farfolex inf 100ml - belinda.uk.com
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Trade name: Farfolex.International Nonproprietary Name: Ofloxacin.Dosage form: Solution for infusion.Composition: Each 100 ml contains: Ofloxacin BP 200 mg; Excipients q.s.ATC Code: J01MA01.Pharmacotherapeutic group: Quinolone antibacterials. Fluoroquinolones.Pharmacological action: Pharmacodynamics:Ofloxacin is a quinolone-carboxylic acid derivative with a wide range of antibacterial activity against both Gram-negative and Gram-positive organisms. It inhibits bacterial DNA replication by blocking DNA topo-isomerases, in particular DNA gyrase.Antimicrobial spectrum includes Gram-positive aerobes: Staphylococcus aureus (meticillin-susceptible), Staphylococcus epidermidis (meticillin-susceptible), Staphylococcus saprophyticus, Streptococcus pneumoniae (penicillin-susceptible), Streptococcus pyogenes.Gram-negative aerobes: Acinetobacter calcoaceticus, Bordetella pertussis, Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Haemophilus ducreyi, Haemophilus influenzae, Klebsiella oxytoca, Moraxella catarrhalis, Morganella morganii, Klebsiella pneumoniae, Neisseria gonorrhoeae, Proteus mirabilis, Proteus vulgaris , Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa (quickly develop resistance), Serratia marcescens.Anaerobic bacteria: Clostridium perfringens.Other: Chlamydia trachomatis, Chlamydia pneumoniae, Gardnerella vaginalis, Legionella pneumophlia, Mycoplasma hominis, Mycoplasma pneumoniae, Ureaplasma urealyticum.In most cases, insensitive: Nocardia asteroides, anaerobic bacteria (including Bacteroides spp., Peptococcus spp., Peptostreptococcus spp., Eubacterium spp., Fusobacterium spp., Clostridium difficile), Enterococcus spp., Most of Streptococcus spp., Not effect on Treponema pallidum.Pharmacokinetics:After a single infusion of 200 mg ofloxacin in 60 minutes Cmax is 2.7 mcg / ml , the concentrations at 12 hours after dosing is 0.3 mcg/mL.Steady-state concentrations were attained after four doses, and the area under the curve (AUC) was approximately 40% higher than the AUC after a single dose. The mean peak and trough plasma steady-state levels attained following intravenous administration of 200 mg of ofloxacin q 12 h for seven days were 2.9 and 0.5 Β΅g/mL, respectively. Elimination of ofloxacin is primarily by renal excretion. Approximately 65% of a dose is excreted renally within 48 h.<5% of an administered dose is recovered in the urine as the desmethyl or N-oxide metabolites. 4-8% of an ofloxacin dose is excreted in the feces. This indicates a small degree of biliary excretion of ofloxacin.Indications for use:It is indicated for the treatment of the following infections when caused by sensitive organisms:Ρ Respiratory tract infections (acute and chronic bronchitis,
pneumonia, including those caused by intracellular or atypical pathogens, with the exception of pneumococcal infections);
Ρ Acute, chronic and recurrent infections of upper respiratory tract (except for cases of acute tonsillitis - strains as Streptococcus spp. moderately susceptible to ofloxacin, the drug should not be used as a tool of choice for the treatment of pneumonia caused by pneumococcus, and acute tonsillitis (Γ-hemolytic streptococcus));
Ρ Infections of skin and soft tissue;Ρ Infection of bone (osteitis, osteomyelitis) and joints;Ρ Abdominal infections, including infections of the biliary tract;Ρ Intestinal infections, including escherichiosis, salmonellosis,
shigellosis, cholera, yersiniosis;Ρ Infectious and inflammatory diseases of the pelvic organs
(pelvioperitonit, salpingitis, oophoritis, tubo-ovarian abscesses, endometritis);
Ρ Complicated and uncomplicated infectious and inflammatory diseases of the urinary tract, prostate and urethra, including gonococcal etiology;
Ρ Sepsis;Ρ Prevention of bacterial infections in patients with impaired
immunity, including neutropenia.Contra-indications:Ρ hypersensitivity to fluoroquinolones;Ρ children up to age 18;Ρ pregnancy, lactation;Ρ patients with deficiency of glucose-6-phosphate
dehydrogenase;Ρ epileptics (including history), decrease seizure threshold
(including after brain injury, stroke or inflammation of the central nervous system);
Ρ if there are indications of damage tendons, against previously held receiving fluoroquinolones.
