F. Hoffmann-Roche RoCephin-La Roche treatment powder treated blood infections, meningitis (1g bottle + 10ml tube)

Dosage form Box X 10ml
Specifications Ceftriaxone

Ingredient

Composition information	Content
Ceftriaxone	1

Uses

Indications

RoCephin 1 g i.v. are indicated in the following cases:

Infections caused by ceftriaxon sensitive pathogens, for example:

Blood infection, Meningitis , Lyme Borreliosis spread (early and late stages of the disease). Kidney and urinary tract, respiratory infections, especially pneumonia , and ENT infections.

Pharmacokology

ceftriaxon is a 3rd generation cephalosporin, used in the form of injecting (ceftriaxon sodium). The drug has a bactericidal effect due to the ability to inhibit the synthesis of bacterial cell walls. The drug is attached to one or more penicillin -mounted proteins (PBP) are proteins involved in the composition of bacterial cell membrane structure, thus inhibiting the final step of the biosynthesis process. Like the 3rd generation cephalosporin (cefotaxim, ceftazidim ...), generally ceftriaxon has in vitro activity on staphylococci strains inferior to the first -generation cephalosporin but has a spectrum on Gram -negative bacteria larger than cephalosporins.

antibacterial spectrum

ceftriaxon is sustainable with most beta lactamase (penicillinase and cephalosporinase) of Gram -negative and gram -positive bacteria. Ceftriaxon usually has a Vitro and clinical effect on the following bacteria:

Gram -positive air -loving bacteria: Ceftriaxon has a vitro printing effect on the majority of Gram -positive air -demands including Staphylococcus aureus and S. Epidermidis and not producing penicilinase; Strept. Pneumoniae, S. Pyogenes (Streptococcus Beta blood -soluble blood group); Strept. Agalactiae (Streptococcus group B) and S. Viridans.

Staphylococcus resistant to methicilin is usually resistant to ceftriaxon. Streptococcus group D and Enterococcus includes E. Faecalis (formerly S. Faecalis) is usually resistant to Ceftriaxon.

S. pneumoniae strains have mic (minimum inhibitory concentration) 2 micrograms/ml or larger is often considered Ceftriaxon resistance; The strains with mic 0.5 - 1 microgram/ml isolated in people with meningitis are also considered as Ceftriaxon resistance.

Most of the strains of listeria monocytogenes are resistant to ceftriaxon.

Gram -negative bacteria: Ceftriaxon has a vitro printing effect on Neisseria meningitidis and most N. Gonorrhoeeae strains or non -penicillinase and penic resistance strains (for example, penicilin resistance) or Tetracycline anti -plasmid intermediaries. Ceftriaxon has an in vitro effect on H. Influenzae, H. Parainfluenzae and H.Ducreyi or not born beta lactamase.

ceftriaxon often has the following in vitro effects on the following enterobacteriaceae: Citrobacter Diversus, C.Freundii, Entobacter Clox, E. Aerogenes, E. Coli, Klebsiella Pneumoniae, Morganella Morganii (formerly Proteus MorganiiIIII), P. Mirabilis, P. Vulgaris, Providencia Rettgeri (formerly Proteus Rettgeri), P. Stuartii, Serratia Marcescens, Salmonella, Shigella and Yersinia Enterocolitica. Although Ceftriaxon has a vitro effect on some pseudomonas aeruginosa strains, most of the CEFTRIAXON strains. Ceftriaxon is usually worse than In vitro for PS. Aeruginosa is sensitive, compared to ceftazidim or expanded spectrum penicillins (for example, piperacilin).

Anaerobic bacteria: Ceftriaxon has a Vitro effect on some anaerobic bacteria, including: Actinomyces, Fusobacterium, Lactobacillus, Peptococcus, Peptostreptoccus, Propionibacterium and Veillonella, some Clostridium strains include C. Perfringens; But C. Difficile is usually resistant to ceftriaxon.

