ARANESP Solution for injection in pre-filled syringe / pre-filled pen / vial (2020)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | Amgen Ltd |
|---|---|
| Διεύθυνση | 240 Cambridge Science Park, Milton Road, Cambridge, CB4 0WD |
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Δωρεάν εγγραφή
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Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Aranesp 10 micrograms solution for injection in pre-filled syringe. Aranesp 15 micrograms solution for injection in pre-filled syringe. Aranesp 20 micrograms solution for injection in pre-filled syringe. ...
Qualitative and quantitative composition
Ara*nesp 10 micrograms solution for injection in pre-filled syringe: ach pre-filled syringe contains 10 micrograms of darbepoetin alfa in 0.4 mL (25 mcg/mL). Aranesp 15 micrograms solution for injection ...
Pharmaceutical form
Solution for injection (injection) in pre-filled syringe. Solution for injection (injection) in pre-filled pen (SureClick). Solution for injection (injection) in vial. Clear, colourless solution.
Therapeutic indications
Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients (see section 4.2). Treatment of symptomatic anaemia in adult cancer patients with non-myeloid ...
Posology and method of administration
Aranesp treatment should be initiated by physicians experienced in the above mentioned indications. Posology Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients Anaemia ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Poorly controlled hypertension.
Special warnings and precautions for use
Generalx In order to improve the traceability of erythropoiesis-stimulating agents (ESAs), the trade name of the administered ESA should be clearly recorded (or stated) in the patient file. Blood pressure ...
Interaction with other medicinal products and other forms of interaction
The clinical results obtained so far do not indicate any interaction of darbepoetin alfa with other substances. However, there is potential for an interaction with substances that are highly bound to red ...
Pregnancy and lactation
Pregnancy There are no adequate and well-controlled studies with Aranesp in pregnant women. Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, ...
Effects on ability to drive and use machines
Aranesp has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile Identified adverse reactions associated with Aranesp are hypertension, stroke, thromboembolic events, convulsions, allergic reactions, rash/erythema and pure red cell aplasia ...
Overdose
The maximum amount of Aranesp that can be safely administered in single or multiple doses has not been determined. Therapy with Aranesp can result in polycythaemia if the haemoglobin is not carefully monitored ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antianemic preparations, other antianemic preparations ATC Code: B03XA02 Mechanism of action Human erythropoietin is an endogenous glycoprotein hormone that is the primary regulator ...
Pharmacokinetic properties
Due to its increased carbohydrate content the level of darbepoetin alfa in the circulation remains above the minimum stimulatory concentration for erythropoiesis for longer than the equivalent molar dose ...
Preclinical safety data
In all studies in rats and dogs darbepoetin alfa produced marked increases in haemoglobin, haematocrits, red blood cell counts and reticulocytes, which correspond to the expected pharmacological effects. ...
List of excipients
Sodium phosphate monobasic Sodium phosphate dibasic Sodium chloride Polysorbate 80 Water for injections
Incompatibilities
In the absence of incompatibility studies, this medicinal product must not be mixed or administered as an infusion with other medicinal products.
Shelf life
3 years.
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. For the purpose of ambulatory use, Aranesp may be removed from storage ...
Nature and contents of container
Aranesp 10 micrograms solution for injection in pre-filled syringe: 0.4 mL solution for injection (25 mcg/mL darbepoetin alfa) in a type 1 glass pre-filled syringe with stainless steel 27 gauge needle. ...
Special precautions for disposal and other handling
The carton contains a package leaflet with the full instructions for use and handling. The Aranesp (SureClick) pre-filled pen delivers the complete dose of each presentation. Aranesp is a sterile but unpreserved ...
Marketing authorization holder
Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
Marketing authorization number(s)
Aranesp 10 micrograms solution for injection pre-filled syringe: EU/1/01/185/001 1 Pack Blister EU/1/01/185/002 4 Pack Blister EU/1/01/185/033 1 Pack Unblistered EU/1/01/185/074 1 blister pack with needle ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 8 June 2001 Date of latest renewal: 19 May 2006
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