Application for violations of liver function: the maximum daily dose in hepatic failure - 400 mg / day.Use in renal impairment: in patients with renal impairment (with CC from 50 to 20 ml / min) single dose should be 50% of the average dose in the multiplicity of purposes, 2 times / day. Or complete a single dose administered 1 time / day. When clearance <20 ml/min single dose - 200 mg, then - 100 mg / day, every other day.Dosage and directions for use:General dosage recommendations: The dose of ofloxacin is determined by the type and severity of the infection. A daily dose of up to 400 mg ofloxacin may be given as a single dose. In this case, it is preferable to administer ofloxacin in the morning.Daily doses of more than 400 mg must be divided into two separate doses and be given at approximately equal intervals.Adults: The usual intravenous dosages in adults are:Complicated urinary tract infection: 200 mg daily.Lower respiratory tract infection: 200 mg twice daily.Septicaemia: 200 mg twice daily.Skin and soft tissue infections: 400 mg twice daily.Farfolex solution is only intended for SLOW intravenous infusion; it is administered once or twice daily. The infusion time for Farfolex IV should not be less than 30 minutes for 200 mg. This is of particular importance when ofloxacin is administered concomitantly with drugs that can lead to a reduction in blood pressure or with barbiturate-containing anaesthetics. Generally, individual doses are to be given at approximately equal intervals.The dose may be increased to 400 mg twice daily in severe or complicated infections.Posology in patients with renal insufficiency:In patients with impaired renal function, the following oral or I.V. dosages are recommended:
* According to indication or dose interval.** The serum concentration of ofloxacin should be monitored in patients with severe renal impairment and dialysis patients.Posology in hepatic insufficiency (e.g. cirrhosis with ascites)It is recommended that a maximum daily dose of 400 mg of ofloxacin be not exceeded, because of possible reduction of excretion.Children: Farfolex is not indicated for use in children or growing adolescents.Elderly:Age in itself does not impose to adapt the dosage of Farfolex. However, special attention to renal function should be paid in elderly patients, and the dosage should be adapted accordingly. Duration of treatment: The duration of treatment is determined according to the response of the causative organisms and the clinical picture. As with all antibacterial agents, treatment with Farfolex should be continued for at least 3 days after the body temperature has returned to normal and the symptoms have subsided.In most cases of acute infection, a course of treatment lasting 7 to 10 days is sufficient. Once the patient's condition has improved, the mode of administration should be changed from parenteral to oral, normally at the same total daily dose.Treatment should not exceed 2 months duration.Side-effects:Infections and infestations: Uncommon - Fungal infection, Pathogen resistance.Blood and the lymphatic system disorders: Very rare β Anaemia, Haemolytic anaemia, Leukopenia, Eosinophilia, Thrombocytopenia. Not known β Agranulocytosis, Bone marrow failure.Immune system disorders: Rare - Anaphylactic reaction, Anaphylactoid reaction, Angioedema. Very rare - Anaphylactic shock, Anaphylactoid shock.Metabolism and Nutrition disorders: Rare β Anorexia. Not known - Hypoglycaemia in diabetics treated with hypoglycaemic agents. Hyperglycaemia, Hypoglycaemic coma.Psychiatric disorders: Uncommon - Agitation, Sleep disorder, Insomnia. Rare - Psychotic disorder (for e.g. hallucination), Anxiety, Confusional state, Nightmares, Depression. Not known - Psychotic disorder and depression with self-endangering behaviour including suicidal ideation or suicide attempt, Nervousness.Nervous system disorders: Uncommon - Dizziness, Headache. Rare- Somnolence, Paraesthesia, Dysgeusia, Parosmia. Very rare - Peripheral sensory neuropathy, Peripheral sensory motor neuropathy, Convulsion, Extra-pyramidal symptoms or other
disorders of muscular coordination. Not known - Tremor, Dyskinesia, Ageusia Syncope. Eye disorders: Uncommon - Eye irritation. Rare - Visual disturbance.Ear and labyrinth disorders: Uncommon - Vertigo. Very rare - Tinnitus, Hearing loss. Not known - Hearing impaired.Vascular disorders: Common β Phlebitis. Rare β Hypotension. Not known - During infusion of ofloxacin, tachycardia and hypotension may occur. Such a decrease in blood pressure may, in very rare cases, be severe.Respiratory, thoracic and mediastinal disorders: Uncommon - Cough, Naso-pharyngitis. Rare - Dyspnoea, Bronchospasm. Not known - Allergic pneumonitis, Severe dyspnoea.Gastrointestinal disorders: Uncommon - Abdominal pain, Diarrhoea, Nausea, Vomiting. Rare - Enterocolitis, sometimes haemorrhagic. Very rare - Pseudomembranous colitis, Jaundice cholestatic. Not known β Dyspepsia, Flatulence, Constipation, Pancreatitis.Hepato-bilary disorders: Rare - Hepatic enzymes increased (ALAT, ASAT, LDH, gamma-GT and/or alkaline phosphatase), Blood bilirubin increased. Not known - Hepatitis, which may be severe.Skin and subcutaneous tissue disorders: Uncommon - Pruritus, Rash. Rare - Urticaria, Hot flushes, Hyperhidrosis, Pustular rash. Very rare - Erythema multiforme, Toxic