Bacteria: Ceftriaxon inhibits In Vitro Borrelia Burgdorferi, the cause of Lyme disease, Leptospira and some effects on Treponema Pallidum.

chlamydia: ceftriaxon is often considered non -effective for C. trachomatis.

pharmacokinetics

ceftriaxon is not absorbed through the digestive tract, so intravenous or intramuscular injection. Birth after intramuscular injection is 100%. The average peak concentration in plasma is achieved by 0.5 g and 1.0 g Ceftriaxon injection is about 40 mg/liter and 80 mg/liter after 2 hours. The peak concentration of the serum is achieved when injecting intravenously for 30 minutes, a dose of 1 g of ceftriaxon is about 123 - 150 mg/liter and a dose of 2 g at 223 - 276 mg/liter. Serum concentration at the time 1, 2, 6, 12 and 24 hours after starting to infect 1 g Ceftriaxon average about 110 mg/liter, 70 mg/liter, 40 mg/liter, 24 mg/liter and 7 mg/liter (respectively).

ceftriaxon is widely distributed throughout the tissues and body fluids. The drug passes through the placenta and distributed into the amniotic fluid. The drug goes through both inflammatory and non -inflammatory fibrosis, generally achieving the concentration of treatment in cerebrospinal fluid. About 85 - 90% Ceftriaxon is attached to plasma proteins. The drug is mainly associated with albumin.

In newborns and children, Ceftriaxon is associated with lower protein than adults because plasma albumin levels decrease in this age group and protein attachment also decreases in people with liver failure, kidney failure. The distribution of Ceftriaxon is 3 - 13 liters and serum clearance is 10 - 22 ml/min, while normal kidney clearance is 5 - 12 ml/min.

half -life in the plasma of the drug changes between 6 and 9 hours; It may last longer in newborns, not significantly changed in people with average renal failure, but can last in patients with severe renal impairment, especially when accompanied by liver failure. Half -life excreted is 5.4 - 10.9 hours in people with normal liver and kidney function.

The drug excreted milk with low concentrations. The rate of elimination may be reduced in patients with fertilizer. About 40 - 65% of the injected dose is excreted in the form of unchanged by the kidneys, the rest through the bile and finally come to the feces in the form of unchanged or converted by the intestinal microflora into compounds that are no longer active in antibiotics.

In case of decrease in liver function, the excretion through the kidneys increases and vice versa if the kidney function is reduced, the excretion through bile increases.

ceftriaxon cannot be removed by hemolysis or peritoneal.

Before taking F. Hoffmann-Roche RoCephin-La Roche treatment powder treated blood infections, meningitis (1g bottle + 10ml tube)

How to use

According to general regulations, the solution should be used immediately after mixing. The output drug solution retains physical and chemical stability within 6 hours at room temperature (or 24 hours at a temperature of 2 - 8 ° C). The drug solution is from light yellow to amber, depending on the concentration of the drug and the length of storage time. The discoloration of the solution does not affect the effectiveness and tolerance of the drug.

intramuscularly

When intramuscularly, RoCephin 250 mg or 500 mg is mixed in 2 ml and 1 g of RoCephin in 3.5 ml of solution containing 1% lidocaine hydrochloride and injected into a large muscles of the body. Do not inject more than 1 g of medicine at a position. Never intravenously lidocaine intravenously.

intravenous injection

When intravenously, RoCephin 250 mg or 500 mg is mixed in 5 ml and 1 g of 1 g in 10 ml of sterile water for injection. Should be intravenous for 2-4 minutes.

intravenous dripping

Should be transmitted for at least 30 minutes. Intravenous infusion, 2 g of RoCephine is mixed in 40 ml of one of the following non -calcium solutions: 0.9%NaCl, 0.45%NaCl + Dextrose 2.5%, 5%Dextrose, 10%Dextrose, Dextran 6%in Dexrose 5%, Ethyl Starch 6 - 10%Ethyloxy Hydroxy.

RoCephin solution is not mixed or transmitted with solutions containing other antibiotics or into solutions that are not on the listed list because it may not be compatible.

Do not use diluted solution containing calcium, such as the Ringer or Hartmann solution, to mix roedphin vials or continue diluting a bottle mixed to intravenously because the precipitate can be formed. Ceftriaxon-Calcium precipitate may appear when RoCephin is mixed with a calcium-containing solution that is used in the same line, intravenously.

