“Composition:
100 ml of oral mucosa spray contains as an active substance: 0.16 g lysine salt of ketoprofen, which corresponds to 0.10 g of ketoprofen. For a full list of excipients, see section 6.1.
Excipients
Glycerol 85%, xylitol, methyl parahydroxybenzoate, sodium monobasic phosphate, poloxamer 407, mint flavoring, purified water.
Therapeutic indications
Symptomatic treatment of irritant-inflammatory conditions, also associated with pain in the oropharyngeal cavity (e.g. gingivitis, stomatitis, pharyngitis), including those due to conservative or extraction dental therapy.
Contraindications
OKi Inflammation and Pain 0.16% Oral Mucosal Spray should not be administered to patients with hypersensitivity to the active substance, to other non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients, to patients in whom substances with a similar mechanism of action (eg, acetylsalicylic acid or other NSAIDs) provoke asthma attacks, bronchospasm, acute rhinitis or cause nasal polyps, urticaria or angioedema, in cases of bronchial asthma, during pregnancy and breastfeeding.
Dosage
1-2 sprays up to 3 times a day, directed directly to the affected area. Each spray delivers approximately 0.2 ml of solution, equivalent to 0.32 mg of the active ingredient.
Warnings and precautions
The use of topical preparations, especially long-term, may cause sensitization phenomena, in which case it is necessary to suspend treatment and take appropriate therapeutic measures. The preparation contains methyl parahydroxybenzoate, which is known to cause allergic reactions (possibly delayed type).
Interactions
Currently, there are no known interactions with other drugs: interactions that can be excluded, also taking into account the route of administration and dosage of the administered drug.
Side effects
Local side effects after topical application of ketoprofen lysine salt solution to the oral mucosa are extremely rare and consist of irritating or allergic phenomena (angioedema), especially in individuals with increased sensitivity to NSAIDs. However, given the route of administration and dosage of the drug, systemic side effects did not occur.
Pregnancy and breastfeeding
Like other non-steroidal anti-inflammatory drugs, the drug should not be used in case of confirmed or suspected pregnancy, as well as during breastfeeding.”
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