epidermal necrolysis, Photo-sensitivity reaction, Drug eruption, Vascular purpura, Vasculitis, which can lead in exceptional cases to skin necrosis. Not known - Stevens-Johnson syndrome, Acute generalized exanthemous pustulosis, drug rash Stomatitis.Musculoskeletal and Connective tissue disorders: Rare β Tendonitis. Very rare - Arthralgia, Myalgia,Tendon rupture (e.g. Achilles tendon) which may occur within 48 hours of treatment start and may be bilateral. Not known - Rhabdomyolysis and/or Myopathy, Muscular weakness, Muscle tear, muscle rupture, Ligament rupture, Arthritis.Renal and Urinary disorders: Rare β Serum creatinine increased. Very rare - Acute renal failure. Not known - Acute interstitial nephritis.Congenital and familial/genetic disorders: Not known - Attacks of porphyria in patients with porphyria.General disorders and administration site conditions: Common - Infusion site reaction (pain, reddening). Not known - Asthenia Pyrexia Pain (including pain in the back, chest and extremities).Overdose:Symptoms: CNS symptoms such as confusion, dizziness, impairment of consciousness and seizures, increases QT interval as well as gastrointestinal reactions such as nausea and mucosal erosions.Treatment: Elimination of ofloxacin may be increased by forced diuresis. In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. Antacids may be used for protection of gastric mucosa.A fraction of ofloxacin may be removed from the body with haemodialysis. Peritoneal dialysis and CAPD are not effective in removing ofloxacin from the body. No specific antidote exists.Drug Interactions:Drugs known to prolong QT interval:Ofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval (e.g. Class IA and III anti-arrhythmics, tricyclic antidepressants, macrolides, antipsychotics).Prolongation of bleeding time has been reported during concomitant administration of ofloxacin and anticoagulants.Theophylline, fenbufen or similar non-steroidal anti-inflammatory drugs:No pharmacokinetic interactions of ofloxacin were found with theophylline in a clinical study. However, a pronounced lowering of the cerebral seizure threshold may occur when quinolones are given concurrently with theophylline, nonsteroidal anti-inflammatory drugs, or other agents, which lower the seizure threshold.In case of convulsive seizures, treatment with ofloxacin should be discontinued.Glibenclamide:Ofloxacin may cause a slight increase in serum concentrations of glibenclamide administered concurrently; patients treated with this combination should be closely monitored.Probenecid, cimetidine, furosemide and methotrexate:Caution should be exercised when ofloxacin is co-administered with drugs that affect the tubular renal secretion such as probenecid, cimetidine, furosemide and methotrexate.Vitamin K antagonists:Increased coagulation tests (PT/INR) and/or bleeding, which may be severe, have been reported in patients treated with ofloxacin in combination with a vitamin K antagonist (e.g. warfarin) .Coagulation tests should be monitored in patients treated with vitamin K antagonists because of a possible increase in the effect of coumarin derivatives.Cautions:Diarrhoea, particularly if severe, persistent and/or bloody, during or after treatment with ofloxacin (including several weeks after treatment), may be symptomatic of pseudo-membranous colitis (CDAD). CDAD may range in severity from mild to life threatening, the most severe form which is pseudomembranous colitis. It is therefore important to consider this diagnosis in patients who develop serious diarrhoea during or after treatment with ofloxacin .If pseudo-membranous colitis is suspected, ofloxacin must be stopped immediately.Should be used with caution in patients with a history of
psychotic disorder or in patients with psychiatric disease.Farfolex is not recommended in patients with a known history of myasthenia gravis.It is recommended that patients should not expose themselves unnecessarily to strong sunlight or to artificial UV rays (e.g. sunray lamp, solarium), during treatment and for 48 hours following treatment discontinuation in order to prevent photosensitisation.Farfolex should be discontinued if the patient experiences symptoms of neuropathy in order to prevent the development of an irreversible condition.In diabetic patients, careful monitoring of blood glucose is recommended.If Farfolex has to be used in patients with glucose-6-phosphate-dehydrogenase deficiency, potential occurrence of haemolysis should be monitored.In patients treated with Farfolex, determination of opiates in urine may give false-positive results. It may be necessary to confirm positive opiate screens by more specific method.Patients with rare hereditary disorders of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.Effects on ability to drive and use machines:Since there have been occasional reports of somnolence, impairment of skills, dizziness and visual disturbances, patients should know how they react to Farfolex before they drive or operate machinery. Presentation:1X1, 100 ml FFS Plastic bottle in a monocarton, with instruction for use.Storage:Keep in dry place protected from light at a temperature below 30Β°Π‘. Keep out of reach of children. Do not freeze.Shelf life:Labeled. Do not use after expiry date.Distribution Condition:Prescription only medicine (POM).
