United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)
15-06-2018
Object 1
Bismuth Subnitrate and Iodoform Paste
Impregnated Gauze
Summary of Product Characteristics Updated 18-Feb-2015 | Martindale Pharma
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
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 Contraindications
Known hypersensitivity to Iodoform, iodine and bismuth.
4.4 Special warnings and 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 ability to drive and 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 Preclinical 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 2-8°C. Protect from light.
6.5 Nature and contents of container
An Aluminium laminated pouch of composition:
Polyester
12 micron
Polythene
20g/m2
Aluminium
9 micron
Surlyn
50g/m2
6.6 Special precautions for disposal and other handling
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(s)
PL 12064/0002
9. Date of first authorisation/renewal of the authorisation
12th January 1995
10. Date of revision of the text
June 2002
Company Contact Details
Martindale Pharma
Address
Bampton Road, Harold Hill, Romford, Essex, RM3 8UG
Telephone
+44 (0)1277 266 600
Medical Information e-mail
protected]
http://www.martindalepharma.co.uk
+44 (0)1277 848 976
Customer Care direct line
+(0)800 137 627