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Patient Information On

Tavanic 5 mg/ml Solution for Infusion

Active Substance And Excipients

What does the solution contain?

Each bottle of Tavanic [Levaquin] solution for infusion contains levofloxacin (5 mg/ml) as active ingredient. Tavanic [Levaquin] solution for infusion is available in bottles of 50 ml (250 mg) and 100 ml (500 mg).The solution also contains the following ingredients sodium chloride; sodium hydroxide; hydrochloric acid (qs: pH 4.8) and water for injection, (Na+ concentration: 154mmol/L).

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Pharmaceutical Form And Contents

What does the solution look like?

  • 50 or 100 ml of ready for use solution, which is greenish-yellow in colour. It is provided in either a 50 or 100 ml glass bottle with a rubber stopper.
  • 50 ml bottles are available in packs of (1), (5).
  • 100 ml bottles are available in packs of (1), (5), (20).

Pharmacotherapeutic Group

What type of medicine is Tavanic [Levaquin] solution?

Levofloxacin, the active ingredient of the solution for infusion, is a synthetic antibacterial agent of the fluoroquinolone class (antibiotic) for administration into a vein.

Marketing Authorization Holder And Manufacturer

Who markets Tavanic [Levaquin]

The marketing authorization for Tavanic [Levaquin] in the UK is held by Hoechst Marion Roussel Ltd, Broadwater Park, Denham, Uxbridge, Middlesex UB9 5HR Great Britain. The marketing authorization for Tavanic [Levaquin] in Ireland is held by Hoechst Marion Roussel Ireland Ltd, Cookstown, Tallaght, Dublin 24, Ireland.

The solution for infusion is manufactured by Sanofi-Aventis Deutschland GmbH, Bruningstrasse50, D-65926 Frankfurt am Main, Germany.

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Therapeutic Indications

Why has Tavanic [Levaquin] infusion been prescribed?

The solution for infusion is indicated for the treatment of the following bacterial infections when caused by sensitive micro-organisms:

  • community acquired pneumonia,
  • complicated (difficult to treat) urinary tract infections including pyelonephritis (infection of the kidney),
  • skin and soft tissue infections.
  • infection of the prostate.

Information Necessary Before Administering Tavanic [Levaquin]

Contra-indications

When you should not use Tavanic [Levaquin] infusion?

You should not be administered the infusion if you have ever had an allergic reaction to levofloxacin or any other quinolone antibiotic. Otherwise you could have a similar reaction to Tavanic [Levaquin].

You should not be administered the infusion if you suffer from epilepsy. Otherwise, your risk of getting “fits” (convulsions) is increased. You should not be administered the infusion if you have ever had tendon problems (e.g. tendinitis) related to treatment with an antibiotic of the fluoroquinolone class. This is because there is a risk of getting similar problems with Tavanic [Levaquin], including tendon rupture. You should not be administered the infusion if you are pregnant or breast-feeding a baby. Tavanic [Levaquin] could harm your baby. The infusion is only intended for adults and must not be given to children or growing teenagers. It could harm the cartilage of their growing bones.

Tell your doctor if you have had any problems with medicines in the past.

Special warnings and special precautions for use

What special precautions should be taken ?

The risk of getting “fits” may be increased if in the past you have experienced brain damage (such as stroke or severe brain injury) and are 3 now treated with Tavanic [Levaquin]. (You should not be ad- I ministered the infusion if you suffer from epilepsy). Make sure your doctor knows about your medical history, so he can give you appropriate advice. The risk of getting “fits” may 12 also be increased if you take Tavanic [Levaquin] with certain other drugs (with fenbufen or similar medicines against rheumatic pain and inflammation, or with theophylline).

Probenecid and cimetidine reduce your kidneys ability to get rid of your medicine, this is unlikely to have any clinical relevance. Your medicine may also prolong the effect of ciclosporin. The infusion lead to an increase in bleeding in patients taking Vitamin K anatagonists, such as warfarin. Tell your doctor about all medicines you are taking including any that you bought without a prescription, as some of them could have an interaction with Tavanic [Levaquin]. Furthermore, do not take any new medicine without consulting your doctor.

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Infusion Time

The recommended infusion time of at least 30 minutes for 250 mg or 60 minutes for 500 mg Tavanic [Levaquin] solution for infusion should be observed. It is known for ofloxacin, that during infusion tachycardia and a temporary decrease in blood pressure may develop. In rare cases, as a consequence of a profound drop in blood pressure, circulatory collapse may occur. Should a conspicuous drop in blood pressure occur during infusion of levofloxacin, (l-isomer of ofloxacin) the infusion must be halted immediately.

