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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
Είσοδος χρηστών
Όνομα χρήστη
Συνθηματικό
Εικονίδιο Είσοδος χρήστη
Εικονίδιο Δωρεάν εγγραφή
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Cayston 75 mg powder and solvent for nebuliser solution (2012)

Εκδότης

Εκδότης Gilead Sciences International Ltd
Διεύθυνση Flowers Building, Granta Park, Abington, Cambridge, Cambridge, CB21 6GT, UK
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Περιεχόμενα

Name of the medicinal product

Cayston 75 mg powder and solvent for nebuliser solution.

Qualitative and quantitative composition

Cayston contains aztreonam lysine (formed in situ from 75 mg aztreonam) as a sterile lyophilised powder ...

Pharmaceutical form

Powder and solvent for nebuliser solution. White to off-white, lyophilised powder.

Therapeutic indications

Cayston is indicated for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa ...

Posology and method of administration

Posology Patients should use a bronchodilator before each dose of Cayston. Short acting bronchodilators ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Allergic reactions If an allergic reaction to Cayston does occur, stop administration of the medicinal ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed. However, no evidence of any drug interactions with Cayston ...

Fertility, pregnancy and lactation

Pregnancy There are no data from the use of aztreonam in pregnant women. Animal studies do not indicate ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, based ...

Undesirable effects

a. Summary of the safety profile Assessment of adverse reactions is based on experience in four Phase ...

Overdose

Adverse reactions specifically associated with overdose of Cayston have not been identified. Since the ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antibacterials for systemic use, other beta-lactam antibacterials ATC code: ...

Pharmacokinetic properties

Absorption Sputum concentrations: Individual patients' sputum aztreonam concentrations exhibited considerable ...

Preclinical safety data

A 104-week rat inhalation toxicology study to assess the carcinogenic potential of ascending doses of ...

List of excipients

Powder vial L-Lysine Solvent ampoule Sodium chloride Water for injections

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal ...

Shelf life

Powder vial: 4 years. Solvent: 4 years. After reconstitution, immediate use of Cayston is recommended. ...

Special precautions for storage

Powder vial and solvent ampoule: Store in a refrigerator (2°C 8°C). May be stored outside a refrigerator ...

Nature and contents of container

Powder vial: Type I amber glass vial with siliconised grey rubber stopper and aluminium tear off overseal. ...

Special precautions for disposal and other handling

Reconstitution Cayston should only be reconstituted with the solvent provided. Following reconstitution, ...

Marketing authorization holder

Gilead Sciences International Limited Granta Park Abington Cambridge CB21 6GT United Kingdom

Marketing authorization number(s)

EU/1/09/543/001 EU/1/09/543/002

Date of first authorization / renewal of the authorization

Date of first authorisation: 21 September 2009 Date of latest renewal: 21 September 2010

Date of revision of the text

07/2012
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.