Biseptol 480 mg. 5 ml. 10 ampoules

SOPHARMA
Biseptol 480 mg. 5 ml. 10 ampoules
€ 32.00
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1 ml concentrate for solution for infusion contains:
active ingredient: 80.00 mg and 16.00 mg Sulfamethoxazole Trimethoprim;
auxiliary ingredients: propylene glycol, sodium hydroxide, ethanol 760 g / l, benzyl alcohol, sodium metabisulfite, water for injections.
Biseptol amp. It is a colorless or yellowish liquid.

1 ampoule of 5 ml contains 400 mg Sulfamethoxazole Trimethoprim and 80 mg.

Packaging: 10 ampoules of 5 ml.

Name of the holder of the commercial rights:
Warsaw Pharmaceutical Works Polfa S.A., Poland.

Contents of the package:
1. What biseptol amp. and what it is used
2. Before using the biseptol amp.
3. How to use biseptol amp.
4. Possible side effects
5. Storing biseptol amp.
6. Further information

1. What biseptol amp. and what it is used
The product is combined chemotherapeutic agent sulfamethoxazole and trimethoprim. They inhibit various stages of the biosynthesis of folic acid, thereby reducing the synthesis of bacterial DNA. The combination showed strong antibacterial effect and causes less frequent emergence of resistant strains than either substance alone.
The product should be used if pathogens are not sensitive to the antibacterial agents straight or oral administration of the preparation is not possible (or is not recommended).

Product is indicated for the treatment of acute and chronic acute infections caused by susceptible organisms requiring parenteral therapy:
Acute and chronic infections of the kidneys and urinary tract;
Acute exacerbation of chronic bronchitis and treatment and prevention of pneumonia caused by Pneumocystis carinii;
Infections of the gastrointestinal tract (typhoid, Paratyphoid, Shigellosis and conditions of the carrier associated with them);
Skin infections;
meningitis;
Toxoplasmosis.

2. Before using the biseptol amp.
Do not use biseptol amp. if reported to any of the following:
Hypersensitivity to sulfonamides or trimethoprim;
Glucose 6-phosphate dehydrogenase deficiency;
Severe renal or hepatic impairment (creatinine clearance below 15 ml / min.);
Damage to blood-forming apparatus;
Macrocytic anemia;
Pregnancy and lactation;
In premature neonates and infants under 3 months there is a risk of kernicterus;
Children under 3 years.
Use biseptol amp. with caution because:
High doses can cause hyponatremia and Crystalluria;
One ampoule product contains 0.5 g of ethanol, which is a potential hazard for those suffering from liver disease, alcoholism, epilepsy, brain injury or disease as well as for pregnant women and children under 3 years. Ethanol may change or enhance the effects of other drugs;
The product contains sodium metabisulphite which can cause allergic-type reactions including anaphylactic symptoms and bronchospasm in susceptible people, especially those with a history of asthma or allergy;
Product contains propylene glycol, which is why long-term use can cause lactic acidosis.
The appearance of skin and hematologic reactions, and diarrhea require immediate discontinuation of treatment.
Consult your doctor even when the above-mentioned warnings related to your past.

Special attention in certain special groups using drug
Use of biseptol amp in children
The product contains benzyl alcohol contraindicated in infants and children up to 3 years.

Use of biseptol amp. in patients with renal impairment
Do not administer to patients with impaired renal function.

Use of biseptol amp. in elderly patients or patients with folate deficiency
Recommended hematologic control during prolonged therapy in elderly patients or patients with folate deficiency.
In adult patients at an increased risk of severe adverse reactions, including kidney or liver failure, skin reactions, suppression of bone marrow function and thrombocytopenia.

Pregnancy and lactation:
Do not apply during pregnancy and lactation.

Drive and use machines:
No effect on driving and using machines.

Using other medicines:
Tell your doctor about all medicines you have had recently, even those not you been prescribed.
The product enhances the toxic effects of phenytoin, oral anticoagulants, oral antidiabetic sulfonylureas, folic acid antagonists, thiopental;
Co-administered with cyclosporine reduces plasma concentrations and causes irreversible damage to the kidneys;
Acylate medicaments (eg. High doses of Vit. C) hexamine and nonsteroidal agents (indomethacin, phenylbutazone, salicylates, sulfapirazon) potentiate the effect and toxicity of biseptol (risk of crystalluria);
P-aminosalicylic acid, barbiturates, primidone, potentiate the toxicity of trimethoprim;
In connection with pyrimethamine (antimalarial drug) at a dose of 25 mg per week, biseptolat can cause megaloblastic anemia;
In adult patients receiving alongside some biseptolat diuretics may increase the incidence of thrombocytopenia;
It should be borne in mind that co-administration of cotrimoxazole and rifampicin for about a week, resulting in a shorter half-life of trimethoprim. But this is a minor clinical importance;
In adult patients concomitant use of trimethoprim and digoxin may lead to increased serum concentrations of digoxin.

3. How to use biseptol amp.
Children from 3 to 12 years:
I.v. infusions of 36 mg // kg / 24 hours divided into 2 equal doses.

Adults and children over 12 years:
960 mg (2 amp.) Every 12 hours.

