Fibrinogen with human thrombin sealant matrix implant
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Sealant matrix implant containing human fibrinogen and human thrombin.
Drugs List
Therapeutic Indications
Uses
Adjunctive haemostatic in surgery when other methods insufficient
Neurosurgery dura mater sealant: Prevention of postoperative CSF leakage
Dosage
Adults
Individual dosages have typically ranged from 1 to 3 units in clinical trials. Application of up to 10 units has been reported.
Administration
For epilesional use during surgery only.
Contraindications
Children under 18 years
Precautions and Warnings
Breastfeeding
Haemolytic anaemia
Immunodeficiency syndromes
Pregnancy
Treatment to be initiated and supervised by a specialist
Derived from human proteins - transmission of infective agents possible
Cleanse tissue areas outside desired application site before administration
Record name and batch number of administered product
Remove solutions containing alcohol/iodine/heavy metals before application
Management of cases of shock should follow current medical standards
Discontinue if hypersensitivity reactions occur
Pregnancy and Lactation
Pregnancy
Use fibrinogen with human thrombin with caution during pregnancy.
The manufacturer advises caution if fibrinogen with human thrombin is used during pregnancy. At the time of writing there is limited published information regarding the use of this product during pregnancy. Potential risks are unknown.
Lactation
Use fibrinogen with human thrombin with caution during breastfeeding.
The manufacturer advises caution if fibrinogen with human thrombin is used when breastfeeding. The presence of this product in human breast milk and the effects on exposed infants are unknown.
Side Effects
Adhesions
Anaphylaxis
Angioedema
Antibody formation
Bronchospasm
Burning sensation (local)
Chest tightness
Chills
Flushing
Headache
Hives
Hypersensitivity reactions
Hypotension
Intestinal obstruction
Lethargy
Nausea
Restlessness
Shock
Stinging
Tachycardia
Thrombosis
Tingling sensation
Urticaria
Vomiting
Wheezing
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: September 2019
Reference Sources
Summary of Product Characteristics: TachoSil sealant matrix. Nycomed UK Ltd. Revised May 2018.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.