RETIN-A Cream

ក្រុមហ៊ុនផលិតឱសថ:

 

Janssen-Cilag Ltd., Thailand

ក្រុមហ៊ុនចែកចាយឱសថនៅប្រទេសកម្ពុជា:

 

DKSH

  • សារធាតុសកម្ម
  • ប្រសិទ្ធិភាពព្យាបាល និង កម្រិតប្រើប្រាស់
  • ហាមប្រើ
  • ផលរំខាន
  • អន្តរប្រតិកម្ម
  • ស្ត្រីមានផ្ទៃពោះ និង ស្ត្រីបំបៅដោះកូន
  • ការប្រុងប្រយ័ត្នជាពិសេស
  • បរិយាយប័ណ្ណឱសថ 
  • សារធាតុសកម្ម

    1. RETIN-A Cream 0.025%:

    Tretinoine 0.025%

    2. RETIN-A Cream 0.05%:

    Tretinoine 0.05%

  • ប្រសិទ្ធិភាពព្យាបាល និង កម្រិតប្រើប្រាស់

    គុណភាពព្យាបាល
    ឱសថនេះប្រើលាបលើមុខ សម្រាប់ព្យាបាលជំងឺដូចខាងក្រោម៖
    - ជំងឺមុនលើផ្ទៃមុខ
    - ស្បែកមុខគ្រើម
    - ស្បែកមុខជ្រីវជ្រួញ
    - ស្បែកមុខឡើងពណ៌ និងស្បែកមុខខូចដោយសារប្រតិកម្មជាមួយពន្លឺថ្ងៃ។
    កម្រិត និងរបៀបប្រើ
    - ចំពោះមនុស្សពេញវ័យ៖ កម្រិតណែនាំអោយប្រើគឺត្រូវលាប 1ដងក្នុង1ថ្ងៃ លាបនៅពេលយប់មុនគេង លើកន្លែងដែលមានជំងឺក្នុងបរិមាណគ្រប់គ្រាន់នៃឱសថ។ រយៈពេលព្យាបាលគឺចាប់ពី 2 ទៅ 6 សប្ដាហ៍ អាស្រ័យទៅតាមស្ថានភាពធ្ងន់ឬស្រាលរបស់ជំងឺ។ ប្រសិទ្ធភាពនៃការព្យាបាលអាចទទួលបានគឺនៅសប្ដាហ៍ទី2 ឬ ទី3 ក្រោយពេលចាប់ផ្ដើមប្រើឱសថនេះ។
    - ចំពោះកូនក្មេង៖ មិនមានកម្រិតណែនាំអោយប្រើឱសថនេះទេ។
    <កំណត់សំគាល់>
    - ការលាបក្រែម RETIN-A អាចបណ្ដាលអោយមានអារម្មណ៍ថាក្ដៅឧណ្ហ និងឈឺចាក់ៗនៅលើផ្ទៃមុខ។
    - កាលណាប្រើក្រែមនេះតាមកម្រិតណែនាំ វាធ្វើអោយស្បែកក្រហមតិចតួចស្រដៀងទៅនឹងរលាកស្បែកជាមួយពន្លឺថ្ងៃដែរ។
    - ការលាបក្រែមនេះក្នុងបរិមាណច្រើនជ្រុល វាមិនបានជួយអោយជំងឺឆាប់ជាសះស្បើយលឿននោះទេ។
    - អ្នកជំងឺដែលព្យាបាលដោយលាបក្រែម RETIN-A អាចប្រើគ្រឿងសំអាងលាបមុខបាន ក៏ប៉ុន្តែកន្លែងដែលមានជំងឺ ត្រូវលាងជំរះអោយបានស្អាតជាមុនសិន មុនពេលលាបក្រែម RETIN-A។
    <ការណែនាំពីរបៀបប្រើ>
    - ត្រូវលាងសម្អាតមុខជាមួយទឹក និងសាប៊ូលាងមុខអោយបានស្អាតជាមុនសិន មុនពេលលាបក្រែម RETIN-A។
    - កន្លែងដែលត្រូវលាបមិនត្រូវលាងសម្អាតលើសពី2ដងក្នុង1ថ្ងៃទេ។
    - បន្ទាប់ពីលាងសម្អាតស្បែកមុខរួចហើយ ត្រូវទុកស្បែកអោយស្ងួតសិនក្នុងរយៈពេល20ទៅ30នាទី មុនពេលលាបក្រែម RETIN-A។
    - គួរប្រើឱសថនេះនៅពេលយប់មុនគេង។
    មុននឹងប្រើឱសថនេះ ត្រូវពិគ្រោះជាមួយគ្រូពេទ្យ ឬឱសថការីរបស់អ្នក។

     

    INDICATION

    RETIN-A Is indicated as topical therapy for the treatment of acne vulgaris, amelioration or eliminating roughness, fine wrinkling coarse dermal wrinkling mottled, hyperpigmentation of skin & photoaging.

