ABSEAMED Solution for injection in a pre-filled syringe (2019)
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Περιεχόμενα
Name of the medicinal product
Abseamed 1,000 IU/0.5 mL solution for injection in a pre-filled syringe. Abseamed 2,000 IU/1 mL solution for injection in a pre-filled syringe. Abseamed 3,000 IU/0.3 mL solution for injection in a pre-filled ...
Qualitative and quantitative composition
Abseamed 1,000 IU/0.5 mL solution for injection in a pre-filled syringe: Each mL of solution contains 2,000 IU of epoetin alfa* corresponding to 16.8 micrograms per mL A pre-filled syringe of 0.5 mL contains ...
Pharmaceutical form
Solution for injection in a pre-filled syringe (injection). Clear, colourless solution.
Therapeutic indications
Abseamed is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF): in adults and children aged 1 to 18 years on haemodialysis and adult patients on peritoneal dialysis ...
Posology and method of administration
Treatment with Abseamed has to be initiated under the supervision of physicians experienced in the management of patients with the above indications. Posology All other causes of anaemia (iron, folate ...
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 alfa, blood pressure should be closely monitored and controlled as necessary. Epoetin alfa 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 alfa alters the metabolism of other medicinal products. Medicinal products that decrease erythropoiesis may decrease the response to epoetin ...
Pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of epoetin alfa in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Consequently, epoetin alfa 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. Abseamed 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 epoetin alfa is very wide. Overdosage of epoetin alfa may produce effects that are extensions of the pharmacological effects of the hormone. Phlebotomy may be performed if excessively ...
Pharmacodynamic properties
Pharmacotherapeutic group: other antianaemic preparations, erythropoietin, ATC code: B03XA01 Abseamed is a biosimilar medicinal product. Mechanism of action Erythropoietin (EPO) is a glycoprotein hormone ...
Pharmacokinetic properties
Absorption Following subcutaneous injection, serum levels of epoetin alfa 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
Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Sodium chloride Glycine Polysorbate 80 Water for injections Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment) ...
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
2 years.
Special precautions for storage
Store and transport refrigerated (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 ...
Nature and contents of container
Pre-filled syringes (glass type I), with or without a needle safety guard, with plunger stopper (Teflon-faced rubber) sealed in a blister. <u>Abseamed 1,000 IU/0.5 mL solution for injection in a pre-filled ...
Special precautions for disposal and other handling
Abseamed should not be used and discarded if the liquid is coloured or you can see particles floating in it, if the seal is broken, if you know, or think that it may have been accidentally frozen, or ...
Marketing authorization holder
Medice Arzneimittel Pütter GmbH & Co. KG, Kuhloweg 37, D-58638, Iserlohn, Germany
Marketing authorization number(s)
<u>Abseamed 1,000 IU/0.5 mL solution for injection in a pre-filled syringe:</u> EU/1/07/412/001 EU/1/07/412/002 EU/1/07/412/027 EU/1/07/412/028 <u>Abseamed 2,000 IU/1 mL solution for injection in a pre-filled ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 28 August 2007 Date of latest renewal: 18 June 2012
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