RoCephin is not used simultaneously with intravenous solutions containing calcium, including continuous transmission solution containing calcium such as raising intravenous sugar through the three.

However, in patients not infant, RoCephin and solutions containing calcium can be used successive if the transmission lines are smoothly with a compatible liquid (see interaction with other drugs and other types of interactions).

There are no reports on interactions between ceftriaxon and preparations containing calcium oral or interactive between intramuscular ceftriaxon and calcium -containing preparations (intravenous or orally).

Dosage

recommended dose:

Adults and children over 12 years old

The usual dose is 1 - 2 g of rouphin used once daily (every 24 hours). In severe cases or for infections due to bacteria that are only sensitive to medium levels, which can be increased by up to 4 g, used once a day. Treatment time

The treatment time varies depending on the disease. Normally, like using other antibiotics, it is advisable to continue using RoCephin for at least 48 - 72 hours after the patient has run out of fever or have evidence to kill all bacteria.

Coordination treatment

In the experimental conditions, the synergistic effect between RoCephin and aminoglycosides has been recorded for many Gram -negative bacteria. Although the enhancement of such coordinates is not always predictable, it is advisable to consider coordination when there is a serious infection, life -threatening due to bacteria like Pseudomonas Aeruginosa. Due to the compatibility of reason, the two drugs must be used separately at the recommended dose.

Liver function

For patients with liver damage, no dose reduction if renal function does not decrease.

Renal function

For patients with renal function, no need to reduce the dose of RoCephin if there is no liver failure, only in the case of severe stage kidney failure (creatinine clearance

Older people

Dosage for adults does not require adjusting the dose in old patients.

Children

Babies and children 12 years or less: Need the following dose guide regimen, once daily.

Babies (14 days of age or less): Daily dose is 20-50 mg/kg weight. The daily dose must not exceed 50 mg/kg. There is no need to distinguish between children lacking in months and months. Contraindications to use RoCephin in infants (

For babies, emulsion and young children (from 15 days to 12 years old): Daily dose from 20 - 80 mg/kg used 1 time/day.

For children with a weight of 50 kg or more, should be used according to the usual adult dose. Intravenous dose of 50 mg/kg of weight or more should be dripped for at least 30 minutes.

Meningitis

In bacterial meningitis in children and children, should start treatment at a dose of 100 mg/kg of weight (no more than 4 g), once a day. Immediately after identifying the type of pathogenic bacteria and their sensitivity to their drugs, the corresponding dose can be reduced. The following treatment time shows effective: Neisseria meningiditis 4 days, Haemophilus Influenzae 6 days, Streptococcus Pneumoniae 7 days.

Lyme Borreliosis

The dose is 50 mg/kg until the maximum of 2 g in both adults and children, using once a day for 14 days.

Gonorrhea (strains producing penicillinase enzymes and no penicillinase)

Use a single dose of 250 mg of intramuscular roedphin.

Surgical prophylaxis

Depending on the risk of infection, a single dose of 1-2 g Rocephin, 30-90 minutes before surgery. In Dai - Rectal Surgery, using monochromatic RoCephin or combined with a group 5 - nitroimidazole, such as Ornidazole, has been proven effective (separate use, see the dosage and usage).

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when using overdose? There is no specific antidote. Overdose treatment is only symptomatic treatment.

What to do when forgetting 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using 1 g I.V. , you may experience unwanted effects (ADR).

While using RoCephin, the following side effects have been encountered, they usually stop or after stopping the drug.

Common, (ADR> 1/100)

On the digestive system (about 2% of cases): liquid or diarrhea , nausea, vomiting, stomatitis and tongue inflammation.

