RECTOZORIN OINTMENT

国家: 以色列

语言: 英文

来源: Ministry of Health

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资料单张 资料单张 (PIL)
16-03-2023
产品特点 产品特点 (SPC)
22-08-2023
公众评估报告 公众评估报告 (PAR)
29-11-2022

有效成分:

BENZOCAINE; BISMUTH OXYCHLORIDE; MENTHOL; THYMOL BIIODIDE; ZINC OXIDE

可用日期:

TEVA ISRAEL LTD

ATC代码:

C05AX02

药物剂型:

OINTMENT

组成:

ZINC OXIDE 10 %W/W; BENZOCAINE 4 %W/W; MENTHOL 0.25 %W/W; BISMUTH OXYCHLORIDE 8 %W/W; THYMOL BIIODIDE 2 %W/W

给药途径:

TOPICAL ANNAL

处方类型:

Not required

厂商:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

治疗组:

BISMUTH PREPARATIONS, COMBINATIONS

治疗领域:

BISMUTH PREPARATIONS, COMBINATIONS

疗效迹象:

Symptomatic relief of pain and discomfort in irritated anorectal tissues in: hemorrhoids, proctitis, papillitis, cryptitis, fissures and following anorectal surgery.

授权日期:

2021-06-30

资料单张

                                ةمتت
:مهرم
.جرشلا ةحتف ةقطنم فطلب ففجو لسغإ
●
.فطلب ك
ّ
لدو مهرملا نم ةليلق ةيمك نهدإ
●
.ماكحإب ةبوبنلأا قلغأ
●
.كيدي لسغإ
● لاخدإ بيبطلا تاميلعت بسح كيلع بجوت
اذإ
:يلي امك فرصتف ،جرشلا ةحتف لخاد مهرملا
ةبوبنلأا فرطب )
applicator
( قابطملا لصوأ
●
.ةحوتفملا
.جرشلا ةحتف لخادل قابطملا فرط فطلب
لخدأ
●
.مهرملا جارخلإ ةبوبنلأا ىلع فطلب طغضإ
●
هلسغإو ةبوبنلأا نع قابطملا لصفإ
،ةياهنلا يف
●
.نوباصلاو نخاسلا ءاملاب
ً
اديج
.كيدي لسغإو
ً
اديج ةبوبنلأا قلغأ
●
:لئاتف
.جرشلا ةحتف ةقطنم فطلب ففجو لسغإ
●
طيرش نم ةدحاو ةليتف لصفإ :حتفلا
تاميلعت
●
نسللأا لصفإ ،يكيتسلاپلا فلاغلا ةلازلإ
.لئاتفلا
يكيتسلاپلا فلاغلا نم حطسملا ءزجلا يف
ىلإ ةليتفلا جورخ ىتح بناوجلا وحن بحسإو
نم ليلقلاب ةليتفلا بيطرت ناكملإاب
.جراخلا
.)هاندأ ةظحلاملا رظنأ( لاخدلإا ليهستل
ءاملا
ةطساوب ةليتفلا لخدأو كبناج ىلع قلتسإ
●
.جرشلا ةحتف لخادل
ً
اقيمع كعبصإ
.
ً
اديج كيدي لسغإ ،ةياهنلا يف
●
،يغبني امم رثكأ ةوخر ةليتفلا تناك اذإ
:ةظحلام
ً
ابيرقت ةقيقد 30 ةدمل داربلا يف اهديربت
ناكملإاب
.يكيتسلاپلا فلاغلا ةلازإ لبق دراب ءامب
اهديربت وأ
تعلب اذإ وأ
ً
اطرفم
ً
ايئاود
ً
ارادقم تلمعتسإ اذإ
ً
اروف هجوتلا بجي ،ءاودلا نم أطخلاب لفط
علب وأ
ىفشتسملا يف ئراوطلا ةفرغ ىلإ وأ بيبطلا
ىلإ
نودب 
                                
                                阅读完整的文件
                                
                            

产品特点

                                Rectozorin_Oint_Supp_SPC_06_2023_Notification
Summary of Product Characteristics
Rectozorin Suppositories
Rectozorin Ointment
1.
Name of the medicinal product
Rectozorin Suppositories
Rectozorin Ointment
2.
Qualitative and quantitative composition
Each suppository contains:
Thymol biiodide 150 mg
Bismuth subgallate 100 mg
Zinc oxide 100 mg
Benzocaine 100 mg
Tannic acid 20 mg
Menthol 5 mg
Ointment:
Zinc oxide 10.0%
Bismuth oxychloride 8.0%
Benzocaine 4.0%
Thymol biiodide 2.0%
Menthol 0.25%
Excipient with known effect:
Rectozorin Ointment contains wool fat (lanolin). Wool fat may cause
local skin reactions (e.g.
contact dermatitis).
For full list of excipients, see section 6.1
3. Pharmaceutical form
Rectozorin suppositories
- Yellowish to light brown suppositories.
Rectozorin ointment
- Light yellow homogeneous ointment.
4. Clinical particulars
4.1 Therapeutic indications
.
Suppositories:
Symptomatic relief of pain and discomfort in hemorrhoids.
Ointment:
Symptomatic relief of pain and discomfort in irritated anorectal
tissues in:
hemorrhoids, proctitis, papillitis, cryptitis, fissures and following
anorectal surgery.
4.2 Posology and method of administration
Suppositories:
Anal insertion.
Ointment:
Topical.
For short term use only. If pain persists for more than few days, or
worsens, seek medical
advice.
Rectozorin_Oint_Supp_SPC_06_2023_Notification
Suppository:
_Dosage _
one suppository in the morning, one suppository in the evening and
after every time you empty
your bowels.
_Direction for use _

Wash your hands with soap and water. Dry your hands with a clean towel
or a paper
towel.

Remove any wrapping from the suppository.

If necessary, you can wet the suppository to make it easier to insert
the suppository.

If the suppository is too soft, you can cool it in the refrigerator
for 30 minutes.

Lie down on your side and insert the suppository into the rectum,
push the suppository
with your finger.

Wash your hands with soap and water.
Ointment:
_Dosage _
Apply the ointment once in the morning
                                
                                阅读完整的文件
                                
                            

其他语言的文件

资料单张 资料单张 阿拉伯文 16-03-2023
资料单张 资料单张 希伯来文 23-08-2023