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Epoetin alfa should be used with caution in patients with chronic liver failure. The safety of epoetin alfa has not been established in patients with hepatic dysfunction. These include venous and arterial thromboses and embolism including some with fatal outcomessuch as deep venous thrombosis, pulmonary emboli, retinal thrombosis, and myocardial infarction. Additionally, cerebrovascular accidents including cerebral infarction, cerebral haemorrhage and transient ischaemic attacks have been reported.

The reported risk of these TVEs should be carefully weighed against the benefits to be derived from treatment with epoetin alfa particularly in patients with pre-existing risk factors for TVE, including obesity and prior history of TVEs e. In all patients, haemoglobin levels should be closely monitored due to a potential increased risk of thromboembolic events and fatal outcomes when patients are treated at haemoglobin levels above the concentration range for the indication of use.

There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with epoetin alfa. This regresses during the course of continued therapy. In addition, thrombocythaemia above the normal range has been reported. It is recommended that the platelet count is regularly monitored during the first 8 weeks of therapy. All other causes of anaemia iron, folate or Vitamin B12 deficiency, aluminium intoxication, infection or inflammation, blood loss, haemolysis and bone marrow fibrosis of any origin should be evaluated and treated prior to initiating therapy with epoetin alfa, and when deciding to increase the dose.

In most cases, the ferritin values in the serum fall simultaneously with the rise in packed cell volume. If possible, iron supplementation should be initiated prior to starting epoetin alfa therapy to achieve adequate iron stores. Very rarely, development of or exacerbation of porphyria has been observed in epoetin alfa-treated patients. Epoetin alfa should be used with caution in patients with porphyria. More severe cases have been observed with long-acting epoetins.

At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, EPREX should be withdrawn immediately and an alternative treatment considered.

In order to improve the traceability of erythropoiesis-stimulating agents ESAsthe trade name of the administered ESA should be clearly recorded or stated in the patient file.

Patients should only be switched from one ESA to another under appropriate supervision. Pure Red Cell Aplasia Antibody-mediated pure red cell aplasia PRCA has been reported after months to years of subcutaneous epoetin treatment mainly in chronic renal failure patients.

Cases have also been reported in patients with hepatitis C treated with interferon and ribavirin, when ESAs are used concomitantly. Epoetin alfa is not approved in the management of anaemia associated with hepatitis C. A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin alfa and perform anti-erythropoietin antibody testing.

A bone marrow examination should also be considered for diagnosis of PRCA.

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No other ESA therapy should be commenced because of the risk of cross-reaction. Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients Chronic renal failure patients being treated with epoetin alfa should have haemoglobin levels measured on a regular basis until a stable level is achieved, and periodically thereafter. In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the haemoglobin concentration range as recommended in section 4.

Controlled clinical trials have not shown significant benefits attributable to the administration of epoetins when haemoglobin concentration is increased beyond the level necessary to control symptoms of anaemia and to avoid blood transfusion.

Caution should be exercised with escalation of EPREX doses in patients with chronic renal failure since high cumulative epoetin doses may be associated with an increased risk of mortality, serious cardiovascular and cerebrovascular events. In patients with a poor haemoglobin response to epoetins, alternative explanations for the poor response should be considered see section 4. Chronic renal failure patients treated with epoetin alfa by the subcutaneous route should be monitored regularly for loss of efficacy, defined as absent or decreased response to epoetin alfa treatment in patients who previously responded to such therapy.

This is characterised by a sustained decrease in haemoglobin despite an increase in epoetin alfa dosage see section 4.

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Some patients with more extended dosing intervals greater than once weekly of epoetin alfa may not maintain adequate haemoglobin levels see section 5. Haemoglobin levels should be monitored regularly. Shunt thromboses have occurred in haemodialysis patients, especially in those who have a tendency to hypotension or whose arteriovenous fistulae exhibit complications e.

Early shunt revision and thrombosis prophylaxis by administration of acetylsalicylic acid, for example, is recommended in these patients.

Hyperkalaemia has been observed in isolated cases though causality has not been established. Serum electrolytes should be monitored in chronic renal failure patients.

