Videne 10% w/w Alcoholic Tincture

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Osta se nyt

Lataa Pakkausseloste (PIL)
19-06-2023
Lataa Valmisteyhteenveto (SPC)
22-05-2019

Aktiivinen ainesosa:

Iodinated povidone ph.eur.

Saatavilla:

Ecolab Deutschland GmbH

ATC-koodi:

D08AG; D08AG02

INN (Kansainvälinen yleisnimi):

Iodinated povidone ph.eur.

Annos:

10 percent weight/weight

Lääkemuoto:

Cutaneous solution

Terapeuttinen alue:

Iodine products; povidone-iodine

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

2000-06-23

Pakkausseloste

                                PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VIDENE 10% W/W ALCOHOLIC TINCTURE
Iodinated povidone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or nurse has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What it is and what it is used for
2.
What you need to know before you use
3.
How to use
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IT IS AND WHAT IT IS USED FOR
This product, referred to as VideneAlcoholic Tincture in this
label-leaflet, contains iodinated
povidone as the active substance. It is an antiseptic skin cleanser
for use as a quick-drying antiseptic
for pre-operative skin disinfection, particularly in orthopaedic
surgery. Solutions of iodinated
povidone gradually release iodine to kill or stop the growth of
micro-organisms (bacteria, fungi,
viruses, protozoa, cysts and spores).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE
DO NOT USE:
-
On newborn children.
-
During pregnancy and breastfeeding.
-
If you are sensitive to iodine or any of the other ingredients of this
medicine (listed in section
6).
-
For regular or prolonged periods if you have thyroid problems or if
you are taking lithium (an
anti-depressant).
-
On broken skin as the alcohol could cause stinging.
-
For external use only. Do not swallow
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before using Videne Alcoholic Tincture
if:
-
You are using on large wounds or severe burns as it could product
adverse effects such as changes
in blood chemistry and problems with the kidneys.
-
You are prone to, or have ever been treated in the past for
hyperthyroidism.
OTHER MEDICINES AND VIDENE ALCOHOLIC T
                                
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Valmisteyhteenveto

                                Health Products Regulatory Authority
21 May 2019
CRN0091ZM
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Videne 10% w/w Alcoholic Tincture
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Iodinated povidone 10% w/w.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution.
A dark reddish brown mobile liquid with a characteristic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Videne 10% w/w Alcoholic Tincture is a broad-spectrum antiseptic for
topical application. It is indicated for quick drying
pre-operative skin disinfection, particularly in orthopaedic surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Videne 10% w/w Alcoholic Tincture is applied undiluted to the area to
be incised and painted on thoroughly using a gauze
swab. The solution may be allowed to dry to form a protective film or
may be removed using a sterile gauze swab.
_Neonates:_
Do not use on neonates, refer to Section 4.3.
_Children and Elderly:_
There are no special dosage recommendations for children or elderly
patients.
_Renal Impairment:_
Patients with renal impairment should refer to Section 4.4.
4.3 CONTRAINDICATIONS
Videne 10% w/w Alcoholic Tincture must never be administered orally,
and is contra-indicated in neonates, and during
pregnancy and lactation.
Regular or prolonged use should be avoided in patients with thyroid
disorders or those receiving lithium therapy.
Hypersensitivity to any of the ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Care should be taken with known iodine-sensitive subjects, although
such people do not normally react to iodinated povidone.
Health Products Regulatory Authority
21 May 2019
CRN0091ZM
Page 2 of 4
Videne 10% w/w Alcoholic Tincture must not be used on broken skin
because of the intense stinging caused by the alcohol
present.
The application of povidone-iodine to large wounds or severe burns may
produce systemic adverse effects such as metabolic
acidosis, hypernatraemia, and impairment of renal function.
4.5 INTERACTION W
                                
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