Rotatsef 1g of powder with for solution preparation sol.
- $12.70
The instruction for medical use
of Rotatsef Torgovoye medicine a name
Rotatsef
Mezhdunarodnoye the unlicensed
name Tseftriakson Lekarstvennaya a form
Powder for preparation of solution for injections of 0.5 g and 1.0 g complete with solvent (lidocaine a hydrochloride, 1% solution for injections – 2 ml and 3.5 ml) and without
the Structure solvent
active agent – tseftriakson (in the form of sodium salt) 0.5 g, 1.0 g
Solvent: lidocaine a hydrochloride, water for injections.
The description
Almost white or yellowish crystal powder, is slightly hygroscopic.
Pharmacotherapeutic group
Antibacterial drugs for system use. Cephalosporins of the third generation.
The code of automatic telephone exchange J01DD04
the Pharmacological
Pharmacokinetics At properties intramuscular/intravenous administration tseftriakson well gets into fabrics and liquids of an organism. The bioavailability at intramuscular introduction is 100%. The maximum concentration in blood plasma at intramuscular introduction, is reached in 2 – 3 hours. Reversibly contacts blood plasma albumine for 85-95% and this binding in inverse proportion to its concentration in blood. Tseftriakson quickly diffuses in interstitial liquid where maintains bactericidal action concerning microorganisms, sensitive to it, within 24 hours. Elimination half-life long and at adults makes about 8 hours, at elderly people 75 years are more senior it is extended approximately twice, and at newborns makes 6.5-8 days.
Tseftriakson well gets through a gematoentsnfalichesky barrier.
At adult 50 – 60% of a tseftriakson 40-50% with bile are removed in not changed view with urine. At newborns about 70% of the entered dose of a tseftriakson it is removed by kidneys. In renal failures or a liver at adults the pharmacokinetics of a tseftriakson almost does not change (perhaps insignificant lengthening of elimination half-life) thanks to redistribution of functions: if function of kidneys is broken, discharge with bile increases and if liver pathology takes place, then removal by kidneys amplifies.
The pharmacodynamics
Rotatsef represents an antibiotic of a broad spectrum of activity of a tsefalosporinovy number of the third generation. Has bactericidal effect due to oppression of synthesis of a cell wall of bacteria. It is active concerning the majority of gram-negative, many gram-positive activators and some anaerobe bacterias. It is resistant to action beta laktamaz, produced by bacteria.
Aerobic gram-negative bacteria, sensitive to Rotatsef: Aeromonas spp., Alcaligenes spp., Branhamella catarrhalis, Citrobacter spp., Enterobacter spp. (some strains are steady), E.coli, Haemophilus ducreyi, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella spp. (including, Kl.pneumoniae), Moraxella spp., Morganella morganii, Neisseria gonorrhoeae, Neisseria meningitidis, Plesiomonas shigelloides, Proteus mirabilis, Proteus vulgaris, Providencia spp., Pseudomonas aeroginosa (some strains are steady), Salmonella spp. (including, S.typhi), Serratia spp. (including, S.marcescens), Shigella spp., Vibro spp. (including, V.cholerae), Yersinia spp. (including, Y.enterocolitica).
Many strains of above-mentioned microorganisms which in the presence of other antibiotics, for example, of penicillin, cephalosporins of the first and second generation of aminoglycosides steadily breed are sensitive to Rotatsef. According to clinical data in primary and secondary syphilis are noted good efficiency of drug.
Aerobic gram-positive bacteria sensitive to Rotatsef: Streptococcus agalactiae, Staphylococcus aureus (including the strains producing penicillinase), Streptococcus bovis, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans.
Staphylococcus spp. resistant to Methicillinum, rezistenten and to cephalosporins, including to Rotatsef. Majority of strains of Enterococcus spp. (for example, Streptococcus faecalis) are also resistant to drug.
Anaerobic activators: Bacteroides spp. (including, some strains of B.fragilis), Clostridium spp. (including, Cl.difficile), Fusobacterium spp (except F.mortiferum and F.varium), Peptococcus spp., Peptostreptococcus spp. Some strains of Bacteroides spp. (for example, B.fragilis), the developing beta lactamazu, are resistant to Rotatsef.