02Z
FARFOLEX
CREATININE CLEARANCE
UNIT DOSE mg*
NUMBER / 24 h
INTERVALS h
50 β 20 ml/min 100 β 200 1 24
< 20 ml/min** or haemodialysis or peritoneal dialysis
100 or 200
1 1
24 48
Instruction for use of the drug
FARFOLEX
I αααΌοΏ½αα±αα :
-οΏ½α±ααοΏ½ααααααΌαα»ααοΏ½αααοΏ½αοΏ½ααααοΏ½αοΏ½αααααοΏ½αα» α½
-α‘οΏ½αα’αοΏ½αα α‘ααοΏ½οΏ½ αοΏ½α α ααα»α 100mlα·
II αοΏ½αοΏ½ααα»οΏ½α : αοΏ½α 100ml οΏ½αα α» -Ofloxacinβ¦β¦β¦β¦β¦β¦β¦β¦β¦200mg
III ααα»οΏ½ααοΏ½οΏ½α :
α οΏ½οΏ½ααααα±ααα’ααααααΌαΈαααααααοΏ½αοΏ½αοΏ½α quinolone αοΏ½αααοΏ½αααοΏ½οΏ½ααααοΏ½ααοΏ½α αοΏ½αααααααααααα±αααααααΌα οΏ½αα· αΊαΈ α· αΉα»
α -αααοΏ½ααοΏ½ααοΏ½ααααοΏ½α ααΌα οΏ½ααΊ α» αΌ
α o αααοΏ½ααα½ααΊ
α o αααοΏ½ααααα½αοΏ½αοΏ½α οΏ½οΏ½αααοΏ½α»ααα ααΊ α·
α α -αααοΏ½ααοΏ½ααοΏ½ααααοΏ½αααοΏ½αοΏ½αααοΏ½αοΏ½α οΏ½οΏ½αααοΏ½α»ααα α(αααααααααααοΏ½αοΏ½αοΏ½αοΏ½αοΏ½α οΏ½οΏ½α)αΊ αΊ α· αΈα» αΌ
α -αααοΏ½αααααοΏ½αααοΏ½αοΏ½ααααΊ α· α·
α -αααοΏ½ααοΏ½ααοΏ½ααααοΏ½οΏ½ αααΊ αΉ α·α»
α -αααοΏ½αααοΏ½οΏ½ααοΏ½ααοΏ½ααΊ α»
α -αααοΏ½ααοΏ½ααοΏ½αοΏ½ααααοΏ½αααοΏ½ααΊ α» αΌ
α -αααοΏ½ααααοΏ½ααοΏ½αοΏ½αοΏ½ααΊ α· αΉ
α -αααοΏ½ααααοΏ½ααοΏ½αααοΏ½ααΌααααοΏ½αααοΏ½ααοΏ½αααααοΏ½οΏ½ααααοΏ½αααοΏ½ααΊ α· α· α· α·αΌ αΌ αΌ
α -ααοΏ½αααααοΏ½αααοΏ½α ααοΏ½αααααααοΏ½ααοΏ½αοΏ½ααααοΏ½αα οΏ½ααΌααΌααΊ α· αΉαΌ αΌ
α -αααοΏ½αοΏ½ααααοΏ½αοΏ½οΏ½οΏ½ ααΊ
α -αααααοΏ½αααοΏ½αοΏ½ααοΏ½αοΏ½ααΊ αΈ α»
α α -αοΏ½οΏ½ ααααοΏ½ααοΏ½αοΏ½αααααα ααοΏ½αα’οΏ½ααααααοΏ½αοΏ½ααααοΏ½οΏ½αοΏ½αοΏ½αοΏ½οΏ½αα α»αααοΏ½α (ααΌα οΏ½αααοΏ½αοΏ½αααααα‘αα ααα½α αΊ αΊαΈ αΈ
α α neutrophils α ααοΏ½α α’οΏ½α αα οΏ½αοΏ½ααοΏ½οΏ½ αααααοΏ½ααοΏ½οΏ½ααααοΏ½α)αΊ αΊ
IV οΏ½αοΏ½ααοΏ½οΏ½ οΏ½ :
α±αααααοΏ½ααοΏ½αα ααοΏ½αααοΏ½ααοΏ½ ααΌα οΏ½ααοΏ½οΏ½αα
-α ααοΏ½αα’οΏ½αοΏ½αοΏ½αοΏ½ααααοΏ½οΏ½ααα½αα ofloxacin α¬οΏ½ααα½α±ααααοΏ½αααοΏ½ααοΏ½αοΏ½αοΏ½α fluoroquinolone α· αΉ α»
