BERODUAL RESPIMAT Inhalation solution (2022)
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Περιεχόμενα
1. Name of the medicinal product
Berodual Respimat, oplossing voor inhalatie 20 microgram/50 microgram.
2. Qualitative and quantitative composition
The delivered dose (the dose that leaves the mouthpiece of the Berodual Respimat) is 20 microgram ipratropium bromide monohydrate (equivalent to 19 microgram ipratropium bromide anhydrous) and 50 microgram ...
3. Pharmaceutical form
Inhalation solution. Clear, colourless, inhalation solution.
4.1. Therapeutic indications
Berodual Respimat is indicated for the prevention and treatment of bronchospasm in asthma and chronic obstructive pulmonary disease (COPD). Concomitant anti-inflammatory therapy should be considered. ...
4.2. Posology and method of administration
Posology The dosage should be adapted to the individual requirements. The following dosages are recommended for adults. Acute asthma episodes One actuation of Berodual Respimat is sufficient for prompt ...
4.3. Contraindications
Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to other atropine like substances. Hypertrophic obstructive cardiomyopathy or tachyarrhythmia.
4.4. Special warnings and precautions for use
Hypersensitivity Immediate hypersensitivity reactions may occur after administration of Berodual Respimat, as demonstrated by rare cases of urticaria, angio-oedema, rash, bronchospasm, oropharyngeal oedema ...
4.5. Interaction with other medicinal products and other forms of interaction
The chronic co-administration of Berodual Respimat with other anticholinergic drugs has not been studied. Therefore, the chronic co-administration of Berodual Respimat with other anticholinergic drugs ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no sufficient data from the use of Berodual Respimat in pregnant women. Animal studies do not indicate direct or indirect harmful effect with respect to pregnancy, embryonal/foetal ...
4.7. 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, tremor, accomodation ...
4.8. Undesirable effects
Many of the listed undesirable effects can be assigned to the anticholinergic and beta-adrenergic properties of Berodual Respimat. As with all inhalation therapy Berodual Respimat may show symptoms of ...
4.9. Overdose
Symptoms The effects of overdose are expected to be primarily related to fenoterol. The expected symptoms with overdose are those of excessive ß-adrenergic stimulation, the most prominent being tachycardia, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Adrenergics in combination with anticholinergics for obstructive airway diseases <b>ATC code:</b> R03AL01 Following inhalation, both active substances, fenoterol hydrobromide ...
5.2. Pharmacokinetic properties
The delivery of active substances via inhalation is strongly dependent on the formulation, the device and the technique used. Generally approximately 10-30% of inhaled polar, water-soluble active substances ...
5.3. Preclinical safety data
Animal tests have not produced evidence to suggest that there might be a safety risk for humans. This is based on data from pharmacological studies regarding safety, and data on toxicity following repeated ...
6.1. List of excipients
Benzalkonium chloride, Disodium edetate, Water, purified, Hydrochloric acid for pH adjustment.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years. This includes a 3 months in-use period. The cartridge has an in-use shelf life of 3 months after insertion in the Respimat.
6.4. Special precautions for storage
Do not freeze.
6.5. Nature and contents of container
Type and material of the container in contact with the medicinal product: Solution filled into a 4.5 ml polyethylene/polypropylene cartridge with a polypropylene cap with integrated silicone sealing ring. ...
6.6. Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Boehringer Ingelheim International GmbH, Binger Straße 173, D-55216 Ingelheim am Rhein, Germany
8. Marketing authorization number(s)
Berodual Respimat, oplossing voor inhalatie 20 microgram/ 50 microgram: RVG 26896
9. Date of first authorization / renewal of the authorization
2 October 2002 / 2 October 2007
10. Date of revision of the text
14 July 2022
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