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OCTAPLASLG SOLUTION FOR INFUSION

Active substance(s): HUMAN PLASMA PROTEIN SOLUTION

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Mat-No./CAN/DataMatrix: xxxxxxx-xx (code is a sample) / Version: 08_23.17 / 2018-01-19 / Product code: 952 / Octaplas LG / UK / 420 × 297 mm / Black / Heinemann
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Depending on type and severity of adverse reactions, the infusion rate
must be reduced or the administration must be stopped. Appropriate
action will be taken by your doctor.
If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the
Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App Store. By reporting side effects you
can help provide more information on the safety of this medicine.
5. How to store octaplasLG
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 after
the abbreviation EXP.
Store and transport frozen (at ≤ –18 °C).
Store in the original package in order to protect from light.
After thawing, chemical and physical in-use stability has been demonstrated for
5 days at 2 – 8 °C or 8 hours at room temperature (20 – 25 °C).
From a microbiological point of view, unless the method of opening precludes
the risk of microbial contamination, the product should be used immediately. If
not used immediately, in-use storage times and conditions are the responsibility
of the user.
Do not use this medicine if you notice that the solution is cloudy or contains
deposits and/or discoloration.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help to protect the environment.
6. Contents of the pack and other information
What octaplasLG contains
–– The active substances are ABO-blood group specific human plasma proteins.
A 200 ml bag contains 9 – 14 g (45 – 70 mg/mL).
–– The other ingredients are:
Sodium citrate dihydrate, Sodium dihydrogenphosphate dihydrate and Glycine
What octaplasLG looks like and contents of the pack
octaplasLG is presented as a solution for infusion.
200 ml in bag.
Pack size of 1 and 10.
The frozen solution is (slightly) yellow.

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Marketing Authorisation Holder:
Octapharma Limited
The Zenith Building
26 Spring Gardens
Manchester
M2 1AB
United Kingdom
Tel: 01618373770
Fax: 01618373799
Manufacturers:
Octapharma Pharmazeutika Produktionsges.m.b.H
Oberlaaer Str. 235
1100 Vienna
Austria
Octapharma AB
SE-112 75 Stockholm
Sweden
This leaflet was last revised in
01/2018

Package leaflet: Information for the user
octaplasLG, solution for infusion
ABO-blood group specific human plasma proteins
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 signs of illness are the same as yours.
–– If you get any side effects, talk to your doctor. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What octaplasLG is and what it is used for
2. What you need to know before you use octaplasLG
3. How to use octaplasLG
4. Possible side effects
5. How to store octaplasLG
6. Contents of the pack and other information
1. What octaplasLG is and what it is used for
octaplasLG is human plasma pooled and treated for virus inactivation. Human
plasma is the fluid part of human blood that carries the cells. It contains human
plasma proteins which are important to maintain normal clotting characteristics
and is used the same way as normal fresh-frozen plasma (FFP).
octaplasLG helps in case of complex deficiencies of coagulation factors which
can be caused by severe failure of the liver or massive transfusion. octaplasLG
may also be given in emergency situations when a coagulation factor concentrate
(such as Factor V or Factor XI) is not available or a necessary laboratory diagnosis
is not possible.
It may also be given to rapidly reverse the effects of oral anticoagulants (coumarin
or indanedione type), when vitamin K is insufficient due to impaired liver function
or in emergency situations.
octaplasLG can be given to patients who undergo plasma exchange in order to
restore the balance of the coagulation factors.
2. What you need to know before you use octaplasLG
Do not use octaplasLG:
–– if you are allergic (hypersensitive) to human plasma proteins or any of the other
ingredients of this medicine (listed in section 6).
–– if you know you have antibodies against the immunoglobulin called IgA.
–– if you had previous reactions to any preparation of human plasma or FFP.
–– if you know you have a low level of protein S (a Vitamin K dependent protein
in your blood).
Warnings and precautions
Talk to your doctor before using octaplasLG.
Tell your doctor if you have any other illnesses.
Take special care with octaplasLG:
–– if you have a low level of immunoglobulin A.
–– if you had previous reactions to plasma protein including FFP.
–– if you are suffering from heart failure or fluid in the lungs (pulmonary oedema).

–– if you have known risks for blood clotting (thrombotic) complications because
of the potential increased risk of venous thromboembolism (clots forming in
your veins).
–– in case of increased inhibition of coagulation (fibrinolysis).
octaplasLG is not generally recommended for the treatment of von Willebrand’s
Disease.
Virus safety
When medicines are made from human blood or plasma, certain measures are
put in place to prevent infections being passed on to patients. These include
careful selection of the blood and plasma donors to make sure those at risk of
carrying infections are excluded, and the testing of each donation and pools of
plasma for signs of virus/infections. Manufacturers of these products also include
steps in the processing of the blood or plasma that can inactivate or remove the
viruses. Despite these measures, when medicines prepared from human blood or
plasma are administered, the possibility of passing on 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 human
immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus.
The measures taken may be of limited value against certain non-enveloped
viruses such as hepatitis A virus, hepatitis E virus and Parvovirus B19.
It is strongly recommended that every time you receive a dose of octaplasLG the
name and batch number of the product are recorded in order to maintain a record
of the batch used.
Your doctor may recommend that you consider vaccination against hepatitis
A and B viruses if you regularly/repeatedly receive human plasma-derived
products.
Children
The experience in children is limited.
Other medicines and octaplasLG
During clinical trials, octaplasLG has been administered in combination with
various other medications, and no interactions have been identified.
octaplasLG may not be mixed with other intravenous fluids or medicines except
red blood cells and blood platelets.
To avoid the possibility of blood clots, solutions containing calcium must not be
administered by the same intravenous pathway as octaplasLG.
There are no known reactions with other drugs.
Tell your doctor if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
octaplasLG with food and drink
No effects have been observed.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning
to have a baby, ask your doctor for advice before taking this medicine. You will
only be given octaplasLG if your doctor considers it important for you.
Driving and using machines
No effect has been observed upon the ability to drive or operate machinery. You
alone are responsible to decide if you are in a fit condition to drive a motor vehicle
or perform other tasks that demand increased concentration.

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Allow the content of the bag to warm to approximately +37 °C before infusion.
The temperature of octaplasLG must not exceed +37 °C. Remove the outer
wrapper and examine the bag for cracks or leaks.
Important information about some of the ingredients of octaplasLG
Not applicable. For a list of ingredients please refer to section 6.
3. How to use octaplasLG
octaplasLG will be given to you by a doctor or nurse. It is given by an infusion
into your veins.
Your dosage depends upon your clinical situation and your body weight. Your
doctor will determine the appropriate amount that you should receive.
–– Before octaplasLG can be given to you by infusion an ABO-blood group
compatibility test must be performed.
–– In emergency cases, octaplasLG blood group AB can be given to all patients.
It is important that the infusion rate should not exceed 1 mL octaplasLG per kg of
your body weight per minute. Calcium gluconate may be given into another vein
to minimise the negative effects of the citrate contained in octaplasLG.
You should be observed during and at least for 20 minutes after the administration
in case you develop an allergic reaction (anaphylactic reaction) or shock, in which
case the infusion must be stopped immediately.
If you use more octaplasLG than you should
High dosages may lead to fluid overload, fluid in lungs and/or heart problems.
If you forget to use octaplasLG
Your doctor is responsible to supervise administration and to keep your laboratory
values within the specified range.
If you stop using octaplasLG
Based on laboratory values your doctor decides when to stop administration of
octaplasLG and will assess possible risks.
Do not use after the expiry date given on the label.
There are several options for thawing frozen octaplasLG:
–– Water bath:
Thaw in the outer wrapper for not less than 30 minutes in a circulating water
bath at +30 °C to +37 °C. An overwrap bag may be used to provide further
protection of contents if appropriate.
Prevent water from contaminating the entry port. The minimum thawing time is
30 minutes at 37 °C. Temperature in the water bath must never exceed +37 °C
and should not be lower than +30 °C.
The thawing time depends on the number of bags in the water bath. If more
plasma bags are thawed in parallel, the thawing time can be prolonged, but
should not be longer than 60 minutes.
–– Using a dry tempering system such as the SAHARA-III:
Place the octaplasLG bags on the agitation plate according to the manufacturer
instructions and thaw plasma using the fast tempering function. When a
+37 °C blood component temperature is indicated on the temperature display,
terminate the tempering process and remove the bags.
During thawing of octaplasLG using a dry tempering system, it is recommended
to use the protocol printer to record the course of the blood component
temperature and error messages in event of failure.
–– Others:
Other thawing systems for frozen octaplasLG can be used on the condition that
the methods are validated for that purpose.

The following information is intended for healthcare professionals only:
Dosage and administration
Dosage
The dosage depends upon the clinical situation and underlying disorder, but
12 – 15 mL octaplasLG/kg body weight is a generally accepted starting dose. This
should increase the patient’s plasma coagulation factor levels by approximately
25%.
It is important to monitor the response, both clinically and with measurement of
e.g. activated partial thromboplastin time (aPTT), prothrombin time (PT), and/or
specific coagulation factor assays.
Dosage for coagulation factor deficiencies:
An adequate haemostatic effect in minor and moderate haemorrhages or surgery
in coagulation factor deficient patients is normally achieved after the infusion of

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Avoid shaking.
After thawing the solution is clear to slightly opalescent and free of solid or
gelatinous particles.

During clinical trials with octaplasLG’s predecessor product, and its post-approval use, the following side effects have been identified:
System organ class

Do not use solutions which are cloudy or have deposits and/or discoloration.
Thawed octaplasLG must not be refrozen. Unused product must be discarded.
Any unused medicinal product or waste material should be disposed of in
accordance with local requirements.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them.
Hypersensitivity reactions may rarely be observed. These are usually mild allergic
type reactions consisting of localised or generalised reddening of the skin, hives
or itching. More severe forms can be complicated by drop in blood pressure or
swelling of the face or tongue. Severe whole-body allergic reactions may have a
rapid onset and may be serious. Symptoms are drop in blood pressure, increase
in heart rate, difficulty in breathing, wheezing, coughing, breathlessness, nausea,
vomiting, diarrhoea, abdominal or back pain. Severe reactions may proceed to
shock, unconsciousness, respiratory failure and very rarely even death.
Negative effects can be caused by the citrate contained in octaplasLG and the
related low calcium level especially if the infusion rate is high, if you have liver
function disorders or if you are undergoing plasma exchange procedures. You may
experience symptoms like fatigue, tingling feelings (paraesthesia), tremor and low
calcium levels.
octaplasLG may increase the risk of blood clots in veins of the:
–– limbs, causing pain and swelling of limbs;
–– lung, causing chest pain and breathlessness;
–– brain, causing weakness and/or loss of sensation down one side of the body;
–– heart, causing chest pain;
In all patients at risk for increased clotting of the blood special caution should be
exercised and appropriate measures should be considered.
Rarely, incompatibility between antibodies in octaplasLG and antigens in your
blood can result in destruction of your red blood cells (haemolytic transfusion
reactions). Symptoms are chills; fever; a non-productive cough; difficulty in
breathing; rash; and bleeding within the body.
Infusion of octaplasLG may give rise to specific coagulation factor antibodies.
High dosages or infusion rates may induce increased blood volume; fluid in the
lungs and/or heart failure.

5 – 20 mL octaplasLG/kg body weight. This should increase the patient’s plasma
coagulation factor levels by approximately 10 – 33 %. In the event of major
haemorrhage or surgery, the expert advice of a haematologist should be sought.
Dosage for TTP and haemorrhages in intensive plasma exchange:
For therapeutic plasma exchange procedures, the expert advice of a haematologist
should be sought.
In TTP patients the whole plasma volume exchanged should be replaced with
octaplasLG.

Common
(≥ 1/100 to
< 1/10 or
≥ 1% to < 10%)

Uncommon
(≥ 1/1,000 to
< 1/100 or
≥ 0.1% to < 1%)

Rare
(≥ 1/10,000 to
< 1/1,000 or
≥ 0.01% to < 0.1%)

Blood system disorders

Very rare
(< 1/10,000 or
< 0.01%)
lack of red blood cells
bleeding tendency

Immune system disorders

hypersensitivity

Psychiatric disorders

serious allergic reaction and shock
anxiety
agitation
restlessness

Nervous system disorders

reduced sense
of touch or sensation

dizziness
tingling feelings

Cardiac disorders

failure of the heart
irregular heartbeats
increase in heart rate

Blood vessels and circulatory
disorders

clot in blood vessels
drop in blood pressure
increase in blood pressure
failure of the blood circulation
reddening of the skin

Respiratory disorders

lack of oxygen

respiratory failure
bleeding in the lungs
constriction of the bronchi
fluid in the lungs
breathlessness
difficulty in breathing

Stomach and intestines disorders

vomiting
nausea

abdominal pain

Skin disorders

hives
itching

rash
increased sweating

Muscular and skeletal disorders
General disorders and administration
site conditions

back pain
fever

chest pain
chest discomfort
chills
localised swelling
general discomfort
application site reaction

Investigations

antibody test positive
oxygen in blood decreased

Injury, poisoning and procedural
complications

increased blood volume
citrate poisoning
destruction of red blood cells

Method of administration
Administration of octaplasLG is to be performed blood-group specifically.
In emergency cases, octaplasLG blood group AB can be regarded as universal
plasma since it can be given to all patients regardless of blood group.
After thawing, octaplasLG is to be infused intravenously using infusion equipment
with filters. An aseptic technique must be used throughout the infusion.
Due to the risk of citrate toxicity, the infusion rate should not exceed 0.020 –
0.025 mmol citrate/kg body mass/minute – equal to ≤1 mL octaplasLG/kg body
mass/minute. Toxic effects of citrate can be minimised by giving calcium gluconate
intravenously into another vein.
Warnings and precautionary measures for the administration:
In case of anaphylactic reaction or shock, the infusion must be stopped
immediately. Treatment should follow the guidelines for shock therapy.
Patients should be observed for at least 20 minutes after the administration.

Incompatibilities:
–– octaplasLG product can be mixed with red blood cells and platelets if ABO
compatibility of both preparations is respected.
–– octaplasLG must not be mixed with other medicinal products, as inactivation
and precipitation may occur.
–– To avoid the possibility of clot formation, solutions containing calcium must
not be administered by the same intravenous line as octaplasLG.

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