ALBUREX 5, 50 g/l Solution for infusion Ref.[27528] Active ingredients: Albumin

Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the infusion. 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:

• decompensated cardiac insufficiency
• hypertension
• oesophageal varices
• pulmonary oedema
• haemorrhagic diathesis
• severe anaemia
• renal and post-renal anuria

200–250 g/l human albumin solutions are relatively low in electrolytes compared to the 40–50 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 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).

Hypervolaemia may occur if the dosage and infusion rate are not adjusted to the patient’s 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.

Alburex 5 contains approximately 3.2 mg sodium per ml of solution (140 mmol/l).

That should be taken into consideration for patients on a controlled sodium diet.

Transmissible agents

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 transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.

It is strongly recommended that every time that Alburex 5 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.

No specific interactions of human albumin with other medicinal products are known.

Pregnancy

No animal reproduction studies have been conducted with Alburex 5.

Its safety for use in human pregnancy has not been established in controlled clinical trials and therefore it should only be given with caution to pregnant women. 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.

Breast-feeding

It is unknown whether Alburex 5 is excreted in human milk. Since human albumin is a normal constituent of human blood, treatment of the nursing mother with Alburex 5 is not expected to present a risk to the breastfed newborn/infant.

Fertility

No animal reproduction studies have been conducted with Alburex 5. However, human albumin is a normal constituent of human blood and harmful effects on fertility are not expected.

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

Summary of the safety profile

Mild reactions with human albumin solutions 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 allergic reactions such as anaphylactic shock may occur.

In these cases, the infusion should be stopped immediately and an appropriate treatment should be initiated.

Tabulated list of adverse reactions

The summary table below presents the adverse reactions which have been observed with Alburex during the post-marketing phase, according to the MedDRA system organ classification (SOC and Preferred Term Level).

As the post-marketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not possible to reliably estimate the frequency of these reactions.

Hence the frequency category “not known (cannot be estimated from the available data)” is used.

Reporting of suspected adverse reactions

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:

UK: Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow card in the Google Play or Apple App Store

IE: HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; Email: medsafety@hpra.ie

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

Human albumin must not be mixed with other medicinal products, whole blood and packed red cells.