Avelox. 1gr. flacon
Avelox is used in adults to treat the following bacterial infections: infection of the lungs (pneumonia) acquired outside the hospital Infections of the skin,soft tissue
Avelox. 1gr. flacon
What Avelox is and what it is used?
Avelox contains the active ingredient moxifloxacin , which belongs to a group of antibiotics called fluoroquinolones. Avelox works by killing bacteria that cause infections if they are caused by bacteria susceptible to moxifloxacin .
Avelox is used in adults to treat the following bacterial infections: infection of the lungs ( pneumonia) acquired outside the hospital Infections of the skin and soft tissue
2 . What you should know before you are given Avelox ?
Tell your doctor if you are not sure if you belong to the group of patients described below .
Do not take Avelox :
- If you are allergic to moxifloxacin , other hipolonovi antibiotics or any of the other ingredients of this medicine (listed in Section 6 . Additional Information ) ' if you are pregnant or breast-feeding if you are under 18 years of age;
- If you have a history of disease or damage to the tendons associated with treatment with antibiotics hipolonovi (see Warnings and Precautions and Possible Side Effects ) '
- If you have congenital or documented condition associated with impaired rhythm ( ECG apparent electrical recording of the heart ) , you have a salt imbalance in the blood ( especially low levels of potassium or magnesium in the blood) , slow heart rhythm (called " bradycardia ') have a weak heart ( heart failure), you had irregular heartbeat or are taking other drugs that may lead to changes of E KG (see other medicines and Avelox ) .
Avelox can cause changes in the ECG , namely QT prolongation , ie delay in conduction of electrical signals , if you have severe liver disease or elevated liver enzymes ( transaminases) 5 times upper limit of normal.
Warnings and Precautions
Talk to Our doctor before Avelox can be given for the first time.
Avelox can alter the ECG of your heart , especially if you are female or are elderly .
- If you are currently taking any medications that lower potassium levels in your blood , check with your doctor before taking Avelox to be administered (see also part not take Avelox and other medications and Avelox ) .
- If you suffer from epilepsy or a disease that makes you suffer from seizures , consult your doctor before Avelox is given to you if you have or have ever had mental health problems , consult your doctor before taking Avelox is given to you .
- If you have myasthenia gravis, Avelox may worsen the symptoms of your disease. If you think this applies to you, talk to your doctor .
- If you or someone in your family have a deficiency of glucose- 6-phosphate dehndrogenaza ( rare hereditary disease) , tell your doctor who will advise you whether Avelox is right for you.
Avelox is to be administered intravenously (in the vein ), and should be administered in an artery .
While taking Avelox
- If you get palpitations or an irregular heartbeat during treatment should immediately consult your doctor. He / she may ask you to perform an ECG to measure your heart rhythm .
- The risk of heart problems may increase with dose and rate of infusion into your vein .
- There is a rare opportunity to experience a severe , sudden allergic reaction ( anaphylactic reaction / shock) even with the first dose , with the following symptoms: chest tightness, dizziness , nausea or fainting or dizziness when standing up . If this occurs , treatment with Avelox should be discontinued immediately.
- Avelox can cause rapid and severe inflammation of the liver that can lead to life-threatening hepatic failure (including fatal cases , see section 4 . Possible side effects). Please tell your doctor before you continue treatment if you suddenly feel unwell or if you notice yellowing of the whites of the eyes, dark urine, itchy skin, bleeding tendencies or disorders of thought or maintaining wakefulness .
- If you get a skin reaction or blistering and / or peeling of the skin and / or mucosal reactions (see section 4 . Possible side effects) , tell your doctor before you continue treatment.
- Quinolone antibiotics, including Avelox may cause seizures. If this happens , treatment with Avelox should be discontinued . You may experience symptoms of neuropathy such as pain, burning, tingling , numbness and / or weakness. If this happens , tell your doctor before you continue treatment with Avelox .
