- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6. Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
2. Qualitative and quantitative composition
Heparinoid 0.3% w/w (Equivalent to 25 000 Units per 100 g cream).
3. Pharmaceutical form
4. 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.
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.
4.5 Interaction with other medicinal products and other forms of interaction
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
4.8 Undesirable effects
In the absence of any reports of the accidental ingestion of Hirudoid, no specific advice is available. General supportive measures may be appropriate.
5. 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
6. Pharmaceutical particulars
6.1 List of excipients
Anhydrous eucerineEmulsifying cetostearyl alcohol type AGlycerolIsopropyl alcoholMethyl parahydroxybenzoate (E218)Myristyl alcohol, potassium hydroxidePropyl parahydroxybenzoate (E216)Purified waterStearic acidThymol
6.3 Shelf life
6.4 Special precautions for storage
Store below 25°C.
6.5 Nature and contents of container
Lacquered aluminium tubes 14, 40, 50 g.
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
Genus Pharmaceuticals LimitedT/A Genus PharmaceuticalsPark View House65 London RoadNewburyBerkshire RG14 1JNUnited Kingdom
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
02 February 2006
10. Date of revision of the text
23 July 2008
Linthwaite, Huddersfield, West Yorkshire, HD7 5QH, UK
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