KETOSPRAY 10 %

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

KETOPROFEN

Saatavilla:

MEGAPHARM LTD

ATC-koodi:

M02AA10

Lääkemuoto:

SPRAY

Koostumus:

KETOPROFEN 10 %

Antoreitti:

DERMAL

Prescription tyyppi:

Required

Valmistaja:

PHARBIL WALTROP GmbH

Terapeuttinen ryhmä:

KETOPROFEN

Terapeuttinen alue:

KETOPROFEN

Käyttöaiheet:

Topical treatment for the symptomatic relief of soft tissue pain and inflammation due to strains, sprains, distortions, and contusions.

Valtuutus päivämäärä:

2015-09-30

Valmisteyhteenveto

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ketospray 10% - Dermal Spray
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g contains 100 mg of ketoprofen.
1 spray puff (0.2 ml) contains 20 mg ketoprofen.
Excipient with known effect: propylene glycol.
For excipients see 6.1.
3. PHARMACEUTICAL FORM
Cutaneous spray,
yellowish, transparent solution.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Topical treatment for the symptomatic relief of soft tissue pain and
inflammation due to strains, sprains,
distortions, and contusions.
_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION _
Adults and children over 12 years:
Posology
_ _
_PAEDIATRIC POPULATION : _Ketospray 10% – Spray should not be used
in children below 12 years of age because
of safety and efficacy concerns.
Method of administration
_Adults and children over 12 years of age: _
A sufficient amount of solution should be applied on the skin in order
to cover the affected area with Ketospray
10% - Spray. The number of spray puffs depends on the size of the area
to be treated: 2 spray puffs for small
joints (fingers, toes), 4 spray puffs for medium-sized joints (wrist,
ankle) and up to 6 spray puffs for larger joints
(shoulder, knee) or larger areas (f.i. on the back). Therefore 0.4 –
1.2 g spray are applied per application, which
equals 40 – 120 mg ketoprofen. Treatment should be carried out 3
times per day. The maximum daily dose
should not exceed 18 spray puffs (equals 3.6 g spray, or 360 mg
ketoprofen).
The solution is gently spread over the affected area after 1 – 2
spray puffs each and let dry.
Do not apply occlusive dreesing to the treated area
Hands should be washed subsequently, unless they are also included in
the treatment. The treatment may be
stopped after the symptoms (pain and swellings) have eased. 7 days
duration of treatment is sufficient in most
cases.
Elderly:
The same dosage as for adults may be applied.
_4.3 _
_CONTRAINDICATIONS _
Children under 12 years of age.
Ketospray 10% – Spray must not be used in