Hematology changes (about 2%): Nothing hypernysis, leukopenia, granulocytosis, hemolytic anemia, thrombocytopenia. In some cases, the loss of granulocytes (

Uncommon, (1/100> ADR> 1/1000)

Skin reactions (about 1%): rash, atopic dermatitis, itching, urticaria, edema. A few cases of severe adverse reactions on the skin (diverse roses, Stevens - Johnson syndrome or lyell syndrome/toxic epidermal necrotic syndrome).

headache and dizziness, the symptoms of the phenomenon of precipitation of Ceftriaxon calcium salt in the gallbladder, liver enzymes, urinary disorders, serum creatinine, fungal infections in the genital tract, fever, tremor, anaphylactic reactions or anaphylaxis. Can reduce them, by injecting slowly (2 to 4 minutes). Intramuscularly without using Lidocaine solution will cause pain.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

RoCephin 1 g i.V . Contraindications in the following cases:

Patients recorded a history of hypersensitivity to cephalosporin antibiotics. Patients with hypersensitivity to penicillin, may also have an allergic reaction to RoCephin.

Do not use ceftriaxon for babies with hyperplades of blood bilirubin and premature infants. In vitro studies show that Ceftriaxon can occupy bilirubin serum albumin and therefore have the potential to cause bilirubin brain disease in these children.

Contraindicated to use RoCephin in infants (

If you need to be treated with intravenous infusion solution containing calcium, including continuous transmission solutions such as eating intravenously by the risk of precipitation of Ceftriaxon-Calci. In some of these cases, RoCephin and a solution containing calcium and intravenous pathway and in some cases, observations of precipitation in intravenous lines. Do not observe the crystalline agent in infants when autopsy.

Be cautious when using

Before starting treatment with ceftriaxon, a thorough investigation of the patient's allergic history with cephalosporin, penicillin or other drugs.

There is a risk of cross -allergy in people with penicillin allergies. In cases of renal failure, be careful to consider the dose.

For patients with significant impaired renal and liver function, Ceftriaxon dose should not exceed 2 g/day if not closely monitored in plasma concentrations.

Ceftriaxon may be complex with calcium that causes precipitation, so avoid infusion of calcium -containing solution for 48 hours after ceftriaxon injection in all patients.

Precautions when treatment lasts more than 14 days; When dehydrated due to the risk of Ceftriaxon precipitating in the gallbladder.

Must find the cause of anemia during cephalosporin treatment (including ceftriaxon) because cephalosporin has the potential to cause severe hemolytic anemia to death through the immune mechanism. If the cause is due to the drug, it must be stopped immediately.

The ability to drive and operate machinery

Documents do not show any side effects on the ability to drive and control machines.

Pregnancy

ceftriaxon through the placenta fence. Safety on pregnant women has not been established. Animal reproductive studies show that there is no toxic effect on embryos, fetuses, teratogenic or adverse events on the fertility of both male and female animals, on the birth and development after birth. On the primates, there is no toxicity on the fetus or the teratization.

Breastfeeding period

Cefriaxon is excreted into breast milk with low concentrations. Be careful when using RoCephin for breastfeeding women.

Medicinal interaction

Cloramphenicol: When combined with Ceftriaxon, In vitro is antagonistic.

Poisoning with the kidneys of cephalosporins may be increased by gentamicin, colistin, Furosemid.

Unlike many other types of cephalosporin, Probenecid does not affect the kidney clearance of ceftriaxon.

Avoid simultaneous use of ceftriaxon with calcium salts (infusion) and Ringer Lactat injection solution.

ceftriaxon may increase the effects of antagonistic drugs vitamin K .

Ceftriaxon's effectiveness may be increased when used simultaneously with ureteric acidic agents.

ceftriaxon can reduce the effect of typhoid vaccine.

Cavalry: The transmission or syringe must be carefully coated with 0.9% sodium chloride solution between ceftriaxon injections and other drugs like vancomycin to avoid precipitation.

Do not mix Ceftriaxon with other antibacterial drugs.

Ceftriaxon is not mixed with solutions containing calcium and must not be mixed with aminoglycosides, amsacrin, vancomycin or fluconazole.

Storage

Do not store over 30 ° C, hold the vial in the box. The mixed drug solution retains the physical and chemical properties for 6 hours at room temperature (or 24 hours in the refrigerator from 2 - 8 ° C).

Expiry date: 36 months from the date of production.

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