- Approval Id
- af95d1ef6a584af4
- Drug Approval Emc Name
- Sudosalve Nappy Rash Treatment 0.15%w/w Cream
- Drug Name
- Sudosalve Nappy Rash Treatment 0.15%w/w Cream
- Company Address
- Field House, Station Approach, Harlow, Essex, CM20 2FB
- Company Website
- http://www.tevauk.com
- Company Telephone
- +44(0) 207 540 7000
- Company Medical Info Direct Line
- +44(0) 207 540 7117
- Company Medical Info Email
- medinfo@tevauk.com
- Company Medical Info Fax
- +44 (0) 207 000 1216
- Company Stock Availability
- 0800 590 502
- Atc Code
- D08AC01
- Legal Category
- General Sales List
- Authorisation Holder
- Teva UK Limited,
Ridings Point,
Whistler Drive,
Castleford,
WF10 5HX,
United Kingdom
- Authorisation Number
- PL 00289/2629
- Authorisation Date
- 17/08/2009
- Instruction Authorisation Holder
- Teva UK Limited,
Ridings Point,
Whistler Drive,
Castleford,
WF10 5HX,
United Kingdom
- Instruction Authorisation Number
- PL 00289/2629
- Instruction Authorisation Date
- 17/08/2009
- Instruction Composition
- Dibrompropamidine isetionate 0.15%w/w
For a full list of excipients, see section 6.1.
- Instruction Dosage Form
- Cream
A smooth, white cream.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
Indications
(a) First aid dressing for minor burns, scalds, abrasions and other open injuries and their routine treatment.
(b) For the treatment of surface infections due to susceptible organisms, particularly in cases with penicillin resistant Staphylococci or certain Gramnegative bacilli.
(c) Treatment of ringworm of the scalp (Microsporum canis) and other superficial fungal infections.
(d) Treatment of pyodermias, including sycosis barbae.
(e) Treatment of otitis externa.
(f) Treatment of nappy rash.4.2 Posology and method of administration
Adults: apply to the affected area, either directly or on a light dressing, two or three times a day.
Elderly and children: no specific recommendations.
For cutaneous use.4.3 Contraindications
Sudosalve nappy rash treatment 0.15%w/w Cream should not be used in patients with known hypersensitivity to dibrompropamidine or any of the other ingredients.4.4 Special warnings and precautions for use
Prolonged use may interfere with healing and cause skin necrosis in infants.
This medicine contains the following excipients:
• Methyl parahydroxybenzoate (E218) may cause allergic reactions (possibly delayed)
• Castor oil may cause skin reactions
• Cetostearyl alcohol may cause local skin reactions (eg. contact dermatitis).4.5 Interaction with other medicinal products and other forms of interaction
None known4.6 Fertility, pregnancy and lactation
There is no evidence of the drug's safety in human use nor is there any evidence from animal work that it is free from hazard. Avoid unless considered essential.4.7 Effects on ability to drive and use machines
None.4.8 Undesirable effects
There is always the possibility, although rare, of a sensitisation reaction or contact dermatitis occurring: in such an event, treatment should be discontinued immediately.
\*\*Reporting of suspected adverse reactions\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
The 25g tube of Sudosalve nappy rash treatment 0.15%w/w Cream contains 37.5mg of dibrompropamidine, the 30g contains 45mg and the 50g contains 75mg. No toxic effects are likely to occur even if the contents of a full tube are accidentally ingested. Similarly, the ingredients of the base are unlikely to have toxic effects in the quantities present.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
ATC code: D08AC01
Dibrompropamidine isetionate is an antibacterial agent active against pathogenic Streptococci and Staphylococci, including penicillin resistant strains, and has some activity against a number of Gram negative bacilli. Its antibacterial action is not inhibited by pus, blood or p-aminabenzoic acid. In addition, it has useful activity against certain species of pathogenic fungi. Sudosalve nappy rash treatment 0.15%w/w Cream is well tolerated and rarely gives rise to sensitisation reactions or contact dermatitis.5.2 Pharmacokinetic properties
No data available.5.3 Preclinical safety data
No relevant data.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Castor oil, virgin
Cetostearyl alcohol
Polyethylene glycol 600 monostearate
Methyl parahydroxybenzoate
Silicone MS Antifoam A
Purified water6.2 Incompatibilities
Not applicable.6.3 Shelf life
36 months6.4 Special precautions for storage
Store below 25°C.6.5 Nature and contents of container
Collapsible aluminium internally lacquered tube with extended nozzle containing 25g, 30g or 50g cream. Polythene plug seal cap.6.6 Special precautions for disposal and other handling
Not applicable.
