- Approval Id
- 2a7cbf8065799176
- Drug Approval Emc Name
- Hirudoid Cream
- Drug Name
- Hirudoid Cream
- Company Address
- Linthwaite, Huddersfield, West Yorks, HD7 5QH
- Company Website
- http://www.thorntonandross.co.uk
- Company Medical Info Direct Line
- +44 (0) 1484 848164
- Company Medical Info Email
- thorntonross@medinformation.co.uk
- Company Customer Care Direct Line
- +44(0)1484 848200
- Legal Category
- Pharmacy
- Authorisation Holder
- Thornton & Ross Ltd.
Linthwaite,
Huddersfield,
HD7 5QH, UK
- Authorisation Number
- PL 00240/0556
- Authorisation Date
- 02/02/2006
- Instruction Authorisation Holder
- Thornton & Ross Ltd.
Linthwaite,
Huddersfield,
HD7 5QH, UK
- Instruction Authorisation Number
- PL 00240/0556
- Instruction Authorisation Date
- 02/02/2006
- Instruction Composition
- Heparinoid 0.3% \*wlw\* (Equivalent to 25 000 Units per 100 g cream).
\*\*Excipient(s) with known effect\*\*
| | |
| --- | --- |
| Anhydrous eucerine (contains lanolin) | 7.515% w/w |
| Cetostearyl alcohol | 3.105% w/w |
| Methyl parahydroxybenzoate | 0.16% w/w |
| Propyl parahydroxybenzoate | 0.04% w/w |
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Topical cream.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
Hirudoid is indicated for the treatment of superficial thrombophlebitis and the soothing relief of superficial bruising and haematoma.4.2 Posology and method of administration
Adults, the elderly and children over 5 years of age:
Two to six inches (5-15 cm) to be applied up to four times daily to the affected area and gently massaged into the skin.4.3 Contraindications
Not to be used on large areas of skin, broken skin, sensitive areas of skin or mucous membranes. Not to be used in individuals with a known sensitivity to any active or inactive component of the formulation. Not to be used in children under 5 years of age.4.4 Special warnings and precautions for use
For external use only. If symptoms persist or worsen, seek medical advice. Do not exceed the stated dose.
Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
\*\*Ingredients with specified warnings\*\*
This product contains Cetostearyl alcohol and lanolin which may cause local skin reactions (e.g. contact dermatitis).
This product contains propyl parahydroxybenzoate and ethyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).4.5 Interaction with other medicinal products and other forms of interaction
None known.4.6 Pregnancy and lactation
There is no evidence to suggest that Hirudoid should not be used during pregnancy and lactation.4.7 Effects on ability to drive and use machines
None.4.8 Undesirable effects
None known.
\*\*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
In the absence of any reports of the accidental ingestion of Hirudoid, no specific advice is available. General supportive measures may be appropriate.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Heparinoid is recognised as having: a weak inhibitory effect on PGE2 synthesis and an indirect effect on LTB4 production (based on in vitro studies), anti-coagulant activity (as a heparinoid), thrombolytic activity (through potentiation of urokinase activity), anti-exudatory activity (through inhibition of hyaluronidase).5.2 Pharmacokinetic properties
Radiochemical studies of absorption following cutaneous application of heparinoid (mucopolysaccharide polysulphate) have shown that between 0.3 and 4% of the mucopolysaccharide administered is absorbed by various tissues (other than the treated area) within the first 8 hours. Typically between 1.7% and 4.6% will be absorbed within 2 to 4 days. Animal studies have also shown that mucopolysaccharide is bound intracellularly within the subcutis. Peak serum concentrations following cutaneous application are below the threshold of physiological relevance for coagulation. Mucopolysaccharide is excreted in the urine partly unchanged and partly as depolymerized, shorter chain length molecules.5.3 Preclinical safety data
None stated.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Anhydrous eucerine (contains lanolin)
Emulsifying cetostearyl alcohol type A
Glycerol
Isopropyl alcohol
Methyl parahydroxybenzoate (E218)
Myristyl alcohol
Potassium hydroxide
Propyl parahydroxybenzoate (E216)
Purified water
Stearic acid
Thymol6.2 Incompatibilities
None.6.3 Shelf life
5 years.6.4 Special precautions for storage
Store below 25°C.6.5 Nature and contents of container
Lacquered aluminium tubes 14, 40, 50g.6.6 Special precautions for disposal and other handling
Not applicable.