    RECOMMENDED DOSAGE

    ADULTS

    RETIN-A should be applied once daily before retiring to the area of skin where acne lesions occur. Only a sufficient quantity of medication should be applied to cover the affected areas lightly, using a gauze swab, cotton wool or the tips of clean fingers. Over-saturation should be avoided since excess medication could run into the eyes, angles of the nose or other areas when treatment is not intended.

    Application of RETIN-A may cause a transitory feeling of warmth or slight stinging. When administered according to recommended guidelines, Retin-A may produce a slight erythema similar to that of mild sunburn. In case where it is necessary to temporarily discontinue therapy or reduce the frequency of application, therapy should be resumed or the frequency of application increased when the patient becomes able to tolerate the treatment.

    Excess application of RETIN-A does not provide more rapid or better results. In fact, marked redness, peeling or discomfort can occur. If excess application occurs accidentally or through over enthusiastic use, RETIN-A should be discontinued for several days before resuming therapy.

    For the Treatment of Acne

    Therapeutic effects may be noticed after two to three weeks of use but more than six weeks of therapy may be required before definite beneficial effects are seen. During the early weeks of treatment, an apparent exacerbation of inflammatory lesions may occur. This is due to the action of the medication on deep, previously unseen lesions and should not be considered a reason to discontinue therapy. Once a satisfactory response has been obtained, it may be possible to maintain this improvement with less frequent applications.

    For Photodamage treatment

    Therapeutic effects may be noticed after 3 to 4 months after initiating treatment, but 6 months may be necessary before definite beneficial effects are seen. Once maximum beneficial effects have been achieved, they can be maintained with the application of RETIN-A one or three times weekly. If maintenance therapy is not used, the beneficial effect achieved will diminish over time.

    Prior to treatment with RETIN-A, areas being treated should be thoroughly cleansed with water and mild, non-medicated soap, the treated areas should be washed no more than twice a day. After washing, the skin should be dried gently and completely without rubbing it. Areas of the skin being treated should be avoided to dry for at least 20 to 30 minutes before application of RETIN-A.

    Cosmetics and moisturizers may be used during therapy with RETIN-A, but the areas of the skin to be treated should be washed thoroughly before RETIN-A is applied. Astringent toiletries should be avoided.

  • ហាមប្រើ

    ការហាមប្រើ
    - អ្នកងាយមានប្រតិកម្មជាមួយនឹង Tretinoin ឬជាមួយសារធាតុផ្សំណាមួយនៃឱសថនេះ
    - ចំពោះស្ត្រីមានផ្ទៃពោះ
    - ចំពោះស្ត្រីបំបៅដោះកូន
    - កុមារតូចៗនិងកូនក្មេង។

    Hypersensitivity to any component of this product.

  • ផលរំខាន

    ផលរំខានរួមមាន៖
    - វិបត្តិស្បែក និងជាលិកាក្រោមស្បែក: ក្រហាយស្បែក ស្បែកស្ងួត ស្អិតលើស្បែក រមាស់ កន្ទួលស្បែក
    - វិបត្តិប្រព័ន្ធសរសៃប្រសាទ: ឈឺក្បាល។

     

    +Skin and subcutaneous tissue disorders:

    - Hyperkeratosis

    - Skin irritation

    - Pain of skin

    - Erythema

    - Pruritus

    - Rash papular

    - Rash

    - Dermatitis

    - Dry skin

    - skin exfoliation

    +Nervous System Disorders

    - Headache

  • អន្តរប្រតិកម្ម

    ត្រូវប្រុងប្រយ័ត្នជាមួយផលិតផលលាបមុខដទៃទៀតដែលមានសារធាតុ benzoyl peroxide, sulfur, rescorcinol, salicylic acid, alcohol ជាដើម ដោយសារផលិតផលទាំងនេះអាចមានអន្តរកម្មជាមួយ Tretinoin។

     

    The following products or medications should be used with caution because of possible Interaction with tretinoin. It is advised to allow the effects of such preparations to subside before use of RETIN·A is begun:

    • concomitant topical medication;

    • preparations containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid;

    • toiletry preparations having an abrasive, drying, or desquamative effect, including soaps, shampoos, cosmetics, and products with high concentrations of alcohol, astringents, spices or lime.

  • ស្ត្រីមានផ្ទៃពោះ និង ស្ត្រីបំបៅដោះកូន

    Use during pregnancy:

    Topical tretinoin has not been shown to be teratogenic in Wistar rats and rabbits when given in doses 1000 and 320 times the topical human dose, respectively, assuming that a 50 kg adult applies 250 mg of 0.1 % RETIN-A cream topically.