- Instruction Content
- ## Composition
Dibrompropamidine isetionate 0.15%w/w
For a full list of excipients, see section 6.1.
## Pharmaceutical Form
Cream
A smooth, white cream.
## Clinical Particulars
4.1 Therapeutic indications
Indications
(a) First aid dressing for minor burns, scalds, abrasions and other open injuries and their routine treatment.
(b) For the treatment of surface infections due to susceptible organisms, particularly in cases with penicillin resistant Staphylococci or certain Gramnegative bacilli.
(c) Treatment of ringworm of the scalp (Microsporum canis) and other superficial fungal infections.
(d) Treatment of pyodermias, including sycosis barbae.
(e) Treatment of otitis externa.
(f) Treatment of nappy rash.4.2 Posology and method of administration
Adults: apply to the affected area, either directly or on a light dressing, two or three times a day.
Elderly and children: no specific recommendations.
For cutaneous use.4.3 Contraindications
Sudosalve nappy rash treatment 0.15%w/w Cream should not be used in patients with known hypersensitivity to dibrompropamidine or any of the other ingredients.4.4 Special warnings and precautions for use
Prolonged use may interfere with healing and cause skin necrosis in infants.
This medicine contains the following excipients:
• Methyl parahydroxybenzoate (E218) may cause allergic reactions (possibly delayed)
• Castor oil may cause skin reactions
• Cetostearyl alcohol may cause local skin reactions (eg. contact dermatitis).4.5 Interaction with other medicinal products and other forms of interaction
None known4.6 Fertility, pregnancy and lactation
There is no evidence of the drug's safety in human use nor is there any evidence from animal work that it is free from hazard. Avoid unless considered essential.4.7 Effects on ability to drive and use machines
None.4.8 Undesirable effects
There is always the possibility, although rare, of a sensitisation reaction or contact dermatitis occurring: in such an event, treatment should be discontinued immediately.
\*\*Reporting of suspected adverse reactions\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
The 25g tube of Sudosalve nappy rash treatment 0.15%w/w Cream contains 37.5mg of dibrompropamidine, the 30g contains 45mg and the 50g contains 75mg. No toxic effects are likely to occur even if the contents of a full tube are accidentally ingested. Similarly, the ingredients of the base are unlikely to have toxic effects in the quantities present.
## Pharmacological Properties
5.1 Pharmacodynamic properties
ATC code: D08AC01
Dibrompropamidine isetionate is an antibacterial agent active against pathogenic Streptococci and Staphylococci, including penicillin resistant strains, and has some activity against a number of Gram negative bacilli. Its antibacterial action is not inhibited by pus, blood or p-aminabenzoic acid. In addition, it has useful activity against certain species of pathogenic fungi. Sudosalve nappy rash treatment 0.15%w/w Cream is well tolerated and rarely gives rise to sensitisation reactions or contact dermatitis.5.2 Pharmacokinetic properties
No data available.5.3 Preclinical safety data
No relevant data.
## Pharmaceutical Particulars
6.1 List of excipients
Castor oil, virgin
Cetostearyl alcohol
Polyethylene glycol 600 monostearate
Methyl parahydroxybenzoate
Silicone MS Antifoam A
Purified water6.2 Incompatibilities
Not applicable.6.3 Shelf life
36 months6.4 Special precautions for storage
Store below 25°C.6.5 Nature and contents of container
Collapsible aluminium internally lacquered tube with extended nozzle containing 25g, 30g or 50g cream. Polythene plug seal cap.6.6 Special precautions for disposal and other handling
Not applicable.
- Company Detail Path
- /organization/teva-pharma-b-v
