ALPHANINE 500 IU/10 ML Порошок и раствор для раствора для внутривенного введения

Содержание инструкции

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

AlphaNine 500 IU, 1000 IU and 1500 IU Powder and solvent for solution for infusion

Blood coagulation factor IX

Read this leaflet carefully before you use 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is AlphaNine and what is it used for

AlphaNine is supplied as a powder and solvent for infusion solution containing 500, 1000 or
1500 IU per vial of human coagulation factor IX, produced from human donor plasma,
highly purified in vials, with double viral inactivation. (Please note that IU means international
units, which is a standardized measure of activity).
Once reconstituted with 10 ml of water for injectable preparations (solvent), each vial
contains approximately 50, 100 or 150 IU of factor IX/ml.
AlphaNine belongs to the group of medicines called coagulation factors.
AlphaNine is used for the treatment and prevention of bleeding in patients with
Hemophilia B (congenital factor IX deficiency) and in subjects with acquired Factor IX deficiency.

2. What you need to know before using AlphaNine

Do not use AlphaNine

• If you are allergic to human coagulation factor IX or to any of the other ingredients of this medicine (listed in section 6) (see important information about some excipients of AlphaNine at the end of this section).

Consult your doctor for more detailed information.

Warnings and precautions
Consult your doctor, pharmacist or nurse before using AlphaNine.

• Rarely, anaphylactic reactions (sudden and severe allergic reactions) such as skin rash, feeling of tightness in the chest, dizziness, vertigo or nausea, or a feeling of

vertigo when standing up may occur. If these symptoms occur, you should immediately stop using the product and contact your doctor.

• Your doctor must perform some tests to ensure that the dose of AlphaNine is sufficient to achieve and maintain adequate levels of factor IX and therefore stop any bleeding.
• If your bleeding is not controlled with AlphaNine, consult your doctor immediately. You may have developed inhibitors of factor IX: these are antibodies that block the coagulating effect of factor IX. The doctor will perform some tests to confirm if such inhibitors are present in the blood.
• Given the possibility of blood clotting, factor IX must be used with caution in patients with liver disease, after surgery, in newborns or in patients at risk of blood clot formation or disseminated intravascular coagulation (DIC).
• In patients who have cardiovascular risk factors, replacement therapy with factor IX may increase the cardiovascular risk.
• If you need a central venous access device (CVAD) to administer AlphaNine, your doctor should consider the risk of CVAD-related complications, including: local infections, bacteria in the blood (bacteremia) and the formation of clots in the blood vessel (thrombosis) where the catheter is inserted.

Viral safety
When medicines are produced from human blood or plasma, specific measures are put in place to prevent the transmission of infections to patients. These measures include:

• Careful selection of blood and plasma donors, to ensure that potentially infected donors are excluded.
• Testing of each donation and pool of plasma, to highlight any presence of viruses/infections.
• Inclusion of certain steps in the processing of blood or plasma, capable of inactivating or removing viruses. Despite these measures, when specialty medicines prepared from human blood or plasma are administered, the possibility of transmission of infectious agents cannot be totally excluded. This also applies to viruses or other types of emerging or unknown infectious agents.

The measures taken are considered effective for enveloped viruses such as the human immunodeficiency virus (HIV), the hepatitis B virus (HBV) and the hepatitis C virus (HCV). But they may have limited value against non-enveloped viruses such as the hepatitis A virus and parvovirus B19. Infection with parvovirus B19 can be severe for pregnant women (fetal infection) and for individuals who are immunocompromised or who have certain types of anemia (e.g., sickle cell anemia or hemolytic anemia).
Your doctor may recommend that you consider vaccination against hepatitis A and B, if you regularly/repeatedly receive doses of factor IX from human plasma.
It is strongly recommended that each time you receive a dose of AlphaNine, the name and batch number of the product are recorded, in order to maintain the traceability of the batch used.
See section 4.

Children and adolescents
The warnings and precautions listed apply to both adults and children.

Other medicines and AlphaNine
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
No interactions of AlphaNine with other medicines are known.
Do not mix AlphaNine with other medicines that you receive by injection.

Pregnancy and breastfeeding
Since hemophilia B is rare in women, there are no data on the use of factor IX during pregnancy or breastfeeding. Therefore, factor IX can only be used during pregnancy and breastfeeding if clearly indicated.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
No effects on the ability to drive and use machines have been observed.

AlphaNinecontains sodium and heparin
The residual sodium content in AlphaNine, from the manufacturing process, is from 1.3 to 3.0 millimoles (from 29.9 mg to 69 mg) per 10 milliliters of solution (volume after reconstitution of the powder contained in a single package of AlphaNine). This corresponds to 1.49% and 3.45% of the maximum recommended daily intake for an adult. However, depending on the patient's body weight and dosage, the patient may receive more than one vial. This should be taken into account by patients on a controlled diet regarding sodium intake.
AlphaNine contains small amounts of heparin. Heparin can cause allergic reactions and a reduced platelet count that can affect the blood clotting system. Patients with a history of allergic reactions to heparin should avoid the use of medicines containing heparin.

3. How to use AlphaNine

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
Reconstitute the product as described at the end of this leaflet (see pictograms on the back of
the leaflet). The product must be administered intravenously. The administration rate
must never exceed 10 ml/min, to avoid undesirable side effects. Inject AlphaNine
immediately after reconstitution.
The amount of AlphaNine that you should use depends on many factors, such as weight, clinical condition and
the type and severity of bleeding. The doctor will calculate the dose, frequency and intervals of
AlphaNine administration in order to achieve the necessary level of factor IX in the blood.
Your doctor will inform you about the duration of treatment with AlphaNine.

