Fibrinogen with human thrombin 40mg + 250 units/ml 2ml, 4ml, 10ml sealant
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Surgical sealant containing fibrinogen and human thrombin.
Drugs List
Therapeutic Indications
Uses
Adjunctive haemostatic in surgery when other methods insufficient
Supportive treatment in adults where standard surgical techniques are insufficient:
for improvement of haemostasis,
as suture support: in vascular surgery.
Dosage
Adults
The volume of sealant to be applied and the frequency of application depends on the underlying clinical needs of the individual patient, the type of surgical intervention, the size of the area, the mode of application and the number of applications.
In clinical trials the individual dosage ranged from 0.3ml to 12ml. Larger volumes may be required for some procedures.
The initial volume to be applied should be sufficient to entirely cover the intended application area. The application may be repeated if required.
Administration
For epilesional administration.
The surface of the wound should be as dry as possible before the sealant is applied.
Application by dripping
Keep the tip of the applicator as close to the tissue surface as possible (not touching the tissue) and apply individual drops to the area to be treated.
Application by spraying
Connect the applicator to the pressure regulator according to the manufacturers instructions.
The solution should be sprayed at least 2cm away from the target tissue. Increase distance accordingly to achieve desired coverage of the target area.
Contraindications
Severe or brisk arterial haemorrhage
Precautions and Warnings
Children under 18 years
Breastfeeding
Pregnancy
Derived from human proteins - transmission of infective agents possible
Cover all the tissue adjacent to the site of sealing before application
Record name and batch number of administered product
Remove solutions containing alcohol/iodine/heavy metals before application
Treatment to be administered under the supervision of a specialist
For epilesional use only
Management of cases of shock should follow current medical standards
Discontinue if hypersensitivity reactions occur
Unintentional intravascular application may lead to life threatening thromboembolic complications.
The sealant should only be used if it is possible to accurately judge the spray distance, especially during laparoscopy.
Apply sealant as a thin layer. Excessive clot thickness may impair efficacy and the wound healing process.
Fibrinogen with human thrombin sealant should not be used in tissue gluing, neurosurgery, gastrointestinal anastomoses or application through a flexible endoscope for treatment of bleeding.
Pregnancy and Lactation
Pregnancy
Use fibrinogen with human thrombin sealant with caution during pregnancy.
The manufacturer does not recommend using fibrinogen with human thrombin sealant during pregnancy unless it is clearly needed. At the time of writing there is limited published information regarding the use of fibrinogen with human thrombin sealant during pregnancy. Potential risks are unknown.
Lactation
Use fibrinogen with human thrombin sealant with caution during breastfeeding.
The manufacturer does not recommend breastfeeding whilst using fibrinogen with human thrombin sealant unless it is clearly needed. The presence of fibrinogen with human thrombin in human breast milk and the effects on exposed infants are unknown.
Side Effects
Abnormal INR
Abscess
Alanine aminotransferase increased
Anaemia
Anaphylaxis
Angioedema
Antibody formation
Anxiety
Aspartate aminotransferase increased
Atrial fibrillation
Back pain
Bladder spasm
Bronchospasm
Cellulitis
Chest tightness
Chills
Conjunctival irritation
Constipation
Contusion
Deep vein thrombosis (DVT)
Dyspnoea
Dysuria
Ecchymosis
Elevated blood glucose (transient)
Emboli formation
Erythema
Flatulence
Flushing
Haematoma
Haemoglobin decrease
Haemorrhage
Haemorrhagic anaemia
Headache
Hives
Hyperglycaemia
Hyperkalaemia
Hypersensitivity reactions
Hypertension
Hyperthermia
Hypocalcaemia
Hypoglycaemia
Hypokalaemia
Hypomagnesaemia
Hyponatraemia
Hypoproteinaemia
Hypotension
Hypoxia
Ileus
Increase in serum transaminases
Increased partial thromboplastin time
Infections
Insomnia
Lethargy
Leukocytosis
Leukopenia
Local burning
Nausea
Operative wound haemorrhage
Painful extremities
Parvovirus B19 infection
Peripheral oedema
Peritonitis
Plasma cell myeloma
Pleural effusion
Pleurisy
Post procedural haemorrhage
Procedural hypotension
Procedural pain
Prothrombin time increased
Pruritus
Pulmonary embolism
Pulmonary oedema
Pyrexia
Restlessness
Retroperitoneal haematoma
Rhonchi
Serum bilirubin increased
Somnolence
Stinging
Tachycardia
Tingling sensation
Urinary retention
Urticaria
Vascular graft complications
Vascular graft occlusion
Vascular graft thrombosis
Ventricular tachycardia
Vessel puncture site haematoma
Vomiting
Wheezing
Wound secretion
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: November 2020
Reference Sources
Summary of Product Characteristics: VeraSeal solutions for sealant. Instituto Grifols, S.A. Revised November 2017.
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