α¬οΏ½ααα½οΏ½αοΏ½αα»αοΏ½ οΏ½α ααα½ααα±αααααα
α -α ααοΏ½αα’οΏ½αααααΌαααοΏ½αοΏ½αα»αοΏ½οΏ½αα‘α¨οΏ½οΏ½ ααΊ
-α ααοΏ½αοΏ½αοΏ½οΏ½αααοΏ½αοΏ½ααΈ
-α ααοΏ½αοΏ½αοΏ½αααοΏ½αοΏ½αααΌααΈ
α -α ααοΏ½αα’οΏ½ααααααααα α»αααααα’αα αοΏ½α glucose-6-phosphate dehydrogenaseαΊ α· αΈα»
α -α ααοΏ½αα’οΏ½ααααοΏ½αοΏ½αοΏ½ααΊ α½
α α -α ααοΏ½αα’οΏ½αοΏ½ααααοΏ½ααααααα½αοΏ½α αα»ααοΏ½αοΏ½αοΏ½ααοΏ½αα±αααοΏ½αοΏ½αοΏ½α fluoroquinolone ααοΏ½ααααΉ α»
V οΏ½αοΏ½οΏ½ οΏ½αοΏ½οΏ½ ααα οΏ½ :
α±αααααοΏ½αοΏ½αοΏ½αοΏ½αοΏ½ααααοΏ½α ααοΏ½αααοΏ½ααοΏ½ ααΌα οΏ½ααοΏ½οΏ½αα
α α -α ααοΏ½αα’οΏ½ααααοΏ½αοΏ½αοΏ½α α¬α’οΏ½αοΏ½οΏ½ αοΏ½ααοΏ½αααοΏ½αααααοΏ½ααααοΏ½ααααοΏ½αοΏ½ααοΏ½οΏ½ ααΊ αΊα· α½
α α α -α ααοΏ½αα’οΏ½αααοΏ½οΏ½ αοΏ½ααοΏ½αααοΏ½αααααααοΏ½αοΏ½α αα»ααΊ αΊα·
α -α ααοΏ½αα’οΏ½αααααοΏ½ααα»αοΏ½αααοΏ½α α¬αα»αοΏ½ααααααοΏ½ααΊ
α α -α ααοΏ½αααΌαααοΏ½αααααα»αοΏ½αααααα·
-α ααοΏ½αααα»αοΏ½οΏ½αα
-αοΏ½αα’αα‘ααααα¬αοΏ½οΏ½αοΏ½ααοΏ½οΏ½ααοΏ½ααοΏ½αα±αααααοΏ½α ααοΏ½α²οΏ½οΏ½ααοΏ½αοΏ½αααοΏ½ααοΏ½αοΏ½οΏ½ ααοΏ½αααοΏ½αα α» α»αααΌαα οΏ½αοΏ½αοΏ½ααοΏ½οΏ½αοΏ½αααοΏ½αα±αααααοΏ½οΏ½ αα οΏ½αααααοΏ½οΏ½ααοΏ½αααααα’οΏ½αααοΏ½ααοΏ½ααοΏ½αααοΏ½αααΊ α·
α α -α±αααααααοΏ½αοΏ½αοΏ½αααοΏ½α²αοΏ½αοΏ½αοΏ½ααΌαοΏ½α ααοΏ½αααΌαααοΏ½α ααααα»αοΏ½ααααα αααααααααοΏ½αααα αααααοΏ½α α οΏ½αοΏ½αααααα· α· α·
α -α ααοΏ½αα’οΏ½αααααααοΏ½οΏ½ααοΏ½ααοΏ½αα±ααααα οΏ½α ααοΏ½α²οΏ½αααοΏ½αααααααοΏ½ααααοΏ½οΏ½ααοΏ½αοΏ½ααοΏ½αααοΏ½αοΏ½αα»ααοΏ½ααοΏ½α αααοΏ½ααΊ α· α· αΉα» α»
α -α ααοΏ½αα’οΏ½αααααααοΏ½οΏ½ααοΏ½ααοΏ½αα±αααααοΏ½αοΏ½αααοΏ½αοΏ½ααααοΏ½ααοΏ½οΏ½ ααοΏ½ααα½ααοΏ½οΏ½ααοΏ½ααοΏ½ α¬οΏ½αααοΏ½ UVαΊ αΊ α· αΈ
α -α ααοΏ½αα’οΏ½αοΏ½ααααααααΌααοΏ½ααααααοΏ½αααααοΏ½αααα½ααοΏ½αοΏ½αα»οΏ½οΏ½αααΌαααΊ α· αΉ
-α±αααααοΏ½α ααοΏ½α²οΏ½αααοΏ½ααααααααοΏ½οΏ½ααααααααοΏ½ααοΏ½οΏ½ αοΏ½αοΏ½αοΏ½ααα»α α· αΈ