Do not stay out in strong sunlight for unnecessarily long periods and do not use a sun-lamp or solarium while you are taking Tavanic [Levaquin]. This is because some patients may become more sensitive to light whilst receiving the infusion (sunburn-like reactions).

Tell your doctor immediately if you have severe, persistent and/or bloody diarrhoea during or after treatment with the infusion. This may be a sign of a serious bowel inflammation (pseudomembranous colitis) which may occur following treatment by antibiotics, and it may be necessary to stop treatment and start specific therapy.

Tavanic [Levaquin] may, in rare cases, cause pain and inflammation in tendons, particularly in elderly patients or in patients taking corticosteroids (cortisone and similar medicines). If you experience any tendon complaints whilst or shortly after receiving the infusion, seek medical advice immediately and rest the affected limb to avoid tendon damage. It may be necessary to stop treatment (see also under Contra-Indications).

Patients with some abnormality of an enzyme called glucose-6-phosphate dehydrogenase (G6-PD) (a rare hereditary disease) may be prone to destruction of red blood cells (hemolysis) when treated with quinolone antibacterial agents, and so levofloxacin should be used with caution in these patients.

What special precautions should be taken when driving a car or operating machinery?

Some side-effects like dizziness, drowsiness, visual disturbances (see also under Side-Effects) may impair your ability to concentrate and react. Do not drive, operate dangerous machinery or have similar activities if you feel that your ability to concentrate and react is impaired.

Instructions For Proper Use

How is Tavanic [Levaquin] used?

Dosage

The dose of levofloxacin is determined by the type and severity of the infection.

Your doctor or nurse will decide how to give your medicine.

Dosage in patients with normal kidney function

(creatinine clearance above 50 ml/min):

Indication Daily dose regimen(according to severity)
Prostatitis 500 mg once daily
Community acquired pneumonia 500 mg once or twice daily
Complicated urinary tract infections including pyelonephritis 250 mg* once daily
Skin and soft tissue infections 500 mg twice daily

* consideration should be given to increasing the dose in cases of severe infection

Elderly patients and patients with impaired liver function (but normal kidney function) should receive the same dosage as normal adult.

Much of the information that follows is intended for your doctor or nurse.

Dosage in patients with renal insufficiency

(creatinine clearance < 50 ml/min):

If your renal function is below normal your doctor will reduce the dose of Tavanic [Levaquin] as shown below.

Dose regimen

250 mg/24 h 500 mg/24 h 500 mg/12 h
Creatinine clearance first dose 250 mg first dose 500 mg first dose 500 mg
50-20 ml/min then:125 mg/24 h then:250 mg/24h then:250mg/12h
19-10 ml/min then:125mg/48h then:125mg/24h then:125mg/12h
<10 ml/min (including hemodialysis and CAPD)* then: 125mg/48h then:125mg/24h then:125mg/24h

* No additional doses are required after hemodialysis or continuous ambulatory peritoneal dialysis (CAPD).

Administration

The solution for infusion is ready for use, and should only be administered by slow infusion into a vein. The infusion time should not be less than 30 minutes (V2 hour) for 250 mg (50 ml) or not be less than 60 minutes (1 hour) for 500 mg (100 ml) Tavanic [Levaquin] solution for infusion (See precautions for use). Protection from light is not necessary during infusion time (see How to store and handle this medicine). For incompatibilities / compatibilities see How to store and handle this medicine.

Duration of treatment

The duration of treatment is determined according to your clinical condition and your response to treatment. As with all antibacterial agents, treatment with Tavanic [Levaquin] (infusion solution or tablets) should be continued for at least 2 to 3 days after body temperature has returned to normal and the symptoms have subsided. Once your condition has improved, the way your treatment is given may be changed from an infusion into a vein to tablets given orally at the same daily dose. Overdose

Your doctor or nurse will ensure that you will receive the correct dose into the vein. An accidental overdose might result in central nervous system symptoms such as confusion, dizziness, impairment of consciousness, and (convulsive) fits and heart disorders, possibly leading to abnormal heart rhythm. In the event of overdose treatment is according to symptoms. Levofloxacin is not removed from the body by dialysis. No specific antidote exists.

Undesirable Effects

What side-effects may occur?

The side-effects in this section are given with an estimation of the frequency with which they may occur. For this purpose the following frequency categories and denominations have been used:

Common: side-effects which may occur in 1 to 10 out of 100 patients.

Uncommon: side-effects which may occur in less than 1 out of 100 patients.

Rare: side-effects which may occur in less than 1 out of 1000 patients.

Very rare: side-effects which may occur in less than 1 out of 10 000 patients.

Isolated cases: even more rare.

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General allergic reactions, skin reactions

Uncommon: itching and rash.

