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octaplas SPC

Last Updated on eMC 23-Jun-2009 View changes  | Octapharma Limited Contact details

1. Name of the medicinal product

octaplas, solution for infusion

2. Qualitative and quantitative composition

Octaplas is presented as a solution for infusion containing 45 - 70 mg/mL human plasma proteins.

For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Solution for infusion.

Octaplas is supplied as a frozen solution, which appears slightly yellow.

4. Clinical particulars
4.1 Therapeutic indications

Indications for Octaplas are identical to those for fresh-frozen plasma (FFP):

• Complex deficiencies of coagulation factors such as coagulopathy due to severe hepatic failure or massive transfusion.

• Substitution therapy in coagulation factor deficiencies, in emergency situations, when a specific coagulation factor concentrate, e.g. factor V or factor XI, is not available or when a precise laboratory diagnosis is not possible.

• Reversal of the effect on fibrinolysis and rapid reversal of effects of oral anticoagulants (coumarin or indanedione type), when vitamin K is insufficient due to impaired liver function or in emergency situations.

• Thrombotic thrombocytopenic purpura (TTP), usually in conjunction with plasma exchange.

• In intensive plasma exchange procedures, Octaplas should only be used to correct the coagulation abnormality when abnormal haemorrhage occurs.

4.2 Posology and method of administration

Dosage:

The dosage depends upon the clinical situation and underlying disorder, but 12-15 ml Octaplas/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 prothrombin time (PT), partial thromboplastin time (PTT) 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 5-20 ml Octaplas/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:

In TTP patients the whole plasma volume exchanged should be replaced with Octaplas.

For the treatment of haemorrhages in intensive plasma exchange procedures the expert advice of a haematologist should be sought.

Method of administration:

Administration of Octaplas must be based on ABO-blood group compatibility. In emergency cases, Octaplas blood group AB can be regarded as universal plasma since it can be given to all patients.

Octaplas must be administered by intravenous infusion after thawing as described in section 6.6, using an infusion set with a filter. 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 weight/min equal to ≤1 ml Octaplas/kg body weight/min. Toxic effects of citrate can be minimised by giving calcium gluconate i.v. into another vein.

The experience in children is limited.

4.3 Contraindications

- Contra-indications for Octaplas are identical to those for FFP

- IgA deficiency with documented antibodies against IgA

- Severe deficiencies of protein S

Hypersensitivity to the active substance, to any of the excipients or to residues from the manufacturing process as stated in section 5.3.

4.4 Special warnings and precautions for use

Octaplas should be used with caution under the following conditions:

• IgA deficiency.

• Plasma protein allergy.

• Previous reactions to FFP.

• Manifest or latent cardiac decompensation.

• Pulmonary oedema.

Octaplas should be used with caution in patients with risks for thrombotic complications because of potential increased risk of venous thromboembolism due to reduced protein S activity of Octaplas compared with single donor FFP.

Octaplas should not be used as volume expander in patients where no coagulation factor deficiency has been documented.

Octaplas should not be used in cases of bleeding caused by von Willebrand's Disease or other coagulation factor deficiencies where a specific factor concentrate is available for use.

Octaplas should not be used to correct hyperfibrinolysis caused by a deficiency of the plasmin inhibitor, named alpha2-antiplasmin as dilution with solvent/detergent (S/D) treated plasma (which contains low levels of alpha2-antiplasmin) will further reduce alpha2-antiplasmin levels. Special attention must be paid to signs of excessive bleeding tendency in patients likely to require massive transfusions e.g. in liver transplantation or other conditions with complex disturbances of haemostasis.

Standard measures to prevent infections resulting from the use of medical products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pool for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown and emerging viruses and other pathogens.

The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV.

The measures taken may be of limited value against non-enveloped virus such as HAV, HEV and Parvovirus B19. However, the risk of transmission of infective agents is reduced by testing of each plasma pool for genomic material. Only plasma pools that are negative in all applicable serological tests as well as in NAT for HIV, HBV, HCV and HAV, and that contain a maximum of 10.0 IU/μl Parvovirus B19 are accepted.

Parvovirus B19 infection may be serious for pregnant woman (fetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia). HEV may also seriously affect seronegative pregnant women. Therefore Octaplas should only be administered to these patients if strongly indicated.

A maximum of 1520 single donations are used for the manufacture of Octaplas.