-ααοΏ½αοΏ½ααοΏ½αα±ααααααααααααααοΏ½αα· α·
-ααοΏ½αοΏ½ααοΏ½αα±αααααα α½αοΏ½ααααα οΏ½ααοΏ½αοΏ½οΏ½ααα· α·
-ααοΏ½αοΏ½ααοΏ½αα±ααααααα οΏ½αααααααΌαα»ααοΏ½ααοΏ½ααααα‘ααοΏ½α αα¬ααοΏ½οΏ½ αα· α· α» α»
VI ααααοΏ½α :
αααοΏ½ααααααααοΏ½αααααΌαααοΏ½ααααααα±αααααααα½οΏ½αα α· αΉ
α α α -αααοΏ½αααοΏ½αοΏ½ααοΏ½ααααοΏ½αα αααοΏ½ααΊ αΊ αΊα· α·
-αααοΏ½οΏ½οΏ½αοΏ½ααααοΏ½ααααοΏ½αααοΏ½οΏ½αοΏ½ααα ααααα‘αα ααα½α eosinophilsα· α· α· α·
-αααοΏ½οΏ½ααααοΏ½οΏ½αοΏ½αα»ααοΏ½αοΏ½α οΏ½ααααοΏ½οΏ½οΏ½α οΏ½οΏ½ααααα· α· αΈ α· αΈ α·
-αααοΏ½οΏ½οΏ½ααΌααοΏ½αοΏ½ααααοΏ½ααΌααα ααααΌαοΏ½οΏ½ αα· α· α· αΈ α·
-αααοΏ½αοΏ½αα αοΏ½α ααααοΏ½α ααααααααα· α· α· α·αΌ
-αααοΏ½οΏ½ααααοΏ½ααααοΏ½αοΏ½αα ααοΏ½α αααοΏ½α ααααααα αααααΌαααααοΏ½αα· αΉα· αΊ αΈ α· α· α·
α -αααοΏ½α αοΏ½α οΏ½αοΏ½αααοΏ½α αοΏ½ααααοΏ½αα· α· α»
-αααοΏ½οΏ½ααα οΏ½αααααααααααααα α αοΏ½ααα οΏ½α αααα»αα· α·α· α· αΉ
-αααοΏ½αααααΌαα αααααΌααααοΏ½ααα· α·
-αααοΏ½ααααοΏ½αα αοΏ½αααααοΏ½α α· α·
-αααοΏ½αοΏ½ααααοΏ½αα αοΏ½ααααααοΏ½αα· α· α·αΌ
-αααοΏ½οΏ½ααααοΏ½αααοΏ½αα αοΏ½α α αοΏ½οΏ½ α οΏ½α αα ααοΏ½α αοΏ½ααοΏ½ααοΏ½οΏ½α α· α· α·α½
-αααοΏ½ααοΏ½αααοΏ½αοΏ½αααα αα‘αααοΏ½ααοΏ½αα οΏ½αα αααοΏ½α αοΏ½οΏ½ αοΏ½αοΏ½α α· α· α· α· α½
-αααοΏ½ααοΏ½αααοΏ½αοΏ½αααα ααααα‘αα’αα αοΏ½ααοΏ½αααοΏ½α ααααα‘ααααααααΈααα»ααααΈααοΏ½αααοΏ½αα· α· α· αΈ α· αΈα» α» α»
α α α -αααοΏ½αοΏ½αοΏ½α αα»αα ααοΏ½αοΏ½α αα»α ααοΏ½οΏ½ α ααοΏ½ααααααα½αοΏ½α αα»αα· α· αΉ αΊ αΉ αΊ
-αααοΏ½αααααοΏ½αα ααααα‘ααααα creatinine αοΏ½αοΏ½αα· α· α· α»
-αααοΏ½ααΌαοΏ½αααααααοΏ½ααοΏ½αα α’αααοΏ½οΏ½ αα αοΏ½οΏ½ αοΏ½α ααααααοΏ½ααοΏ½αα· α· α· αΊ α½
Π¨ οΏ½αοΏ½ααοΏ½ααοΏ½οΏ½αοΏ½ααα½οΏ½αοΏ½αααοΏ½ οΏ½αααααοΏ½αοΏ½ααααοΏ½αοΏ½ααοΏ½ααα½ααααα‘ααα· α· α·
VII α’ααοΏ½ ααα±οΏ½ αα :
αα½αααοΏ½αοΏ½ααοΏ½αααα½αοΏ½οΏ½αοΏ½ οΏ½ααα½α±ααααΌα οΏ½ααοΏ½οΏ½αα