In severe urinary tract infection and shigellosis - up to 1440 mg (1.44 g, 3 MP.).
As an exception, may be infused at 960 mg every 8 hours for 3 days.
Upon infection with Pnemnocystis carinii - 120 mg / kg / 24 hours divided into 4 equal doses for 14 days.
Patients c renal insufficiency (creatinine clearance 15-30 ml / min) to appoint half the recommended dose.
Are determined by the attending physician.
Product should be administered as a slow drip, after preliminary dissolution. Thoroughly prepared to dissolve the solution should be used immediately. Do not use if the reconstituted solution has opalestsenziya or precipitation.

The solution must be prepared in accordance with the following schedule:
1 vial (5 ml) was dissolved in 125 ml solvent;
2 ampoules (10 ml) was dissolved in 250 ml of solvent.
As solvents can be used:
5% and 10% glucose solution;
0.9% sodium chloride solution;
Ringer's solution;
0.45% NaCl solution with 2.5% glucose solution.
Do not use other solvents.

Note:
If a patient can not accept large amounts of liquids may be used a solution with a higher concentration of cotrimoxazole - 5 ml of the preparation to be dissolved in 75 ml of 5% glucose solution.
Product should not be administered as an intravenous bolus infusion.

If you take more biseptol amp. than had
When taking higher than recommended dose as signs of overdose can occur: loss of appetite, cramping pain, nausea, vomiting, dizziness, headache, somnolence, loss of consciousness.
Temperature, blood or crystals in the urine were also spotted.
Late symptoms of overdose can be manifested by changes in blood counts and jaundice.
It takes full blood tests. If there is evidence of significant changes in blood count or jaundice, appropriate treatment should begin immediately.

4. Possible side effects
Like all medicines, biseptol amp. may cause side effects.
As co-trimoxazole contains trimethoprim and a sulfonamide is expected type and frequency of adverse reactions correspond to the frequency / duration / their use until now.
Data from published large clinical trials to determine the frequency of very common to rare side effects.
They were originally established very rare side effects in data analysis after sales and therefore relate more to the reflecting statistics than is considered "real" rate.
In addition, side effects may vary in their incidence depending on the symptoms.

The following chart is used for classification of adverse reactions by frequency:
Very common 1/10;
Common 1/100 and <1/10;
Uncommon 1/1000 and <1/100;
Rare 1/10 000 and <1/1000;
Very rare <1/10 000.
infections:
Common - candidiasis.
Blood and lymphatic system:
Very rare - leukopenia, neutropenia, thrombocytopenia, agranulocytosis, megaloblastic anemia, aplastic anemia, hemolytic anemia, methemoglobinemia, eosinophilia, purpura, haemolysis in certain susceptible patients with G-6-PD deficiency.
Violations by the immune system:
Very rare - Serum sickness, anaphylaxis, allergic myocarditis, angioedema, drug fever, allergic vasculitis resembling Henon-Shonlayn purpura, periarteriitis nodosa, systemic lupus erythematosus.
Metabolic disorders:
Very common - Hyperkalaemia;
Very rare - Hypoglycemia, hyponatremia, anorexia.
Psychiatric disorders:
Very rare - depression, hallucinations.
Disorders of the nervous system:
Common - headache;
Very rare - Aseptic meningitis, convulsions, peripheral neuritis, ataxia, vertigo, tinnitus, dizziness.
Aseptic meningitis quickly resolved after discontinuation of therapy, but reciprocating in some cases re-exposure to co-trimoxazole or just trimethoprim.

Respiratory system disorders:
Very rare - cough, pulmonary infiltrates.
Cough and pulmonary infiltrates may be early signs of respiratory hypersensitivity, which very rarely can be fatal.

Disorders of the gastrointestinal system:
Common - Nausea, diarrhea;
Uncommon - Vomiting;
Very rare - Glossitis, stomatitis, pseudomembranous colitis, pancreatitis.
Visual disturbances:
Very rare - uveitis.
Violations by the gallbladder and liver:
Very rare - Increases in serum transaminases, increases in bilirubin levels, cholestatic jaundice, hepatic necrosis; Cholestatic jaundice and liver necrosis.
Skin and subcutaneous tissue disorders:
Common - Skin rashes;
Very rare - photosensitivity, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, Lyell / toxic epidermal necrolysis /. This syndrome is associated with high mortality.
Musculoskeletal - Musculoskeletal and connective tissue disorders:
Very rare - arthralgia and myalgia.
Urinary system disorders:
Very rare - impaired renal function / sometimes reported as renal failure / interstitial nephritis.
Effects associated with the treatment of Pn. carinii Pneumonitis - PCP
Very rare - Severe hypersensitivity reactions, rash, fever, neutropenia, thrombocytopenia, elevated liver enzymes, hyperkalemia, hyponatremia, rhabdomyolysis.
In high dosages used to treat PCP reported severe hypersensitivity reactions requiring emergency treatment discontinuation.
If there are signs of bone marrow failure, apply calcium folinate - 5-10 mg / day. Severe hypersensitivity reactions have been reported in patients with PCP at a re-exposure of co-trimoxazole, sometimes after dosing interval of several days.
Rhabdomyolysis has been observed in HIV-positive patients receiving co-trimoxazole for the treatment or prophylaxis of PCP.

Some individuals might develop other side effects during use of biseptol amp.
Please tell your doctor if you notice any side effects not listed in this leaflet.

5. Storing biseptol amp.
Do not store above 25 ° C.
Protect from light.
Keep out of reach and sight of children field.
Do not use biseptol amp. after the expiry date stated on the packaging.
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