RETACRIT Solution for injection (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe. Retacrit 2 000 IU/0.6 ml solution for injection in pre-filled syringe. Retacrit 3 000 IU/0.9 ml solution for injection in pre-filled ...
Qualitative and quantitative composition
Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe: 1 pre-filled syringe with 0.3 ml solution for injection contains 1 000 international units (IU) epoetin zeta* (recombinant human erythropoietin). ...
Pharmaceutical form
Solution for injection in pre-filled syringe (injection). Clear, colourless solution.
Therapeutic indications
Retacrit is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF): in adults and paediatrics aged 1 to 18 years on haemodialysis and adult patients on peritoneal ...
Posology and method of administration
Treatment with Retacrit has to be initiated under the supervision of physicians experienced in the management of patients with above indications. Posology All other causes of anaemia (iron, folate or Vitamin ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients who develop pure red cell aplasia (PRCA) following treatment with any erythropoietin should not receive ...
Special warnings and precautions for use
General In all patients receiving epoetin zeta, blood pressure should be closely monitored and controlled as necessary. Epoetin zeta should be used with caution in the presence of untreated, inadequately ...
Interaction with other medicinal products and other forms of interaction
No evidence exists that indicates that treatment with epoetin zeta alters the metabolism of other medicinal products. Medicinal products that decrease erythropoiesis may decrease the response to epoetin ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of epoetin zeta in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Consequently, epoetin zeta should ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Retacrit has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most frequent adverse drug reaction during treatment with epoetin alfa is a dose-dependent increase in blood pressure or aggravation of existing hypertension. Monitoring ...
Overdose
The therapeutic margin of erythropoietin is very wide. Overdosage of erythropoietin may produce effects that are extensions of the pharmacological effects of the hormone. Phlebotomy may be performed if ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other antianaemic preparations, erythropoietin ATC code: B03XA01 Retacrit is a biosimilar medicinal product. Detailed information is available on the website of the European ...
Pharmacokinetic properties
Absorption Following subcutaneous injection, serum levels of erythropoietin reach a peak between 12 and 18 hours post-dose. There was no accumulation after multiple dose administration of 600 IU/kg administered ...
Preclinical safety data
In repeated dose toxicological studies in dogs and rats, but not in monkeys, epoetin alfa therapy was associated with subclinical bone marrow fibrosis. Bone marrow fibrosis is a known complication of chronic ...
List of excipients
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride Calcium chloride dihydrate Polysorbate 20 Glycine Leucine Isoleucine Threonine Glutamic acid Phenylalanine Water for injections ...
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
30 months.
Special precautions for storage
Store in a refrigerator (2°C to 8°C). This temperature range should be closely maintained until administration to the patient. For the purpose of ambulatory use, the medicinal product may be taken out ...
Nature and contents of container
Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe: Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle ...
Special precautions for disposal and other handling
Retacrit should not be used and discarded if the seal is broken, if the liquid is coloured or you can see particles floating in it, if any liquid has leaked out of the pre-filled syringe or condensation ...
Marketing authorization holder
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium
Marketing authorization number(s)
<u>Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe:</u> EU/1/07/431/001 1 pre-filled syringe EU/1/07/431/002 6 pre-filled syringes EU/1/07/431/026 1 pre-filled syringe with needle ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 18 December 2007 Date of latest renewal: 15 November 2012
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