- Possible occurrence of mental health problems , even after the first application of hipolonovi antibiotics, including Avelox . In very rare cases depression or mental health problems can lead to suicidal thoughts or self-injury , and suicide attempts (see section 4 . Possible side effects). If you experience such reactions occur, treatment with Avelox should be discontinued . You may get diarrhea during or after treatment with antibiotics, including Avelox . If it becomes severe or persistent or you notice that your stool contains blood or mucus , you should stop Avelox immediately and consult your doctor. In this situation , you should not take medicines that stop or slow down bowel movement .
- Avelox may occasionally cause pain and inflammation of your tendons , even within 48 hours of treatment and several months after stopping treatment with Avelox . The risk of inflammation and rupture of the tendon is increased if you are elderly or being treated with corticosteroids . At the first sign of any pain or irritation you should discontinue use of Avelox , rest the affected (s) limb (s ) at rest and immediately consult your doctor. Avoid unnecessary exercise , as this can increase the risk of tendon rupture (see sections not take Avelox and 4. Possible side effects). if you are elderly and have kidney problems , be sure to drink enough fluids because dehydration can increase the risk of renal failure.
- If your eyesight becomes impaired or have other eye disturbances while using Avelox immediately consult an eye specialist (see Driving and using machines and 4. Possible side effects).
- Quinolone antibiotics may make your skin more sensitive to sunlight or UV rays. You should avoid prolonged exposure to sunlight or strong sunlight and should not use a sunbed or any other UV lamp while using Avelox .
Experience with the use of sequential intravenous / oral Avelox for treatment of lung infection (pneumonia ) acquired outside the hospital is limited. The efficacy of the treatment of Avelox severe burns , deep tissue infections and diabetic foot infections with osteomyelitis ( bone marrow infection ) has not been established .
Children and adolescents
This medicine should not be given to children and adolescents under the age of 18 years , as safety and efficacy have not been established in this age group (see section not take Avelox ) .
Other medicines and Avelox
Tell your doctor or pharmacist if you are taking , have recently taken or take any other medicines unless Avelox .
For Avelox should know the following:
- If you use Avelox and other drugs that act on the heart, there is an increased risk of changes in your heart rhythm . Therefore, do not use Avelox with the following drugs : drugs that belong to the group of antiarrhythmic (eg, quinidine, hydroquinidine , disopyramide , amnodaron , sotalol , dofetilide , ibutilide ) , antipsychotics (eg phenothiazines , pimozide, sertipdol , haloperidol, sultopride ) tritsiklichpi antidepressants, some antimicrobial products (e.g., saquinavir , sparfloxacin , intravenous eritromitsii , pentamidine , antimalarials particularly halofantrine ), some antihistamines (e.g., terfenadine, astemizole, mizolastine ) upset anyone else drugs (eg cisapride , intravenous vincamine , bepridil and diphemanil ) .
You should tell your doctor if you take other medicines that can lower potassium levels in the blood ( eg some diuretics, laxatives and enemas some [ high dose ] or corticosteroids [ anti-inflammatory drugs ] , amphotericin B ) or cause delay heartbeat , as they may also increase the risk of serious heart rhythm abnormalities while using Avelox . If you are currently taking oral anticoagulants ( eg, warfarin ) may be necessary for your doctor to monitor your blood clotting .
Avelox with food and drink
Avelox effect is not affected by food , including dairy products.
Pregnancy, lactation and fertility
Do not use Avelox if you are pregnant or breastfeeding.
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant , ask your doctor or pharmacist before taking this medicine. Studies in animals have shown that fertility will be reduced through the use of this medicine.
Driving and using machines
Of Avelox may experience dizziness or fainting, can suddenly temporarily lose vision or briefly lose consciousness. If you are affected , do not drive or operate machinery.
This product contains 787 mg ( approximately 34 mmol) of sodium per dose. If you are on a controlled sodium diet sodium , please contact your doctor immediately .
3 . How to use Avelox ?
Avelox will always be given by a doctor or medical professional.
The recommended dose for adults is one bottle bag once daily.
Avelox is for intravenous use . Your doctor must ensure that the infusion is done at a constant speed for 60 minutes.
No dose adjustment is required in elderly patients , patients with low body weight or patients with kidney problems.
