Alburex 5, 50 g/l, resolution for infusion
2. Qualitative and quantitative composition
Alburex five may be a resolution containing fifty g/l of total supermolecule of that a minimum of ninety six is human simple protein.
One phial of one hundred cubic centimetre contains five g of human simple protein
One phial of 250 cubic centimetre contains twelve.5 g of human simple protein
One phial of five hundred cubic centimetre contains twenty five g of human simple protein
Alburex five is gently hypooncotic to traditional plasma.
Excipient with illustrious effect:
Alburex five contains roughly three.2 mg Na per cubic centimetre of resolution (140 mmol/l).
For the total list of excipients, see section half-dozen.1.
3. Pharmaceutical kind
Solution for infusion.
A clear, slightly viscous liquid; it's nearly colourless, yellow, amber or inexperienced.
4. Clinical particulars
4.1 Therapeutic indications
Restoration and maintenance of current blood volume wherever volume deficiency has been incontestible and use of a mixture is suitable.
The choice of simple protein instead of artificial mixture can rely on the clinical state of affairs of the individual patient, supported official recommendations.
4.2 pharmacology and technique of administration
The concentration of the simple protein preparation, indefinite quantity and also the infusion rate ought to be adjusted to the patient's individual needs.
Posology
The dose needed depends on the dimensions of the patient, the severity of trauma or malady and on continued fluid and supermolecule losses. Measures of adequacy of current volume and not plasma simple protein levels ought to be wont to confirm the dose needed.
If human simple protein is to be administered, haemodynamic performance ought to be monitored regularly; this might include:
• blood pressure and heart rate
• central blood pressure
• artery wedge pressure
• body waste output
• solution
• haematocrit / hemoprotein
Paediatric population
The pharmacology in kids and adolescents (0-18 years) ought to be adjusted to the patient's individual needs.
Method of administration
Human simple protein ought to be administered by the blood vessel route solely.
The infusion rate ought to be adjusted per the individual circumstances and also the indication.
In plasma exchange the infusion rate ought to be adjusted to the speed of removal.
4.3 Contraindications
Hypersensitivity to simple protein preparations or to any of the excipients listed in section half-dozen.1.
4.4 Special warnings and precautions to be used
Suspicion of allergic or hypersensitivity reaction kind reactions needs immediate ending of the infusion. just in case of shock, commonplace medical treatment for shock ought to be enforced.
Albumin ought to be used with caution in conditions wherever blood disorder and its consequences or haemodilution may represent a special risk for the patient. samples of such conditions are:
• decompensated insufficiency
• high blood pressure
• oesophageal varices
• respiratory organ hydrops
• injury predisposition
• severe anaemia
• nephritic and post-renal illness
200–250 g/l human simple protein solutions square measure comparatively low in electrolytes compared to the 40–50 g/l human simple protein solutions. once simple protein is given, the solution standing of the patient ought to be monitored (see section four.2) and applicable steps taken to revive or maintain the balance.
If relatively massive volumes square measure to get replaced, controls of curdling and haematocrit square measure necessary. Care should be taken to confirm adequate substitution of different blood constituents (coagulation factors, electrolytes, platelets and erythrocytes).
Hypervolaemia might occur if the indefinite quantity and infusion rate aren't adjusted to the patient's circulatory state of affairs. At the primary clinical signs of vas overload (headache, dyspnoea, vena congestion), or multiplied vital sign, raised blood pressure and respiratory organ hydrops, the infusion is to be stopped straightaway.
Alburex five contains roughly three.2 mg Na per cubic centimetre of resolution (140 mmol/l).
That should be taken into thought for patients on a controlled Na diet.
Transmissible agents
Standard measures to forestall infections ensuing from the utilization of medicative product ready from human blood or plasma embody choice of donors, screening of individual donations and plasma pools for specific markers of infection and also the inclusion of effective producing steps for the inactivation/removal of viruses. Despite this, once medicative product ready from human blood or plasma square measure administered, the chance of sending infective agents can't be wholly excluded. This additionally applies to unknown or rising viruses and different pathogens.
There aren't any reports of virus transmissions with simple protein factory-made to European collection specifications by established processes.
It is powerfully suggested that each time that Alburex five is run to a patient, the name and batch range of the merchandise square measure recorded so as to keep up a link between the patient and also the batch of the merchandise.
4.5 Interaction with different medicative product and different styles of interaction
No specific interactions of human simple protein with different medicative product square measure illustrious.
4.6 Fertility, physiological condition and lactation
Pregnancy
No animal copy studies are conducted with Alburex five.
Its safety to be used in human physiological condition has not been established in controlled clinical trials and so it ought to solely lean with caution to pregnant ladies. However, clinical expertise with simple protein suggests that no harmful effects on the course of physiological condition, or on the craniate and also the newborn square measure to be expected.
