- Approval Id
- f83da2b8a41bd01b
- Drug Name
- VERASEAL SOLUTIONS FOR SEALANT, 80 mg/ml, 500 IU/ml
- Product Name
- VERASEAL SOLUTIONS FOR SEALANT, 80 mg/ml, 500 IU/ml
- Approval Number
- SIN16143P
- Approval Date
- 2021-04-01
- Registrant
- GRIFOLS ASIA PACIFIC PTE. LTD.
- Licence Holder
- GRIFOLS ASIA PACIFIC PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- SOLUTION
- Dosage
- **Posology and method of administration**
The use of VeraSeal is restricted to experienced surgeons who have been trained in the use of this medicinal product.
Posology
The volume of VeraSeal to be applied and the frequency of application should always be oriented towards the underlying clinical needs for the patient.
The dose to be applied is governed by variables including, but not limited to, the type of surgical intervention, the size of the area and the mode of intended application, and the number of applications.
Application of the product must be individualised by the treating physician. In clinical trials, the individual dosages have typically ranged from 0.3 to 12 ml. For other procedures, larger volumes may be required.
The initial volume of the product to be applied at a chosen anatomic site or target surface area should be sufficient to entirely cover the intended application area. The application can be repeated, if necessary.
_Paediatric population_
The safety and efficacy of VeraSeal in children aged 0 to 18 years has not yet been established. Currently available data are described in section _Pharmacodynamic properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_, but no recommendation on a posology can be made.
Method of administration
For epilesional use.
For instructions on preparation of the medicinal product before administration, see section _Instructions for use, handling and disposal_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. The product should only be administered according to the instructions and with the devices recommended for this product (see section _Instructions for use, handling and disposal_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Prior to applying VeraSeal, the surface area of the wound needs to be dried by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices).
For spray application, see sections _Special warnings and precautions for use_ and _Instructions for use, handling and disposal_ for specific recommendations on the required distance from tissue per surgical procedure – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
- Route Of Administration
- OTHERS
- Indication Info
- **Therapeutic indications**
VeraSeal is indicated as supportive treatment in adults where standard surgical techniques are insufficient:
- for improvement of haemostasis.
- as suture support: in vascular surgery.
- Contraindications
- **Contraindications**
VeraSeal must not be applied intravascularly.
Hypersensitivity to the active substance or to any of the excipients listed in section _List of excipients_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
VeraSeal must not be used for the treatment of severe or brisk arterial bleeding.
- Atc Code
- B02BC
- Atc Item Name
- 局部止血药
- Pharma Manufacturer Name
- GRIFOLS ASIA PACIFIC PTE. LTD.
- Company Detail Path
- /organization/f2f647919cb88a86/grifols-asia-pacific-pte-ltd