Octaplas is produced from plasma pools containing a specified minimum antibody level which has been shown to have neutralising effect against HAV, HEV and Parvovirus B19. A possible risk of infection by non-enveloped viruses should be weighed against the benefit of the inactivation of lipid-enveloped viruses such as HIV, HBV and HCV by the S/D treatment.

Appropriate vaccination (e.g. against HAV and HBV) for patients in regular receipt of medicinal products derived from human blood or plasma should be considered.

Administration of Octaplas must be based on ABO-blood group compatibility. In emergency cases, Octaplas blood group AB can be regarded as universal plasma since it can be given to all patients.

It is strongly recommended that every time that Octaplas is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

Patients should be observed for at least 20 minutes after the administration.

In case of anaphylactic reaction or shock, the infusion must be stopped immediately. Treatment should follow the guidelines for shock therapy, see section 4.8.

Data on the use of Octaplas in premature babies are very limited, therefore, the product should only be administered to these individuals if the likely benefits clearly outweigh potential risks.

4.5 Interaction with other medicinal products and other forms of interaction

During clinical trials, Octaplas has been administered in association with various concomitant medications, and no interactions have been identified.

Incompatibilities are identical to those of FFP:

• Octaplas must not be mixed with other drugs as inactivation and precipitation may occur. The product can be mixed with red blood cells and platelets.

• To avoid the possibility of clot formation, solutions containing calcium must not be administered by the same intravenous line as Octaplas.

• Interactions with other drugs are unknown.

4.6 Pregnancy and lactation

The safety of Octaplas for use in human pregnancy has not been established in controlled clinical trials. The product should be administered to a pregnant or lactating woman only if alternative therapies are regarded inappropriate. For potential risk of Parvovirus B19 and HEV transmission, see section 4.4.

4.7 Effects on ability to drive and use machines

After ambulant infusion, the patient should rest for one hour.

There are no indications that Octaplas may impair the ability to drive or to operate machines.

4.8 Undesirable effects

Acute mild allergic reaction due to hypersensitivity to infused proteins and characterised by urticaria, fever, chills, nausea, vomiting, and abdominal or back pain may commonly be observed.

Acute and sometimes severe allergic (anaphylactic or anaphylactoid) type of reactions characterised by flushing, hypotension, chest pain, bronchospasms, dyspnoea, and cardio-respiratory collapse may rarely be observed.

High infusion rates may rarely cause cardiovascular effects as a result of citrate toxicity (fall in ionised calcium), especially in patients with liver function disorders. In the course of plasma exchange procedures, symptoms attributable to citrate toxicity such as fatigue, paraesthesia, tremor, and hypocalcemia may be observed rarely.

Very rarely incompatibility between antibodies in Octaplas and antigens of recipient red blood cells can result in immediate or delayed type of haemolytic transfusion reactions, especially in cases of transfusion errors. Therefore, administration of Octaplas must be based on ABO-blood group compatibility.

For safety with respect to transmissible agents, see section 4.4.

System Organ Class

Common

(> 1% to < 10%)

Uncommon

(> 0.1% to < 1%)

Rare

(> 0.01% to <0.1%)

Very Rare

(< 0.01%)

Blood and lymphatic system disorders

 

 

 

 

 

 

haemolytic anaemia

Immune system disorders

 

 

 

 

anaphylactic reaction

anaphylactic shock

 

 

 

 

 

 

anaphylactoid reaction

 

 

 

 

 

 

 

 

hypersensitivity

 

 

Metabolism and nutrition disorders

 

 

 

 

citrate toxicity

alkalosis

Psychiatric disorders

 

 

 

 

agitation

 

 

Cardiac disorders

 

 

 

 

transfusion-related circulatory overload

arrhythmia

 

 

 

 

 

 

tachycardia

cardiac arrest

Vascular disorders

 

 

hypotension

flushing

thrombo-embolism

 

 

 

 

 

 

haemorrhagic diathesis

hypertension

 

 

 

 

 

 

 

 

circulatory collapse

Respiratory, thoracic and mediastinal disorders

 

 

bronchospasm

dyspnoea

acute pulmonary oedema

 

 

 

 

respiratory disorder

 

 

pulmonary haemorrhage

Gastrointestinal disorders

nausea

vomiting

 

 

 

 

Skin and subcutaneous tissue disorders

rash

urticaria

rash erythematous

 

 

pruritus

 

 

hyperhidrosis

 

 

General disorders and administration site conditions

chills

localised oedema

chest pain

application site reaction

 

 

pyrexia

 

 

 

 

 

 

Investigations

 

 

 

 

antibody test positive

 

 

Injury, poisoning and procedural complications

 

 

 

 

 

 

haemolytic transfusion reaction

4.9 Overdose

• High dosages or infusion rates may induce hypervolaemia, pulmonary oedema and/or cardiac failure.