Use in children and adolescents
Data from clinical studies are insufficient to recommend the use of AlphaNine in
children under 6 years of age.

If you use more AlphaNinethan you should
No cases of overdose with human coagulation factor IX have been reported. However, if you have
used AlphaNine more than required, consult your doctor or pharmacist immediately.

If you forget to use AlphaNine
Proceed immediately with the next dose and continue at regular intervals as indicated by your
doctor. Do not use a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In rare cases, some of the following side effects may occur after the
administration of AlphaNine. Please contact your doctor immediatelyif
you experience:

• itching, local reactions at the injection site (e.g., burning and transient redness);
• allergic reactions (e.g., chest tightness / feeling of unwellness, dizziness, nausea and a slight drop in blood pressure that may make you feel dizzy when standing up);
• fever;
• fast heartbeat (tachycardia)
• chills
• widespread hives
• headache
• feeling of drowsiness (lethargy)
• agitation
• tingling
• vomiting
• wheezing.

Occasionally, anaphylactic shockmay occur. If you observe any of the following symptoms during
injection / infusion, stop the injection / infusion and contact your doctor immediately:

• chest tightness / feeling of unwellness;
• dizziness;
• mild hypotension (slight drop in blood pressure with dizziness when standing up);
• nausea.

Allergic reactions to the product components cannot be completely ruled out. In some cases,
these reactions have progressed to severe anaphylaxis and have occurred in conjunction with the development of
factor IX inhibitors. The formation of neutralizing factor IX antibodies (inhibitors) is a
well-known complication in the treatment of patients with hemophilia B. Study results demonstrate
that those using factor IX for the first time are more likely to be affected. You will be
carefully monitored for the development of these inhibitors.
Nephrotic syndrome has been reported following attempts to induce immunotolerance in
patients with hemophilia B with factor IX inhibitors and a history of allergic reactions.
There is a possibility of blood clot formation, especially in the presence of clinical risk factors.

Additional side effects in children and adolescents
The frequency and severity of adverse reactions in children appear comparable to those of
adults.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly to
http://www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can
help to provide more information on the safety of this medicine.

5. How to store AlphaNine

Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2-8 °C). Do not freeze. Protect from light.
Do not use this medicine after the expiry date which is stated on the label of the vial and on the
pack after Exp.
Do not use this medicine if you notice that the solution is cloudy or contains deposits. Generally, the
solution is clear or slightly opalescent. If the solution is discolored or cloudy, discard it.
After reconstitution, the product must be used immediately.
Any unused product or waste material must be disposed of in accordance with current
regulations.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What AlphaNine Contains
The active ingredient is human coagulation Factor IX.
AlphaNine is presented as powder and solvent for solution for infusion containing 500, 1000 or
1500 IU of human coagulation factor IX per vial. The contents of a vial of
powder are reconstituted with 10 ml of water for injections.
The other ingredients are heparin and dextrose (see section 2. “What you need to know before you use
AlphaNine”, for more information about the other ingredients).

Description of AlphaNine and Package Contents
Vial containing a hygroscopic powder or a friable solid of white or pale yellow color and
pre-filled syringe with water for injections (solvent).
Package: 1 lyophilized vial, 1 pre-filled syringe with the solvent and accessories (an vial adapter, a
microfilter, 2 disinfecting wipes and an infusion set).
Not all package sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Grifols Italia S.p.A.
Viale Enrico Forlanini, 23
20134 Milan - ITALY

Manufacturer:
Instituto Grifols, S.A.
Can Guasc, 2 - Parets del Vallès
08150 Barcelona - SPAIN

Instructions for Use / Handling
Follow these instructions unless otherwise indicated by your doctor.
Any product remaining should never be used a second time, nor stored in a refrigerator.
Reconstitution and withdrawal must be carried out under aseptic conditions.
To prepare the solution:

• 1. Warm the vial and syringe, without exceeding 30 °C.
• 2. Insert the plunger into the syringe containing the solvent.
• 3. Remove the filter from its packaging. Remove the cap from the syringe connector and connect it to the filter.
• 4. Remove the vial adapter from its packaging and connect it to the filter on the syringe.
• 5. Remove the plastic protection from the vial and clean the stopper with the provided disinfecting wipe.
• 6. Puncture the vial stopper with the needle of the adapter.
• 7. Transfer all the solvent from the syringe to the vial.
• 8. Rotate the vial without shaking, until all the product has dissolved. As this is a solution for parenteral use, do not use the product if it has not dissolved completely or if particles are visible.
• 9. Quickly separate the syringe with the filter from the vial with the adapter, in order to release the vacuum. Proceed immediately to steps 10 and 11.
• 10. With the vial held upside down, draw the solution into the syringe.
• 11. Prepare the injection site, disconnect the syringe and inject the product using the butterfly needle set provided. Inject slowly into a vein at a rate not exceeding 10 ml/minute.

Do not reuse the administration sets.
It is important to use the infusion set provided with the medicine. If other medical infusion systems are used, the compatibility of these systems with the pre-filled syringe must be verified.
Adapters must be used if necessary to ensure correct
administration of the product.