Albunorm 2 hundredth, 200 g/l, answer for infusion
2. Qualitative and quantitative compositionAlbunorm 2 hundredth may be a answer containing two hundred g/l of total supermolecule of that a minimum of ninety six is human simple protein.
A bottle of fifty cubic centimetre contains ten g of human simple protein.
A bottle of a hundred cubic centimetre contains twenty g of human simple protein.
Excipients:
Sodium (144-160 mmol/l)
Albunorm 2 hundredth may be a hyperoncotic answer.
For a full list of excipients, see section vi.1.
3. Pharmaceutical kind
Solution for infusion.
The solution may be a clear, slightly viscous liquid; it's 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 depend upon 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, dose and therefore 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 health problem and on continued fluid and supermolecule losses. Measures of adequacy of current volume and not plasma simple protein levels ought to be accustomed verify the dose needed.
If human simple protein is to be administered, haemodynamic performance ought to be monitored regularly; this could include:
• blood pressure and vital sign
• central blood pressure
• artery wedge pressure
• excretion output
• solution
• haematocrit/haemoglobin
Paediatric population
Data on the employment of Albunorm 2 hundredth in youngsters area unit limited; so, the merchandise ought to solely be administered to those people if the advantages clearly outweigh potential risks.
Method of administration
Human simple protein may be directly administered by the blood vessel route, or it also can be diluted in Associate in Nursing solution (e.g. five-hitter aldohexose or zero.9% metallic element chloride).
The infusion rate ought to be adjusted consistent with the individual circumstances and therefore 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.
4.4 Special warnings and precautions to be used
Suspicion of allergic or hypersensitivity reaction sort reactions needs immediate ending of the injection. just in case of shock, customary medical treatment for shock ought to be enforced.
Albumin ought to be used with caution in conditions wherever blood disease and its consequences or haemodilution may represent a special risk for the patient.
Examples of such conditions are:
• Decompensated insufficiency
• cardiovascular disease
• Oesophageal varices
• respiratory organ swelling
• hurt predisposition
• Severe anaemia
• nephritic and post-renal illness
In a post-hoc follow-up study of critically sick patients with traumatic brain injury, fluid revitalization with simple protein was related to higher mortality rates than was revitalization with saline. whereas the mechanisms underlying this determined distinction in mortality don't seem to be clear, caution is suggested within the use of simple protein in patients with severe traumatic brain injury.
The colloid-osmotic result of human simple protein two hundred or 250 g/l is more or less fourfold that of plasma. Therefore, once targeted simple protein is run, care should be taken to assure adequate association of the patient. Patients ought to be monitored fastidiously to protect against circulatory overload and hyperhydration.
200-250 g/l human simple protein solutions area unit comparatively low in electrolytes compared to 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.
Albumin solutions should not be diluted with water for injections as this could cause hemolysis in recipients.
If relatively massive volumes area unit to get replaced, controls of natural process and haematocrit area unit necessary. Care should be taken to make sure adequate substitution of different blood constituents (coagulation factors, electrolytes, platelets and erythrocytes).
Hypervolaemia could occur if the dose and rate of infusion don't seem to be adjusted to the patients circulatory state of affairs. At the primary clinical signs of vas overload (headache, dyspnoea, vena jugularis congestion), or magnified vital sign, raised blood pressure and respiratory organ swelling, the infusion is to be stopped directly.
This healthful product contains seven.2 –8 mmol / fourteen.4 –16 mmol metallic element per one bottle of fifty cubic centimetre /100 cubic centimetre simple protein answer, this should be taken into thought by patients on a controlled metallic element diet.
This drugs contains most 1mmol metal per one bottle of a hundred cubic centimetre simple protein answer, this should be taken into thought for patients with reduced urinary organ perform or patients on a controlled metal diet.
Standard live to forestall infections ensuing from the employment of healthful product ready from human blood or plasma embody choice of donors, screening of individual donations and plasma pools for specific markers of infection and therefore the inclusion of effective producing steps for the inactivation/removal of viruses. Despite this, once healthful product ready from human blood or plasma area unit administered, the chance of sending infective agents can not be all excluded. This additionally applies to unknown or rising viruses and different pathogens.
There are not any reports of virus transmissions with simple protein factory-made to European aggregation specifications by established processes.
It is powerfully suggested that each time that Albunorm 2 hundredth is run to a patient, the name and batch variety of the merchandise area unit recorded so as to take care of a link between the patient and therefore the batch of the merchandise.
4.5 Interaction with different healthful product and different sorts of interaction
No specific interactions of human simple protein with different healthful product area unit well-known.
4.6 Fertility, maternity and lactation
The safety of Albunorm 2 hundredth to be used in human maternity has not been established in controlled clinical trials. However, clinical expertise with simple protein suggests that no harmful effects on the course of maternity, or on the foetus and therefore the newborn baby area unit to be expected.
No animal copy studies are conducted with Albunorm 2 hundredth. However, human simple protein may be a traditional constituent of human blood.
4.7 Effects on ability to drive and use machines
No effects on ability to drive and use machines are determined.
