SUDAFED NOSE SPRAY Aqueous solution (2019)
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Περιεχόμενα
Name of the medicinal product
Non-Drowsy Sudafed Decongestant Nasal Spray. Sudafed Blocked Nose Spray. Sudafed Mucus Relief 0.1% Nasal Spray. Sudafed Sinus-Ease 0.1% Nasal Spray.
Qualitative and quantitative composition
This product is an aqueous solution of Xylometazoline Hydrochloride 0.1% w/v presented in a metered-dose pack, delivering 0.14 ml per actuation. For the full list of excipients, see section 6.1.
Pharmaceutical form
Aqueous solution.
Therapeutic indications
This product is indicated for the symptomatic relief of nasal congestion associated with the common cold, influenza, sinusitis, allergic and non-allergic rhinitis, and other upper respiratory tract allergies. ...
Posology and method of administration
Posology Adults and children 12 years and over One spray to be expressed into each nostril 2-3 times daily, as necessary. Maximum daily dose: 3 sprays in 24 hours. Use for more than seven consecutive days ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Children under 12 years of age. This product is contraindicated in individuals who are taking or have taken monoamine ...
Special warnings and precautions for use
There is minimal systemic absorption with topically applied imidazoline sympathomimetics such as xylometazoline, however, this product should be used with caution in patients suffering coronary artery ...
Interaction with other medicinal products and other forms of interaction
Due to the low systemic absorption of xylometazoline when administered intra-nasally, interaction with drugs administered via other routes is considered unlikely. No interaction studies have been performed. ...
Pregnancy and lactation
Pregnancy There are no adequate and well-controlled studies in pregnant women. This product should not be used during pregnancy unless the potential benefit of treatment to the mother outweighs the possible ...
Effects on ability to drive and use machines
It is not known if xylometazoline has an effect on the ability to drive and use machines.
Undesirable effects
Adverse Drug Reactions (ADRs) identified during clinical trials and post-marketing experience with xylometazoline are listed below by System Organ Class (SOC). The frequencies are defined in accordance ...
Overdose
Symptoms Systemic action is unlikely when applied nasally due to the local vasoconstriction that inhibits absorption. If systemic absorption does occur xylometazoline as an α<sub>2</sub>-adrenergic agonist ...
Pharmacodynamic properties
Pharmacotherapeutic group: Nasal preparations, sympathomimetics, plain ATC code: R01AA07 It acts directly on α-adrenoreceptors but does not act on β-receptors. When used topically as a nasal decongestant, ...
Pharmacokinetic properties
Absorption, Distribution, Biotransformation and Elimination Little information is available concerning the absorption, distribution, Biotransformation and elimination of xylometazoline in man. Absorption ...
Preclinical safety data
Mutagenicity There is insufficient information available to determine whether xylometazoline has mutagenic potential. Carcinogenicity There is insufficient information available to determine whether xylometazoline ...
List of excipients
Benzalkonium chloride solution Disodium edetate Sodium dihydrogen phosphate dihydrate Sodium monohydrogen phosphate dihydrate Sodium chloride Sorbitol solution, 70% (Non crystalline) Purified water
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Amber glass bottle of either 10 ml or 15 ml nominal fill volume. The bottle is sealed with an integral snap-on metered 0.14 ml pump consisting of a white plastic actuator and natural polyethylene pull-off ...
Special precautions for disposal and other handling
No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
McNeil Products Limited, Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom
Marketing authorization number(s)
PL 15513/0074
Date of first authorization / renewal of the authorization
21/April/1999
Date of revision of the text
03 January 2019
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