Summary of Product Characteristics (SmPC) - Bismuth Subnitrate and Iodoform paste Impregnated Gauze
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 BIPP, however none of the cases reported have occurred following ENT procedures.
4.9 Overdose
Severe iodine poisoning is characterised by headache, somnolence, delirium and rapid feeble pulses. General supportive procedures are required. Overdose is not usually a problem when gauzes are packed in small cavities associated with the middle ear and mastoid operations.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic Properties
Iodoform:-
Has a marked anaesthetic and antiseptic action due to the release of iodine.
Bismuth subnitrate:-
Bismuth subnitrate action is both as an astringent and absorbent.
5.2 Pharmacokinetic Properties
Pharmacokinetic particulars are not applicable since the active constituents are not systemically absorbed.
5.3 Pre-clinical Safety Data
Not applicable
6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Paraffin Liquid BP
X-Ray detectable Fast Edge Ribbon Gauze May also contain Purified water BP.
6.2 Incompatibilities
The paste is incompatible with oxidising agents - lead, silver and mercuric salt.
6.3 Shelf-Life
2 years
6.4 Special Precautions for Storage
Store between 2-8oC.
Protect from light.
6.5 Nature and Content of the Container:
An Aluminium laminated pouch of composition:
Polyester 12 micron Polythene 20g/m2
Aluminium 9 micron
Surlyn 50g/m2
6.6 Instructions for Use, Handling and Disposal
Discard any unused gauze at the end of a procedure or session. Do not use if the pouch is damaged.
7. MARKETING AUTHORISATION HOLDER
Aurum Pharmaceuticals Limited
Bampton Road
Harold Hill
Romford
Essex RM3 8UG
8. MARKETING AUTHORISATION NUMBER
PL 12064/0002
9. DATA OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
12th January 1995
10. DATA OF PARTIAL REVISION OF THE TEXT
June 2002