4.8 Undesirable effects
Mild reactions like flush, urticaria, fever, and nausea occur seldom. These reactions usually disappear quickly once the infusion rate is over-involved or the infusion is stopped. terribly seldom, severe reactions like shock could occur. just in case of severe reactions, the infusion ought to be stopped Associate in Nursingd an applicable treatment ought to be initiated.
The following adverse reactions are determined for human simple protein solutions throughout the postmarketing part and may so even be expected for Albunorm 2 hundredth.
System Organ category
Reactions
(frequency not known)*
Immune system disorders
anaphylactic shock hypersensitivity reaction reaction
hypersensitivity
Psychiatric disorders
confusional state
Nervous system disorders
headache
Cardiac disorders
tachycardia
bradycardia
Vascular disorders
hypotension
hypertension
flushing
Respiratory, body part and mediastinal disorders
dyspnoea
Gastrointestinal disorders
nausea
Skin and connective tissue tissue disorders
urticaria
angioneurotic swelling
rash erythematosus
hyperhidrosis
General disorders and administration web site conditions
pyrexia
chills
* can not be calculable from the out there information
For safety with reference to transmissible agents, see 4.4.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions once authorisation of the healthful product is very important. It permits continuing watching of the benefit/risk balance of the healthful product. aid professionals area unit asked to report any suspected adverse reactions via World Wide Web.mhra.gov.uk/yellowcard.
4.9 Overdose
Hypervolaemia could occur if the dose and rate of infusion area unit too high. At the primary clinical signs of vas overload (headache, dyspnoea, vena jugularis congestion), or magnified vital sign, raised central blood pressure and respiratory organ swelling, the infusion ought to be stopped directly and therefore the patient´s haemodynamic parameters fastidiously monitored.
5. medicine properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: blood substitutes and protein fractions,
ATC code: B05AA01
Human {albumin|albumen|simple supermolecule} accounts quantitatively for quite 1/2 the overall supermolecule within the plasma and represents regarding 100% of the protein synthesis activity of the liver.
Physico-chemical data:
Human simple protein two hundred or 250g/l contains a corresponding hyperoncotic result.
The most vital physiological perform of simple protein results from its contribution to oncotic pressure of the blood and transport perform. simple protein stabilises current blood volume and may be a carrier of hormones, enzymes, healthful product and toxins.
5.2 Pharmacokinetic properties
Under traditional conditions the overall exchangeable simple protein pool is 4-5 g/kg weight, of that 40-45% is gift intravascularly and 55-60% within the extravascular area. magnified capillary permeableness can alter simple protein mechanics and abnormal distribution could occur in conditions like severe burns or septic shock.
Under traditional conditions, the typical half-life of simple protein is regarding nineteen days. The balance between synthesis and breakdown is generally achieved by feedback regulation. Elimination is preponderantly intracellular and thanks to organelle proteases.
In healthy subjects, but 100% of infused simple protein leaves the intravascular compartment throughout the primary a pair of hours following infusion. there's hefty individual variation within the result on plasma volume. In some patients the plasma volume will stay magnified for a few hours. However, in critically sick patients, simple protein will get around of the tube area in substantial amounts at haphazard rate.
5.3 diagnosis safety information
Human simple protein may be a traditional constituent of human plasma and acts like physiological simple protein.
In animals, single-dose venomousity testing is of very little relevancy 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-fetal toxicity, oncogenic or agent potential.
No signs of acute toxicity are delineate in animal models.
6. Pharmaceutical particulars
6.1 List of excipients
Sodium chloride
5.7 g/l
N-acetyl-DL-tryptophan
3.9 g/l
Caprylic acid
2.3 g/l
Water for injections
ad 1000 ml
Electrolytes
Sodium
144-160 mmol/l
6.2 Incompatibilities
Human simple protein answer should not be mixed with different healthful product, blood, packed red cells and water for injections.
6.3 period
3 years
After the ampule has been opened, the content ought to be used directly.
6.4 Special precautions for storage
Do not store higher than +25 °C.
Store within the original instrumentality so as to safeguard from light-weight.
Do not freeze.
6.5 Nature and contents of instrumentality
• fifty cubic centimetre of answer in infusion bottle (type II glass) with stopper (bromobutyl rubber).
o Pack size of one or ten.
• a hundred cubic centimetre of answer in infusion bottle (type II glass) with stopper (bromobutyl rubber).
o Pack size of one or ten.
Not all pack sizes is also marketed all told countries.
6.6 Special precautions for disposal and different handling
The solution may be directly administered by the blood vessel route, or it also can be diluted in Associate in Nursing solution (e.g. five blood sugar or zero.9 nonsteroidal anti-inflammatory drug chloride).
Albumin solutions should not be diluted with water for injections as this could cause hemolysis in recipients.
If massive volumes area unit administered, the merchandise ought to be warm to area or blood heat before use.
Do not use solutions that area unit cloudy or have deposits. this could indicate that the supermolecule is unstable or that the answer has become contaminated.
Once the instrumentality has been opened the content ought to be used directly.
Any unused product ought to be disposed of in accordance with native needs.
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