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نشرة الممارس الصحي نشرة معلومات المريض بالعربية نشرة معلومات المريض بالانجليزية صور الدواء بيانات الدواء
  SFDA PIL (Patient Information Leaflet (PIL) are under review by Saudi Food and Drug Authority)

Properties :
Dexamethasone acetate ( a fluorinated corticosteroid) is
characterized by anti-inflammatory, antiallergic,
anti-exudative and anti-pruritic action. Salicylic acid has a
good k.eratolytic, squamolytic and antiseptic properties,
therefore it improves skin penetration. Salidex Topical
Solution is suitable for treatment of the hairy areas of the body.
Indications:
Subacute and chronic, especially hyperkeratotic
dermatoses e.g. chronic exogenous eczemas,
neurodermatitis, lichen chronicus, lichen ruber, psoriasis
vulgaris and lupus erythematodes


Precautions :
Avoid contact with the eyes. In pregnant women and
young children treatment of large areas of the skin should
be avoided.


Directions :
Apply on the affected skin araas two to three times daily
or as directed by the physician.


NA


keep at room temperature not to exceed 30°C


Each 1 ml of topical solution contains : Dexamethasone
acetate USP 1.2 mg and Salicylic acid B.p 20.0 mg in an
alcoholic vehicle.


Solution 30 ml plastic bottle

Philadelphia Pharmaceuticals

10. St. King Abdullah II Industrial City / Amman – Jordan

 


30-05-2003
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

 الخواص:

تتميز خلات الديكساميثازون (كورتيكوستيرويد مفلور) بمقاومتها ضد الالتهابات وحساسية الجلد والإفرازات التي تحدث به ومختلف الحكاك الجلدي، بينما يتمتع حامض الساليسيلك بخصائصه في إزالة الأنسجة القرنية والحرشفية ومنع التعفنات وتطهيرها مما يساعد على تحسين نفاذية الجلد. إن مسحضر ساليديكس محلول موضهي مناسب للإستعمال للمناطق المكسوة بالشعر من الجسم.

الإستعمال:

الأمراض الجلدية شبه الحادة المزمنة والجلدية المزمنة وخاصة الشديدة التقرنية مثل حالات الأكزيما الخارجية المزمنة. الالتهابات الجلدية العصبية الأشنة (الحزاز) الجلدي المزمن.

الأشنة (الحزاز) الحكاكي. داء الصدفية الجلدي العادي.ومرض الذئبة العادي الجلدي الحمامي الإلتهابي

موانع الاستعمال:

سل الجلد. السلفس . حالات العدوى الفيروسية للجلد.

 

تحذير:

تجنب ملامسة المستحضر للعينين  كما يجب تجنب استعمال هذا الدواء لعلاج مساحات كبيرة في جلد النساء الحوامل والأطفال الصغار

 

https://localhost:44358/Dashboard

يمسح على المناطق المصابة مرتين الى ثلاث مرات يوميا. أو حسب ارشادات الطبيب

NA

يحفظ ساليديكس بدرجة حرارة دوم 30 م.

يحتوي كل 1 ملليتر  من المحلول الموضعي على خلات الدييكسميثازون ف.و.م. 1,2 ملغم وعلى حامض السالسيليك ف.ب 20 ملغم

NA

شركة فیلادلفیا لصناعة الأدویة

شارع ۱۰ مدینة الملك عبدلله الثاني الصناعیة - عمان / الاردن

30/05/2003
 Read this leaflet carefully before you start using this product as it contains important information for you

Salidex Topical Solution

Salidex Topical Solution contains: Dexamethasone Acetate 1.2 mg and Salicylic acid 20 mg For full list of excipients, see section 6.1

Topical Solution for topical administration

In the treatment of mild to moderately severe cases of chronic skin disease associated with a thickened dry, flaky and itchy skin such as all forms of chronic eczema, neurodermatitis, psoriasis, etc.


Apply a thin layer of Salidex® on the affected skin areas one to two times daily or as directed by physician. An occlusive dressing should be applied upon doctor’s recommendation only, Salidex Topical Solution is non greasy and suitable for treatment of the hairy areas of the body.


Hypersensitivity to the active substance or to any of the excipients, Salidex must not be used in the case of skin infections such as tuberculosis of the skin, Syphilis, viral infections, (Chicken pox, herpes zoster) or vaccination reaction .the preparation must not be used by infants. It is also not suitable for the treatment of severely inflamed, weeping or exudative conditions.

The patient should not exceed the treatment period and area of application recommended by the physician, as skin damage may otherwise occur.


No interaction studies have been performed. Interactions with systemically administered medicinal products are considered minimal as the systemic absorption of topical Salidex Topical Solution is negligible.


Although no adverse effects have been reported following application of Salidex® during pregnancy, animal studies indicate a risk of deformity at high dose levels. For these reasons, this product should not be used during pregnancy, especially during the first trimester.
Lactating mothers should only apply the preparation for short period and to small areas. In all cases, use of this product is subjected to medical advice.


Salidex Topical Solution administered topically has no or negligible influence on the ability to drive or to use machines.


Local side effects such as skin irritation. Burning sensation, itching and dryness as well as hypersensitivity reactions may occur.


Overdose is unlikely to occur.


ATC Code: D07XB05
Salicylic acid is applied topically in the treatment of hyperkeratotic and scaling conditions where its keratotic action facilitates penetration of the corticosteroid.
In pharmacological doses, corticosteroids are used primarily for their anti-inflammatory and/or immune suppressive effects.
Topical corticosteroids such as dexamethasone are effective in the treatment of a range of dermatoses because of their anti-inflammatory, anti-pruritic and vasoconstrictive actions. However, while the physiologic, pharmacologic and clinical effects of the corticosteroids are well known, the exact mechanisms of their action in each disease are uncertain


Salicylic acid exerts only local action after topical application.
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including vehicle, integrity of the epidermal barrier and the use of occlusive dressings.
Topical corticosteroids can be absorbed through intact, normal skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.
Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees, are metabolized primarily in the liver and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted in the bile


There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.


Isopropyl Alcohol Propylene Glycol Sodium Hydroxide Purified Water


Not applicable


2 years

Store below 30°C


30 ml Plastic bottle


Not applicable


Philadelphia Pharmaceuticals 10. St. King Abdullah II Industrial City / Amman – Jordan P.O.Box : 276 – Amman 11512 Jordan Tel : + 962 6 402 9181 Fax : + 962 6 402 9182 Website : www.philapharma.com

02/2017
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