Indications
- upper respiratory tract infections: pneumonia, abscess of lungs, a pleura empyema
- infections of abdominal organs: the cholangitis, an empyema of a gall bladder, inflammatory diseases of digestive tract, peritonitis
- infections of bones and joints
- infections of skin and soft tissues
- infections of urinary tract (including pyelonephritis)
- infections of genitals (including gonorrhea)
- contaminated wounds and burns
- meningitis, sepsis
- prevention of postoperative infections
Rotatsef enter the Route of administration and doses intramusculary and intravenously struyno or by drop infusion.
Usual doses for adults and children at the age of 12 years are also more senior make 1-2 g of Rotatsef once a day. An interval between introductions – 24 hours. In hard cases or in the infections caused by moderately sensitive bakteria, the daily dose of drug should not exceed 4 g.
The newborn (to two-week age) Rotatsef appoint in a dose 20 – 50 mg/kg of body weight once a day. Exceeding a dose is inadmissible because of immaturity of a fermental system at newborns.
For babies and children up to 12 years the daily dose of Rotatsef makes 20 – 80 mg/kg of body weight once a day. Children with body weight have 50 kg and more apply usual doses to adults.
Duration of treatment depends on character and disease severity. As well as in case of use of other antibiotics, Rotatsef's introduction is recommended to continue not less than within 3 days after normalization of body temperature.
In bacterial meningitis to newborns and children drug appoint in an initial dose 100 mg/kg of body weight once a day. The maximum daily dose – 4 g. After identification of the activator, the dose can be reduced.
At treatment of a gonococcal infection of lower parts of an urinogenital system without complications the recommended dose makes 250 mg of Rotatsef once in oil.
Treatment of the complicated gonococcal infection of an urinogenital system and bodies of a small pelvis: Rotatsef of-1.0 g intramusculary each 24 hours (in oil). Treatment of patients should be performed in stationary conditions.
Patients with renal failures on condition of normal function of a liver and at patients with abnormal liver functions on condition of the kept function of kidneys have no need for reduction of a dose of drug. In case of the profound renal failure (clearance of creatinine
In a simultaneous abnormal liver function and kidneys and also at the patients who are on a hemodialysis it is regularly necessary to control concentration of a tseftriakson in blood serum.
For prevention of postoperative infections the single introduction of 1-2 g of Rotatsef in 30-90 min. prior to operation is recommended.
For introduction in oil 0.5 g of a tseftriakson dissolve in 2 ml, and 1.0 g – in 3.5 ml of 1% of solution of lidocaine. It is recommended to enter no more than 1.0 g of drug into one buttock.
For intravenous (in / c) injections of 0.5 g of a tseftriakson dissolve in 5 ml, and 1 g – in 10 ml of water for injections. Enter in/in slowly (2-4 min.).
Intravenous administration of drug in a dose more than 50 mg/kg has to be carried out by drop infusion within not less than 30 minutes.
For in/in injections dissolve 2 g of a tseftriakson in 40 ml of solution, not calciferous. Usually use: 0.9% solution of sodium of chloride, 5-10% solution of a dextrose, 5% levulose solution.
It is necessary to use only freshly cooked solutions.
Side effects
- stomatitis, a glossitis, nausea, vomiting, ease of a chair or diarrhea
- a leukopenia, a granulocytopenia, an eosinophilia, hemolytic anemia, thrombocytopenia,
- an eosinophilia, allergic dermatitis, an itching, a small tortoiseshell, fever, an acute anaphylaxis, a multiformny erythema, a dieback
- a candidiasis, etc. superinfections
it is rare
- a headache, dizziness
- increase in activity of hepatic transaminases, a hyperbilirubinemia, a pseudo-cholelithiasis ("sludge-syndrome")
- an oliguria, increase the content of creatinine, urea in blood serum, a hamaturia
In isolated cases
- pseudomembranous colitis
- fibrillation disturbances, nasal bleedings
- a glucosuria
- at intravenous administration: morbidity on the vein course, phlebitis
- at intramuscular introduction: the morbidity
- hypersensitivity to cephalosporins and penicillin
- the first trimester of pregnancy
Medicinal interactions
At simultaneous use with loopback diuretics (for example, furosemide) increases in the injection site of the Contraindication risk of development of nephrotoxic action.
