Source: Marketing Authorisation Holder Revision Year: 2021 Publisher: Sanquin Plasma Products B.V., Plesmanlaan 125, NL-1066 CX Amsterdam, The Netherlands
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment for shock should be implemented.
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:
The colloid-osmotic effect of human albumin 200 g/l 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.
200 g/l human albumin solutions are relatively low in electrolytes compared to the 40 g/l human albumin solutions. When albumin is given, the electrolyte status of the patient should be monitored (see section 4.2) and appropriate steps taken to restore or maintain electrolyte balance.
Albumin solutions must not be diluted with water for injections as this may cause haemolysis in recipients.
If comparatively large volumes of albumin solution 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).
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 should be stopped immediately.
This medicinal product contains 100 mmol/l of sodium (2.3 g/l):
115 mg sodium per vial of 50 ml, equivalent to 6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
230 mg sodium per vial of 100 ml, equivalent to 12% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
To be taken into consideration by patients on a controlled sodium diet.
Standard measures 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.
There are no reports of virus transmission with albumin manufactured to European Pharmacopoeia specifications by established processes.
No specific interactions of human albumin with other medicinal products are known.
The safety of Albuman for use in human pregnancy has not been established in controlled clinical trials. However, clinical experience with albumin suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.
No animal reproduction studies have been conducted with Albuman.
Experimental animal studies are insufficient to assess the safety with respect to reproduction, development of the embryo or foetus, the course of gestation and peri- and post-natal development. However, albumin is a normal constituent of human blood.
No effects on the ability to drive and use machines have been observed.
Mild reactions such as flush, urticaria, fever and nausea occur rarely. These reactions normally disappear rapidly when the infusion rate is slowed down or the infusion is stopped. Very rarely, severe reactions such as shock may occur. In these cases, the infusion should be stopped and an appropriate treatment should be initiated.
For safety with respect to transmissible agents, see 4.4.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Netherlands pharmacovigilance centre Lareb; Website: www.lareb.nl.
This medicinal product must not be mixed with other medicinal products, whole blood and packed red cells (except the solutions mentioned in 6.6).
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