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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Intal CFC-free Inhaler 5mg Pressurised Inhalation, Suspension (2011)

Εκδότης

Εκδότης SANOFI
Διεύθυνση 1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

Name of the medicinal product

Intal CFC-free Inhaler 5mg Pressurised Inhalation, Suspension.

Qualitative and quantitative composition

The active component of Intal CFC-free is sodium cromoglicate 3.521% w/w. Each canister provides at least ...

Pharmaceutical form

Intal CFC-free pressurised inhalation suspension is presented as a metered dose inhaler, containing sodium ...

Therapeutic indications

Intal CFC-free is indicated for the preventative treatment of bronchial asthma, in adults and children. ...

Posology and method of administration

Intal CFC-free is for oral inhalation use only. It is essential to instruct the patient how to use the ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Intal CFC-free ...

Special warnings and precautions for use

Intal CFC-free must not be used for relief of an acute attack of bronchospasm. Since therapy is prophylactic, ...

Interaction with other medicinal products and other forms of interaction

Sodium cromoglicate has been used for the treatment of a variety of indications in man for many years ...

Fertility, pregnancy and lactation

Pregnancy As with all medication, caution should be exercised especially during the first trimester of ...

Effects on ability to drive and use machines

Intal CFC-free has no or negligible influence on ability to drive and use machines.

Undesirable effects

Mild throat irritation, coughing and transient bronchospasm may occur. Headache and rhinitis have also ...

Overdose

Animal studies have shown that sodium cromoglicate has a very low local or systemic toxicity and extended ...

Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for obstructive airway disease; Antiallergic agents, exclusive corticosteroids ...

Pharmacokinetic properties

After inhalation in man via a metered dose inhaler approximately 10% of a dose of sodium cromoglicate ...

Preclinical safety data

Pre-clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated ...

List of excipients

Polyvidone K30 Polyethylene glycol (PEG) 600 Apaflurane (HFA 227 a non ozone depleting propellant). ...

Incompatibilities

Not applicable.

Shelf life

30 months.

Special precautions for storage

Do not refrigerate or freeze. As the aerosol inhaler canister is pressurised it should be protected from ...

Nature and contents of container

The aluminium can is fitted with a metering valve which delivers 112 actuations each containing 5 mg ...

Special precautions for disposal and other handling

No special requirements for disposal.

Marketing authorization holder

Sanofi-aventis One Onslow Street Guildford Surrey GU1 4YS UK

Marketing authorization number(s)

PL 04425/0179

Date of first authorization / renewal of the authorization

Date of first authorisation: 3 November 2000 Date of latest renewal: 1 March 2006

Date of revision of the text

16 December 2011
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.