Breast-feeding
It is unknown whether or not Alburex five is excreted in human milk. Since human simple protein may be a traditional constituent of human blood, treatment of the nursing mother with Alburex five isn't expected to gift a risk to the breastfed newborn/infant.
Fertility
No animal copy studies are conducted with Alburex five. However, human simple protein may be a traditional constituent of human blood and harmful effects on fertility aren't expected.
4.7 Effects on ability to drive and use machines
No effects on the flexibility to drive and use machines are discovered.
4.8 Undesirable effects
Summary of the protection profile
Mild reactions with human simple protein solutions like flush, urticaria, fever and nausea occur seldom. These reactions unremarkably disappear chop-chop once the infusion rate is stalled or the infusion is stopped. terribly seldom, severe hypersensitive reactions like anaphylaxis might occur.
In these cases, the infusion ought to be stopped straightaway associated an applicable treatment ought to be initiated.
Tabulated list of adverse reactions
The outline table below presents the adverse reactions that are discovered with Alburex throughout the post-marketing section, per the MedDRA system organ classification (SOC and most well-liked Term Level).
As the post-marketing coverage of adverse reactions is voluntary and from a population of unsure size, it's unfeasible to faithfully estimate the frequency of those reactions.
Hence the frequency class “not illustrious (cannot be calculable from the offered data)” is employed.
MedDRA System Organ category
(SOC)
Adverse Reaction
Frequency
Immune system disorders
Hypersensitivity reactions (including hypersensitivity reaction and shock)
Not known
Gastrointestinal disorders
Nausea
Not known
Skin and hypodermic tissue disorders
Flush, urticaria
Not known
General disorders and administration website conditions
Fever
Not known
Reporting of suspected adverse reactions
Reporting suspected adverse reactions once authorisation of the medicative product is vital.
It permits continued observance of the benefit/risk balance of the medicative product.
Healthcare professionals square measure asked to report any suspected adverse reactions via:
UK: Yellow Card theme. Website: WWW.mhra.gov.uk/yellowcard or hunt for MHRA Yellow card within the Google Play or Apple App Store
IE: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - port 2; Tel: +353 one 6764971; Fax: +353 one 6762517. Website: WWW.hpra.ie; Email: medsafety@hpra.ie
For safety data with regard to transmissible agents, see section four.4.
4.9 Overdose
Hypervolaemia might occur if the indefinite quantity and infusion rate square measure too high. At the primary clinical signs of vas overload (headache, dyspnoea, vena congestion) or multiplied vital sign, raised central blood pressure and respiratory organ hydrops, the infusion ought to be stopped straightaway and also the patient's haemodynamic parameters rigorously monitored.
5. medicine properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: plasma substitutes and protein fractions,
ATC code: B05AA01.
Human {albumin|albumen|simple supermolecule} accounts quantitatively for quite 1/2 the full supermolecule within the plasma and represents regarding 100 percent of the protein synthesis activity of the liver.
Physico-chemical data: human simple protein fifty g/l is gently hypooncotic to traditional plasma.
The most necessary physiological performs of simple protein results from its contribution to oncotic pressure of the blood and transport function. simple protein stabilises current blood volume and may be a carrier of hormones, enzymes, medicative product and toxins.
5.2 Pharmacokinetic properties
Distribution
Under traditional conditions, the full exchangeable simple protein pool is 4–5 g/kg weight, of that 40–45% is gift intravascularly and 55–60% within the extravascular house. multiplied capillary porosity can alter simple protein dynamics and abnormal distribution might occur in conditions like severe burns or septic shock.
Elimination
Under traditional conditions, the typical half-life of simple protein is regarding nineteen days. The balance between synthesis and breakdown is often achieved by feedback regulation. Elimination is preponderantly living thing and thanks to cell organ proteases.
In healthy subjects, but 100 percent of infused simple protein leaves the intravascular compartment throughout the primary two hours following infusion. there's right smart individual variation within the impact on plasma volume. In some patients the plasma volume will stay multiplied for a few hours. However, in critically sick patients, simple protein will leak of the vascular house in substantial amounts at haphazard rate.
5.3 diagnosis safety knowledge
Human simple protein may be a traditional constituent of human plasma and acts like physiological simple protein.
In animals, single dose virulentity testing is of very little connectedness and doesn't allow the analysis of toxic or deadly doses or of a dose-effect relationship.
Repeated dose toxicity testing is unfeasible thanks to the event of antibodies to heterologous supermolecule in animal models.
To date, human simple protein has not been reported to be related to embryo-foetal toxicity, oncogenic or agent potential.
No signs of acute toxicity are represented in animal models.
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