-Antiarrythmics, Tricyclic antidepressants, Macrolides, Antipsychotics
-Anticoagulants
-Theophylline, Fenbufen or NSAIDs
-Glibenclamid
-Probenecid, Cimetidine, Furosemide, Methotrexate
-Vitamin K antagonists
VIII οΏ½αααοΏ½ααα» :
o -οΏ½αοΏ½αααοΏ½αα»ααοΏ½ααα»αοΏ½ οΏ½ααοΏ½οΏ½α 30 CαΈ
-οΏ½αοΏ½ααα»αααα»α²οΏ½οΏ½αοΏ½ααααοΏ½ααοΏ½ ααααααα α·
-οΏ½αοΏ½ααα»αα²οΏ½αα»ααααααΌαααοΏ½ααΈ
IX αααοΏ½α αοΏ½ααααοΏ½ ααοΏ½οΏ½ οΏ½ :
vαααααοΏ½ααα·
α -αααααοΏ½αα±ααααααοΏ½οΏ½ααααοΏ½οΏ½αοΏ½αααααααοΏ½ααοΏ½αααοΏ½ααααααααοΏ½αα αααααοΏ½αοΏ½αοΏ½αααοΏ½ααααα±αααααοΏ½α αοΏ½ααα αΌαααααΊα· αΊ α· α·
400mg αοΏ½αααα‘αααα ααοΏ½αα‘ααοΏ½α αοΏ½αααααοΏ½ααααααα οΏ½οΏ½ααοΏ½οΏ½ααα α±ααααααα½ααοΏ½ααοΏ½αααοΏ½ααα αΈ αΉα» α»
-οΏ½αοΏ½αααααοΏ½αοΏ½αοΏ½αααοΏ½αααα 400mg οΏ½αοΏ½ααοΏ½ααα αοΏ½α’αα αοΏ½αα αοΏ½οΏ½ ααααααοΏ½αοΏ½οΏ½ αοΏ½αααοΏ½α α· αΈ α» α»
α α ααοΏ½αααα»αοΏ½αααααα α αααααοΏ½αααοΏ½οΏ½οΏ½αααααοΏ½αα ααοΏ½αααα»αοΏ½αααααοΏ½αααΌα οΏ½ααοΏ½οΏ½ααα·
α -ααοΏ½αααοΏ½οΏ½ααααοΏ½ααοΏ½ααοΏ½αααοΏ½ααοΏ½αααααοΏ½οΏ½ααααααααοΏ½ααα ααααααοΏ½α²αοΏ½αοΏ½αα 200mg αοΏ½αα‘ααοΏ½ααΊ α· α· α· α· αΊα» αΌ αΌ α»
α -ααοΏ½αααοΏ½οΏ½ααααοΏ½ααοΏ½ααοΏ½ααααοΏ½αα ααααααοΏ½α²αοΏ½αοΏ½αα 200mg αοΏ½αα’αα αοΏ½αα‘ααοΏ½ααΊ α· αΊ α» αΌ α»
α -ααοΏ½αααοΏ½οΏ½ααααααοΏ½αοΏ½αοΏ½ααοΏ½αοΏ½αα ααααααοΏ½α²αοΏ½αοΏ½αα 200mg αοΏ½αα’αα αοΏ½αα‘ααοΏ½ααΊ α· αΊ α» α»
α -αααοΏ½αααααοΏ½αααοΏ½αοΏ½αααα αααααοΏ½αα 400mg αοΏ½αα’αα αοΏ½αα‘ααοΏ½ααΊ α· α· α· αΊ α»
α α α ααοΏ½αααΌαααοΏ½α ααααα»αοΏ½ααααααα α·
α α -α±αααααααααοΏ½α²αοΏ½αοΏ½αα ααοΏ½αααΌαααοΏ½αααααα»αοΏ½αααααααααα»αααΌαοΏ½αααααα· α·
α ααοΏ½αααα»αοΏ½οΏ½ααα α ααααααοΏ½ααοΏ½οΏ½ααααοΏ½οΏ½αοΏ½αααααααοΏ½ααααααα creatinine ααααα’οΏ½αααααΊ αΊα· αΊ α· α·
α α α ααοΏ½αα’οΏ½αααααοΏ½ααα»αοΏ½ααααααοΏ½αα αααααοΏ½αα±ααααααοΏ½οΏ½ααααοΏ½οΏ½ααααα creatinine αοΏ½αοΏ½αααααα’οΏ½αααααΌα οΏ½α αοΏ½οΏ½αααΊ αΊα· αΊ α· α»