Rare: general allergic reactions (anaphylactic / anaphylactoid reactions) (which may sometimes occur even with the first dose and which may develop during infusion or fast within minutes or hours of infusion) with symptoms such as wheals (urticaria), cramping of the bronchi and possibly severe breathing problems, as well as in very rare cases swelling of the skin and mucous membranes (e.g. in the face and throat).

Very rare: sudden drop in blood pressure or collapse (shock). Such general allergic reactions may sometimes be preceded by e.g. mild skin reactions.

Increased sensitivity of the skin to sun and ultraviolet light may also occur.

Isolated cases: severe blistering reactions of the skin and mucous membranes (Steven’s Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome) and erythema exsudativum multiforme.

Gastro-intestinal, metabolism

Common: nausea, diarrhoea.

Uncommon: loss of appetite, stomach upset (dyspepsia), vomiting or pain in the abdominal region.

Rare: bloody diarrhoea which in very rare cases may be indicative of enterocolitis (inflammation of the bowel), including pseudomembranous colitis, (see also under Special Warnings and Special Precautions for Use).

Very rare: fall of blood sugar to a too low level (hypoglycaemia) which may be of special importance in patients treated for diabetes.

Some medicines in this class may trigger attacks of porphyria in patients with porphyria (a very rare metabolic disease). This might therefore also occur with Tavanic [Levaquin].

Nervous system

Uncommon: headache, dizziness, drowsiness, sleeping problems.

Rare: feeling like tingling, e.g. in the hands (paraesthesia), trembling, “fits” (convulsions) and confusion may be experienced.

Very rare: vision and hearing disorders, disturbances of taste and smell, numbness. Disorders of movement, including walking difficulties.

Psychiatric disorders

Rare: anxiety, depression, psychotic reactions, restlessness (agitation).

Very rare: hallucinations, psychotic reactions with risk of suicidal thoughts or actions.

Cardiovascular system

Rare: abnormally rapid beating of the heart, abnormally low blood pressure.

Very rare: circulatory collapse (anaphylactic like shock).

Isolated cases: heart disorders, possibly leading to abnormal heart rhythm.

Muscles, tendon, bones

Rare: tendon pain and inflammation (tendinitis), joint pain or muscle pain.

Very rare: tendon rupture (e.g.: Achilles tendon). As with other fluoroquinolones, this side-effect may occur within 48 hours of starting treatment and may be bilateral. Muscular weakness, which may be of special importance in patients with myasthenia gravis (a rare disease of the nervous system).

Isolated cases: muscle reactions with muscle cell damage.

Blood

Uncommon: increase or decrease in the number of white blood cells.

Rare: decrease in the number of blood platelets leading to a tendency to bruise and bleed easily.

Very rare: severe decrease in the number of white blood cells leading to symptoms such as recurrence or persistence of fever, sore throat and feeling more ill again.

Isolated cases: decrease in red blood cells (anaemia) due to blood cell damage; decrease in the number of all types of blood cells.

Liver, kidney

Common: increase in blood levels of liver enzymes.

Uncommon /blood test abnormalities due to liver or kidney problems.

Very rare: inflammation of the liver; disturbances of kidney function and occasional kidney failure which may be due to allergic kidney reactions (interstitial nephritis).

Other reactions

Common: pain, reddening of the injection site and inflammation of the vein.

Any antibacterial treatment that kills certain germs may lead to a disturbance of the microorganisms (bacteria / fungi) that are normally found in humans. Consequently, the number of other bacteria or fungi may increase, which in rare cases requires treatment.

Uncommon: general weakness.

Very rare: fever, allergic inflammation of small blood vessels or allergic lung reactions.

Tell your doctor if you experience any of these side-effects or any other unexpected effect. As with all medicines, to prevent serious reactions contact your doctor (or nurse) immediately if you experience a severe side-effect or a side-effect with sudden onset or fast progression.

How To Store And Handle This Medicine?

Before purchase Levofloxacin, you must read how to store

Your doctor or nurse will ensure that Tavanic [Levaquin] is properly stored. As with all medicines it must be kept out of the reach of children. This medicine should be kept in its cardboard box for protection from light until use. No protection from light is required during the injection, or within three days after removal from the outer packaging if stored under indoor light conditions. Once the infusion bottle has been opened (rubber stopper perforated) the solution should be used immediately (within 3 hours) in order to prevent any bacterial contamination. This medicine should not be mixed with certain other solutions (e.g. sodium hydrogen carbonate) or with heparin.

This medicine may be given alone or with one of the following solutions: 0.9% sodium chloride solution, USR 5% dextrose injection, USR 2.5% dextrose in Ringer solution, combination solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes). Do not use this medicine after the expiry date shown on the packaging.

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Other information

The information in this leaflet applies only to Tavanic [Levaquin] 5 mg/ml solution for infusion.

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