Bula do remedy Ronvan

the package insert of the medicine Ronvan. Active principles Fosfetrol.

what For?

Carcinoma metastatic to the prostate.

Contraindications

When should I not use?

there are No known absolute contra-indications.

Dosage

How to use?

The administration of RONVAN injectable should be performed by intravenous injection slowly, with the patient lying down. Doses of 20 ml or more should be administered only in an infusion drip. The pills should be taken with a little liquid, before food. Patients with disorders of gastric should dissolve slowly the tablet in the mouth, favoring the absorption by the buccal mucosa. The dosage varies from one patient to another and is different in initial therapy and in maintenance. The dosage indicated to follow r should be considered a general rule. Initial treatment should be intensive, with intravenous injections daily. Start with 600mg (two vials), every day, by intravenous injection slowly, over five to ten days. Then, administer every day 300mg (one ampoule), during ten to 20 days. In special cases, the injections intravenous should extend for a longer period, and the doses may be increased to up to 1200 mg (four vials) a day. Patients with insufficiency of the myocardium, d istúrbios kidney or liver should also receive doses imciais under 300mg daily (one ampule) by intravenous injection slowly, over a period of ten to 20 days. If it is not possible to administer injections RONVAN, daily, the initial therapy can also be performed orally, with administration of three to four tablets RONVAN three times a day. in cases that are not very advanced. Maintenance treatment – to establish the improvement of the clinical point of view, and the biochemical, the maintenance treatment can be carried out with a dosage lower. In this case, it is recommended the use of RONVAN tablets, starting with two tablets three times a day, for two to three months, reducing the dose, and later to one tablet, three times a day. during two to three months. Finally, administer one to two tablets a day. It is very important that the daily treatment is done semqualquer interrupt. If there are signs of worsening of the disease, the doses diàrias should be increased, returning, if necessary, to the schema of the initial treatment. Therapy mamutenção can also be performed with intravenous injections of RONVAN, administering, at the beginning, one to two ampoules, three aquatro times per week for one to two months. Then, one to two light bulbs, two times per week, for two to four months. Finally, an injection of 300mg (1 ampoule) once a week, during vános months. The route of administration and the dose should be determined according to the clinical data and the biochemical of the patient. Thus, it is necessary to carry out the provisions of phosphatases serum at regular intervals of time.Attention -RONVAN should be used with caution in patients with disorders of liver function. Patients with insufficiency cariovascular or circulatory (manifest or latent) should be treated appropriately.

Side Effects

What are the evils that can cause me?

injections of RONVAN can be accompanied by burning, itching or pain in the anogenital. These manifestations during or
immediately after the injections are harmless and disappear quickly. To control this adverse reaction, you may administer a sedative or umanti-histamine effect sedatvo, or inject the RONVAN solution of glucose or levulose. These symptoms also
may manifest after administration of tablets RONVAN.

Warnings and Precautions

what should I know before using?

Although estrogenic side effects are relatively mild, one can not exclude the possibility that heart failure
(latent or manifest), disorders circulatónos or liquid retention may be aggravated during treatment with RONVAN.

There is heart failure or circulatory disorders, you should establish promptly an adequate treatment. Patients with disorders of liver function require special care

Drug Interactions

RONVAN injectable solution must not be mixed with solutions for infusion containing salts of calcium salts or magnesium.

Introduction

Ronvan® fosfestrol tetrossódico

Rendering and Display

injectable Solution – each ampoule of 5ml contains 300mB of fosfestrol tetrassódico corresponding to 250mg of diphosphate
dietilestilbestrol.

Tablets -each tablet contains 120mg of fosfestrol tetrassódico corresponding to 100mg of e dietilestilbestrol.

RONVAN is presented in a box with ten vials of 5 ml box with 50 tablets.

Properties

Pharmacology – fosfestrol and transformed into dietilestilbostrol , citostaticamente active , through sdoramento enzimatico
groups of phosphoric acid. Odietilestilbestrol is quickly inactivated in the serum and in the tissues which binds to proteins. In carcinomade prostate and their metastases are quite favorable conditions for the unfolding of enzyme molecule fosfestrol, that is, the pH around 5.5 with high activity of acid phosphatase. Thus, a large amount of dieblestilbestrol free and slightly soluble is released intracelularmente,depositing in the tissues tumor.It is in this particuaridade biochemistry of prostatic tissue that resides agreat specificity organic effect RONVAN.

Pharmacokinetic – the phosphatases are able to desfosforilar e dietilestilbestrol in vitro and in vivo. In the blood, the
dietilestilbestrol livrejápode serdetectado five minutes after the injection of fosfestrol tetrassódico. This breakdown enzyme
promotes the release of monophosphate dietilestilbestrol in the body. Proved if also the release of monotosfato
dedietilestilbestrol in vitro. The metabolite main fosfestrol, that is, the dietilestilbestrol, represents the way citostaticamente active
prepared. The rest of the metabolizacão occurs rapidly by conjugation with glicuronato or sulfate.

Laboratory

Asta Médica Ltda.

Tel: (11) 3209-1660

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Attention: the remedy of The earth is a space character only, with issues related to health and well-being, The information here disclosed shall not be used as a substitute for a doctor’s prescription for the treatment of any disease.