• High infusion rates may cause cardiovascular effects as a result of citrate toxicity (fall in ionised calcium), especially in patients with liver function disorders.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Plasma substitutes and plasma protein fractions,

ATC code: B05A A.

Octaplas possesses the same clinical activity as normal human FFP. After SD treatment and subsequent removal of the SD reagents, the plasma protein content and distribution in Octaplas remain at comparable levels to those in FFP, i.e. 45-70 mg/ml.

The coagulation activity values are close to the corresponding values for normal human FFP and a minimum of 0.5 IU/ml is obtained for each coagulation factor.

The finished product is tested for coagulation factors V, VIII and XI.

However, as a result of the SD treatment and purification, the content in lipids and lipoproteins is reduced. This is of no relevance within the indications for Octaplas.

5.2 Pharmacokinetic properties

Octaplas has similar pharmacokinetic properties as FFP.

5.3 Preclinical safety data

Virus inactivation is carried out by the S/D method, using 1 % Tri (N-Butyl) Phosphate (TNBP) and 1 % Triton X-100. These S/D reagents are removed during the purification process. The maximum amounts of TNBP and Triton X-100 in the finished product are 2 µg/ml and 5 µg/ml, respectively.

Pharmacological and toxicological studies in animals indicate that these residual levels should present no clinical problem for the indications and dosages specified.

6. Pharmaceutical particulars
6.1 List of excipients

Sodium citrate dihydrate

Sodium dihydrogenphosphate dihydrate

Glycine

6.2 Incompatibilities

Octaplas should not be mixed with other medicinal products as inactivation and precipitation may occur.

6.3 Shelf life

The shelf-life of Octaplas is four years when stored at ≤ -18 °C and protected from light.

Once the bag has been opened, the product must be used immediately.

6.4 Special precautions for storage

Octaplas frozen product should be stored and transported according to temperature and conditions as mentioned above (see section 6.3).

6.5 Nature and contents of container

Octaplas is filled into sterile, plasticised polyvinyl chloride blood bags which are over-wrapped with a polyamide/polyethylene film. One bag contains 200 mL of Octaplas

6.6 Special precautions for disposal and other handling

Octaplas should be transported and stored at ≤ -18 °C.

Do not use after the expiry date given on the label.

There are several options for thawing frozen Octaplas:

- Using a water bath:

Thaw in the outer wrapper in a water bath with good circulation at +30 to +37 °C. It is important to prevent water from contaminating the entry port. Temperature in the water bath must never exceed +37 °C and should not be lower than +30 °C. The thawing procedure should not take more than 30 minutes.

- Using a dry tempering system such as the SAHARA-III:

Place the Octaplas bags on the agitation plate according to the manufacturer instructions and thaw plasma using the fast tempering function. When +37°C blood component temperature is indicated on the temperature display terminate the tempering process and remove the bags.

During thawing of plasma using a system such as the SAHARA-III 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.

- Other thawing systems for frozen Octaplas can be used on the condition that the methods are validated for that purpose.

Allow the content of the bag to warm to approximately +37 °C before infusion. The temperature of Octaplas must not exceed +37 °C. Remove the outer wrapper and examine the bag for cracks or leaks.

Avoid shaking.

Do not use solutions which are cloudy or have deposits.

After thawing Octaplas can be stored for up to 8 hours at +4°C or for up to 4 hours at room temperature (+20-25°C) before use.

Thawed Octaplas must not be refrozen. Unused product must be discarded.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorisation holder

Octapharma Limited

The Zenith Building

26 Spring Gardens

Manchester

M2 1AB

8. Marketing authorisation number(s)

PL 10673/0009

9. Date of first authorisation/renewal of the authorisation

05 March 1998

10. Date of revision of the text

13 January 2009

Company contact details

Octapharma Limited

Company image
Address

The Zenith Building, 26 Spring Gardens, Manchester, Lancashire, M2 1AB

Fax

+44 (0)161 837 3799

Medical Information e-mail
Telephone

+44 (0)161 837 3770

Medical Information Direct Line

0845 1300 522

Medical Information Fax

+44 (0)161 837 3799

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

human plasma proteins

Legal categories

POM - Prescription Only Medicine

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