INDICATIONS
For short-term use (2 to 8 days) in hemophilia patients to reduce or prevent haemorrhage and to reduce the need for replacement therapy during and following tooth extraction.
For many hemostatic purposes including prevention of bleeding after surgery of trauma (e.g. Tonsillectomy and adenoidectomy, prostatic surgery, ocular trauma and cervical conisation), and to prevent TR bleeding of subarachnoid haemorrhage, spontaneous bleeding in hemophilis and spontaneous or postoperative comeal edema.
To treat primary or IUD-induced menorrhagia , gastric and intestinal haemorrhage, recurrent epistaxis and hereditary angioneurotic  treatment with plasminogen activators.

USAGE IN PREGNANCY
Reproduction studies in mice, rates and rabbits have not revealed any evidence of impaired fertility or adverse effects on the foetus. There are no adequate and well controlled studies in pregnant woman, however, HEMSAMIC passes the placenta and appears in cord blood at concentrations approximately equal to maternal concentrations. Use only if clearly needed.

USAGE IN LACTATION
HEMSAMIC is present in breast milk at 1% of the corresponding serum levels.
Exercise caution when administering to nursing women.

USAGE IN CHILDREN
The drug has had limited use in children principally in connection with tooth extraction. Limited data suggest that dosing instructions for adults can be used for children needing HEMSAMIC therapy.

DOSAGE AND ADMINISTRATION
For dental extraction in patients with hemophilia: immediately before surgery, substitution therapy is given with HEMSAMIC 10mg/kg IV. After surgery, give 25 mg/kg orally 3 to 4 times daily for 2 to 8 days.

Alternative:
Give 25 mg/kg orally, 3 to 4 times/day beginning one day prior to surgery.
Parenteral:
10 mg/kg 3 to 4 times/day for patients unable to take oral medication.

(Dose should be reduced in renal impediment)
Impaired renal function (moderate to severe):
The following dosages are recommended:

Preparation of Solution:
For IV infusion, HEMSAMIC may be mixed with most solutions for infusion such as electrolyte, carbohydrate, amino acids & dextran solutions. Prepare mixture the same day solution is to be used . Heparin may be added to solution for injection. Do not mix with blood. The drug is a synthetic amino acid . DO NOT mix with solutions containing penicillin.

PRESENTATIONS
500 mg/5 ml Ampoules of 1 x 5’s in a carton.

Manufatured by:
TABROS PHARMA (PVT) LTD., Pakistan