-οΏ½αοΏ½αααα creatinine αοΏ½α αοΏ½οΏ½ αα 50ml/min αοΏ½ 20ml/minα αααααοΏ½αα 100mg αοΏ½ 200mg ααοΏ½αοΏ½ααα’α€αοΏ½αααοΏ½αα· αΈ α· αΊ
-οΏ½αοΏ½αααα creatinine ααΌα οΏ½α 20ml/minα αααααοΏ½αα 100mg ααοΏ½αοΏ½ααα’α€αοΏ½αααοΏ½αα· α· αΊ
-αααοΏ½αοΏ½αα αααααοΏ½αα 200mg ααοΏ½αοΏ½ααα€α¨αοΏ½αααοΏ½α αΈ α· αΊ
α α ααοΏ½αα’οΏ½αααααοΏ½ααα»αοΏ½αααοΏ½αα αΊ
-ααααααοΏ½α²αοΏ½αοΏ½ααααοΏ½αοΏ½ααοΏ½ααααα 400mg αοΏ½αα‘ααοΏ½αααα· αΊ α· αΈ α»
vοΏ½αααοΏ½αααααοΏ½ααοΏ½αααΈ
-α±ααααααοΏ½αοΏ½αααοΏ½αοΏ½αααααοΏ½ααααα»ααοΏ½οΏ½ αα α½
α -οΏ½αοΏ½αααοΏ½αοΏ½οΏ½ αααααααοΏ½αααααααααααααοΏ½ααοΏ½αοΏ½αοΏ½ααοΏ½αααααοΏ½αα αΊ αΈαΌ
vαααααααοΏ½οΏ½αα
α -αααααααοΏ½οΏ½ααοΏ½οΏ½ααααοΏ½οΏ½αοΏ½αααοΏ½ααααααααααοΏ½ααοΏ½ααααααΊαΊ
-ααΌα οΏ½α±ααα’ααααααΌαΈαααααοΏ½αααοΏ½αααα οΏ½ααοΏ½οΏ½ααοΏ½ααοΏ½αα±αααααοΏ½αοΏ½αααοΏ½αοΏ½αααααααα£ααοΏ½αααοΏ½αααοΏ½ααοΏ½οΏ½αααααΈ α·
α οΏ½α ααοΏ½α αοΏ½οΏ½ ααααΊ
α -αοΏ½ααααοΏ½ααοΏ½α ααααααοΏ½αοΏ½αοΏ½α οΏ½οΏ½α αααααααοΏ½οΏ½ααοΏ½ααοΏ½αα±ααααααοΏ½ααααααααα§αοΏ½α‘α ααοΏ½α αοΏ½ααααΊαΈ αΊ αΈα»
α α α α ααααοΏ½ααοΏ½οΏ½ ααοΏ½αααΌαοΏ½οΏ½ααα α α’οΏ½αααοΏ½αοΏ½ααοΏ½αοΏ½οΏ½ ααααοΏ½αοΏ½αοΏ½ααααααοΏ½ααααοΏ½αοΏ½ααααοΏ½οΏ½ οΏ½οΏ½ααααα οΏ½αοΏ½α αααααΊ αΊ α· αΈ αΌ
-οΏ½ααοΏ½οΏ½ααοΏ½ααοΏ½αα±ααααααααοΏ½αοΏ½αααααααααααα’ααααα αΊ α· αΈ
Π¨ αα»ααααοΏ½αα±ααααα οΏ½αοΏ½αααοΏ½οΏ½αοΏ½ααα½οΏ½αοΏ½αααοΏ½ααΉ α·
X ααααοΏ½οΏ½ α·οΏ½: CAM N0153IP-17
XI ααα·ααοΏ½α: Abaris Healthcare Pvt. Ltd. (India)
οΏ½ααααοΏ½αααοΏ½αοΏ½ααααοΏ½αοΏ½αοΏ½ααοΏ½οΏ½ αα±αα α ααοΏ½οΏ½α ααοΏ½οΏ½ ααααοΏ½ αααοΏ½αοΏ½αααοΏ½ααα· α· α· αΈ α· α·
ααα :α‘α§α€α¦/α‘α§ α±α’αα α α»αααοΏ½α α α₯ αα ααα»οΏ½ οΏ½οΏ½ α’αα α‘α§ αΈ α·
ααοΏ½οΏ½ααααοΏ½ α±αα
οΏ½οΏ½ α α‘οΏ½ οΏ½α αοΏ½αοΏ½αααααοΏ½ααΌ α½
Solution for InfusionOfloxacin 200mg
280 x 250 mm