OCTALBIN Solution for infusion Ref.[50395] Active ingredients: Albumin

General

Standard measure to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools 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 or emerging viruses and other pathogens.

Albumin is a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extreme remote risk for transmission of viral diseases. A theoretical transmission of Creutzfeldt-Jakob Disease (CJD), including variant Creutzfeldt-Jakob Disease (vCJD), also is considered remote. No cases of transmission of viral diseases or CJD, including vCJD, have ever been identified for albumin.

Albumin manufactured to European Pharmacopoeia specifications by established processes has a reassuring viral safety record.

The physician should discuss the risks and benefits of the product with the patient, before prescribing or administering to the patient.

If allergic or anaphylactic-type reactions occur, the infusion should be stopped immediately and appropriate treatment instituted. In case of shock, the current medical standards for shocktreatment should be observed.

Albumin solutions must not be diluted with water for injection as this may cause haemolysis in recipients.

Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. In the interest of the patient, it is recommended that, whenever possible, every time that Octalbin 25% (Albumin (Human) 25%) is administered to them, the name and batch number of the product is recorded.

Albumin solutions must not be used in patients at high risk of developing circulatory overload (e.g. congestive cardiac failure, renal insufficiency) or severe deficiency of oxygen carrying capacity (severe anemia).

Albumin should be used with caution in conditions where hypervolaemia and its consequences or haemodilution could represent a special risk for the patient. Examples of such conditions are:

• Decompensated cardiac insufficiency
• Hypertension
• Oesophageal varices
• Pulmonary oedema
• Haemorrhagic diathesis
• Severe anaemia
• Renal and post-renal anuria

The colloid-osmotic effect of human albumin 25% is approximately four times that of blood plasma. Therefore, when concentrated albumin is administered, care must be taken to assure adequate hydration of the patient. Patients should be monitored carefully to guard against circulatory overload and hyperhydration.

Hypervolaemia may occur if the dosage and rate of infusion are not adjusted to the patients circulatory situation. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure, raised venous pressure and pulmonary oedema, the infusion is to be stopped immediately.

20-25% Human albumin solutions are relatively low in electrolytes compared to the 4-5% human albumin solutions. When albumin is given, the electrolyte status of the patient should be monitored (see section DOSAGE AND ADMINISTRATION) and appropriate steps taken to restore or maintain the electrolyte balance.

If comparatively large volumes are to be replaced, controls of coagulation and haematocrit are necessary. Care must be taken to ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets and erythrocytes).

Special Populations

Pregnant Women

The safety of Octalbin 25% for use in human pregnancy has not been established in controlled clinical trials. While it is not known if it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity, it should be given to a pregnant woman only if clearly needed.

No animal reproduction studies have been conducted with Octalbin 25%. However, human albumin is a normal constituent of human blood.

Nursing Women

See Pregnant Women above.

Geriatrics (>65 years of age)

No subgroup analysis was performed and therefore no safety or tolerability data regarding a geriatric population can be presented.

Pediatrics (<12 years of age)

Data on the use of Octalbin 25% in children including premature babies are very limited. The product should only be administered to these individuals if the likely benefits clearly outweigh potential risks.

Adverse Drug Reaction Overview

Adverse reactions for Octalbin 25% are rare. These reactions normally disappear rapidly when the infusion rate is slowed down or the infusion is stopped. In case of severe reactions, the infusion should be stopped and an appropriate treatment should be initiated.

Clinical Trial Adverse Drug Reactions

Not applicable.

Less Common Clinical Trial Adverse Drug Reactions (<1%)

Not applicable.

Abnormal Hematological and Clinical Chemistry Findings

There were no particular issues raised for any laboratory parameters in any of the published studies.

Post-Market Adverse Drug Reactions

The following adverse reactions have been observed for human albumin during the postmarketing phase. Therefore, these reactions can also be expected for Octalbin 25%.

Overview

No specific interactions of human albumin with other medicinal products are known. Human albumin solution must not be mixed with other medicinal products, whole blood and packed red cells.

Drug-Food Interactions

Interactions with food have not been established.

Drug-Herb Interactions

Interactions with herbal products have not been established.

Drug-Laboratory Interactions

Interactions with laboratory tests have not been established.

Drug-Lifestyle Interactions

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