ENSPRYNG Solution for injection (2021)
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Περιεχόμενα
1. Name of the medicinal product
Enspryng 120 mg solution for injection in pre-filled syringe.
2. Qualitative and quantitative composition
Each pre-filled syringe (PFS) contains 120 mg of satralizumab in 1 mL. Satralizumab is produced in Chinese hamster ovary cells by recombinant DNA technology. For the full list of excipients, see section ...
3. Pharmaceutical form
Solution for injection (injection). Colourless to slightly yellow liquid. The solution has a pH of approximately 6.0 and an osmolality of approximately 310 mOsm/kg.
4.1. Therapeutic indications
Enspryng is indicated as a monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients from ...
4.2. Posology and method of administration
Treatment should be initiated under the supervision of a physician experienced in the treatment of neuromyelitis optica (NMO) or NMOSD. Posology Enspryng can be used as a monotherapy or in combination ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Traceability In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infections Administration of satralizumab ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Population pharmacokinetic (PK) analyses did not detect any effect of azathioprine (AZA), oral corticosteroids (OCs) or mycophenolate mofetil (MMF) on the clearance ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no data from the use of satralizumab in pregnant women. Studies in monkeys do not indicate harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary ...
4.7. Effects on ability to drive and use machines
Enspryng has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile The most frequently reported adverse reactions observed were: headache (19.2%), arthralgia (13.5%), white blood cell count decreased (13.5%), hyperlipidaemia (13.5%), and ...
4.9. Overdose
In the event of an overdose, the patient should be closely supervised, treated symptomatically, and supportive measures instituted as required.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> immunosuppressants, interleukin inhibitors <b>ATC code:</b> L04AC19 Mechanism of action Satralizumab is a recombinant humanised immunoglobuline G2 (IgG2) monoclonal antibody ...
5.2. Pharmacokinetic properties
The pharmacokinetics of satralizumab have been characterised both in Japanese and Caucasian healthy volunteers, and in NMO and NMOSD patients. The pharmacokinetics in NMO and NMOSD patients using the recommended ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and toxicity to reproduction and development. Carcinogenicity No rodent ...
6.1. List of excipients
Histidine Aspartic acid Arginine Poloxamer 188 Water for injections
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Store in a refrigerator (2°C–8°C). Do not freeze. Do not use the syringe if it has been frozen. Always keep the syringe dry. Keep the PFS in the outer carton in order to protect from light and moisture. ...
6.5. Nature and contents of container
1 mL solution in a PFS (polymer) with a staked-in, stainless steel needle, fitted with a chlorinated butyl rubber-polypropylene rigid needle shield and sealed with a chlorinated butyl rubber plunger stopper. ...
6.6. Special precautions for disposal and other handling
After removing the carton from the refrigerator, the sealed carton should be open and the PFS carefully lifted out of the carton by holding the barrel. It is important to let the PFS reach room temperature ...
7. Marketing authorization holder
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
8. Marketing authorization number(s)
EU/1/21/1559/001 EU/1/21/1559/002
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