Symptomatic treatment in traumatology, benign: sprains, bruises

Reserved for adults (over 15 years).

Local channel.

Dosage

2 applications per day.

Mode of administration

Make the gel penetrate through a gentle and prolonged massage on the painful or inflammatory area.

Wash hands thoroughly and prolonged after use.

NON-STEROID ANTI-INFLAMMATORY, FOR TOPICAL USE

ATC code: M02AA10.

Ketoprofen is a non-steroidal anti-inflammatory drug of the group of propionics, derived from aryl-carboxylic acid.
Not applicable.

This medication is contraindicated in the following situations

· Antecedent of photosensitivity reactions

· Known hypersensitivity reactions such as symptoms of asthma and allergic rhinitis to ketoprofen, fenofibrate, acid, tiaprofenic acid, acetylsalicylic acid or other NSAIDs >

· A history of skin allergy to ketoprofen, tiaprofenic acid, fenofibrate, anti-U.V. Or perfumes

· Antecedent of allergy to any of the excipients

Injured skin, whatever the lesion, oozing dermatoses, eczema, lesion, infected, burning or wound

Over 24 weeks of amenorrhea (5 months of pregnancy) (see section Pregnancy and breastfeeding)

Exposure to sunlight, even in the case of a sunny sun, and UV radiation in the solarium should be avoided throughout the treatment and every two weeks after discontinuation.
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· In the absence of specific safety studies conducted in children, this medication is only for adults (> 15 years of age). >
· It is recommended to protect the areas, treated by wearing a garment throughout the duration of treatment and the two weeks following its stop to avoid any risk of photosensitization.

· Proceed with careful and prolonged hand washing after each use of the gel.

· Treatment should be immediate, discontinued in the event of a skin reaction, including skin reactions, occurring after co-application of products containing octocrylene
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· Do not apply on mucous membranes or eyes.
· It is not recommended to apply ketoprofen gel under occlusive dressing.

· Extrapolation with other routes of administration: during the prescription, the doctor should take into account the fact that cases of secondary anovulatory infertility due to failure of the De Graaf follicle, Discontinuation of treatment, have been described, in patients treated on a long-term basis by some prostaglandin synthesis inhibitors

Due to the low systemic passage during normal use of the gel, the reported drug interactions for ketoprofen are unlikely.

Not applicable.

In case of overdose, rinse thoroughly with water. Take into account the presence of terpene derivatives as excipients which may lower the epileptogenic threshold and cause agitation and confusion in the elderly.

The application of too high doses may also lead to the exacerbation of undesirable effects: irritation, erythema, pruritus

Pregnancy

Malformative aspect: 1st quarter

Animal studies have not demonstrated teratogenicity

In the absence of teratogenic effect in animals, a malformative effect in the human species is not expected. Indeed, to date, the substances responsible for malformations in the human species have been shown to be teratogenic in animals during studies, well conducted on 2 species.

In the human species, no particular malformative effect related to administration during the first trimester of pregnancy has been reported. However, supplementary epidemiological studies are needed to confirm the absence of risk.

Fetotoxic and neonatal aspect, 2nd and 3rd trimester

This is class toxicity, involving all prostaglandin synthesis inhibitors.

Administration during the 2nd and 3rd quarter exposes to

· Renal Functional Impairment

O utero can be observed as early as 12 weeks, amenorrhea (initiation of diuresis, fetal): oligoamnios (most often reversible at cessation of treatment), or even anamnios Extended exposure

O at birth, renal insufficiency (reversible or not) may persist especially in cases of late and prolonged exposure (with a risk of delayed severe hyperkalaemia)
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· A risk of cardiopulmonary disease

O Partial or complete constriction in utero of the duct arterial. Constriction of the ductus arteriosus can occur after 5 months and may lead to fetal or neonatal right heart failure or even fetal death in utero. This risk is all the more important since the catch is close to the term (lesser, reversible). This effect exists even for a one-time catch.

O risk of longer bleeding time for the mother and the child

As a result

· Up to 12 weeks of amenorrhea, the use of KETOPROFENE BIOGARAN should only be considered if necessary

· Between 12 and 24 weeks of amenorrhea (between the beginning of the fetal diuresis and 5 months), a brief intake should be prescribed only if necessary. A prolonged intake is strongly discouraged.

Above 24 weeks of amenorrhea (5 months, overdose): any single dose is contraindicated (see section Contraindications). An inadvertent intake beyond 24 weeks of amenorrhea (5 months) warrants cardiac and renal, fetal and / or neonatal monitoring according to the term of exposure. The duration of this monitoring will be adapted to the half-life, elimination of the molecule.

Breastfeeding

A.I.N.S. Passing into breast milk as a precaution, it should be avoided administered to women who are breastfeeding

Effects, undesirable pathways, administration

· Local skin reactions with redness, pruritus and burning sensations

· Exceptionally, eczema-like, bullous or phlyctenular reactions that may be severe and may spread or become widespread.


· Dermatological: photosensitization

· Respiratory: the onset of asthma attacks may be linked in some subjects to an allergy to acetylsalicylic acid, an A.I.N.S. Or fenofibrate. In this case, this drug is contraindicated.

· General: type reactions, anaphylactic.

Other systemic effects of A.I.N.S.

They are a function of the transdermal passage of the active ingredient and therefore of the amount of applied gel, the surface treated, the degree of skin integrity, the duration of treatment and the use or not of a dressing Occlusive (digestive effects, renal).
Related to: excipients
Due to the presence of ethanol (alcohol), frequent applications on the skin can cause irritation and dryness of the skin

Symptomatic treatment in traumatology, benign: sprains, bruises