OCTAPLAS 200 ML Infusion solution

Зміст інструкції

1. OCTAPLAS
   1. OCTAPLAS
   2. HOW TO USE OCTAPLAS
   3. POSSIBLE SIDE EFFECTS
   4. CONTENUTO DELLA CONFEZIONE E ALTRE INFORMAZIONI

OCTAPLAS

Human plasma proteins 9.0-14.0 grams
infusion solution
Read this leaflet carefully before 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. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4. Contents of this leaflet: What OCTAPLAS is and what it is used for
• 2. What you need to know before you use OCTAPLAS
• 3. How to use OCTAPLAS
• 4. Possible side effects
• 5. How to store OCTAPLAS
• 6. Contents of the pack and other information
• 1. What OCTAPLASis OCTAPLAS is a solution of specific ABO blood group frozen human plasma pooled from multiple donors, subjected to a specific viral inactivation treatment. Human plasma is the fluid part of human blood and contains plasma proteins which are important for maintaining normal blood coagulation characteristics and is used similarly to fresh frozen plasma (FFP) obtained from individual donations.

OCTAPLAS is indicated in cases of complex coagulation factor deficiencies, which may be caused by
severe liver damage or massive transfusion in the event of accidents. OCTAPLAS can also be administered
in emergency situations when a specific coagulation factor concentrate (e.g. factor V
or factor XI) is not available or a specific laboratory diagnosis is not possible.
It can also be administered for rapid reversal of the effect of oral anticoagulants (coumarin or
indanedione type) when vitamin K is insufficient due to decompensated liver function or in emergency situations.
OCTAPLAS can be administered to patients undergoing plasmapheresis to restore the balance between coagulation
factors, in patients with thrombotic thrombocytopenic purpura (TTP), in which there is a reduction in the
number of particular blood cells called platelets, and for the treatment of internal bleeding following
intensive plasma exchange procedures.

2. OCTAPLAS

Do not use OCTAPLAS:

• if you are allergic (hypersensitive) to human plasma proteins or to any of the other ingredients of this medicine (listed in section 6);
• if you know you have antibodies against an immunoglobulin called IgA;
• if you have had previous reactions to any plasma-containing preparation or to FFP (Fresh Frozen Plasma);
• if you know you have low levels of protein S (a vitamin K-dependent protein in the blood).

Warnings and precautions
Talk to your doctor before using OCTAPLAS.

Pay particular attention with OCTAPLAS

• If you have low levels of immunoglobulin A.
• If you have had previous reactions to plasma proteins including FFP.
• If you suffer from heart failure or have fluid in the lungs (pulmonary edema).
• If you have known risks of complications with blood clot formation (thrombotic) due to the possible increased risk of venous thromboembolism (clots that form in the veins).
• In case of increased inhibition of coagulation (fibrinolysis).

Tell your doctor if you are at risk of hypercoagulability of the blood (thrombus formation) due to the possible
increased risk of venous thromboembolism (formation of blood clots that obstruct venous vessels at a
distance from their site of formation)
OCTAPLAS is generally not recommended for the treatment of von Willebrand disease.
Viral safety
When medicines are made from human blood or plasma, certain measures are taken to
prevent any infections from being transmitted to patients. These include careful selection of
blood or plasma donors to ensure that those at risk of carrying infections are
excluded, and the testing of each donation and plasma pool to check for signs of the presence of
viruses/infections. Manufacturers of these products also include in the processing of blood or
plasma steps that are able to inactivate or remove viruses. Despite these measures, when
administering medicines prepared from blood or plasma, the possibility of transmitting an infection
cannot be totally excluded. This also applies to any unknown or emerging viruses or other
types of infections.
The measures taken are considered effective for enveloped viruses such as the human immunodeficiency
virus (HIV), the hepatitis B virus and the hepatitis C virus.
The measures taken may be of limited value against certain non-enveloped viruses such as the hepatitis A virus, the hepatitis E virus and the Parvovirus B19.
It is strongly recommended that the name and batch number of the product are recorded each time you
are given a dose of OCTAPLAS in order to have documentation of the batch used.
Your doctor may suggest that you consider vaccination against hepatitis A and B viruses
if you are regularly/repeatedly given human plasma-derived products.
When a medicine is purified or made from human blood or plasma, there is a very limited possibility that
infectious agents contained therein may be transmitted to the patient. OCTAPHARMA only uses carefully tested plasma for the production of OCTAPLAS. Donors are subjected to careful screening
at donation centers and plasma is tested for the presence of viruses after donation.
After pooling, OCTAPHARMA tests the plasma again after several batches of plasma have been mixed.
During the production process of OCTAPLAS, a special step is performed using a chemical
(solvent/detergent) and helps to destroy other viruses that may not have been detected during the
initial tests. However, this step is not always completely effective against all viruses.
OCTAPLAS contains antibodies that protect against many viruses. These antibodies have nevertheless demonstrated
to protect patients against many viruses not destroyed during the solvent/detergent purification process.
However, despite all the precautionary measures taken by OCTAPHARMA, the possibility of transmitting a blood infection cannot be completely excluded.

Children
During therapeutic plasmapheresis in children, cases of hypocalcemia have been observed, probably caused by
binding to citrate. Monitoring of ionized calcium is recommended during such use of OCTAPLAS.

Other medicines and OCTAPLAS
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
During clinical studies, OCTAPLAS has been administered in association with various other drugs and no
interactions have been identified.
Due to passive transmission of pregnancy hormone (β-hCG), false positive pregnancy test results on blood may occur.
OCTAPLAS should not be mixed with other medicines or intravenous infusion fluids, except red blood cells
or platelet concentrates.
To avoid clot formation, solutions containing calcium should not be administered in the same infusion line.
There are no known interactions with other medicines.

OCTAPLASwith food, drinks and alcohol
No effects have been observed.

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

Driving and operating machinery
OCTAPLAS does not impair or impairs negligibly the ability to drive and operate
machinery.

Important information about some ingredients of OCTAPLAS
For a complete list of excipients, see section 6.
This medicine contains up to 920 mg of sodium (the main component of common salt) per
bag. This is equivalent to 46% of the recommended maximum daily intake of sodium with the diet of an
adult.

3. HOW TO USE OCTAPLAS

Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor.
OCTAPLAS will be administered to you exclusively by a doctor or nurse via infusion into a
vein (intravenously).
The recommended dose depends on the clinical condition and body weight of the patient. The doctor
will determine the appropriate amount to administer.

• Before OCTAPLAS can be administered by infusion, a blood group AB0 compatibility test must be performed.
• In emergency cases, OCTAPLAS for blood group AB can be administered to all patients, as it can be considered as universal plasma.

It is important that the infusion rate does not exceed 1 mL of OCTAPLAS per kg of body weight per
minute. Calcium gluconate can be administered in another vein to minimize the negative effects
of citrate contained in OCTAPLAS.
Allow the contents of the bag to warm in a thermostatic bath to approximately 37 °C before infusion. The
temperature of OCTAPLAS must not exceed 37 °C.
The thawing procedure should not exceed 30 minutes.

Use in children and adolescents
Data relating to children and adolescents (0-16 years) are limited.

If you use more OCTAPLAS than you should
High doses can lead to fluid overload (edema), fluid in the lungs (pulmonary edema) and/or heart problems (cardiocirculatory failure).

If you forget to take OCTAPLAS
The doctor is responsible for monitoring the administration and maintaining laboratory test values within the specified range.

If you stop taking OCTAPLAS
If you have any doubts about the use of this medicine, consult your doctor.
Based on laboratory test values, the doctor will decide when to stop the
administration of OCTAPLAS and assess possible risks.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These effects may include: fatigue, general feeling of unwellness, tremors, flushing, redness,
chills (tremor with or without fever), nausea, vomiting, local swelling (edema), fever, abnormal symptoms in the lungs
and low levels of calcium. Some patients may have allergic-type reactions such as hives, fever, chills,
nausea, vomiting, abdominal or back pain (lumbar pain). Rarely, blood transfusion can
cause anaphylactic shock (an immediate and severe allergic reaction that causes skin redness, a sudden and significant drop in blood pressure, difficulty breathing, loss of consciousness). High infusion rates
of the medicine can cause circulatory disorders, especially in patients with liver (hepatic) dysfunction.
Rarely, incompatibility between the antibodies present in OCTAPLAS and the antibodies present in the blood may
cause hemolytic-type reactions (rupture of blood cells), chills, fever, dry cough, difficulty
breathing, skin rashes and internal organ bleeding (internal hemorrhages).
The infusion of OCTAPLAS may cause the appearance of specific antibodies to coagulation factors.
High doses or high infusion rates may lead to an increase in circulating blood volume
with consequent accumulation of fluid in the lungs (pulmonary edema) and/or heart problems (heart failure).
Acute respiratory problems have been reported during or after the infusion of OCTAPLAS.
Depending on the type and severity of the adverse reactions, the infusion rate must be reduced or the
administration must be stopped. The doctor will take appropriate measures.
If any of these side effects get worse, or if you notice any side effect not listed
in this leaflet, tell your doctor.

Paediatric population
Hypocalcaemia may be observed in children during plasma exchange procedures, especially in
patients with impaired liver function or in case of high infusion rates. Monitoring of ionized calcium is recommended
during such use of OCTAPLAS.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor. You can also report side effects directly through the Italian Medicines Agency (AIFA), website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

HOW TO STORE OCTAPLAS
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 label. The expiry date refers to the last day of that month.
Store in a freezer at ≥ –18  C and protect from light.
Always check the expiry date stated on the label. OCTAPLAS has a shelf life of 4 years.
Do not use this medicine after the expiry date which is stated on the label after the abbreviation
Exp.
After thawing OCTAPLAS can be stored for up to 8 hours at +4 °C or up to 4 hours at
room temperature (+20-25 °C) before use.
Once the bag has been opened, the product must be used immediately.
Thawed OCTAPLAS must not be refrozen. Unused product must be discarded.
Do not use this medicine if you notice that the solution is cloudy or contains deposits.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. CONTENUTO DELLA CONFEZIONE E ALTRE INFORMAZIONI

Cosa contiene OCTAPLAS

• Il principio attivo è costituito da proteine del plasma umano (45-70 mg/mL).
• Gli altri componenti sono: sodio citrato diidrato, sodio diidrogeno fosfato biidrato e glicina

Descrizione dell’aspetto di OCTAPLAS e contenuto della confezione
OCTAPLAS è una soluzione per infusione.
OCTAPLAS è una soluzione limpida o leggermente opalescente di colore giallo. OCTAPLAS è
disponibile in transfusion bags of 200 mL.

Titolare dell’autorizzazione all’immissione in commercio e produttore:
Octapharma Pharmazeutika Produktionges.m.b.H.
Oberlaaerstr. 235
A-1100 Vienna
Austria

Produttori:
Octapharma Pharmazeutika Produktionsges.m.b.H
Oberlaaer Strasse 235
A-1100 Vienna
Austria
Octapharma AB
SE-112 75 Stoccolma, Sweden

Le informazioni seguenti sono destinate esclusivamente agli operatori sanitari:
Dosaggio e somministrazione
Dosaggio
The dosage depends on the clinical condition and the underlying pathology, but 12-15 mL of
OCTAPLAS/kg of body weight is a generally accepted initial dose. This should increase the
patient's plasma concentrations of coagulation factors by approximately 25%.
It is important to monitor the response, clinically and by measuring, for example, the activated partial
thromboplastin time (aPTT), prothrombin time (PT) and/or specific coagulation factor assays.
Dosage for coagulation factor deficiencies:
In patients with coagulation factor deficiencies, an adequate hemostatic effect is normally achieved in minor and moderate bleeding or surgical procedures after infusion of 5-20 mL
of OCTAPLAS/kg of body weight. This should increase the patient's plasma concentrations of coagulation
factors by approximately 10-33%. In case of major bleeding or surgery, the opinion of a hematologist is required.
Dosage for TTP and bleeding in intensive plasma exchange procedures:
For therapeutic plasma exchange procedures, the opinion of a hematologist is required.
In patients with TTP, the entire volume of plasma exchanged should be replaced with OCTAPLAS.

Modo di somministrazione
The administration of OCTAPLAS should be based on the patient's specific blood group.
In emergency cases, OCTAPLAS for blood group AB can be considered universal plasma
as it can be administered to all patients regardless of blood group.
After thawing, OCTAPLAS should be infused intravenously using infusion equipment
with filters. Aseptic technique must be used during infusion.
Citrate toxicity can occur with volumes greater than 0.020-0.025 mmol of citrate per kg of
body weight/minute. Therefore, the infusion rate should not exceed 1 mL of OCTAPLAS per kg
of body weight/minute. Toxic effects of citrate can be minimized by administering calcium
gluconate intravenously in another vein.
Warnings and precautionary measures for administration:
If an anaphylactic reaction or shock occurs, the infusion should be stopped immediately. Treatment should
follow guidelines for shock therapy.
Patients should be observed for at least 20 minutes after administration.
Incompatibilities:
The OCTAPLAS product can be mixed with red blood cells and platelets.
OCTAPLAS should not be mixed with other drugs as inactivation or precipitation may occur.
To avoid the possibility of clot formation, solutions
containing calcium should not be administered through the same intravenous infusion line as OCTAPLAS.
Interferences:
Due to the passive transmission of human chorionic gonadotropin (β-hCG) hormone, false positive pregnancy test results may be detected.

Periodo di validità
The shelf life of OCTAPLAS is 4 years when stored at  -18 °C and protected from light.
Do not use after the expiry date stated on the label.
After thawing, OCTAPLAS can be stored for up to 8 hours at +4 °C or up to 4 hours at
room temperature (+20-25 °C) before use.
Once the bag has been opened, the product must be used immediately.