FIBRASE POM 40G 1.5%

FIBRASE

active ingredients

Capsules: Each 50 mg capsule contains: Active ingredient: Pentosano polysolfoestere (SP 54) mg Eccipienti: corn starch 71.5 mg magnesium stearate 0.5 mg talc 3,0 mg Capsula orpercolate: iron oxide (E172) 0.276 mg erythrosine (E 127) 0.031 mg titanium dioxide 0,853mg gelatin 38,840 mg Fairytale: Each 1 ml vial contains: Active ingredient: Pentosano polysolfoestere (SP 54) 100 mg Eccipienti: sodium levulinated 15.5 mg water for injectable preparations q. b. 1 ml Potato: 100 g of pomata contain: Active ingredient: Polysulphur dioxide (SP 54) 1,5 g Excipients: decil oleato 10 g Glicerilmonostearato 6,0 g cetistearilic alcohol mixture and non-ionic emulsifiers 6,0 g potassium sorbet 0.2 g propylene glycol 0,75 g palm-hydroxybenzoate mixture 0.2 g sorbitol 70 % non-sylized q.b.a 100 g

Excellent

FIBRASE capsules: Maize starch, magnesium stearate, talc, iron oxide (E172), erythrosine (E 127), titanium dioxide, gelatin. FIBRASE: Excipients Sodium levulinate, water for injectable preparations. FIBRASE ointment: Excipients Decil oleato, glycerylmonostearate, cetilstearilic alcohol mixture and nonionic emulsifiers, sorbate potassium, propylene glycol, p-hydroxybenzoate mixture, 70 % non crystallized sorbitol, antioxidant mixture, (BHA - BHT ascorbile palmitato), 2-bromo-23-nitropropano-1.

Therapeutic indications

Capsules and vials: Vascular pathology with thrombotic risk. Potato: Prophylaxis and treatment of superficial thrombophlebittes; varicose and ulcers; post-trombotic and post-traumatic edemas; hematomas, contusions, sprains, bites, tendovaginiti, frosts, hemorrhoids.

Contraindications

Manifest bleeding or hemorrhagic diathesis. Emofilia. Immediate abortion, habitual abortion, suspect of placenta after, danger of birth break. Gastroduodenal ulcer in place. Damn cerebro-vasculars. Subacute bacterial endocarditis. Previous manifestations of thrombocytopenia with heparin. Individual hypersensiblility ascertained towards the product and towards the heparin.

Population

50 mg capsules: Trombophlebits and acute and chronic surface fiebotrombosis: start care (first two weeks): 2 capsules, 3 times a day, preferably away from meals. Prosecution of care (for another 4 weeks, or more, in medical opinion): 2 capsules, 2 times a day, preferably far from meals. Fairytale: Acute and chronic surface thrombophobics and phlebotrombosis, thrombotic complications of varics: 1 vial per day, for 1 week, then continue with Fibrase capsules for at least 4 weeks, or more, according to the doctor. Prophylaxis of veined trombosis deep postoperatives: half a vial i.m. 2 hours before surgery, half vial indi i.m. every 12 hours starting from the next day the intervention throughout the period of time during which the patient is forced to immobility. Potato: Place the ointment on the skin of the sick part several times a day and spread it slightly in thin layer without frying. Depending on the extension of the process, squeeze from the tube 2 - 5 cm of pomata. It is not necessary to bend because in a few minutes the ointment is absorbed by the skin. in case of ulcers spread the ointment for 3 - 4 cm around the edges.

Conservation

Store at a temperature not exceeding 25°C

Warnings

Capsules and vials: Although the product has little effect on the coagulation mechanism, it can be recommended especially in subjects with increased hemorrhagic risk (e.g. severe hepatopathics, thrombocytopenes, etc.) periodic controls of the main clotting tests and platelet counts. FIBRASE can be taken orally or parentally. Capsules: when the drug is taken orally, the low molecular weight makes it possible to absorb it at the intestinal level and determines its good tolerance. Fiale (i.m. or e.v.): the injectable Fibrase election is the intramuscular one. However, the preparation may also be administered intravenously: in this case, before starting any intravenous treatment, it is necessary to test the possible intolerance of the patient to the drug by skinning (ml 0.1-0.2 intradermically) and to give up the intravenous path in case local reactions occurred. Potato: For its low molecular weight, Fibrase pomata does not give rise to anaphylactic reactions and, due to the absence of vasodilating component, it is devoid of rubefaceting effect. For negligible anticoagulant power and for the absence of diffuser enzymes, Fibrase pomata does not delay the healing of skin ulcers, does not favor the formation of edema and does not carry out prologistic effect. Products for topical application, especially when used for protracted periods of time, can give rise to phenomena of hypersensitivity. In this case it is necessary to stop the treatment and establish suitable therapy.

Interactions

Capsules and vials: In the case of contemporary administration of Fibrase and other drugs that influence hemocoagulation (dicurnarolici, non-steroidal anti-inflammatory, anti-platelet, right-wing aggregants), one must take into account the mutual strengthening of the activity. Potato: None.

Effects

Similarly, with heparine, a moderate and reversible decrease in the number of platelets can occur: trombocytopenes have rarely been reported, very serious, which can sometimes complicate with thrombosis. Some cases of reversible alopecia have been described during intensive and prolonged treatments. It is possible the appearance of hematomas in the injection, and the result of an increase in transamines. Systemic or local allergic reactions have rarely been observed.

Overdosing

No overdose cases have been reported.

In the case of pregnancy established or presumed and during breastfeeding administer only in case of actual need and under the direct control of the doctor.

Source: Farmadati