TruScient
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
03-02-2015
Karatteristiċi tal-prodott
(SPC)
03-02-2015
Rapport ta 'Valutazzjoni Pubblika
(PAR)
03-02-2015
Ingredjent attiv:
dibotermin alfa
Disponibbli minn:
Zoetis Belgium SA
Kodiċi ATC:
QM05BC01
INN (Isem Internazzjonali):
dibotermin alfa
Grupp terapewtiku:
Dogs
Żona terapewtika:
Bone morphogenetic proteins
Indikazzjonijiet terapewtiċi:
Osteoinductive agent for use in the treatment of long-bone fractures as an adjunct to standard surgical care using open fracture reduction in dogs.
Sommarju tal-prodott:
Revision: 4
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2011-12-14
Fuljett ta 'informazzjoni
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
TruScient 0.66 mg kit for implant for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of lyophilisate contains:
Dibotermin alfa (rhBMP-2)*
0.66 mg
After reconstitution TruScient contains 0.2 mg/ml of dibotermin alfa
(rhBMP-2)
*Dibotermin alfa (recombinant human Bone Morphogenetic Protein-2;
rhBMP-2) is a human protein
derived from a recombinant Chinese Hamster Ovary (CHO) cell line.
Two sponges made of Bovine Type I collagen.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Kit for implant
White lyophilisate and a clear colourless solvent.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of diaphyseal fractures as an adjunct to standard surgical
care using open fracture reduction
in dogs.
4.3
CONTRAINDICATIONS
Do not use in dogs with a known hypersensitivity to the active
substance or to any of the excipients.
Do not use in dogs that are skeletally immature, have an active
infection at the operative site,
pathological fracture, or any active malignancy.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
This veterinary medicinal product should be used by an appropriately
qualified veterinarian.
Failure to follow the TruScient instructions for preparation and use
may compromise safety and
effectiveness.
Medicinal product no longer authorised
3
In order to avoid excessive postoperative swelling, use only the
amount of prepared TruScient sponge
needed to achieve coverage of accessible fracture lines and defects
(less than one to up to two prepared
sponges).
TruScient can cause initial resorption of surrounding trabecular bone.
Therefore, in the absence of
clinical data, the veterinary medicinal product should not be used for
direct applications to trabecular
bone when transient bone r
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
TruScient 0.66 mg kit for implant for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of lyophilisate contains:
Dibotermin alfa (rhBMP-2)*
0.66 mg
After reconstitution TruScient contains 0.2 mg/ml of dibotermin alfa
(rhBMP-2)
*Dibotermin alfa (recombinant human Bone Morphogenetic Protein-2;
rhBMP-2) is a human protein
derived from a recombinant Chinese Hamster Ovary (CHO) cell line.
Two sponges made of Bovine Type I collagen.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Kit for implant
White lyophilisate and a clear colourless solvent.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of diaphyseal fractures as an adjunct to standard surgical
care using open fracture reduction
in dogs.
4.3
CONTRAINDICATIONS
Do not use in dogs with a known hypersensitivity to the active
substance or to any of the excipients.
Do not use in dogs that are skeletally immature, have an active
infection at the operative site,
pathological fracture, or any active malignancy.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
This veterinary medicinal product should be used by an appropriately
qualified veterinarian.
Failure to follow the TruScient instructions for preparation and use
may compromise safety and
effectiveness.
Medicinal product no longer authorised
3
In order to avoid excessive postoperative swelling, use only the
amount of prepared TruScient sponge
needed to achieve coverage of accessible fracture lines and defects
(less than one to up to two prepared
sponges).
TruScient can cause initial resorption of surrounding trabecular bone.
Therefore, in the absence of
clinical data, the veterinary medicinal product should not be used for
direct applications to trabecular
bone when transient bone r
Aqra d-dokument sħiħ
