Bismuth Subnitrate and Iodoform Paste Impregnated Gauze
Nazione: Malta
Lingua: inglese
Fonte: Medicines Authority
Foglio illustrativo
(PIL)
15-05-2024
Scheda tecnica
(SPC)
15-05-2024
Principio attivo:
BISMUTH SUBNITRATE, IODOFORM, LIQUID PARAFFIN
Commercializzato da:
Macarthys Laboratories Limited Bampton Road, Harold Hill, Romford Essex, RM3 8UG, United Kingdom
Codice ATC:
D09AA13
INN (Nome Internazionale):
BISMUTH SUBNITRATE 20 % (W/W) IODOFORM 40 % (W/W) LIQUID PARAFFIN 40 % (W/W)
Forma farmaceutica:
IMPREGNATED DRESSING
Composizione:
BISMUTH SUBNITRATE 20 % (W/W) IODOFORM 40 % (W/W) LIQUID PARAFFIN 40 % (W/W)
Tipo di ricetta:
OTC
Area terapeutica:
MEDICATED DRESSINGS
Stato dell'autorizzazione:
Withdrawn
Data dell'autorizzazione:
2007-01-17
Foglio illustrativo
IN THIS LEAFLET:
1.
What Bismuth & Iodoform Gauze is and what it is used for
2. Before Bismuth & Iodoform Gauze is used
3. How Bismuth & Iodoform Gauze is used
4. Possible side effects
5. How to store Bismuth & Iodoform Gauze
6. Further information
1. WHAT BISMUTH AND IODOFORM GAUZE IS AND
WHAT IS IT USED FOR
Bismuth Subnitrate is a substance that reduces blood flow from
an open blood vessel and has a drying or absorbent action.
Iodoform is an antiseptic (preventing infection) and anaesthetic.
Bismuth & Iodoform Gauze is an antiseptic gauze used to
prevent infection and reduce bleeding.The impregnated gauze
is used to pack cavities after ear, nose or throat surgery or to
reduce or stop a severe nosebleed.
2. BEFORE BISMUTH & IODOFORM GAUZE IS USED
BISMUTH & IODOFORM GAUZE SHOULD NOT BE USED IF:
• you are allergic (hypersensitive) to Bismuth Subnitrate or
Iodoform.
TAKE SPECIAL CARE WITH BISMUTH & IODOFORM GAUZE IF:
• you have an overactive thyroid gland.
• you are pregnant.
If any of the above applies to you, please tell your doctor or
nurse.
PREGNANCY AND BREAST-FEEDING
If you are pregnant, trying for a baby or breast-feeding your
doctor will decide whether Bismuth & Iodoform Gauze should
be used.
3. HOW BISMUTH & IODOFORM GAUZE IS USED
AFTER EAR, NOSE OR THROAT SURGICAL PROCEDURES:
Enough impregnated gauze should be packed into the cavity to
protect the operation site from germs and to reduce or stop
bleeding. The gauze is left in place until the wound has healed
or the graft has taken. It is recommended that the gauze is not
placed over open wounds.
TO REDUCE OR STOP A SEVERE NOSEBLEED:
Enough impregnated gauze should be pack
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Scheda tecnica
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Bismuth Subnitrate and Iodoform Paste Impregnated Gauze.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
A lemon yellow paste impregnated gauze with characteristic antiseptic odour.
The gauze is impregnated with a paste of composition.
Bismuth Subnitrate
BPC 1973
20% w/w
Iodoform
BPC 1954
40% w/w
Paraffin Liquid
BP
40% w/w
3.
PHARMACEUTICAL FORM
A paste impregnated gauze.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
a) Post ENT Surgical Procedures
_ _
As an antiseptic gauze used to prevent infection and thus assist healing following ENT
procedures. It is not recommended that the impregnated gauze be placed into open wounds.
b)_ _Acute Epistaxis_ _
To pack the nasal cavity in order to reduce/stop the flow of blood.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
a) In ENT surgical procedures
Sufficient impregnated gauzes should be packed into the cavity to protect the operation site
from bacterial challenge. The gauze is left in place until the wound has healed or graft
taken. It is not recommended that the impregnated gauze be placed into open wounds.
b) Acute epistaxis
Sufficient impregnated gauze(s) is packed up in the nose to stop the blood flow. The gauze
is removed the following day or when clinical judgement dictates.
4.3.
CONTRA-INDICATIONS
Known hypersensitivity to Iodoform, iodine and bismuth.
Page 2 of 4
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Use with caution with patients suffering from hyperthyroidism.
4.5
INTERACT
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