    At these topical doses, however, a delayed ossification of several bones occurred in rabbits. In rats, a dose-dependent increase of supernumerary ribs was observed. These Changes are considered variants of normal development. The ossification changes are usually spontaneously corrected after weaning.

    There have been isolated reports of birth defects among babies born to women exposed to topical tretinoin during pregnancy. To date, there have been no adequate and well-controlled prospective studies performed in pregnant women, and the teratogenic blood level of tretinoin is not known. However, a well-conducted retrospective cohort study of babies born to women exposed to topical tretinoin during the first trimester of pregnancy found no excess birth defects among these babies when compared with babies born to women in the same cohort who were not similarly exposed. Topical tretinoin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    Use during lactation:

    It is not known whether tretinoin is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when RETIN-A is administered to a nursing mother.

  • ការប្រុងប្រយ័ត្នជាពិសេស

    ការប្រើឱសថនេះត្រូវមានការប្រុងប្រយ័ត្នដូចខាងក្រោម៖
    - មិនត្រូវប្រើឱសថនេះលាបលើភ្នែក លើគែមរន្ធច្រមុះ ឬមាត់
    - មិនត្រូវកោររោមមុខនៅពេលយប់ មុនពេលលាបក្រែមនេះ ព្រោះវាអាចធ្វើអោយក្រហាយស្បែកមុខ
    - អ្នកជំងឺដែលមានប្រតិកម្មជាមួយពន្លឺថ្ងៃ។

     

    General Precautions

    In order to minimize the potential for additional skin irritation, care should be taken to avoid contact with the eyes, eyelids, angles of the nose, mouth, mucous membranes or other areas where treatment Is not intended.

    Patients will be able to remove hair as usual (e.g. plucking, electrolysis, depilatories but should avoid these procedures at night before applying RETIN-A as they might result in skin irritation.

    Permanent wave solutions, waxing preparations, medicated soaps and shampoos can sometimes irritate even normal skin. Caution should be used so that these products do not contact with skin treated with RETIN-A.

    Local irritation

    It is not recommended to initiate treatment with RETIN-A or continue its use in the presence of skin irritation (e.g., erythema, peeling, pruritus, sunburn, etc.) until these symptoms subside.

    In certain sensitive individuals, RETIN-A may induce severe local erythema, swelling, pruritus, warmth, burning or slinging. blistering, crusting and/or peeling at the site of application. If the degree of local irritation warrants, the patient should be instructed to either apply the medication less frequently or discontinue its use temporarily.

    Tretinoin has been reported to cause severe irritation on eczematous skin and should be used with utmost caution in patients with this condition. If a patient experiences severe or persistent irritation, the patient should be advised to discontinue application of RETIN-A completely, and if necessary, consult a physician.

    In order to minimize the potential for additional skin irritation, RETIN-A should be kept away from the eyes, the mouth, paranasal creases of the nose, and mucous membranes or other areas where treatment is not intended.

    Weather extremes, such as wind, cold and low humidify may be irritating to skin treated with RETIN-A and may increase its dryness.

    Patients will be able to remove hair as usual (e.g. plucking, electrolysis, depilatories) but should avoid these procedures at night before applying RETIN-A as they might result in skin irritation.

    Permanent wave solutions, waxing preparations, medicated soaps and shampoos can sometimes irritate even normal skin. Caution should be used so that these products do not come into contact with skin treated with RETIN-A.

*ព័ត៌មានឱសថត្រូវបានរៀបរៀងដោយ អ៊ីម៉ាតុគឹ មេឌីក (ខេមបូឌា) ដោយផ្អែកលើប្រភពព័ត៌មានខាងក្រោម។ សម្រាប់ព័ត៌មានលម្អិត សូមស្វែងរកនៅក្នុងក្រដាសព័ត៌មាននៃឱសថនីមួយៗ ឬ សាកសួរទៅកាន់ក្រុមហ៊ុនឱសថឬតំណាងចែកចាយនៃឱសថនីមួយៗ។

ប្រភពព័ត៌មាន៖

- ក្រដាសព័ត៌មាននៃឱសថសម្រាប់អ្នកជំនាញវេជ្ជសាស្ត្រដែលប្រើប្រាស់នៅប្រទេសជប៉ុន (Pharmaceutical and Medical Devices Agency, Pmda): https://www.pmda.go.jp

- ព័ត៌មានសង្ខេបនៃឱសថសម្រាប់អ្នកជំងឺដែលប្រើប្រាស់នៅប្រទេសជប៉ុន: http://www.rad-ar.or.jp