Fibrase Ointment 40g 1.5%

NAME
FIBRASE

PHARMACOTHERAPEUTIC CATEGORY
Antithrombotics.

ACTIVE PRINCIPLES
Pentosane polysulfester (SP 54).

EXCIPIENTS
Capsules: corn starch, magnesium stearate, talc, iron oxide (E172), erythrosine (E 127), titanium dioxide, gelatin. Ampoules: sodium levulinate, water for injections. Ointment: decyl oleate, glyceryl monostearate, mixture of cetylstearyl alcohol and non-ionic emulsifiers, potassium sorbate, propylene glycol, mixture of p-hydroxybenzoates, 70% non-crystallizable sorbitol, mixture of antioxidants, (BHA -BHT ascorbyl palmitate), 2-bromo-2 -nitropropane-1,3-diol, purified water.

INDICATIONS
Capsules and ampoules: vascular pathology with thrombotic risk. Ointment: prophylaxis and therapy of superficial thrombophlebitis; varicose veins and varicose ulcers; post-thrombotic and post-traumatic edema; hematomas, contusions, sprains, bursitis, tendovaginitis, chilblains, hemorrhoids.

CONTRAINDICATIONS / SECONDARY EFFECT
Manifest bleeding or bleeding diathesis; haemophilia; immediate abortion, habitual abortion, suspicion of placenta previa, danger of placental rupture; gastroduodenal ulcer in progress; cerebro-vascular accidents; subacute bacterial endocarditis; previous manifestations of thrombocytopenia with heparin; ascertained individual hypersensitivity to the product and to heparin.

DOSAGE
>> 50 mg capsules. Acute and chronic superficial thrombophlebitis and fiebothrombosis: beginning of treatment (first two weeks) 2 capsules, 3 times a day, preferably between meals. Continuation of treatment (for another 4 weeks, or more, in the opinion of the doctor): 2 capsules, 2 times a day, preferably between meals. >> Vials. Acute and chronic superficial thrombophlebitis and phlebothrombosis, prophylaxis of thrombotic complications of varicose veins: 1 ampoule per day, for 1 week, then continue with the drug in capsules for at least 4 weeks, or more, according to the doctor's judgment. Prophylaxis of postoperative deep vein thrombosis: half ampoule im 2 hours before surgery, then half ampoules. every 12 hours starting from the day following the operation for the entire period of time during which the patient is forced to immobility. Ointment: place the ointment on the skin of the diseased part several times and spread it lightly in a thin layer without rubbing. Depending on the extent of the process, squeeze 2-5 cm of ointment from the tube. It is not necessary to bandage because in a few minutes the pomade is absorbed by the skin. in case of ulcers, spread the ointment for 3 - 4 cm around the edges.

STORAGE
Store at a temperature not exceeding 25 degrees C.

WARNINGS
Capsules and ampoules: although the product has little influence on the coagulation mechanism, they are recommended especially in subjects at increased bleeding risk (eg severe liver disease, thrombocytopenias, etc.) periodic checks of the main coagulation tests and platelet counts. The medicine can be taken orally or parenterally. Capsules: when the drug is taken orally, the low molecular weight makes it possible for it to be absorbed well in the intestine and determines its good tolerability. Vials (im or iv): the route of choice of the injectable drug is the intramuscular one. However, the preparation can also be administered intravenously: in this case, before starting any intravenous treatment, it is necessary to test the patient's possible intolerance to the drug by skin reaction (ml 0.1-0.2 intradermally ) and give up the intravenous route in case of local reactions. Ointment: due to its low molecular weight, the ointment does not give rise to anaphylactic reactions and, due to the absence of a vasodilator component, it has no rubefacient effect. Due to its negligible anticoagulant power and the absence of diffusing enzymes, the ointment does not delay the healing of skin ulcers, does not favor the formation of edema and does not have a proflogistic effect. The products for topical application, especially if used for prolonged periods of time, can give rise to hypersensitivity phenomena. In this case, treatment must be interrupted and appropriate therapy instituted.

INTERACTIONS
Capsules and ampoules: in case of concomitant administration of the drug and other drugs that affect haemocoagulability (dicurnarolics, non-steroidal anti-inflammatory drugs, antiplatelet agents, dextrans), the reciprocal enhancement of activity must be taken into account.

SIDE EFFECTS
Similarly to what has been reported with heparin, a moderate and reversible decrease in the number of platelets may occur: major, very serious thrombocytopenias have rarely been reported, which can sometimes be complicated by thrombosis. Some cases of reversible alopecia have been described during intensive and prolonged treatments. It is possible the appearance of hematomas at the injection site, and the finding of an increase in transaminases. Systemic or local allergic reactions have been observed very rarely.

PREGNANCY AND BREASTFEEDING
In case of ascertained or presumed pregnancy and during breastfeeding, administer only if clearly needed.