- Instruction Content
- ## Composition
Heparinoid 0.3% \*wlw\* (Equivalent to 25 000 Units per 100 g cream).
\*\*Excipient(s) with known effect\*\*
| | |
| --- | --- |
| Anhydrous eucerine (contains lanolin) | 7.515% w/w |
| Cetostearyl alcohol | 3.105% w/w |
| Methyl parahydroxybenzoate | 0.16% w/w |
| Propyl parahydroxybenzoate | 0.04% w/w |
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Topical cream.
## Clinical Particulars
4.1 Therapeutic indications
Hirudoid is indicated for the treatment of superficial thrombophlebitis and the soothing relief of superficial bruising and haematoma.4.2 Posology and method of administration
Adults, the elderly and children over 5 years of age:
Two to six inches (5-15 cm) to be applied up to four times daily to the affected area and gently massaged into the skin.4.3 Contraindications
Not to be used on large areas of skin, broken skin, sensitive areas of skin or mucous membranes. Not to be used in individuals with a known sensitivity to any active or inactive component of the formulation. Not to be used in children under 5 years of age.4.4 Special warnings and precautions for use
For external use only. If symptoms persist or worsen, seek medical advice. Do not exceed the stated dose.
Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
\*\*Ingredients with specified warnings\*\*
This product contains Cetostearyl alcohol and lanolin which may cause local skin reactions (e.g. contact dermatitis).
This product contains propyl parahydroxybenzoate and ethyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).4.5 Interaction with other medicinal products and other forms of interaction
None known.4.6 Pregnancy and lactation
There is no evidence to suggest that Hirudoid should not be used during pregnancy and lactation.4.7 Effects on ability to drive and use machines
None.4.8 Undesirable effects
None known.
\*\*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
In the absence of any reports of the accidental ingestion of Hirudoid, no specific advice is available. General supportive measures may be appropriate.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Heparinoid is recognised as having: a weak inhibitory effect on PGE2 synthesis and an indirect effect on LTB4 production (based on in vitro studies), anti-coagulant activity (as a heparinoid), thrombolytic activity (through potentiation of urokinase activity), anti-exudatory activity (through inhibition of hyaluronidase).5.2 Pharmacokinetic properties
Radiochemical studies of absorption following cutaneous application of heparinoid (mucopolysaccharide polysulphate) have shown that between 0.3 and 4% of the mucopolysaccharide administered is absorbed by various tissues (other than the treated area) within the first 8 hours. Typically between 1.7% and 4.6% will be absorbed within 2 to 4 days. Animal studies have also shown that mucopolysaccharide is bound intracellularly within the subcutis. Peak serum concentrations following cutaneous application are below the threshold of physiological relevance for coagulation. Mucopolysaccharide is excreted in the urine partly unchanged and partly as depolymerized, shorter chain length molecules.5.3 Preclinical safety data
None stated.
## Pharmaceutical Particulars
6.1 List of excipients
Anhydrous eucerine (contains lanolin)
Emulsifying cetostearyl alcohol type A
Glycerol
Isopropyl alcohol
Methyl parahydroxybenzoate (E218)
Myristyl alcohol
Potassium hydroxide
Propyl parahydroxybenzoate (E216)
Purified water
Stearic acid
Thymol6.2 Incompatibilities
None.6.3 Shelf life
5 years.6.4 Special precautions for storage
Store below 25°C.6.5 Nature and contents of container
Lacquered aluminium tubes 14, 40, 50g.6.6 Special precautions for disposal and other handling
Not applicable.
- Company Detail Path
- /organization/thornton-and-ross-ltd
