred. If the syringe cap is loose or missing, do not use the pre-filled syringe.	l F a r m
Carefully screw the pre-filled syringe onto the adapter until you feel resistance. a i l	n a d e
a 4. Reconstitute the powder with the solvent Hold the pre-filled syringe slightly tilted with the vial pointing downwards. t I Press the plunger to inject all the solvent into the vial. a i z n

Keep the plunger pressed down and gently rotate the vial until the powder dissolves. Do not shake the vial as this causes foaming. Check the reconstituted solution. It should be clear to opalescent (slightly cloudy). If you notice visible particles or discoloration, do not use it. Use a new pack instead.	F a r m a c o
NovoEight must be used immediately after reconstitution. If not used, the l medicine may no longer be sterile and may cause infections. e If you cannot use the reconstituted NovoEight solution immediately, it must be used within 4 d hours if stored at room temperature or up to 40°C and within 24 hours if stored between 2 °C – 8 °C. Store the reconstituted medicine in the vial. a Do not freeze the reconstituted NovoEight solution or store it in the syringe. n Do not store the solution without medical advice. a i l If your dose requires more than one vial, repeat steps A to J with the other vials, adapters and a pre-filled syringes, until the required dose is reached.
t Keep the plunger pressed down. I Rotate the syringe with the vial pointing downwards. a Stop pressing the plunger and let it return back on its own as the reconstituted solution fills the syringe. i z n Gently pull back the plunger to draw the reconstituted solution into the syringe. e If you only need a portion of the entire dose, use the scale on the syringe to see how much reconstituted solution you need to administer, according to the instructions provided by your doctor or nurse. If, at this point, there is too much air in the syringe, inject the air into the vial.

Holding the vial downwards, gently tap the syringe to make any air bubbles rise to the top. Slowly push the plunger until all air bubbles have risen.	c o
Unscrew the adapter with the vial. Do not touch the tip of the syringe. If you touch it, germs from your fingers may be transferred.	a r m a
F 5. Inject the reconstituted solution Inject the reconstituted solution according to the instructions of your doctor or nurse. l e Inject slowly for 2 - 5 minutes. d Do not mix NovoEight with another intravenous solution or with other medicines. a Inject NovoEight through needleless connectors for central venous catheters n Caution: The pre-filled syringe is made of glass and is designed to be compatible with standard luer-lock connectors. Some needleless connectors with an internal end are not compatible with pre-filled syringes. a This incompatibility may prevent the administration of the medicine and/or damage the needleless connector. i l Inject the solution through a central venous access (CVA) system such as a central venous catheter or a subcutaneous port: a t Use an aseptic technique and without germs. Follow the instructions on the correct use of the connector and central venous catheter (CVA) as suggested by your doctor or nurse. I Injection into a CVA may require the use of a sterile 10 ml plastic syringe to withdraw the reconstituted solution. This step must be done after point J. If the CVA tubing needs to be flushed before and after injection with NovoEight, use an injectable solution of sodium chloride 9 mg/ml.
z Disposal n After injection, discard any unused NovoEight solution, the syringe with the infusion set, the vial with the adapter and other waste materials as indicated by your pharmacist. e Do not discard them with household waste.

Do not disassemble the material before disposal.
Do not reuse the material.