Bismuth subnitrate and Iodoform paste

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Osta se nyt

Pakkausseloste Pakkausseloste (PIL)
01-05-2002
Valmisteyhteenveto Valmisteyhteenveto (SPC)
01-06-2002

Aktiivinen ainesosa:

Bismuth subnitrate; Iodoform

Saatavilla:

A A H Pharmaceuticals Ltd

ATC-koodi:

C05AX02

INN (Kansainvälinen yleisnimi):

Bismuth subnitrate; Iodoform

Annos:

252mg/1gram ; 503mg/1gram

Lääkemuoto:

Cutaneous paste

Antoreitti:

Cutaneous

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 13100500

Pakkausseloste

                                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 packed into the nostril(s).
The gauze can be removed the following day or at a time
advised by your doctor.
If you have any further questions on the use of this product, ask
your doctor, nurse or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Bismuth & Iodoform Gauze can cause side
effects, although not everybody gets them.
• A rash may appear where the gauze is applied but th
                                
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Valmisteyhteenveto

                                1.
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.
4.
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.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Use with caution with patients suffering from hyperthyroidism.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.6
PREGNANCY AND LACTATION
There is insufficient evidence of safety in pregnancy, as with all
drugs it is not
recommended the product is used in pregnancy.
4.7
EFFECTS ON THE ABILITY TO DRIVE OR USE MACHINES
Not applicable.
4.8
UNDESIRABLE EFFECTS
Hypersensitivity to iodine can result in an erythematous rash, which
subsides on removal of
the gauze.
Although rare, there are reports within the published literature of
the development of
encephalopathy associated with the application of BIP
                                
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