Your doctor will decide the length of your treatment with Avelox . In some cases your doctor may start your treatment with Avelox and then proceed with Avelox tablets.
The duration of treatment depends on the type of infection and how you respond to treatment, but the recommended duration of administration is:
- Infection of the lungs ( pneumonia) acquired outside the hospital -7-14 days
Most patients with pneumonia were switched to oral treatment with Avelox tablets within 4 days.
- Infections of the skin and soft tissues , 7-21 days
In patients with complicated skin and skin structure mean duration of intravenous therapy was approximately 6 days , and the average total duration of treatment ( infusion followed by a tablet ) is 13 days.
It is important to complete the course of treatment even if you begin to feel better after a few days. If you stop using this medicine too soon , your infection may not be completely cured , it can return or your condition may worsen or you can develop bacterial resistance to antibiotics .
The recommended dose and duration of treatment should not be exceeded ( see section 2. Cocoa need to know before you apply Avelox Warnings and Precautions ) .
If you receive more than the amount of Avelox
If you feel that you have been given more than you should , contact your doctor immediately .
If you forget to use Avelox
If you feel that you have missed a dose of Avelox , tell your doctor. If you stop taking Avelox
If you stop treatment with this medicine too soon , your infection may not be completely cured . Consult your doctor if you wish to stop treatment with Avelox Avelox tablets or before the end of the treatment course .
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4 . Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them .
The following adverse reactions have been reported during treatment with Avelox . The frequency of possible side effects listed below is defined using the following conditions:
Common: may affect up to 1 in 10 patients
Uncommon: may affect up to 1 in 100 patients
Rare: may affect up to 1 in 1000 patients
Very rare: may affect up to 1 in 10 000 patients
Common Infections caused by resistant bacteria or fungi , eg . oral and vaginal infections caused by Candida .
Blood and lymphatic system
Uncommon : low red blood cell count, low white blood cell count , decreased number of specialized white blood cells (neutrophils ), a decrease or increase in the number of specific cells necessary for blood clotting , increased number of specialized white blood cells ( eosinophils ) , decreased blood clotting very rare: Increased blood clotting , a significant reduction of specific white blood cells ( agranulocytosis)
Uncommon: Allergic reaction
Rare: Severe, sudden allergic reaction including generalized . very rarely life-threatening shock (eg, difficulty breathing , drop in blood .
pressure , heart rate ) , edema (including potentially life-threatening swelling of the airways)
Changes in laboratory results
Nechssti : Elevated blood lipids (fats )
Rare: Increased blood sugar, elevated uric acid in the blood
Uncommon : Anxiety, restlessness / agitation
Rare: Emotional instability , depression ( in very rare cases leading to self-harm , and intentions / thoughts of suicide or suicide attempts ) , hallucinations
Very rare : Feeling separation from himself ( not herself) , insanity (potentially leading to self-harm, such as intentions / thoughts of suicide or suicide attempts )
Common: Headache, dizziness
Uncommon: Tingling ( pins and needles) and / or numbness , changes in taste ( in very rare cases, loss of taste) , confusion and disorientation, sleep problems (mostly insomnia), tremors , feeling dizziness ( vertigo or sinking ) , somnolence
Rare: feeling of skin damage , changes in smell (including loss of smell ) , abnormal dreams , abnormal balance and poor coordination (due to dizziness) , convulsions, impaired concentration , impaired speech , partial or complete loss of memory problems nervous system, pain, burning , tingling , numbness and / or weakness in the limbs
Very rare: Skin sensitization
Uncommon : Visual disturbances incl . double and blurred vision Very rare : Temporary loss of vision
Rare: Ringing / tinnitus, hearing impairment including deafness (usually reversible )
Cardiac system ( see section 2. What you should know before you are given Avelox )
Common: Change in heart rate (ECG ) in patients with low levels of potassium in the blood
Uncommon : Change in heart rate (ECG ) , heart palpitations , irregular and fast heartbeat , severe cardiac arrhythmias , angina pectoris
Rare : abnormal rapid heartbeat , loss of consciousness
Very rare: Abnormal heart rhythm zhnvotozastrashavashta irregular heartbeat , heart failure
Uncommon: dilation of blood vessels
Rare: high blood pressure , low blood pressure
Uncommon: Difficulty breathing , incl. asthmatic conditions
Common: Nausea, vomiting, stomach and abdominal pain, diarrhea,
Uncommon: decreased appetite and food intake , flatulence and constipation , upset stomach , indigestion / heartburn , inflammation of the stomach, increase of certain digestive enzymes in the blood
Rare: Difficulty swallowing , mouth sores , severe diarrhea with blood and / or mucus ( antibiotic associated colitis , incl. Pseudomembranous colitis ), which in very rare circumstances could develop into complications that are life threatening.
Common: Increase of certain liver enzymes in the blood / transaminase /
Uncommon: Impaired hepatic function (including raising of certain liver enzymes in the blood (LDH)), elevated bilirubin , elevated liver enzymes specific blood (gamma- glutamyl -transferase and / or alkaline phosphatase)
Rare: Jaundice (yellowing of the whites of the eyes or skin) , inflammation of the liver
Very rare fulminant liver inflammation , potentially leading to life-threatening hepatic failure (including fatal cases).
Uncommon: pruritus , rash , skin hives , dry skin
Very rare: changes in skin and mucous membranes ( painful blisters in the mouth / nose or penis / vagina ) , a potentially life-threatening ( syndrome Stevens-Johnson, toxic epidermal necrolysis)
Muscles and joints
Uncommon: joint pain, muscle pain
Rare : Pain and swelling of the tendons ( tendonitis ), muscle cramps, muscle spasms , muscular weakness
Very rare: Rupture of tendon , joint inflammation , muscle rigidiost , worsening of symptoms of myasthenia gravis
Rare: renal impairment ( incl. increase of results of specific laboratory tests katoureya kidney and creatinine) , renal failure
General side effects
Uncommon: Malaise (mainly weakness or tiredness) , pain in the back, chest , pelvis and extremities, sweating
Rare: swelling ( hands , feet , ankles , lips , mouth, throat)
Common: pain or inflammation at the injection site
Uncommon: Inflammation of a vein
The following symptoms have been reported with higher frequency in patients treated with intravenously administered game and moxifloxacin :
Common: Elevated levels of specific liver enzymes in the blood (gamma glutamyl transferase ) Uncommon : abnormal rapid heart rate , low blood pressure , swelling of the hands, feet , ankles , lips , mouth, throat) , severe diarrhea with blood and / or mucus ( antibiotic associated colitis) , in very rare cases turning into life-threatening complications , convulsions , hallucinations, renal impairment (including raising specific laboratory indicators such as urea and creatinine) , renal failure
Moreover, there are very rare cases of the following adverse reactions during treatment with other antibiotics hipolonovi that may occur during treatment with Avelox : elevated levels of sodium in the blood , elevated levels of calcium in the blood, a special type of reduction in the number of red blood cells ( hemolytic anemia ), muscle reactions with damage to muscle cells , increased skin sensitivity to sunlight or UV rays.
If you get any side effects , tell your doctor, pharmacist or nurse for advice before you receive your next dose. This includes all listed in this leaflet .
5 . How to store LVELOKS ?
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the bottle bag and carton. The expiry date refers to the last day of that month.
Do not store above 15 ° C.
Use immediately after first opening and / or dilution.
This product is for single use only . Any unused solution should be discarded. I] second of storage at low temperatures can be formed a precipitate, which was dissolved at room temperature .
Do not use this medicine if you notice any particles in the solution or is cloudy .
DO NOT dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . Package Contents and more information
What does Avelox
The active agent is moxifloxacin. Each bottle contains 400 mg of bag moxifloxacin (as hydrochloride ) . 1 ml contains 1,6 ml moxifloxacin (as hydrochloride ) .
The other ingredients are: sodium chloride, hydrochloric acid (to adjust pi I), sodium hydroxide ( for pH adjustment ) and water for injection ( see section Avelox sodium ) .
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder