Infusion solution. ABO blood group-specific human plasma protein
What octaplasLG is and what it is used for
octaplasLG is human plasma, which has been pooled and treated for virus inactivation. Human plasma is the liquid part of human blood that transports cells. It contains human plasma protein, which is important for maintaining normal coagulation properties. octaplasLG is used in the same way as normal, fresh frozen plasma (FFP).
octaplasLG is used in complex coagulation factor deficiency that can be caused by severe liver failure or massive transfusion. octaplasLG can also be given in acute situations when no coagulation factor concentrate (such as factor V or factor XI) is available or when a necessary laboratory diagnosis is not possible.
octaplasLG can also be given to quickly counteract the effects of oral anticoagulants (coumarin or indanedione type) when vitamin K levels are too low due to hepatic impairment or in an emergency.
octaplasLG can be given to patients undergoing plasma exchanges to restore the balance between coagulation factors.
What you need to know before using octaplasLG
Do not use octaplasLG
- if you are allergic (hypersensitive) to human plasma protein or any of the other ingredients of this medicine (listed in section 6).
- if you know you have an antibody to immunoglobulin IgA
- if you have previously reacted to any human plasma product or to fresh frozen plasma
- if you know you have low levels of protein S (a vitamin K-dependent protein in your blood).
Warnings and cautions
Talk to your doctor before using octaplasLG.
Tell your doctor if you have any other illnesses.
Take special care with octaplasLG
- if you have low levels of immunoglobulin A.
- if you have previously reacted to plasma protein including fresh frozen plasma .
- if you suffer from heart failure or fluid in the lungs ( pulmonary edema ).
- if you have known risks of blood clot formation (thrombotic complications) as there is a potential increased risk of venous thromboembolism (formation of blood clots in your veins).
- in case of increased inhibition of coagulation ( fibrinolysis ).
octaplasLG is not normally recommended for the treatment of von Willebrand’s disease.
Virus security
When medicines are made from human blood or human plasma or blood, special measures are taken to prevent the transmission of infection to patients. This includes careful selection of blood and plasma donors to ensure that people at risk of being carriers are excluded, as well as testing of individual donations and plasma pools for signs of virus/infection. The manufacturers of these products also include steps in the processing of blood and plasma that can inactivate and secrete viruses. Nevertheless, the risk of transmission of infection can not be completely ruled out when drugs are made from human blood or plasmas. This also applies to new, hitherto unknown viruses and other types of infection.
The measures taken are considered to be effective against enveloped viruses, such as human immunodeficiency virus ( HIV ), hepatitis B virus, and hepatitis C virus.
The measures may be of limited value against non-enveloped viruses such as hepatitis A virus, hepatitis E virus, and parvovirus B19.
It is strongly recommended that each time octaplasLG is given to a patient, the product name and batch number should be noted to record which batch was used for the patient.
Your doctor may suggest hepatitis A and B vaccination if you are regularly / repeatedly treated with plasma-derived products.
Children
Some cases of low calcium, possibly due to citrate binding, have been observed during therapeutic plasma exchange in children. Monitoring of calcium is recommended during such use of octaplasLG.
Other medicines and octaplasLG
In clinical trials, octaplasLG has been given in combination with many other medicines and no interaction has been observed.
When administering octaplasLG, you may also receive substances (eg pregnancy hormones) that may lead to false-positive test results (eg positive pregnancy test even though you are not pregnant).
octaplasLG must not be mixed with other intravenous fluids or medicines other than red blood cells and platelets.
To avoid blood clots, a solution containing calcium should not be administered in the same vein as octaplasLG.
Interactions of octaplasLG with other drugs are not known.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
octaplasLG with food and drink
No effects were observed.
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 this medicine. octaplasLG will only be given to you if your doctor considers it important for you.
Driving and using machines
There is no evidence that octaplasLG can affect the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Important information about some of the ingredients of octaplasLG
For a list of the other ingredients, see section 6.
This medicine contains a maximum of 920 mg sodium (the main ingredient in table salt/table salt) per bag. This corresponds to a maximum of 46% of the maximum recommended daily intake of sodium for adults.
How to use octaplasLG
octaplasLG will be given to you by a doctor or nurse. It is given to you by infusion into a vein.
Your dose depends on your clinical situation and how much you weigh. Your doctor will determine the appropriate dose for you.
Before an octaplasLG infusion can be given, and ABO blood group determination must be made.
– In emergencies, octaplasLG for blood group AB can be given to all patients.
The infusion rate mustn’t exceed 1 mL octaplasLG per kilogram body weight per min.
To minimize the negative effects of the citrate contained in octaplasLG, calcium gluconate may be given into another vein.
You will be monitored during treatment and for at least 20 minutes after treatment in the event of an allergic reaction ( anaphylactic reaction ) or shock. Infusion one is then stopped immediately.
Use for children and adolescents
Data for children and adolescents (0-16 years) are limited.
If you use more octaplasLG than you should
High doses can cause fluid overload, accumulation of fluid in the lungs, and/or heart problems.
If you forget to use octaplasLG
Your doctor is responsible for monitoring your medication supply and ensuring that your laboratory values are appropriate.
If you stop using octaplasLG
Your doctor is responsible for monitoring your medication supply and ensuring that your laboratory values are appropriate.
Do not use it after the expiry date which is stated on the label.
Frozen octaplasLG can be thawed in several ways:
- – Water bath:
Thaw in the outer casing for at least 30 minutes in a circulating water bath at + 30 ° C to
+ 37 ° C. If appropriate, a cover bag can be used to further protect the contents.
Prevent water from contaminating the connection port. The minimdefrostsost time is 30 minutes at 37 ° C. The temperature in the water bath must never exceed + 37 ° C and should not be lower than + 30 ° C.
The time for thawing depends on the number of bags in the water bath. If several plasma bags are thawed at the same time, the thawing time can be extended, but should not be longer than 60 minutes.
- Use of dry heating systems, such as SAHARA-III:
Place the octaplasLG bags on the agitation plate according to the manufacturer’s instructions and thaw the plasma with the quick defrost function. When the temperature display shows that the blood component has reached +37 ° C, the thawing process should be terminated and the bags removed.
During defrosting of octaplasLG with a dry heating system, it is recommended that the printer function be used to document the temperature course and error messages in the event of deviations.
- Others:
Other thawing methods for frozen octaplasLG may be used provided that these methods are validated for this purpose.
Heat the contents of the bag to approximately + 37 ° C before infusion one. The temperature of octaplasLG must not exceed + 37 ° C. Remove the outer casing and check the bag for cracks and leaks.
Avoid shaking the bag.
Once thawed, the solution is clear to slightly opalescent and free of solid or gelatinous particles.
Do not use solutions that are cloudy or contain precipitates and/or are discolored.
Thawed octaplasLG must not be re-frozen. Unused products must be discarded.
Any unused product or waste material should be disposed of following local requirements.
Possible side effects
Like all medicines, octaplasLG can cause side effects, although not everybody gets them.
In rare cases, hypersensitivity reactions may be observed. These are usually mild allergic reactions and consist of localized or generalized redness, rash, or itching More severe forms can be complicated by a drop in blood pressure or swelling of the face or tongue. Severe allergic reactions throughout the body can set in quickly and can become serious. Symptoms include a drop in blood pressure, increased heart rate, difficulty breathing, wheezing, coughing, shortness of breath, nausea, vomiting, diarrhea, abdominal or back pain. Severe reactions can lead to shock, unconsciousness, respiratory failure, and in very rare cases even to death.
Side effects can be caused by the citrate contained in octaplasLG and by the low calcium levels associated with it, especially if the infusion rate is high, if you have impaired liver function or if you are undergoing plasma exchange procedures. You may experience symptoms such as fatigue, tingling ( paresthesia ), tremors, and low calcium levels.
octaplasLG may increase the risk of blood clots in the veins in:
- legs and / or arms, causing pain and swelling in legs and / or arms;
- the lung, causing chest pain and shortness of breath;
- the brain, which causes weakness and / or loss of sensation along one side of the body;
- the heart, which causes chest pain;
For all patients at increased risk of blood clots, special care should be taken and appropriate measures considered.
In rare cases, reactions between antibodies in octaplasLG and with antigens in your blood can result in degradation of red blood cells (hemolytic transfusion reactions) such as chills, fever, dry cough, difficulty breathing, rash, and bleeding in the body.
Infusion of octaplasLG may give rise to specific coagulation factor antibodies.
High dose or high infusion rate may result in increased blood volume, fluid in the lungs, and/or heart failure.
During clinical trials with octaplasLG’s precursors and their use after authorization, the following adverse reactions have been identified:
| Classification of organ systems | Common (≥ 1/100 to <1/10 ) | Uncommon (≥ 1/1,000 to <1/100 ) | Rare (≥ 1 / 10,000 to <1 / 1,000 ) | Very rare (<1 / 10,000) |
|---|---|---|---|---|
| Blood disorders | lack of red blood cells bleeding tendency | |||
| Disorders of the immune system | hypersensitivity | severe allergic reaction and shock | ||
| Mental disorders | anxiety agitation restlessness | |||
| Disorders of the nervous system | reduced sensation of touch and feeling | dizziness stinging sensation | ||
| Disorders of the heart rhythm | heart failure irregular heartbeat increased heart rate | |||
| Blood vessel and circulatory disorders | blood vessel clots drop-in blood the pressure increase in blood pressure disorders in the blood circulation | |||
| Respiratory disorders | acid deficiency | respiratory failure bleeding in the lungs -contraction of the trachea fluid in the lungs shortness of breath breathing difficulties | ||
| Gastrointestinal disorders | vomiting nausea | abdominal pain | ||
| Skin disorders | hives itching | rash increased sweating | ||
| Musculoskeletal disorders | back pain | |||
| General disorders and administration site conditions | fever | chest pain discomfort in the chest chills localized swelling general malaise local reaction at the infusion site | ||
| Surveys | positive antibody test reduced oxygen content in the blood | |||
| Injuries, poisonings and treatment complications | increased blood volume citrate poisoning degradation of red blood cells |
Your doctor will decide if the infusion rate should be reduced or if the infusion should be stopped depending on the type and severity of the side effect.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Additional side effects are in children
During plasma exchange procedures, low calcium levels may be observed in children, especially in patients with hepatic impairment or at high infusion rates. Monitoring of calcium is recommended during such use of octaplasLG.
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 EXP.
Store and transport in a frozen state (at ≤ –18 ° C).
Store in the original package. Sensitive to 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, the product should be used immediately, unless the opening method excludes the risk of microbial contamination. If the product is not used immediately, the user is responsible for storage times during use and conditions before use.
Do not use this medicine if you notice that the solution is cloudy or contains precipitates and/or is discolored.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is ABO blood group-specific human plasma protein . A 200 ml bag contains 9-14 g (45-70 mg / ml).
- Other ingredients are:
- Sodium citrate dihydrate
- Sodium dihydrogen phosphate dihydrate
- Glycine
What the medicine looks like and contents of the pack
octaplasLG is supplied as an infusion solution.
200 ml in a bag.
Pack sizes of 1 and 10.
The frozen solution is (light) yellow.
Marketing Authorisation Holder
Octapharma AB
SE-112 75 Stockholm
Manufacturer
Octapharma AB
SE-112 75 Stockholm