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If an elevated or rising serum potassium level is detected, then in addition to appropriate treatment of the hyperkalaemia, consideration should be given to ceasing epoetin alfa administration until the serum potassium level has been corrected. An increase in heparin dose during haemodialysis is frequently required during the course of therapy with epoetin alfa as a result of the increased packed cell volume.

Occlusion of the dialysis system is possible if heparinisation is not optimum. Based on information available to date, correction of anaemia with epoetin alfa in adult patients with renal insufficiency not yet undergoing dialysis does not accelerate the rate of progression of renal insufficiency.

Treatment of patients with chemotherapy-induced anaemia Cancer patients being treated with epoetin alfa should have haemoglobin levels measured on a regular basis until a stable level is achieved, and periodically thereafter. Epoetins are growth factors that primarily stimulate red blood cell production. Erythropoietin receptors may be expressed on the surface of a variety of tumour cells.

As with all growth factors, there is a concern that epoetins could stimulate the growth of tumours. The role of ESAs on tumour progression or reduced progression-free survival cannot be excluded. In controlled clinical studies, use of epoetin alfa and other ESAs have been associated with decreased locoregional tumour control or decreased overall survival: In view of the above, in some clinical situations blood transfusion should be the preferred treatment for the management of anaemia in patients with cancer.

The decision to administer recombinant erythropoietin treatment should be based on a benefit-risk assessment with the participation of the individual patient, which should take into account the specific clinical context. Factors that should be considered in this assessment should include the type of tumour and its stage; the degree of anaemia; life-expectancy; the environment in which the patient is being treated; and patient preference see section 5.

In cancer patients receiving chemotherapy, the 2 to 3 week delay between ESA administration and the appearance of erythropoietin-induced red cells should be taken into account when assessing if epoetin alfa therapy is appropriate patient at risk of being transfused. Surgery patients in autologous predonation programmes All special warnings and special precautions associated with autologous predonation programmes, especially routine volume replacement, should be respected. Patients scheduled for major elective orthopaedic surgery Good blood management practices should always be used in the perisurgical setting.

Patients scheduled for major elective orthopaedic surgery should receive adequate antithrombotic prophylaxis, as thrombotic and vascular events may occur in surgical patients, especially in those with underlying cardiovascular disease. In addition, special precaution should be taken in patients with predisposition for development of DVTs. Drugs that decrease erythropoiesis may decrease the response to epoetin alfa.

Since cyclosporin is bound by RBCs there is potential for a drug interaction. If epoetin alfa is given concomitantly with cyclosporin, blood levels of cyclosporin should be monitored and the dose of cyclosporin adjusted as the haematocrit rises.

No evidence exists that indicates an interaction between epoetin alfa and G-CSF or GM-CSF with regard to haematological differentiation or proliferation of tumour biopsy specimens in vitro.

Eprex 2,000 IU/ml solution for injection in pre-filled syringe

Studies in animals have shown reproduction toxicity see section 5. Consequently, epoetin alfa should be used in pregnancy only if the potential benefit outweighs the potential risk to the foetus.

The use of epoetin alfa is not recommended in pregnant surgical patients participating in an autologous blood predonation. Breastfeeding It is not known whether exogenous epoetin alfa is excreted in human milk. Epoetin alfa should be used with caution in nursing women. The use of epoetin alfa is not recommended in lactating surgical patients participating in an autologous blood predonation programme.

Fertility There are no studies assessing the potential effect of epoetin alfa on male or female fertility.

Monitoring of the blood pressure should be performed, particularly at the start of therapy see section 4. The most frequently occurring adverse drug reactions observed in clinical trials of epoetin alfa are diarrhoea, nausea, vomiting, pyrexia and headache.

Influenza-like illness may occur especially at the start of treatment. Agitation can be safely addressed with benzodiazepines such as lorazepam or diazepam. Neuroleptics such as haloperidol are recommended against because they may have adverse effects. LSD is rapidly absorbed, so activated charcoal and emptying of the stomach will be of little benefit, unless done within 30—60 minutes of ingesting an overdose of LSD.

