Indication:
Fleroxacin and Dextrose Injection can be used for acute bronchitis caused by sensitive bacterial, acute exacerbation of chronic bronchitis and respiratory infections such as pneumonia and etc; cystitis, pyelonephritis, prostatitis, epididymitis, Neisseria gonorrhoeae urethritis and other genitourinary tract infections; Salmonella typhi infections, bacillary dysentery and other digestive system infection; skin and soft tissue infections, bone infections, intra-abdominal infections and pelvic infections.

Dosage and Administration
This injection is for intravenous use only.
Slow intravenous infusion without light:0.2~0.4g/day(1~2 bottles)

Contraindications
Fleroxacin and Dextrose Injection is contraindicated in patients with hypersensitivity to Quinolone products and pregnancy Nursing mother and Pediatric use.

Adverse Reactions
1).Adverse reactions more commonly reported in gastrointestinal tract  include: Abdominal discomfort or pain, diarrhea, nausea and vomiting, loss of appetite, jaundice, etc.
2).Adverse reactions in Central nervous system inculde: dizziness, headache, excitement, sleepiness or insomnia, such as the direction of the obstacles
3). Allergic skin rash, skin itching, urticaria, palpitation, spasm, can occur even exudative erythema multiforme and angioneurotic edema, severe cases, shock may occur. A small number of patients have photosensitive reactions.
4). Blood aminotransferase can occurs in A small number of patients, Liver muscle blood urea nitrogen increased, and peripheral blood leukocytes as reduced.
5).Thrombocytopenia, mostly mild and show transient.
6). Occasionally can occur:
A. epileptic seizures, psychosis, irritability anxiety, confusion, hallucinations, tremor.
B, hematuria, fever, rash, such as the performance of interstitial nephritis.
C. the crystallization of urine, was particularly prevalent in the high-dose applications.
D. joint pain.
E. phlebitis.
F: interstitial pneumonia, fever, cough, difficulty in breathing, chest abnormalities, such as X performance.
G: Achilles tendon inflammation and rupture of Achilles tendon, muscle pain, weakness, CPK increased, etc.

Precautions:
1). Impaired liver function be used with caution, if used, should adjust the dose according to the degree of decline.

2). Liver dysfunction used with caution, if used, care should be taken to monitor liver function.

3). The original diseases in patients with central nervous system, including a history of cerebral arteriosclerosis or epilepsy should avoid those applications, there are indications for the application when weighing the pros and cons.

4). Allergic cross-reactions exist in Quinolones, allergic to any of the quinolones are not allowed to use this product.

5). In patients with urinary pH values above 7 crystalluria prone, so the daily water intake must be sufficient to enable the daily urine output remained at more than 1200 ~ 1500ml.

6). This product can cause photosensitive reactions, at least 12 hours after light exposure before treatment, during treatment and after treatment within a few days too long to avoid exposure to bright light. When indications of photosensitive reactions such as skin burning, redness, swelling, blisters, skin rash, itching, dermatitis treatment should be stopped.

7). Occasional the rupture of Achilles tendon Achilles tendon inflammation  reported of using drug ,if the above symptoms should immediately stop, walking is prohibited until the symptoms disappear.

8). This product should not be too fast infusion, each 100ml of at least need 45 ~ 60 minutes .

9). This product should not be mixed with other drugs.

10). This product is not allowed to use together with dextrose and sodium chloride injection or sodium chloride injection.

11). In case turbid liquid, foreign matters, bottle broken, rolling loose, please do not use. If could not finish the in first use, re-use is prohibited.

Overdose
Not known yet.

Drug interactions
1). This product can not be used together with divalent metal ions with calcium and magnesium in the same infusion solution. DdI should not be applied (DDI), as the aluminum and magnesium in it can be chelated with fluoroquinolones.

2). Urine alkalization agent can reduce the chemicals in the urine solubility, resulting in the crystallization of urine and renal toxicity.

3). Probenecid may delay excretion of the products, so that the product resulting from increased concentrations of blood toxicity.

4). With warfarin or its derivatives at the same time, the application time of  plasminogen should be monitored and other blood coagulation tests should be done.

5). With non-steroidal anti-inflammatory drugs, there is the possibility of triggering convulsions.

6). Combined with oral hypoglycemic agents may cause high blood sugar or low blood sugar.

7). Using together with theophylline at the same time should be avoided.

Pharmaco-toxicological
This product is quinolone antibacterial, has a strong anti-bacterial effect on Gram-negative bacteria, Escherichia coli, Bacillus pneumoniae, Proteus genera, Salmonella typhi, Salmonella paratyphi, Shigella, Enterobacter cloacae, Enterobacter aerogenes, citrate species, Serratia Serratia, Pseudomonas aeruginosa, Neisseria meningitidis, Haemophilus influenzae, Moraca bacteria Legionella pneumophila, Neisseria gonorrhoeae,etc.And has a moderate anti-bacterial effect on Staphylococcus, Streptococcus, such as hemolytic gram-positive cocci and etc.

Mechanism of this product: inhibition of bacterial DNA gyrase into sterilization.

Pharmacokinetics
For healthy people, intravenous drip injection Fleroxacin 0.1g, the peak plasma concentration (Cmax)rise to 2.85μg/ml, plasma elimination half-life (t1/2β)is 8.6 ± 1.3 hours, peak time is 0.33 hours. Apparent volume of distribution (Vd) is 110L. This product in most tissues is close to or higher than the concentration of the blood concentration of the same period, but the low concentration in the central nervous system. Administration of 60% to 70% will be excreted by the kidneys in the form of prototype and metabolite,a small portion excreted by bile and only 3% of it is excreted by feces.

Storage:shading, confined preservation.

Packing: polypropylene bottle packed with butyl rubber stopper and aluminum cap,100ml/bottle.

Validity period:24 months

Number of product licence:GYZZ 20066373