Betadine Surgical Scrub 75 mg/ml Cutaneous Solution

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Iodinated povidone

متاح من:

Mundipharma Pharmaceuticals Limited

ATC رمز:

D08AG; D08AG02

INN (الاسم الدولي):

Iodinated povidone

جرعة:

75 milligram(s)/millilitre

الشكل الصيدلاني:

Cutaneous solution

المجال العلاجي:

Iodine products; povidone-iodine

الوضع إذن:

Not marketed

تاريخ الترخيص:

1983-04-01

نشرة المعلومات

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BETADINE SURGICAL SCRUB 75 MG/ML CUTANEOUS SOLUTION
POVIDONE IODINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING BETADINE
SURGICAL SCRUB 75 MG/ML
CUTANEOUS SOLUTION.
-
Keep this leaflet. You may need to read it again.
-
If you have any questions, ask your doctor or pharmacist.
-
This medicine has been prescribed to you. Do not pass it on to others.
It may harm them, even if
their symptoms are the same as yours.
-
If any of the side effects become serious, or if you notice any side
effects not listed in this
leaflet, stop using Betadine Surgical Scrub straightaway and tell your
doctor or pharmacist.
IN THIS LEAFLET:
1.
What Betadine Surgical Scrub is and what it is used for
2.
Before you use Betadine Surgical Scrub
3.
How to use Betadine Surgical Scrub
4.
Possible side effects
5.
How to store Betadine Surgical Scrub
6.
Further information
1.
WHAT BETADINE SURGICAL SCRUB 75 MG/ML CUTANEOUS SOLUTION IS AND WHAT
IT IS USED FOR
Betadine Surgical Scrub contains povidone iodine which kills a wide
range of germs including
bacteria, viruses, fungi and simple organisms. Betadine Surgical Scrub
is used as an antiseptic for pre-
operative and post-operative treatment of skin. It is also used as a
pre-operative surgical preparation.
2.
BEFORE YOU USE BETADINE SURGICAL SCRUB 75 MG/ML CUTANEOUS SOLUTION
DO NOT USE BETADINE SURGICAL SCRUB 75 MG/ML CUTANEOUS SOLUTION:
-
if you are allergic (hypersensitive) to povidone iodine or any of the
other ingredients listed.
-
if you currently have or have ever had a thyroid problem, including
swelling (nodular colloid
goitre, endemic goitre or Hashimoto’s thyroiditis), as using
Betadine Surgical Scrub in these
circumstances can further affect the function of your thyroid
-
if you are currently having lithium therapy for depression as this
type of medicine can interact
with Betadine Surgical Scrub to affect the function of your thyroid
-
on children under two years of age.
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING BETADINE SURG

خصائص المنتج

Health Products Regulatory Authority
09 July 2019
CRN0091J5
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betadine Surgical Scrub 75 mg/ml Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Iodinated Povidone 75 mg/ml (7.5% w/v).
This yields approx 8 mg/ml (0.8% w/v) of available iodine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution
Clear, dark brown colour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an antiseptic in pre- and post-operative treatment of skin. As a
pre-operative surgical preparation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical administration.
Apply to the appropriate area as a pre-operative antiseptic skin
cleanser.
4.3 CONTRAINDICATIONS
Hypersensitivity to iodine, polyvinylpyrrolidone or to any excipient.
History of abnormal thyroid function or goitre (in particular
nodular colloid goitre, endemic goitre and Hashimoto’s thyroiditis).
Use in children under two years of age. Regular use should
be avoided in patients on concurrent lithium therapy.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Use of this preparation may interfere with tests of thyroid function.
Iodine is absorbed through burns and broken skin and to a
lesser extent through intact skin and may lead to toxic levels of
iodine in the blood, particularly in patients with renal
insufficiency. If symptoms occur suggesting changes in thyroid
function, these should be investigated. In patients with
impaired renal function, blood levels of iodine should be monitored.
If local irritation and hypersensitivity develop, then discontinue
treatment. Refer to section 4.8 for further information.
Betadine Surgical Scrub can permanently discolour white gold jewellery
and it is recommended that this type of jewellery
should be removed before using Betadine Surgical Scrub.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
Use with concurrent lithium therapy has been shown to exhibit additive
hypothyroidic effects. Abso