Betadine 40mg/ml Shampoo

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Povidone iodinated

Tilgjengelig fra:

Mundipharma Pharmaceuticals Limited

ATC-kode:

D11AC; D11AC06

INN (International Name):

Povidone iodinated

Dosering :

40 milligram(s)/millilitre

Legemiddelform:

Shampoo

Terapeutisk område:

Medicated shampoos; povidone-iodine

Autorisasjon status:

Not marketed

Autorisasjon dato:

1975-11-25

Preparatomtale

Health Products Regulatory Authority
09 July 2019
CRN0091J5
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betadine 40mg/ml Shampoo
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 40 mg providone iodine
For excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Shampoo
A golden brown, clear, viscous liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of seborrhoeic conditions or superficial infections.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
1. Apply to moistened hair and massage into scalp.
2. Rinse thoroughly.
3. Treatment should be twice weekly or as directed by the physician.
4.3 CONTRAINDICATIONS
Use in patients with hypsersensitivity to iodine.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Use of the preparation may interfere with tests of thyroid function.
If the condition is aggravated, or there is no improvement, a doctor
should be consulted.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
None stated.
4.6 FERTILITY, PREGNANCY AND LACTATION
Regular use of povidone-iodine should be avoided in pregnant or
lactating women as absorbed iodine can cross the placental
barrier and can be secreted into breast milk.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.
4.8 UNDESIRABLE EFFECTS
If local irritation or sensitivity develops, discontinue treatment.
Health Products Regulatory Authority
09 July 2019
CRN0091J5
Page 2 of 3
4.9 OVERDOSE
In the case of accidental ingestion of large quantities of Betadine,
symptomatic and supportive treatment should be provided
with special attention to electrolyte imbalance and renal and thyroid
function
5 PHARMACOLOGICAL PROPERTIES
5.1 PHARMACODYNAMIC PROPERTIES
D08AG02-Antiseptics and disinfectants.
Betadine Shampoo contains povidone-iodine, a complex of iodine which
shows all the broad spectrum germicidal activity of
elemental iodine.
5.2 PHARMACOKINETIC PROPERTIES
Not applicable.
5.3 PRECLINICAL SAFETY DATA
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIEN