TruScient

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
03-02-2015
Summary of Product characteristics Summary of Product characteristics (SPC)
03-02-2015
Public Assessment Report Public Assessment Report (PAR)
03-02-2015

Active ingredient:

dibotermin alfa

Available from:

Zoetis Belgium SA

ATC code:

QM05BC01

INN (International Name):

dibotermin alfa

Therapeutic group:

Dogs

Therapeutic area:

Bone morphogenetic proteins

Therapeutic indications:

Osteoinductive agent for use in the treatment of long-bone fractures as an adjunct to standard surgical care using open fracture reduction in dogs.

Product summary:

Revision: 4

Authorization status:

Withdrawn

Authorization date:

2011-12-14

Patient Information leaflet

                                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
                                
                                Read the complete document

Summary of Product characteristics

                                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
                                
                                Read the complete document

Similar products

Active ingredient dibotermin alfa

dibotermin alfa

ATC code QM05BC01

QM05BC01

Marketed by Zoetis Belgium SA

Zoetis Belgium SA

INN (International Name) dibotermin alfa

dibotermin alfa

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Patient Information leaflet Patient Information leaflet Bulgarian 03-02-2015
Summary of Product characteristics Summary of Product characteristics Bulgarian 03-02-2015
Public Assessment Report Public Assessment Report Bulgarian 03-02-2015
Patient Information leaflet Patient Information leaflet Spanish 03-02-2015
Summary of Product characteristics Summary of Product characteristics Spanish 03-02-2015
Public Assessment Report Public Assessment Report Spanish 03-02-2015
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Patient Information leaflet Patient Information leaflet Danish 03-02-2015
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Public Assessment Report Public Assessment Report Danish 03-02-2015
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Summary of Product characteristics Summary of Product characteristics German 03-02-2015
Public Assessment Report Public Assessment Report German 03-02-2015
Patient Information leaflet Patient Information leaflet Estonian 03-02-2015
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Public Assessment Report Public Assessment Report Estonian 03-02-2015
Patient Information leaflet Patient Information leaflet Greek 03-02-2015
Summary of Product characteristics Summary of Product characteristics Greek 03-02-2015
Public Assessment Report Public Assessment Report Greek 03-02-2015
Patient Information leaflet Patient Information leaflet French 03-02-2015
Summary of Product characteristics Summary of Product characteristics French 03-02-2015
Public Assessment Report Public Assessment Report French 03-02-2015
Patient Information leaflet Patient Information leaflet Italian 03-02-2015
Summary of Product characteristics Summary of Product characteristics Italian 03-02-2015
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Public Assessment Report Public Assessment Report Hungarian 03-02-2015
Patient Information leaflet Patient Information leaflet Maltese 03-02-2015
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Patient Information leaflet Patient Information leaflet Dutch 03-02-2015
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Patient Information leaflet Patient Information leaflet Romanian 03-02-2015
Summary of Product characteristics Summary of Product characteristics Romanian 03-02-2015
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Patient Information leaflet Patient Information leaflet Slovak 03-02-2015
Summary of Product characteristics Summary of Product characteristics Slovak 03-02-2015
Public Assessment Report Public Assessment Report Slovak 03-02-2015
Patient Information leaflet Patient Information leaflet Slovenian 03-02-2015
Summary of Product characteristics Summary of Product characteristics Slovenian 03-02-2015
Public Assessment Report Public Assessment Report Slovenian 03-02-2015
Patient Information leaflet Patient Information leaflet Finnish 03-02-2015
Summary of Product characteristics Summary of Product characteristics Finnish 03-02-2015
Public Assessment Report Public Assessment Report Finnish 03-02-2015
Patient Information leaflet Patient Information leaflet Swedish 03-02-2015
Summary of Product characteristics Summary of Product characteristics Swedish 03-02-2015
Public Assessment Report Public Assessment Report Swedish 03-02-2015
Patient Information leaflet Patient Information leaflet Norwegian 03-02-2015
Summary of Product characteristics Summary of Product characteristics Norwegian 03-02-2015
Patient Information leaflet Patient Information leaflet Icelandic 03-02-2015
Summary of Product characteristics Summary of Product characteristics Icelandic 03-02-2015

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