Biseptol 480 concentrate for the preparation of solution for infusion 80 mg + 16 mg in ampoules of 5 ml 10 pcs — Made in Poland — Free Delivery

Name: Biseptol 480 concentrate for the preparation of solution for infusion 80 mg + 16 mg in ampoules of 5 ml 10 pcs — Made in Poland — Free Delivery
Brand: Polfa Warszawa
Price: 72.6985 USD
Availability: InStock

Brand: Polfa Warszawa
Product Code: Biseptol 480
Availability: In Stock

$72.70

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Description

Product description

Biseptol 480 is an antibacterial preparation containing two active substances - sulfamethoxazole and trimethoprim.

Trimethoprim is excreted mainly by the kidneys, and approximately 50% unchanged in the urine within 24 hours. Several metabolites of trimethoprim have been identified in urine. Sulfamethoxazole is a weak acid with pKa = 6.0. The concentration of the active form of sulfamethoxazole in amniotic fluid, bile, cerebrospinal fluid, middle ear secretion, sputum, synovial fluid, intracellular fluid ranges from 20% to 50% sulfamethoxazole, which is in the blood plasma.

About 66% of sulfamethoxazole binds to plasma proteins. The half-life in individuals with normal renal function is 9 to 11:00. In persons with impaired renal function, the change in the half-life of the active form of sulfamethoxazole has not been established, but an increase in the half-life of the main acetylated metabolite is observed if the creatinine clearance is less than 25 ml / min.

Sulfamethoxazole is excreted primarily by the kidneys, from 15% to 30% of the administered dose is found in urine in an active form. In elderly patients, there is a decrease in the renal clearance of sulfamethoxazole.

Indications for use

Indications of co-trimoxazole in the form of a concentrate for preparation of solution for infusion are the same as for oral forms.

Urinary tract infections: treatment of severe uncomplicated urinary tract infections

treatment and prevention of pneumonia caused by Pneitosustis jiroveci (formerly P. carinii) (PCP)

treatment and prevention of toxoplasmosis.

Contraindications

Hypersensitivity to active ingredients, sulfonamides or trimethoprim, or to any of the excipients.

Severe parenchymal liver disease.

Severe renal impairment (creatinine clearance <15 ml / min), if it is not possible to periodically determine the concentration of trimethoprim and sulfamethoxazole in blood plasma.

Megaloblastic anemia due to folate deficiency.

Immune thrombocytopenia caused by trimethoprim and / or sulfonamides.

Hematological disorders.

Combination with dofetilide.

Deficiency of glucose-6-phosphate dehydrogenase.

Age during the first 6 weeks of life and premature infants, with the exception of PCP prophylaxis in infants from 4 weeks of age.

Method of administration and dosage

Biseptol 480, a concentrate for solution for infusion, is intended for intravenous administration only. Dilute before use.

Biseptol 480 must be diluted immediately before use. When mixing the preparation Biseptol 480 with solutions for infusion, the resulting mixture must be shaken vigorously for complete mixing. If a precipitate is detected or crystals appear in the diluted concentrate, it should be destroyed and a new infusion prepared. The following wiring diagram for Biseptol 480 is recommended:

1 ampoule (5 ml) of Biseptol 480 in 125 ml solution for infusion;

2 ampoules (10 ml) of Biseptol 480 in 250 ml solution for infusion;

3 ampoules (15 ml) of Biseptol 480 in 500 ml solution for infusion.

To dilute the preparation Biseptol 480 use such solutions for infusion

5% and 10% glucose solution

0.9% sodium chloride solution

Ringer's solution;

0.45% sodium chloride solution with 2.5% glucose solution.

Do not use other solutions for diluting the preparation Biseptol 480, except for the above.

The prepared solution of the preparation should not be mixed with other preparations.

The infusion of the preparation should last approximately 60-90 minutes and depends on the patient's degree of hydration.

If the patient is contraindicated in the administration of a large amount of liquid, it is allowed to use a higher concentration of co-trimoxazole - 5 ml in 75 ml of 5% glucose. The finished solution of the preparation should be injected no more than 1:00.

Discard unused solution.

Overdose

The maximum dose tolerated by humans is unknown. Symptoms of acute overdose: nausea, vomiting, diarrhea, colic, headache, vertigo, dizziness, drowsiness, loss of consciousness, confusion, fever, intellectual and visual disturbances, jaundice, blood disorders, in severe cases - crystalluria, hematuria and anuria.

Symptoms of chronic overdose: inhibition of hematopoiesis (thrombocytopenia, leukopenia, megaloblastic anemia), as well as other pathological changes in the blood picture due to folic acid deficiency.

Treatment. In the event of an established, suspected or accidental overdose, the preparation should be discontinued immediately. Increased renal excretion by forced diuresis (alkalinization of urine promotes the elimination of sulfamethoxazole), hemodialysis (peritoneal dialysis is ineffective). It is necessary to monitor the blood picture and the level of electrolytes. With pronounced pathological changes in the blood picture or jaundice, prescribe specific treatment. To eliminate the effect of trimethoprim on hematopoiesis, calcium folinate can be prescribed at a dose of 3-6 mg for 5-7 days.

special instructions

Use during pregnancy or lactation

Pregnancy.

There are no reliable data regarding the use of co-trimaxozole in pregnant women. Studies have shown a possible link between the action of folate antagonists and the development of fetal damage. Trimethoprim is a folic acid antagonist, in animal studies, both active ingredients caused fetal abnormalities.

Co-trimaxozole should not be used during pregnancy, especially in the first trimester, unless absolutely necessary. If necessary, pregnant women should consider the use of folic acid.

Sulfamethoxazole competes with bilirubin for the binding site with blood plasma albumin. If the preparation was used by the mother immediately before childbirth, significant concentrations of the preparation obtained from the mother's body are stored in the newborn for several days, and there is a risk of bilirubin deposition or increased hyperbilirubinemia, which is theoretically associated with the risk of developing kernicterus. This is especially true for newborns with an increased risk of developing hyperbilirubinemia, especially in premature babies and in children with glucose-6-phosphate dehydrogenase deficiency.

Breastfeeding.

Since trimethoprim and sulfamethoxazole pass into breast milk, breastfeeding while taking Biseptol 480 is not recommended, especially for children with hyperbilirubinemia or at risk of developing it.

In addition, the use of co-trimaxozole in infants younger than 8 weeks should be avoided, given the tendency to develop neonatal hyperbilirubinemia.

Children

For use in children over 6 weeks of age.

The ability to influence the reaction rate when driving or driving other mechanisms

Biseptol 480 usually does not directly affect the ability to drive vehicles or work with other mechanisms. However, there is a possibility of side effects from the nervous system and psyche that can affect this ability, in some cases - to a large extent.

Compound

active ingredients: sulfamethoxazolum, trimethoprimum;

1 ml of concentrate contains 80 mg sulfamethoxazole, 16 mg trimethoprim

Excipients: propylene glycol, ethanol 96%, benzyl alcohol, sodium metabisulfite (E 223), sodium hydroxide, sodium hydroxide 10%, water for injection

1 ampoule (5 ml of concentrate) contains 400 mg of sulfamethoxazole and 80 mg of trimethoprim.

Storage conditions

Store in its original packaging at a temperature not exceeding 25 ° C. Do not freeze.

Keep out of the reach of children.

The shelf life is 5 years.

Do not use after the expiration date.

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