Summary of Product Characteristics (SmPC) - Bismuth Subnitrate & Iodoform paste for Gauze
1 NAME OF THE MEDICINAL PRODUCT
Bismuth Subnitrate & Iodoform Paste For Gauze
2. Qualitative and Quantitative Composition
Iodoform BPC 1954 40%w/w
Bismuth subnitrate BPC 1973 20% w/w
3. Pharmaceutical Form
A paste of composition Iodoform 40% w/w, Bismuth Subnitrate 20% w/w and Paraffin Liquid 40% w/w. presented in a labelled aluminium laminated pouch.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
The paste is spread evenly onto a suitable length of sterile ribbon gauze. The impregnated gauze is then used in the following:
ENT Surgical Procedures
As an antiseptic gauze used to prevent infection and thus assists healing following ENT surgical procedures.
It is not recommended that the gauze is placed into open wounds
Acute Epistaxis
To pack the nasal cavity in order to stop/reduce the flow of blood.
4.2. Posology and Method of Administration
The paste is evenly spread onto a suitable length of sterile gauze and packed into the post surgical cavity or the nose.
It is not recommended that the gauze is placed into open wounds.
4.3. Contra-indications
Hypersensitivity to iodoform, iodine or bismuth.
4.4 Special warnings and precautions for use
Use in caution with patients suffering from hyperthyroidism
4.5 Interaction with other medicinal products and other forms of interaction
Not Known
4.6. Pregnancy and Lactation
There is insufficient evidence of safety in pregnancy, therefore, 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 pulse. General supportive procedures are needed. Over dosage is not usually a problem when the gauzes are used in small cavities associated with the middle ear and mastoid operations.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Iodoform has a marked anaesthetic effect and antiseptic action due to the release of iodine.
Bismuth Subnitrate has both an astringent and absorbent action.
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
6.2. Incompatibilities
Oxidising agents. Lead silver and mercury salts
6.3. Shelf Life
36 Months.
6.4. Special Precautions for Storage
Store between 2-8°C
6.5. Nature and Contents of Container
A Bismuth Subnitrate & Iodoform paste for gauze is presented in a laminated Aluminium pouch of composition:-
Polyester 12 micron Polythene 20 gsm Aluminium 9 micron Surlyn 50 gsm
Each pouch contains either 15, 30, 45 or 60g of paste.
6.6. Instructions for Use/Handling
Do not use if the pouch is damaged.
Discard any unused paste at the end of the session.
Do not attempt to sterilise the pouch by autoclaving or irradiation, as it will result in severe discolouring of the paste due to the release of Iodine.
The paste has a tendency to separate out on standing. Before opening, the contents of the pouch must be gently kneaded to mix the contents.
7. MARKETING AUTHORISATION HOLDER
Aurum Pharmaceuticals Ltd.
Bampton Road,
Harold Hill,
Romford,
Essex,
RM3 8UG.
8. MARKETING AUTHORISATION NUMBERS
PL 12064/0012
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
04/01/2007
10 DATE OF REVISION OF THE TEXT
04/01/2007