SEPTAL SCRUB

Country: Israel

Bahasa: Inggeris

Sumber: Ministry of Health

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
08-12-2023
Ciri produk Ciri produk (SPC)
09-08-2023
Laporan Penilaian Awam Laporan Penilaian Awam (PAR)
03-06-2020

Bahan aktif:

CHLORHEXIDINE GLUCONATE

Boleh didapati daripada:

TEVA MEDICAL LTD

Kod ATC:

D08AC02

Borang farmaseutikal:

SOLUTION - EXTERNAL

Komposisi:

CHLORHEXIDINE GLUCONATE 4 %W/V

Laluan pentadbiran:

TOPICAL

Jenis preskripsi:

Not required

Dikeluarkan oleh:

VITAMED PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Kumpulan terapeutik:

CHLORHEXIDINE

Kawasan terapeutik:

CHLORHEXIDINE

Tanda-tanda terapeutik:

• Antiseptic hand wash• Pre-operative Surgical Scrub • Pre-operative Skin Preparation

Tarikh kebenaran:

2014-12-31

Risalah maklumat

                                ءاملاب
ً
اديج لسغإ
.6
ً
اديج نيديلا ففج
.7
:ةيحارج ةيلمع زايتجإ ىلع نيمدقملا
نيجلاعتملل دلجلا ريهطتل
يف ةدحاو ةرم ةداع ،لقلأا ىلع نيترم
،باركس لاتپس نم للم 25 ـب مسجلا لك لسغإ
.1
.ةيحارجلا ةيلمعلا موي يف ةيناثلا
ةرملاو ةيحارجلا ةيلمعلا قبسي يذلا
مويلا
.ءاملاب
ً
اديج لسغإ
.2
.
ً
اديج مسجلا ففج
.3
.هب ىصوملا يئاودلا رادقملا زواجت زوجي
لا
باركس لاتپس أطخلاب تعلب اذإ
ىفشتسملا يف ئراوطلا ةفرغل وأ بيبطلا
ىلإ
ً
لااح هجوت ،باركس لاتپس أطخلاب تعلب اذإ
.ءاودلا ةبلع كعم رضحأو يئاودلا رادقملا نم دكأتلاو ءاودلا
عباط صيخشت بجي !ةمتعلا يف ةيودأ لوانت
زوجي لا
.كلذ رملأا مزل اذإ ةيبطلا تاراظنلا عض
.ءاود اهيف لوانتت ةرم لك يف
.يلديصلا وأ بيبطلا رشتسإ ،ءاودلا اذه
لامعتسإ لوح ةيفاضإ ةلئسأ كيدل ترفوت
اذإ
ةيبناجلا ضارعلأا )4
.نيلمعتسملا ضعب دنع ةيبناج
ً
اضارعأ ببسي دق باركس لاتپس لامعتسإ نإ
،ءاود لكب امك
.اهنم
ً
ايأ يناعت لاأ زئاجلا نم .ةيبناجلا
ضارعلأا ةمئاق نم شهدنت لا
خافتنإ( ةيقأت ةمدص كلذ يف امب ةيساسحلا
طرفل ةردان نايحأ يف نيديسكيهرولك ببسي
دق
،رارمحإ ،ةكح ،دلجلا باهتلإ( ةيسسحت لعف
دودرو )مدلا طغض ضافخنإو نيتفشلا وأ
ةرجنحلا
.)تلاصيوح ،دلجلا يف جيهت ،ىرش ،حفط
،اميزكإ
.يروف يبط جلاع يقلتل هجوتلاو لامعتسلإا
نع فقوتلا بجيف ،هذه لعفلا دودر ىدحإ
ت
                                
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Ciri produk

                                Septal Scrub MW SPC minor updates 07/2023
SUMMARY OF PRODUCT CHARACTERISTICS
Septal Scrub
®
1
NAME OF THE MEDICINAL PRODUCT
Septal Scrub
®
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlorhexidine Gluconate 4% w/v.
3
PHARMACEUTICAL FORM
Solution -External.
Clear or slightly opalescent, viscous red liquid.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
•
Antiseptic hand wash
•
Pre-operative Surgical Scrub
•
Pre-operative Skin Preparation
4.2
Posology and method of administration
Antiseptic hand wash - wet the hands and forearms, apply 5 ml of skin
cleanser and
wash for one minute. Rinse thoroughly and dry.
Pre-operative Surgical Scrub - wet hands and forearms, apply 5 ml of
skin cleanser
and wash for one minute, cleaning the finger nails with a brush. Rinse
and repeat the
procedure using a further 5 ml of skin cleanser and wash for 2
minutes. Rinse
thoroughly and dry.
Septal Scrub MW SPC minor updates 07/2023
Pre-operative Skin Preparation - the patient should wash his whole
body with 25
ml of the cleanser on at least two occasions, usually the day before
and on the day of
the operation.
4.3
Contraindications
Avoid contact with eyes, middle ear, brain and meninges.
Known hypersensitivity-to the product or any of its components,
especially in those
with a history of possible chlorhexidine-related allergic reactions
(see sections 4.4 and
4.8).
4.4
Special warnings and precautions for use
For external use only.
Keep out of the reach and sight of children.
Do not use in body cavities.
The use of chlorhexidine solutions, both alcohol based and aqueous,
for skin
antisepsis prior to invasive procedures has been associated with
chemical burns in
neonates. Based on available case reports and the published
literature, this risk
appears to be higher in preterm infants, especially those born before
32 weeks of
gestation and within the first 2 weeks of life.
Remove any soaked materials, drapes or gowns before proceeding with
the
intervention. Do not use excessive quantities and do not allow the
solution to pool in
s
                                
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