Arista 3mg hemostase poeder

Arista hemostase poeder

Arista AH is indicated in surgical procedures (except neurological and ophthalmic) as an adjunctive hemostatic device to assist when control of capillary, venous, and arteriolar bleeding by pressure, ligature, and other conventional procedures are ineffective or impractical.

CONTRAINDICATIONS
Do not inject or place Arista AH into blood vessels as potential for embolization and death may exist.

WARNINGS
Arista AH is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis.
Once hemostasis is achieved, excess Arista AH should be removed from the site of application by irrigation and aspiration particularly when used in and around foramina of bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm. Arista AH swells to its maximum volume immediately upon contact with blood or other fluids. Dry, white Arista AH should be removed. The possibility of the product interfering with normal function and/or causing compression necrosis of surrounding tissues due to swelling is reduced by removal of excess dry material.

Safety and effectiveness of Arista AH have not been clinically evaluated in children and pregnant women. Because there have been reports of decreased amylase activity in newborns up to 10 months, absorption rates of Arista AH in this population may be longer than 48 hours.
Arista AH should be used with caution in the presence of infection or in contaminated areas of the body. If signs of infection or abscess develop where Arista AH has been applied, re-operation may be necessary in order to allow drainage. Safety and effectiveness in neurosurgical and ophthalmic procedures has not been established.
Arista AH should not be used for controlling post-partum bleeding or menorrhagia.

PRECAUTIONS
When Arista AH is used in conjunction with autologous blood salvage circuits, carefully follow instructions in the Administration section of the IFU regarding proper filtration and cell washing.
Arista AH is intended to be used in a dry state. Contact with saline or antibiotic solutions prior to achieving hemostasis will result in loss of hemostatic potential.
Arista AH is not recommended for the primary treatment of coagulation disorders. No testing has been performed on the use of Arista AH on bone surfaces to which prosthetic materials are to be attached with adhesives and is therefore not recommended. Arista AH is supplied as a sterile product and cannot be resterilized. Unused, open containers of Arista AH should be discarded.
Do not apply more than 50g of Arista AH in diabetic patients as it has been calculated that amounts in excess of 50g could affect the glucose load.
In urological procedures, Arista AH should not be left in the renal pelvis or ureters to eliminate the potential foci for calculus formation.

ADVERSE REACTIONS
None of the adverse events that occurred in a randomized prospective, concurrently controlled clinical trial were judged by the Data Safety Monitoring Board to be related to the use of Arista AH. The most common recorded adverse events were pain related to surgery, anemia, nausea, lab values out of normal range, arrhythmia, constipation, respiratory dysfunction and hypotension – all reported in greater than 10% of the Arista AH treated patients. The details of this clinical trial’s adverse events can be reviewed in the IFU supplied with the product and are also available at www.bd.com.
Caution: Federal (USA) law restricts this device to sale by or on order of a licensed physician or properly licensed practitioner.