Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr για έναν μήνα
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Μητρότητα και φάρμακα Ενημερωθείτε για την ασφάλεια χορήγησης ενός φαρμάκου κατά τη διάρκεια της εγκυμοσύνης ή του θηλασμού
Συνδρομές Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Ενδείξεις και αγωγές Βρείτε θεραπευτικές ενδείξεις και αγωγές για νόσους, συμπτώματα και ιατρικές πράξεις
Γνωρίζατε ότι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του Galinos.gr από το 2011 μέχρι σήμερα

OXLUMO Solution for injection (2020)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

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

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

Μπορείτε να υποστηρίξετε τον Γαληνό στην αποστολή του να παρέχει δωρεάν έγκυρη πληροφόρηση για κάθε φάρμακο απενεργοποιώντας το Ad Blocker για αυτόν τον ιστότοπο.