LASONIL 5000/15000 %v/v Ointment
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
03-05-2024
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Active ingredient:
HEPARINOID HYALURONIDASE
Available from:
Bayer PLC
INN (International Name):
HEPARINOID HYALURONIDASE
Dosage:
5000/15000 %v/v
Pharmaceutical form:
Ointment
Authorization status:
Withdrawn
Authorization date:
2007-09-04
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lasonil 0.8 % w/w Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100g of ointment contains heparinoid 5000 HDB-U (Heparinoid Bayer Units) equivalent to 0.8 % w/w.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Ointment
Yellow ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The topical management of traumatic conditions, e.g. bruises, sprains and soft tissue injuries.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Lasonil should be applied thickly and gently massaged into the affected area two or three times daily. There is no
special dosage for children.
4.3 CONTRAINDICATIONS
The ointment is contraindicated for use in patients with known hypersensitivity to any of the ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Lasonil should be applied to unbroken skin only. Lasonil should not be applied to open or infected wounds or ulcers.
A physician should be consulted if symptoms persist.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
Concurrent use of this product with systemically administered anticoagulants may lead to further prolongation of
prothrombin time.
4.6 PREGNANCY AND LACTATION
There is no evidence to suggest that Lasonil should not be used during pregnancy and lactation. However, it should be
used with caution during the first trimester.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 10/08/2006_
_CRN 2026635_
_page number: 1_
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.
4.8 UNDESIRABLE EFFECTS
Very rarely (<1/10,000) erythema and hypersensitivity reactions occur which subside when treatment with the ointment
is stopped.
4.9 OVERDOSE
In the unlik
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