BIO-BACTEDENE GEL 10%WW

Krajina: Malajzia

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktívna zložka:

Povidone Iodine

Dostupné z:

Top Biopharma Sdn Bhd

INN (Medzinárodný Name):

Povidone Iodine

Počet v balení:

10 gm

Výrobca:

Macrophar Co.,Ltd

Súhrn charakteristických

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PACKAGE INSERT
1.
Product Name: B
IO-B
ACTEDENE GEL 10%w/w
2.
Name and strength of active ingredients (S):
Povidone -Iodine 10g/100g (equivalent to iodine 1g).
3.
Product Description: Brown gel
4.
Indication: B
io-B
actedene is used for prevention of infection in cuts, abrasions, burns
and use for pre-operative
disinfection of the skin.
5.
Pharmacodynamics
Povidone – iodine is a complex of Iodine which retains the
broad-spectrum germicidal activity of elemental iodine
without its disadvantages. The germicidal activity is maintained in
the presence of bloods, pus, serum and necrotic
tissues.
6.
Pharmacokinetics
B
io-B
actedene is applied topically to the affected area.
7.
Recommended Dose: Apply 2-3 times daily.
8.
Mode of Administration: Topical
9. Contraindication
-Hypersensitivity to iodine, polyvinylpyrrolidone or to any excipient.
- History of abnormal thyroid function or goiter (in particular
nodular colloid goitre, endemic goitre
and Hashimoto’s thyroiditis).
-Regular use should be avoided in patients on concurrent lithium
therapy.
10. Warnings and Precautions
-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 level of iodine in the blood, particularly patients with renal
insufficiency. If symptoms occur suggesting
changes in thyroid function, these should investigated.
- In patients with impaired renal function, blood levels of iodine
should be monitored.
- If local irritation and hypersensitivity develop, then discontinue
treatment.
11. Interactions with Other Medicaments
- Use with concurrent lithium therapy has been shown to exhibit
additive hypothyroidic effects.
- Absorption of iodine from povidone iodine through either intact skin
or broken skin may interfere with thyroid
function tests.
- Contamination with povidone iodine of several types of tests for the
detection of occult blood in faeces or blood in
urine may produce false-positive results.
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