Rotatsef and aminoglycosides have synergism concerning many gram-negative bacteria. The similar combination is proved at treatment heavy and life-threatening infections (for example, the caused Pseudomonas aeruginosa).
Non-steroidal anti-inflammatory drugs and other inhibitors of aggregation of thrombocytes increase bleeding probability. It is incompatible with ethanol.
It is not necessary to mix Rotatsef rolled into one or the syringe with other antibiotics.
Special instructions
As well as in case of use of other cephalosporins, at the Rotatsef drug treatment it is necessary to consider a possibility of development of anaphylactic reactions.
At long-term treatment by drug regular control of a picture of peripheral blood, indicators of a functional condition of a liver and kidneys is necessary.
In rare instances at ultrasonic diagnostics the emergence of blackout of a gall bladder which izchezat after drug withdrawal is possible. Even if this phenomenon is followed by pains in right hypochondrium, it is recommended to continue administration of drug against the background of symptomatic treatment.
Prescribing of vitamin K can be required by the elderly and weakened patients.
It is necessary to appoint drug with care the newborn, in particular premature, in connection with high risk of development of a hyperbilirubinemia. In a simultaneous heavy renal and liver failure, at the patients who are on a hemodialysis it is regularly necessary to define concentration of drug in blood.
During treatment the ethanol use as disulfiramopodobny effects are possible (hyperaemia of the person, abdominal spasms, nausea, vomiting, a headache, a lowering of arterial pressure, tachycardia, an asthma) is contraindicated.
Freshly cooked Rotatsefa solutions physically are also chemically stable within 6 hours at the room temperature.
Tseftriakson should not mix up or be accepted along with solutions or products, calciferous even in separate ways of infusions. Kaltsiysoderzhashchy solutions or products should not be accepted within 48 hours after the last reception of a tseftriakson.
Pregnancy and the period of a lactation
Use of the drug Rotatsef in II and III trimesters of pregnancy is possible only when the expected advantage for mother exceeds potential risk for a fruit (tseftriakson gets through a placental barrier).
In need of use of the drug Rotatsef in the period of a lactation it is necessary to resolve an issue of the breastfeeding termination (tseftriakson it is allocated with breast milk).
Features of influence of medicine on ability to run the vehicle or potentially dangerous
Rotatsef mechanisms do not vliit on ability of driving of the car and the performance of work demanding the high speed of psychomotor reactions.
Overdose
Symptoms: strengthening of manifestations of the described side effects.
Treatment: symptomatic therapy. The hemodialysis and peritoneal dialysis is inefficient.
A form of release and packing
On 0.5 g and 1 g in the bottles from colourless glass corked by rubber bungs, which are pressed out by aluminum caps "under a running in" and closed by a plastic cover.
On each bottle paste the paper label.
On 2.0 ml, 3.5 ml of solvent in ampoules from dark glass. On an ampoule paste the self-adhesive label.
On 1 bottle of drug together with 1 ampoule of solvent place in blister strip packaging.
On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages place in a cardboard pack.
On 1 or 10 bottles with drug without solvent together with the instruction for medical use in the state and Russian languages place in a cardboard pack.
To Store storage conditions in the dry, protected from light place at a temperature from 15 ° - 25 °C.
To store out of children's reach!