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Sedation or physical restraint is rarely required, and excessive restraint may cause complications such as hyperthermia over-heating or rhabdomyolysis. Intravenous administration of anticoagulantsvasodilatorsand sympatholytics may be useful with massive doses.

The lower the dissociation constant Kithe more strongly LSD binds to that receptor i. The horizontal line represents an approximate value for human plasma concentrations of LSD, and hence, receptor affinities that are above the line are unlikely to be involved in LSD's effect. Data averaged from data from the Ki Database Most serotonergic psychedelics are not significantly dopaminergicand LSD is therefore atypical in this regard.

The agonism of the D2 receptor by LSD may contribute to its psychoactive effects in humans. LSD exhibits functional selectivity at the 5-HT2A and 5HT2C receptors in that it activates the signal transduction enzyme phospholipase A2 instead of activating the enzyme phospholipase C as the endogenous ligand serotonin does. LSD is a chiral compound with two stereocenters at the carbon atoms C-5 and C-8, so that theoretically four different optical isomers of LSD could exist.

The C-5 isomers of lysergamides do not exist in nature and are not formed during the synthesis from d -lysergic acid. Retrosyntheticallythe C-5 stereocenter could be analysed as having the same configuration of the alpha carbon of the naturally occurring amino acid L- tryptophanthe precursor to all biosynthetic ergoline compounds.

However, LSD and iso-LSD, the two C-8 isomers, rapidly interconvert in the presence of basesas the alpha proton is acidic and can be deprotonated and reprotonated. Non-psychoactive iso-LSD which has formed during the synthesis can be separated by chromatography and can be isomerized to LSD.

Pure salts of LSD are triboluminescentemitting small flashes of white light when shaken in the dark. Synthesis LSD is an ergoline derivative. It is commonly synthesized by reacting diethylamine with an activated form of lysergic acid. Activating reagents include phosphoryl chloride [70] and peptide coupling reagents. Threshold effects can be felt with as little as 25 micrograms of LSD. By comparison, dosages of most drugs, both recreational and medicinal, are measured in milligrams mgor thousandths of a gram.

For example, an active dose of mescalineroughly 0. As a salt, in water, cold, and free from air and light exposure, it is stable indefinitely. The C8 proton is more labile due to the electron-withdrawing carboxamide attachment, but removal of the chiral proton at the C5 position which was once also an alpha proton of the parent molecule tryptophan is assisted by the inductively withdrawing nitrogen and pi electron delocalisation with the indole ring.

Because of this, chlorine destroys LSD molecules on contact; even though chlorinated tap water contains only a slight amount of chlorine, the small quantity of compound typical to an LSD solution will likely be eliminated when dissolved in tap water.

Urine fortified with LSD and stored in amber glass or nontransparent polyethylene containers showed no change in concentration under any light conditions. Stability of LSD in transparent containers under light was dependent on the distance between the light source and the samples, the wavelength of light, exposure time, and the intensity of light.

It was also demonstrated that trace amounts of metal ions in buffer or urine could catalyze the decomposition of LSD and that this process can be avoided by the addition of EDTA.

Detection in body fluids LSD may be quantified in urine as part of a drug abuse testing programin plasma or serum to confirm a diagnosis of poisoning in hospitalized victims or in whole blood to assist in a forensic investigation of a traffic or other criminal violation or a case of sudden death. Both the parent drug and its major metabolite are unstable in biofluids when exposed to light, heat or alkaline conditions and therefore specimens are protected from light, stored at the lowest possible temperature and analyzed quickly to minimize losses.

At home I lay down and sank into a not unpleasant intoxicated-like condition, characterized by an extremely stimulated imagination. In a dreamlike state, with eyes closed I found the daylight to be unpleasantly glaringI perceived an uninterrupted stream of fantastic pictures, extraordinary shapes with intense, kaleidoscopic play of colors.

After some two hours this condition faded away. History of lysergic acid diethylamide LSD was first synthesized on November 16, [84] by Swiss chemist Albert Hofmann at the Sandoz Laboratories in BaselSwitzerland as part of a large research program searching for medically useful ergot alkaloid derivatives. LSD's psychedelic properties were discovered 5 years later when Hofmann himself accidentally ingested an unknown quantity of the chemical.