BRAUNODERM NON-COLOURED 500/10 mg/g Cutaneous Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

IODINATED POVIDONE PH.EUR. ISOPROPANOL

Available from:

B. Braun Medical Limited

INN (International Name):

IODINATED POVIDONE PH.EUR. ISOPROPANOL

Dosage:

500/10 mg/g

Pharmaceutical form:

Cutaneous Solution

Prescription type:

Product not subject to medical prescription

Authorization status:

Withdrawn

Authorization date:

0000-00-00

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Braunoderm Non-Coloured, Isopropyl Alcohol 500mg/g and Iodinated Povidone 10mg/g Cutaneous Solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredients:_
100 g solution contains:
50.0 g Isopropyl Alcohol Ph. Eur.
1.0 g Iodinated Povidone Ph. Eur., with a content of 10% available iodine.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cutaneous solution.
Clear, brown solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a topical antiseptic for disinfection of intact skin.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Apply undiluted Braunoderm non-coloured to the skin area to be disinfected and spread with sterile swab. Wet the skin
to be treated completely and then let dry.
4.3 CONTRAINDICATIONS
Use in patients with hypersensitivity to iodine or the other excipients.
Before and after radio-iodine-therapy (until complete healing).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
None stated.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
Iodine reacts with mercury compounds forming strongly caustic mercurous iodide.
4.6 PREGNANCY AND LACTATION
Care must be taken in the case of pregnant women and infants up to the age of 6 months, as well as patients suffering
from non-infected nodular strumae or latent hyperthyreosis.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 06/03/2008_
_CRN 2047046_
_page number: 1_
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None stated.
4.8 UNDESIRABLE EFFECTS
Allergic reactions.
4.9 OVERDOSE
Because the preparation is only applied locally, no overdose can result.
5 PHARMACOLOGICAL PROPERTIES
5.1 PHARMACODYNAMIC PROPERTIES
Alcoholic soluti