3 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
the Producer Rotatsef is a product and a trademark of the Rotapharm company, Great Britain
LDP – Laboratorios Torlan S.A Is made ".", Spain
(Carretera de Barselona, 135B, Serdañela del Valles, Barselona)
Ph. / fax: 8 (7272) 529090
www.worldmedicine.kz
to Develop the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from the consumer on quality of products (goods) of RK Almaty, Suyunbaya 222 St. of B
of Rotatsef Torgovoye medicine a name
Rotatsef
Mezhdunarodnoye the unlicensed
name Tseftriakson Lekarstvennaya a form
Powder for preparation of solution for injections of 0.5 g and 1.0 g complete with solvent (lidocaine a hydrochloride, 1% solution for injections – 2 ml and 3.5 ml) and without
the Structure solvent
active agent – tseftriakson (in the form of sodium salt) 0.5 g, 1.0 g
Solvent: lidocaine a hydrochloride, water for injections.
The description
Almost white or yellowish crystal powder, is slightly hygroscopic.
Pharmacotherapeutic group
Antibacterial drugs for system use. Cephalosporins of the third generation.
The code of automatic telephone exchange J01DD04
the Pharmacological
Pharmacokinetics At properties intramuscular/intravenous administration tseftriakson well gets into fabrics and liquids of an organism. The bioavailability at intramuscular introduction is 100%. The maximum concentration in blood plasma at intramuscular introduction, is reached in 2 – 3 hours. Reversibly contacts blood plasma albumine for 85-95% and this binding in inverse proportion to its concentration in blood. Tseftriakson quickly diffuses in interstitial liquid where maintains bactericidal action concerning microorganisms, sensitive to it, within 24 hours. Elimination half-life long and at adults makes about 8 hours, at elderly people 75 years are more senior it is extended approximately twice, and at newborns makes 6.5-8 days.
Tseftriakson well gets through a gematoentsnfalichesky barrier.
At adult 50 – 60% of a tseftriakson 40-50% with bile are removed in not changed view with urine. At newborns about 70% of the entered dose of a tseftriakson it is removed by kidneys. In renal failures or a liver at adults the pharmacokinetics of a tseftriakson almost does not change (perhaps insignificant lengthening of elimination half-life) thanks to redistribution of functions: if function of kidneys is broken, discharge with bile increases and if liver pathology takes place, then removal by kidneys amplifies.
The pharmacodynamics
Rotatsef represents an antibiotic of a broad spectrum of activity of a tsefalosporinovy number of the third generation. Has bactericidal effect due to oppression of synthesis of a cell wall of bacteria. It is active concerning the majority of gram-negative, many gram-positive activators and some anaerobe bacterias. It is resistant to action beta laktamaz, produced by bacteria.
Aerobic gram-negative bacteria, sensitive to Rotatsef: Aeromonas spp., Alcaligenes spp., Branhamella catarrhalis, Citrobacter spp., Enterobacter spp. (some strains are steady), E.coli, Haemophilus ducreyi, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella spp. (including, Kl.pneumoniae), Moraxella spp., Morganella morganii, Neisseria gonorrhoeae, Neisseria meningitidis, Plesiomonas shigelloides, Proteus mirabilis, Proteus vulgaris, Providencia spp., Pseudomonas aeroginosa (some strains are steady), Salmonella spp. (including, S.typhi), Serratia spp. (including, S.marcescens), Shigella spp., Vibro spp. (including, V.cholerae), Yersinia spp. (including, Y.enterocolitica).
Many strains of above-mentioned microorganisms which in the presence of other antibiotics, for example, of penicillin, cephalosporins of the first and second generation of aminoglycosides steadily breed are sensitive to Rotatsef. According to clinical data in primary and secondary syphilis are noted good efficiency of drug.
Aerobic gram-positive bacteria sensitive to Rotatsef: Streptococcus agalactiae, Staphylococcus aureus (including the strains producing penicillinase), Streptococcus bovis, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans.
Staphylococcus spp. resistant to Methicillinum, rezistenten and to cephalosporins, including to Rotatsef. Majority of strains of Enterococcus spp. (for example, Streptococcus faecalis) are also resistant to drug.
Anaerobic activators: Bacteroides spp. (including, some strains of B.fragilis), Clostridium spp. (including, Cl.difficile), Fusobacterium spp (except F.mortiferum and F.varium), Peptococcus spp., Peptostreptococcus spp. Some strains of Bacteroides spp. (for example, B.fragilis), the developing beta lactamazu, are resistant to Rotatsef.
Indications
- upper respiratory tract infections: pneumonia, abscess of lungs, a pleura empyema
- infections of abdominal organs: the cholangitis, an empyema of a gall bladder, inflammatory diseases of digestive tract, peritonitis
- infections of bones and joints
- infections of skin and soft tissues
- infections of urinary tract (including pyelonephritis)
- infections of genitals (including gonorrhea)
- contaminated wounds and burns
- meningitis, sepsis
- prevention of postoperative infections
Rotatsef enter the Route of administration and doses intramusculary and intravenously struyno or by drop infusion.
Usual doses for adults and children at the age of 12 years are also more senior make 1-2 g of Rotatsef once a day. An interval between introductions – 24 hours. In hard cases or in the infections caused by moderately sensitive bakteria, the daily dose of drug should not exceed 4 g.
The newborn (to two-week age) Rotatsef appoint in a dose 20 – 50 mg/kg of body weight once a day. Exceeding a dose is inadmissible because of immaturity of a fermental system at newborns.
For babies and children up to 12 years the daily dose of Rotatsef makes 20 – 80 mg/kg of body weight once a day. Children with body weight have 50 kg and more apply usual doses to adults.
Duration of treatment depends on character and disease severity. As well as in case of use of other antibiotics, Rotatsef's introduction is recommended to continue not less than within 3 days after normalization of body temperature.
In bacterial meningitis to newborns and children drug appoint in an initial dose 100 mg/kg of body weight once a day. The maximum daily dose – 4 g. After identification of the activator, the dose can be reduced.
At treatment of a gonococcal infection of lower parts of an urinogenital system without complications the recommended dose makes 250 mg of Rotatsef once in oil.
Treatment of the complicated gonococcal infection of an urinogenital system and bodies of a small pelvis: Rotatsef of-1.0 g intramusculary each 24 hours (in oil). Treatment of patients should be performed in stationary conditions.
Patients with renal failures on condition of normal function of a liver and at patients with abnormal liver functions on condition of the kept function of kidneys have no need for reduction of a dose of drug. In case of the profound renal failure (clearance of creatinine
In a simultaneous abnormal liver function and kidneys and also at the patients who are on a hemodialysis it is regularly necessary to control concentration of a tseftriakson in blood serum.
For prevention of postoperative infections the single introduction of 1-2 g of Rotatsef in 30-90 min. prior to operation is recommended.
For introduction in oil 0.5 g of a tseftriakson dissolve in 2 ml, and 1.0 g – in 3.5 ml of 1% of solution of lidocaine. It is recommended to enter no more than 1.0 g of drug into one buttock.
For intravenous (in / c) injections of 0.5 g of a tseftriakson dissolve in 5 ml, and 1 g – in 10 ml of water for injections. Enter in/in slowly (2-4 min.).
Intravenous administration of drug in a dose more than 50 mg/kg has to be carried out by drop infusion within not less than 30 minutes.
For in/in injections dissolve 2 g of a tseftriakson in 40 ml of solution, not calciferous. Usually use: 0.9% solution of sodium of chloride, 5-10% solution of a dextrose, 5% levulose solution.
It is necessary to use only freshly cooked solutions.
Side effects
- stomatitis, a glossitis, nausea, vomiting, ease of a chair or diarrhea
- a leukopenia, a granulocytopenia, an eosinophilia, hemolytic anemia, thrombocytopenia,
- an eosinophilia, allergic dermatitis, an itching, a small tortoiseshell, fever, an acute anaphylaxis, a multiformny erythema, a dieback
- a candidiasis, etc. superinfections
it is rare
- a headache, dizziness
- increase in activity of hepatic transaminases, a hyperbilirubinemia, a pseudo-cholelithiasis ("sludge-syndrome")
- an oliguria, increase the content of creatinine, urea in blood serum, a hamaturia
In isolated cases
- pseudomembranous colitis
- fibrillation disturbances, nasal bleedings
- a glucosuria
- at intravenous administration: morbidity on the vein course, phlebitis
- at intramuscular introduction: the morbidity
- hypersensitivity to cephalosporins and penicillin
- the first trimester of pregnancy
Medicinal interactions
At simultaneous use with loopback diuretics (for example, furosemide) increases in the injection site of the Contraindication risk of development of nephrotoxic action.
