Osteopen 100 mg/ml Solution for injection for dogs

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Pentosan polysulphate sodium

Διαθέσιμο από:

Chanelle Pharmaceuticals Manufacturing Limited

Φαρμακολογική κατηγορία (ATC):

QM01AX90

INN (Διεθνής Όνομα):

Pentosan polysulphate sodium

Δοσολογία:

100 milligram(s)/millilitre

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική περιοχή:

pentosan polysulfate sodium

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2018-07-20

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
05 May 2021
CRN00C56S
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Osteopen 100 mg/ml Solution for injection for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Pentosan Polysulphate Sodium 100 mg/ml
EXCIPIENTS:
Benzyl Alcohol E1519 10.45 mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection.
A clear pale yellow aqueous solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of lameness and pain of degenerative joint
disease/osteoarthritis (non-infectious arthrosis) in the skeletally
mature dog.
4.3 CONTRAINDICATIONS
Do not use in the treatment of septic arthritis. In this case,
appropriate antimicrobial therapy should be instigated.
Do not use in dogs with advanced liver or kidney impairment, or
evidence of infection.
Do not use in known cases of hypersensitivity to the active substance
or to any of the excipients.
Do not use in the skeletally immature dog (i.e. dogs whose long bone
growth plates have not closed).
As pentosan polysulphate has an anticoagulant effect, do not use in
dogs with blood disorders, coagulation disorders,
bleeding, trauma or malignancy (especially haemangiosarcoma) or during
the peri-operative period within 6 – 8 hours of
surgery.
Do not use in arthritides of immunological origin (e.g. rheumatoid
arthritis).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
A clinical effect may not be observed until after the second injection
of the course of treatment.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Do not exceed the standard dose. Increasing the recommended dose may
result in exacerbation of stiffness and discomfort.
Because of the fibrinolytic action of pentosan polysulphate sodium,
the possibility of internal bleeding from a tumour or
vascular abnormality should be considered and appropriate therapeutic
action taken.
It has bee