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SPC, UK: ATROVENT Nebuliser solution (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Atrovent 250 UDVs, 1 ml. Atrovent UDVs, 2 ml.

Qualitative and quantitative composition

Each single dose unit contains 0.025% w/v ipratropium bromide i.e. 250 micrograms in 1 ml and 500 micrograms in 2 ml. For excipients, see 6.1.

Pharmaceutical form

Nebuliser solution.

Therapeutic indications

ATROVENT UDVs are indicated for treatment of reversible bronchospasm associated with chronic obstructive pulmonary disease (COPD). ATROVENT UDVs are indicated, when used concomitantly with inhaled beta ...

Posology and method of administration

The dosage should be adapted to the individual needs of the patient. In children aged 12 years and under, only ATROVENT 250 UDVs, 1 ml should be used. The following doses are recommended: Adults (including ...

Contraindications

ATROVENT UDVs are contraindicated in patients with known hypersensitivity to atropine or its derivatives (such as the active substance ipratropium bromide) or to any other component of the product.

Special warnings and precautions for use

Use of the nebuliser solution should be subject to close medical supervision during initial dosing. Hypersensitivity Immediate hypersensitivity reactions following the use of ATROVENT have been demonstrated ...

Interaction with other medicinal products and other forms of interaction

The chronic co-administration of ATROVENT inhalation with other anticholinergic drugs has not been studied. Therefore, the chronic co-administration of ATROVENT with other anticholinergic drugs is not ...

Fertility, pregnancy and lactation

Pregnancy The safety of ATROVENT during human pregnancy has not been established. The benefits of using ATROVENT during a confirmed or suspected pregnancy must be weighed against the possible hazards to ...

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, patients should be advised that they may experience undesirable effects such as dizziness, accommodation ...

Undesirable effects

Many of the listed undesirable effects can be assigned to the anticholinergic properties of ATROVENT. As with all inhalation therapy ATROVENT may show symptoms of local irritation. Adverse drug reactions ...

Overdose

No symptoms specific to overdosage have been encountered. In view of the wide therapeutic window and topical administration of ATROVENT, no serious anticholinergic symptoms are to be expected. As with ...

Pharmacodynamic properties

Pharmacotherapeutic group: Anticholinergics ATC Code: R03BB01 ATROVENT is a quaternary ammonium compound with anticholinergic (parasympatholytic) properties. In nonclinical studies, it appears to inhibit ...

Pharmacokinetic properties

Absorption The therapeutic effect of ATROVENT is produced by a local action in the airways. Time courses of bronchodilation and systemic pharmacokinetics do not run in parallel. Following inhalation, 10 ...

Preclinical safety data

The toxicity of ipratropium bromide has been investigated extensively in the following types of studies: acute, subchronic and chronic toxicity, carcinogenicity, reproductive toxicity and mutagenicity ...

List of excipients

Sodium chloride 1N Hydrochloric acid Purified water

Incompatibilities

Not applicable.

Shelf life

Shelf life: 24 months (unopened). As the product contains no preservative, a fresh vial should be used for each dose and the vial should be opened immediately before administration. Any solution left in ...

Special precautions for storage

Do not store above 25°C. Keep vials in the outer carton.

Nature and contents of container

Polyethylene unit dose vials containing either 1 ml or 2 ml of solution. Pack sizes of 10, 20, 30, 50, 60, 80, 100, 120, 150, 200, 300, 500 and 1000. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

None.

Marketing authorization holder

Boehringer Ingelheim Limited, Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS

Marketing authorization number(s)

PL 0015/0108

Date of first authorization / renewal of the authorization

27 August 1986 / 23 December 2005

Date of revision of the text

February 2018

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