Rotatsef and aminoglycosides have synergism concerning many gram-negative bacteria. The similar combination is proved at treatment heavy and life-threatening infections (for example, the caused Pseudomonas aeruginosa).
Non-steroidal anti-inflammatory drugs and other inhibitors of aggregation of thrombocytes increase bleeding probability. It is incompatible with ethanol.
It is not necessary to mix Rotatsef rolled into one or the syringe with other antibiotics.
Special instructions
As well as in case of use of other cephalosporins, at the Rotatsef drug treatment it is necessary to consider a possibility of development of anaphylactic reactions.
At long-term treatment by drug regular control of a picture of peripheral blood, indicators of a functional condition of a liver and kidneys is necessary.
In rare instances at ultrasonic diagnostics the emergence of blackout of a gall bladder which izchezat after drug withdrawal is possible. Even if this phenomenon is followed by pains in right hypochondrium, it is recommended to continue administration of drug against the background of symptomatic treatment.
Prescribing of vitamin K can be required by the elderly and weakened patients.
It is necessary to appoint drug with care the newborn, in particular premature, in connection with high risk of development of a hyperbilirubinemia. In a simultaneous heavy renal and liver failure, at the patients who are on a hemodialysis it is regularly necessary to define concentration of drug in blood.
During treatment the ethanol use as disulfiramopodobny effects are possible (hyperaemia of the person, abdominal spasms, nausea, vomiting, a headache, a lowering of arterial pressure, tachycardia, an asthma) is contraindicated.
Freshly cooked Rotatsefa solutions physically are also chemically stable within 6 hours at the room temperature.
Tseftriakson should not mix up or be accepted along with solutions or products, calciferous even in separate ways of infusions. Kaltsiysoderzhashchy solutions or products should not be accepted within 48 hours after the last reception of a tseftriakson.
Pregnancy and the period of a lactation
Use of the drug Rotatsef in II and III trimesters of pregnancy is possible only when the expected advantage for mother exceeds potential risk for a fruit (tseftriakson gets through a placental barrier).
In need of use of the drug Rotatsef in the period of a lactation it is necessary to resolve an issue of the breastfeeding termination (tseftriakson it is allocated with breast milk).
Features of influence of medicine on ability to run the vehicle or potentially dangerous
Rotatsef mechanisms do not vliit on ability of driving of the car and the performance of work demanding the high speed of psychomotor reactions.
Overdose
Symptoms: strengthening of manifestations of the described side effects.
Treatment: symptomatic therapy. The hemodialysis and peritoneal dialysis is inefficient.
A form of release and packing
On 0.5 g and 1 g in the bottles from colourless glass corked by rubber bungs, which are pressed out by aluminum caps "under a running in" and closed by a plastic cover.
On each bottle paste the paper label.
On 2.0 ml, 3.5 ml of solvent in ampoules from dark glass. On an ampoule paste the self-adhesive label.
On 1 bottle of drug together with 1 ampoule of solvent place in blister strip packaging.
On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages place in a cardboard pack.
On 1 or 10 bottles with drug without solvent together with the instruction for medical use in the state and Russian languages place in a cardboard pack.
To Store storage conditions in the dry, protected from light place at a temperature from 15 ° - 25 °C.
To store out of children's reach!
3 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
the Producer Rotatsef is a product and a trademark of the Rotapharm company, Great Britain
LDP – Laboratorios Torlan S.A Is made ".", Spain
(Carretera de Barselona, 135B, Serdañela del Valles, Barselona)
Ph. / fax: 8 (7272) 529090
www.worldmedicine.kz
to Develop the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from the consumer on quality of products (goods) of RK Almaty, Suyunbaya 222 St. of B
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