OXLUMO Solution for injection (2020)
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Περιεχόμενα
1. Name of the medicinal product
Oxlumo 94.5 mg/0.5 mL solution for injection.
2. Qualitative and quantitative composition
Each mL of solution contains lumasiran sodium equivalent to 189 mg lumasiran. Each vial contains 94.5 mg lumasiran in 0.5 mL. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection. Clear, colourless to yellow solution (pH of approximately 7; osmolality 210 to 390 mOsm/kg).
4.1. Therapeutic indications
Oxlumo is indicated for the treatment of primary hyperoxaluria type 1 (PH1) in all age groups.
4.2. Posology and method of administration
Therapy should be initiated and supervised by a physician experienced in the management of hyperoxaluria. Posology Oxlumo is administered by subcutaneous injection. The recommended dose of Oxlumo consists ...
4.3. Contraindications
Severe hypersensitivity to the active substance or any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Severe or end-stage renal impairment Treatment with lumasiran increases plasma glycolate levels, which may increase the risk of metabolic acidosis or worsening of pre-existing metabolic acidosis in patients ...
4.5. Interaction with other medicinal products and other forms of interaction
No clinical drug interaction studies have been performed (see section 5.2). Concomitant use with pyridoxine Concomitant use of pyridoxine did not meaningfully influence the pharmacodynamics or pharmacokinetics ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no data from the use of lumasiran in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). The use ...
4.7. Effects on ability to drive and use machines
Oxlumo has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile The most common adverse reaction reported was injection site reaction (32%). Tabulated list of adverse reactions Adverse reactions associated with lumasiran obtained from ...
4.9. Overdose
In case of overdose, it is recommended that the patient be monitored as medically indicated for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted.
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: not yet assigned ATC code: not yet assigned Mechanism of action Lumasiran is a double-stranded small interfering ribonucleic acid (siRNA) that reduces levels of glycolate oxidase ...
5.2. Pharmacokinetic properties
Absorption Following subcutaneous administration, lumasiran is rapidly absorbed with a median (range) time to reach maximum plasma concentration (t<sub>max</sub>) of 4.0 (0.5 to 12.0) hours. In children ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and genotoxicity. In rats, but not in monkeys, microscopic changes in the liver (e.g. hepatocellular ...
6.1. List of excipients
Sodium hydroxide (pH adjustment) Phosphoric acid (pH adjustment) 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
3 years. Once the vial is opened, the medicinal product should be used immediately.
6.4. Special precautions for storage
Do not store above 30°C. Keep vial in the outer carton to protect from light.
6.5. Nature and contents of container
Glass vial with a fluoropolymer-coated rubber stopper and an aluminium overseal with a flip-off button. Each vial contains 0.5 mL solution for injection. Pack size of one vial.
6.6. Special precautions for disposal and other handling
This medicinal product is ready-to-use and for single use only. For subcutaneous use only Before administration, materials not included in the pack that are needed for administration should be collected, ...
7. Marketing authorization holder
Alnylam Netherlands B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, Netherlands
8. Marketing authorization number(s)
EU/1/20/1496/001
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