EPORATIO Solution for injection (2022)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe. Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe. Eporatio 3,000 IU/0.5 ml solution for injection in pre-filled ...
Qualitative and quantitative composition
<u>Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe:</u> One pre-filled syringe contains 1,000 international units (IU) (8.3 µg) epoetin theta in 0.5 ml solution for injection corresponding ...
Pharmaceutical form
Solution for injection (injection). The solution is clear and colourless.
Therapeutic indications
Treatment of symptomatic anaemia associated with chronic renal failure in adult patients. Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. ...
Posology and method of administration
Epoetin theta treatment should be initiated by physicians experienced in the above-mentioned indications. Posology Symptomatic anaemia associated with chronic renal failure Anaemia symptoms and sequelae ...
Contraindications
Hypersensitivity to the active substance, other epoetins and derivatives or to any of the excipients listed in section 6.1. Uncontrolled hypertension.
Special warnings and precautions for use
General Supplementary iron therapy is recommended for all patients with serum ferritin values below 100 µg/l or with transferrin saturation below 20%. To ensure effective erythropoiesis, iron status has ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of epoetin theta in pregnant women. Animal studies with other epoetins do not indicate direct harmful effects ...
Effects on ability to drive and use machines
Epoetin theta has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile Approximately 9% of patients can be expected to experience an adverse reaction. The most frequent adverse reactions are hypertension, influenza-like illness and headache. ...
Overdose
The therapeutic margin of epoetin theta is very wide. In the case of overdose, polycythaemia can occur. In the event of polycythaemia, epoetin theta should be temporarily withheld. If severe polycythaemia ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other antianemic preparations ATC code: B03XA01 Mechanism of action Human erythropoietin is an endogenous glycoprotein hormone that is the primary regulator of erythropoiesis ...
Pharmacokinetic properties
General The pharmacokinetics of epoetin theta have been examined in healthy volunteers, in patients with chronic renal failure and in cancer patients receiving chemotherapy. The pharmacokinetics of epoetin ...
Preclinical safety data
Non-clinical data with epoetin theta reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity. Non-clinical data with other epoetins reveal no ...
List of excipients
Sodium dihydrogen phosphate dihydrate Sodium chloride Polysorbate 20 Trometamol Hydrochloric acid (6M) (for pH adjustment) Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
<u>Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe:</u> 2 years. <u>Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe:</u> 2 years. <u>Eporatio 3,000 IU/0.5 ml ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Keep the pre-filled syringe in the outer carton in order to protect from light.
Nature and contents of container
Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe: 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl ...
Special precautions for disposal and other handling
The pre-filled syringes are for single use only. The solution should be visually inspected prior to use. Only clear, colourless solutions without particles should be used. The solution for injection should ...
Marketing authorization holder
ratiopharm GmbH, Graf-Arco-Straße 3, 89079 Ulm, Germany
Marketing authorization number(s)
<u>Eporatio 1,000 IU/0.5 ml solution for injection in pre-filled syringe:</u> EU/1/09/573/001 EU/1/09/573/002 EU/1/09/573/029 <u>Eporatio 2,000 IU/0.5 ml solution for injection in pre-filled syringe:</u> ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 29 October 2009 Date of latest renewal: 11 September 2014
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