Bula do remedy Septopal

the package insert of the medicine Septopal. Therapeutic class of the Systemic Antibiotics. Active principlesGentamicin and polymethyl methacrylate (pmma). Sale under medical prescription.

what For?

SEPTOPAL is to be inserted surgically in the bones and soft parts, for the treatment and prophylaxis of infections caused by microorganisms sensitive to gentamicin.

Contraindications

When should I not use?

Recognized hypersensitivity to gentamicin; infections by microorganisms sensitive to gentamicin.

Dosage

How to use?

the basic Condition for the effectiveness of antibiotic therapy in infections abscedantes of bones and soft parts, is the careful surgical cleaning of the focus of infection.

Before the implant of the chain septopal, all tissues devitalized, such as kidnappings bone and soft parts necrosadas, as well as any implant aloplástico (material for osteosynthesis and endoprostheses), should be removed completely in the surgical act. if the kidnappings bone are not fully eliminated during surgery or are left parts of osteossínteses, the bacteria present in the tissues of the necrotic and in the spaces existing between the prosthesis and the bone would not be affected, in its entirety, by the antibiotic released on the site.

After a surgical revision with careful removal of the parts desvitalizadas, fills the cavity filling with blood, of the bones or soft parts, with strings of septopal. the amount of chains depends on the size of the cavity to be filled.

In the employment of one or more chains of septopal must consider the direction in which they are placed, to facilitate their future removal. in the cavities rounded the best results were obtained with its placement in the form of meanders, while in the cavities cylindrical should remain stretched out.

The chain septopal may not be bent, in order to avoid the breakage of the yarn during its withdrawal.

The strings of septopal may be used in the short-and long-term, as follows:
1. the application in bone infections in the short term
After total removal of kidnappings bone and careful surgical cleaning, you must completely fill the cavity resulting one or more chains of septopal, taking into account the direction to facilitate its subsequent extraction. put the string, it leaves the last pearl to stand out at the level of the skin.

long enough for septopal to act in the infectious process is 10 to 14 days. after this period is done-if its withdrawal by the pearl exteriorized, through
The manual draw simple, slowly and with constant force, there is no need for anesthesia.

For the removal of the septopal®, you should not let than two weeks after the surgery, because the less time the beads settle in the connective tissue post-operatively, the easier will be the extraction.

When you are planning to stay in the jail for a longer period of time, you can make the withdrawal to the few, externalizing gradually over one or a few pearls from the 10th day of the postoperative period.

2. application in bone infections in the long term
In special cases the string can be fully inserted and extracted after a few months, through new surgical intervention.

in These cases, the chain septopal serves, in addition, to save the place for the sponge or other implant in the same cavity, now free of the infection.

3. application in infections of the soft parts
After a thorough surgical cleaning, the alicação of septopal occurs as is indicated in the item 1. the extraction of the chain can take place from the 7th postoperative day.

Remarks
In all cases the wound should be sutured and, when there is a loss of substance, it is advisable to cover with the graft or synthetic material.

Is contra-indicated, in all cases, the drain of washed and suction. you should use, where necessary, a drain simple drain de redon), in order to avoid the rapid flow of the hematoma post-operatively that will form (in which the gentamicin released is found in high concentrations), which would have led to the fall of the antibacterial action of gentamicin.

Attention
The scholarship paper aluminized (non-sterile), the inner pocket separable (non-sterile) and the plastic bag inner (sterile) containing the product should only be opened at the time of surgery, in the environment aseptic.

The segments of chain septopal, remnants of a surgery, can not be sterilized and should be destroyed.

Conduct in overdose and adverse reactions
Are not expect problems arising from overdosage. as there is no specific antidote, treatment of adverse reactions arising from the gentamicin should be symptomatic and supportive with possible withdrawal early in the chain, and hemodialysis or peritoneal dialysis for the elimination of the antibiotic.

Side Effects

What are the evils that can cause me?

For to be minimum the amount of gentamicin that reaches the systemic circulation after the placement of the chain SEPTOPAL, it is reduced the possibility of occurrence of adverse reactions. With the intramuscular administration or injection of gentamicin can be observed the following reactions:
nephrotoxicity – characterized by significant increase or reduction in the frequency or volume of urination, increased thirst, loss of appetite,
nausea, vomiting;
neurotoxicity – muscle spasms, dormências, seizures, tingling;
ototoxicity – hearing loss, tinnitus, or a sensation of fullness in the ears, tonteiras, nausea, vomiting, loss of balance.

Less frequently observed with the intramuscular administration or injection of gentamicin:
hypersensitivity reactions – itching, erythema, rashes or swellings on the skin;
neuromuscular blockade – breathing difficult, dizziness, weakness.

Warnings and Precautions

what should I know before using?

Despite being minimal the amount of gentamicin that reaches the circulção blood, the product should be applied with caution in:
nefropatas;
patients in use of medicines oto and nephrotoxic;
patients with a history of allergic reactions to other aminoglicosídios;
patients with myasthenia gravis or parkinsonism.