ALOFISEL Suspension for injection (2020)
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Περιεχόμενα
Name of the medicinal product
Alofisel 5 million cells/mL suspension for injection.
Qualitative and quantitative composition
Darvadstrocel is expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue (expanded adipose stem cells eASC). Each vial contains a suspension of 30 million cells (eASC) in ...
Pharmaceutical form
Suspension for injection. The suspension of cells may have settled in the bottom of the vial forming a sediment. After gentle re-suspension, the product is a white to yellowish homogeneous suspension. ...
Therapeutic indications
Alofisel is indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohns disease, when fistulas have shown an inadequate response to at least ...
Posology and method of administration
Alofisel should only be administered by specialist physicians experienced in the diagnosis and treatment of conditions for which Alofisel is indicated. Posology A single dose of Alofisel consists of 120 ...
Contraindications
Hypersensitivity to the product, bovine serum or any of the excipients listed in section 6.1.
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Alofisel may contain trace amounts ...
Interaction with other medicinal products and other forms of interaction
No in vivo interaction studies have been performed. In vitro interaction studies have shown that the cell viability and immunomodulatory function of Alofisel is not affected by the presence of clinically-relevant ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of darvadstrocel in pregnant women. Animal studies are not available with respect to reproductive toxicity (see section 5.3). Darvadstrocel is not recommended during ...
Effects on ability to drive and use machines
Darvadstrocel has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The most common treatment-emergent adverse events were anal abscess (Alofisel: 19.4% patients; control group: 13.7% patients), proctalgia (Alofisel: 14.6% patients; control ...
Overdose
No case of overdose has been reported.
Pharmacodynamic properties
Pharmacotherapeutic group: {not yet assigned} ATC code: {not yet assigned} Mechanism of action Darvadstrocel contains expanded adipose stem cells (eASC), which exhibit immunomodulatory and anti-inflammatory ...
Pharmacokinetic properties
The product is intended for local injection. The nature and intended clinical use of darvadstrocel are such that conventional studies of pharmacokinetics (absorption, distribution, metabolism and elimination) ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity. Reproductive and developmental toxicity studies have not been performed ...
List of excipients
Dulbeccos Modified Eagle´s Medium (DMEM) (containing amino acids, vitamins, salts and carbohydrates) Human albumin
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 72 hours.
Special precautions for storage
Store between 15ºC and 25ºC. Keep the product within the outer carton and inside the shipping container at all times until its administration, to maintain the required temperature. Preserve the container ...
Nature and contents of container
Alofisel is supplied as one treatment dose contained in 4 Type I glass vials. Each vial contains 6 mL of eASC suspension and is closed with a rubber stopper and a flip-off seal. The vials are placed inside ...
Special precautions for disposal and other handling
Alofisel must not be filtered or administered using a needle thinner than 22G (see section 4.4). Immediately before use, Alofisel must be re-suspended by gently tapping the bottom of the vial until a homogeneous ...
Marketing authorization holder
Takeda Pharma A/S, Dybendal Alle 10, 2630 Taastrup, Denmark
Marketing authorization number(s)
EU/1/17/1261/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 23 March 2018
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