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CAYSTON Powder and solvent for nebuliser solution (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Cayston 75 mg powder and solvent for nebuliser solution.

Qualitative and quantitative composition

Each vial contains aztreonam lysine equivalent to 75 mg aztreonam. After reconstitution the nebuliser solution contains 75 mg aztreonam. For the full list of excipients, see section 6.1.

Pharmaceutical form

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

Therapeutic indications

Cayston is indicated for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older. Consideration should be given ...

Posology and method of administration

Posology Patients should use a bronchodilator before each dose of Cayston. Short acting bronchodilators can be taken between 15 minutes and 4 hours and long acting bronchodilators can be taken between ...

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 aztreonam does occur, stop administration of the medicinal product and initiate treatment as appropriate. The occurrence of rash may be indicative of an allergic ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed. However, no evidence of any drug interactions with aztreonam were identified from clinical studies in which Cayston was taken concomitantly with bronchodilators, ...

Fertility, pregnancy and lactation

Pregnancy There are no data from the use of aztreonam in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Systemic ...

Effects on ability to drive and use machines

Cayston has no or negligible influence on the ability to drive or use machines.

Undesirable effects

Summary of the safety profile Assessment of adverse reactions is based on experience in four Phase 3 clinical studies involving CF patients with chronic P. aeruginosa infection and post-marketing spontaneous ...

Overdose

Adverse reactions specifically associated with overdose of Cayston have not been identified. Since the plasma concentration of aztreonam following administration of Cayston (75 mg) is approximately 0.6 ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antibacterials for systemic use, other beta-lactam antibacterials ATC code: J01DF01 Mechanism of action Aztreonam exhibits activity in vitro against gram-negative aerobic pathogens, ...

Pharmacokinetic properties

Absorption Sputum concentrations Individual patients' sputum aztreonam concentrations exhibited considerable variability. For the combined Phase 3 placebo-controlled studies, ten minutes following a single ...

Preclinical safety data

A 104-week rat inhalation toxicology study to assess the carcinogenic potential of ascending doses of aztreonamdemonstrated no drug-related increase in malignant tumours. Genotoxicity (Chromosomal aberration ...

List of excipients

Powder: L-Lysine Solvent: Sodium chloride Water for injections

Incompatibilities

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

Shelf life

Shelf life Powder vial: 4 years. Solvent: 3 years. After reconstitution, immediate use of Cayston is recommended. If not used immediately, the reconstituted solution must be stored at 2°C-8°C and used ...

Special precautions for storage

Powder vial and solvent ampoule: Store in a refrigerator (2°C-8°C). May be stored outside a refrigerator but below 25°C for up to 28 days. For storage conditions of the reconstitued medicinal product, ...

Nature and contents of container

Powder vial: Type I amber glass vial with siliconised grey rubber stopper and aluminium tear off overseal with or without a blue cap. Solvent: 1 ml low density polyethylene ampoule. Each 28-day pack of ...

Special precautions for disposal and other handling

Reconstitution Cayston should only be reconstituted with the solvent provided. Following reconstitution, Cayston is a clear, colourless to slightly coloured solution. It is recommended that Cayston be ...

Marketing authorization holder

Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland

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: 26 May 2016

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