Iodine alcoholic cutaneous solution

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

POTASSIUM IODIDE, IODINE

Commercializzato da:

Lab. Chimico Farmaceutico A Sella S.r.L Via Vicenza 67, Schio, Italy

Codice ATC:

D08AG03

INN (Nome Internazionale):

POTASSIUM IODIDE 5 g/100ml IODINE 7 g/100ml

Forma farmaceutica:

CUTANEOUS SOLUTION

Composizione:

POTASSIUM IODIDE 5 g/100ml IODINE 7 g/100ml

Tipo di ricetta:

OTC

Area terapeutica:

ANTISEPTICS AND DISINFECTANTS

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2006-11-27

Foglio illustrativo

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_ al_
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_on _
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_Iod_
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_ 30_
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_Therapeutic category_
ANTISEPTIC
_Therapeutic category_
ANTISEPTIC
COMPOSITION:
_100 ml contain:_
Iodine 7 g; Potassium iodide
5 g; hydro-alcoholic solution.
USE:
Antiseptic solution.
ATTENTION:
the stated expiry date refers 
to the product in the integral 
packaging, under good 
storage conditions.
FOR EXTERNAL USE ONLY.
DO NOT INGEST.
STORAGE:
store this product in a well-
closed container, protected 
from light.
SHELF LIFE: 5 YEARS.
CONTENT: 30 ml
MA: 0000/0000
MARKETING AUTHORIZATION 
HOLDER:
Lab. Chim. Farm. 
A. SELLA s.r.l.
Via Vicenza, 67 - Schio (VI) - Italy
Iodine cutaneous
solution
_Iodine alcoholic_
_solution I _
°
_Iodine Tincture 30 ml_
Iodine cutaneous
solution
_Iodine alcoholic_
_solution I _
°
_Iodine Tincture 30 ml_
Batch no.
Expiry date
Price 
€
Cod. 00000
Ed. 0
MATERIALE  DI  PROPRIETÀ  DEL  LAB.  CHIM. 
FARM. A. SELLA S.R.L. CHE NON DEVE ESSERE 
ASSOLUTAMENTE MODIFICATO O DANNEGGIATO.
IMPIANTO DI PROPRIETÀ
NERO
LABORATORIO CHIMICO FARMACEUTICO A. SELLA S.R.L. - SCHIO (VI)
IMPIANTO PRODOTTO
TINTURA DI IODIO_ASTUCCIO 30 ML
VERSIONE INGLESE
DATA INIZIO LAVORO
MODIFICHE:
DIMENSIONI
CODICE
DATA PELLICOLE
VISTO SI STAMPI
06.2005
NUOVO IMPIANTO.
41 X 100 X 41
00000
12.2005
REVISIONE
0
LAB.CHIM.FARM. A. SELLA S.R.L.
PANTONE 224
FUSTELLA
GIALLO
FUSTELLA
ESECUZIONE IMPIANTI - STUDIO GUIDO TAMONI - SCHIO (VI) - TEL. [phone]
MATERIALE  DI  PROPRIETÀ  DEL  LAB.  CHIM. 
FARM. A. SELLA S.R.L. CHE NON DEVE ESSERE 
ASSOLUTAMENTE MODIFICATO O DANNEGGIATO.
IMPIANTO DI PROPRIETÀ
NERO
LABORATORIO CHIMICO FARMACEUTICO A. SELLA S.R.L. - SCHIO (VI)
IMPIANTO PRODOTTO
TINTURA DI IODIO_ETICHETTA 30 ML
        VERSIONE INGLESE
DATA INIZIO LAVORO
MODIFICHE:
DIMENSIONI
CODICE
DATA PEL

Scheda tecnica

IODINE - CUTANEOUS ALCOHOLIC SOLUTION
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Iodine alcoholic cutaneous solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
100ml contain:
Active Ingredients:
Iodine 7g
Potassium iodide 5g
For a list of inactive ingredients, see section 6.1
3.
PHARMACEUTICAL FORM
Cutaneous solution, also known as Iodine tincture
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS:
Disinfection of unbroken skin during occasional treatments.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION:
To be painted on the part to be treated.
4.3 CONTRA-INDICATIONS:
Hypersensitivity to the active ingredient or to any of the excipients.
Generally contraindicated in pregnancy (see par. 4.6).
Not to be used in children under 6 months of age.
4.4. SPECIAL CAUTIONS AND PRECAUTIONS FOR USE
For external use only. Do not swallow. Avoid contact with eyes.
Prolonged application may cause irritation and caustic effects on the
treated surface,
therefore the medicinal product should not be used for prolonged
treatment.
The medicine should only be applied to intact and unbroken skin, as it
causes irritation and
delays healing of wounds and abrasions.
Particularly prolonged use may lead to sensitisation. In this case,
stop the treatment and
take appropriate therapeutic measures.
To avoid excessive absorption of iodine, do not cover the treated skin
area with occlusive
bandages.
If used for prolonged periods on large body surfaces, on mucous
membranes or under
occlusive bandages, especially in children and patients with thyroid
disorders, thyroid
function tests must be performed.
Since iodine can alter thyroid function, it is recommended to use with
caution in people with
thyroid disorders, in patients over 45 years of age or with goiter.
In paediatric age use only in cases of actual need and under medical
supervision.
Discontinue treatment at least 10 days before performing a
scintigraphy with marked
iodine.
The results of thyroid function tests may be altered as a result of
treatment, especially in
prem