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

RESPREEZA Powder and solvent for solution (2019)

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

Name of the medicinal product

Respreeza 1,000 mg powder and solvent for solution for infusion. Respreeza 4,000 mg powder and solvent for solution for infusion. Respreeza 5,000 mg powder and solvent for solution for infusion.

Qualitative and quantitative composition

Respreeza 1,000 mg powder and solvent for solution for infusion: One vial contains approximately 1,000 mg of human alpha<sub>1</sub>-proteinase inhibitor*, as determined by its capacity to neutralize human ...

Pharmaceutical form

Powder and solvent for solution for infusion. The powder is white to off-white. The solvent is a clear and colourless solution. The reconstituted solution has an approximate osmolality of 279 mOsmol/kg ...

Therapeutic indications

Respreeza is indicated for maintenance treatment, to slow the progression of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency (e.g. genotypes PiZZ, PiZ(null), Pi(null,null), ...

Posology and method of administration

First infusions should be administered under the supervision of a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency. Subsequent infusions can be administered ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see also section 4.4). IgA deficient patients with known antibodies against IgA, due to the risk of severe hypersensitivity ...

Special warnings and precautions for use

The recommended infusion rate given under section 4.2 should be adhered. During the first infusions, patients clinical state, including vital signs, should be closely monitored throughout the infusion ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

Fertility, pregnancy and lactation

Pregnancy No animal reproduction studies have been conducted with Respreeza and its safety for use in human pregnancy has not been established in controlled clinical trials. Since alpha<sub>1</sub>-proteinase ...

Effects on ability to drive and use machines

Dizziness may occur following the administration of Respreeza (see section 4.8). Therefore, Respreeza may have a minor influence on the ability to drive and use machines.

Undesirable effects

Summary of the safety profile Hypersensitivity or allergic reactions have been observed during the treatment. In the most serious cases, allergic reactions may progress to severe anaphylactic reactions ...

Overdose

Consequences of overdose are unknown. In the event of overdose, the patient should be observed closely for the occurrence of adverse reactions and supportive measures should be available as necessary. ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antihemorrhagics, proteinase inhibitor ATC code: B02AB02 Human alpha<sub>1</sub>-proteinase inhibitor is a normal constituent of human blood. Human alpha<sub>1</sub>-proteinase ...

Pharmacokinetic properties

Four clinical studies were conducted with Respreeza in 89 subjects (59 males and 30 females) to evaluate the effect of Respreeza on serum levels of alpha<sub>1</sub>-proteinase inhibitor. The subjects ...

Preclinical safety data

The safety of Respreeza has been assessed in several preclinical studies. Non-clinical data reveal no special risk for humans based on safety pharmacology and short term toxicity studies. Repeat dose toxicity ...

List of excipients

Powder: Sodium chloride Sodium dihydrogen phosphate monohydrate Mannitol Solvent: Water for injections

Incompatibilities

This medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.

Shelf life

<u>Respreeza 1,000 mg powder and solvent for solution for infusion:</u> 3 years. <u>Respreeza 4,000 mg powder and solvent for solution for infusion:</u> 2 years. <u>Respreeza 5,000 mg powder and solvent ...

Special precautions for storage

Do not store above 25°C. Do not freeze. For storage conditions after reconstitution of the medicinal product, see section 6.3.

Nature and contents of container

Respreeza 1,000 mg powder and solvent for solution for infusion: Respreeza 1,000 mg of powder in a glass vial (type I), closed with a rubber (bromobutyl or chlorobutyl) stopper and an aluminium seal with ...

Special precautions for disposal and other handling

General instructions The reconstitution should be performed according to the instructions provided below. The product must be reconstituted, administered and handled with caution using aseptic technique ...

Marketing authorization holder

CSL Behring GmbH, Emil-von-Behring-Strasse 76, D-35041, Marburg, Germany

Marketing authorization number(s)

EU/1/15/1006/001 EU/1/15/1006/002 EU/1/15/1006/003

Date of first authorization / renewal of the authorization

Date of first authorisation: 20 August 2015

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.