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What is Azibitot and what is it used for?
Azithromycin, the active substance of Azizobot, is from the group of macrolide antibiotics. It is used to treat a number of infections, including:
Acute bacterial sinus infections;
Acute bacterial infections of the ear;
Acute bacterial bronchitis and worsening of chronic bronchitis;
Mild to moderate form of pneumonia;
Mild to moderate infection of the skin and soft tissues, for example folliculitis, cellulitis, erysipelas;
An infection of the tube that carries urine from the bladder (urethra) or the cervix (cervix) caused by bacteria called Chlamydia trachomatis.
2. What do you need to know before taking Azibito?
Do not take Azibiot:
If you are allergic to azithromycin or another macrolide (such as erythromycin or clarithromycin) or to ketolide antibiotics or to any of the other ingredients of this medicine (listed in section 6.1).
Warnings and precautions
Talk to your doctor or pharmacist before taking Asibit:
If you have certain heart conditions (eg severe heart problems, "QT prolongation") or if you are taking medications that induce a change in the electrical conduction of the heart such as cisapride (used to enhance bowel movement);
If you have slow or uneven heart rhythm;
If you have altered blood levels of electrolytes, especially low levels of potassium and magnesium;
If you are taking other medicines that cause abnormal ECG changes (see section "Other medicines and Asbestos");
If you have severe kidney problems;
If you have severe liver problems: Your doctor may need to monitor the function of your liver or stop treatment;
If you have a new infection (which may be a sign of overgrowth of resistant organisms);
You have nervous (neurological) or mental (mental) problems.
If you give this medicine to a baby (less than 6 weeks of age) and it vomits or gets irritable when eating;
Serious hypersensitivity reactions with difficulty breathing, dizziness, swelling of the face and throat, rash, urticaria, blisters (sometimes fatal) have been reported rarely. If these symptoms occur, stop taking Azibito and contact your doctor immediately.
Antibiotics can cause diarrhea, which can be a sign of serious inflammation of the intestine. If you have diarrhea that is watery or bloody, talk to your doctor. Do not use medicines to stop diarrhea unless your doctor has told you to do so.
Other Drugs and Asbestos
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is especially important to tell your doctor or pharmacist if you are taking:
Medicines known as ergot derivatives, for example ergotamine or dihydroergotamine (medicines used to migrate or reduce blood flow), as these medicines should not be taken with Asbestos;
Ciclosporin (a medicine used in skin diseases, rheumatoid arthritis or organ transplant);
Atorvastatin (for the treatment of high blood cholesterol levels);
Cisapride (used to treat stomach problems);
Theophylline (for breathing problems);
Warfarin or other blood thinners;
Digoxin (for heart problems);
Some medicines for abnormal heart rhythm (called antiarrhythmic agents such as quinidine, amiodarone, sotalol). Concomitant use is not recommended;
Zidovudine, efavirenz, indinavir, nelfinavir, didanosine (for HIV infections);
Rifabutin (for HIV-infection or for the treatment of tuberculosis);
Terfenadine (a medicine to treat allergies);
Fluconazole (for the treatment of fungal infections);
Medicines known as antacids (gastric acid-neutralizing medicines). Your Azibiot should be taken at least one hour before or two hours after taking your antacids;
Astemizole (a medicine to treat allergies), alfentanil (painkiller).
Azibito with food and beverages
You can take the medicine with or without food as it does not affect the absorption of azithromycin.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
This medicine should not be used during pregnancy or breastfeeding unless you have discussed this with your doctor.
Driving and using machines
This medicine can make you feel dizzy. If you feel dizzy, do not drive or use any tools or machines.
Azibito contains sucrose and sodium
6.5 ml of the suspension contains 5 g of sucrose. This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
15.6 ml of the suspension contains 1 mmol (or 23 mg) of sodium. This should be considered in patients on a controlled sodium diet.
3. How to take Azibot?
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Azib 40 mg / ml:
Adults and children weighing over 45 kg:
Azithromycin is taken as a 3 or 5 day course:
3 day course: Take 12.5 ml (500 mg) once a day.
5 day course:
take 12.5 ml (500 mg) on Day 1;
take 6.25 ml (250 mg) on Day 2, 3, 4, and 5.
Urethral and cervical infections caused by Chlamydia are considered as 1 day course:
1 day course: 25 ml (1000 mg).
Azibi 20 mg / ml and 40 mg / ml:
Adults and children weighing less than 45 kg:
Azithromycin is taken as a 3 or 5 day course. The daily amount is developed according to the weight of the child.
Azibi 20 mg / ml
Indications for 3-day therapy
Weight Day 1-3
5 kg 2.5 ml (50 mg)
6 kg 3 ml (60 mg)
7 kg 3.5 ml (70 mg)
8 kg 4 ml (80 mg)
9 kg 4.5 ml (90 mg)
10 kg 5 ml (100 mg)
12 kg 6 ml (120 mg)
Weight Day 1 Day 2 - 5
5 kg 2.5 ml (50 mg) 1.25 ml (25 mg)
6 kg 3 ml (60 mg) 1.50 ml (30 mg)
7 kg 3.5 ml (70 mg) 1.75 ml (35 mg)
8 kg 4 ml (80 mg) 2 ml (40 mg)
9 kg 4.5 ml (90 mg) 2.25 ml (45 mg)
10 kg 5 ml (100 mg) 2.5 ml (50 mg)
12 kg 6 ml (120 mg) 3 ml (60 mg)
Azibi 40 mg / ml
Indications for 3-day therapy
Weight Day 1-3
10 kg 2.5 ml (100 mg)
12 kg 3 ml (120 mg)
14 kg 3.5 ml (140 mg)
16 kg 4 ml (160 mg)
14 - 25 kg 5 ml (200 mg)
26 - 35 kg 7.5 ml (300 mg)
36 - 45 kg 10 ml (400 mg)
> 45 kg 12.5 ml (500 mg)
Weight Day 1 Day 2 - 5
10 kg 2.5 ml (100 mg) 1.25 ml (50 mg)
12 kg 3 ml (120 mg) 1.50 ml (60 mg)
14 kg 3.5 ml (140 mg) 1.75 ml (70 mg)
16 kg 4 ml (160 mg) 2 ml (80 mg)
17 - 35 kg 5 ml (200 mg) 2.5 ml (100 mg)
36 - 45 kg 10 ml (400 mg) 5.0 ml (200 mg)
> 45 kg 12.5 ml (500 mg) 6.25 ml (250 mg)
Patients with kidney or liver problems:
You should tell your doctor if you have kidney or liver problems, as your doctor may need to change the usual dose.
Dosage in elderly patients:
Elderly patients are given the same dose as adults.
Shake well before use.
You can take your medicine with or without food because it does not affect the absorption of azithromycin.
Azibit is taken once a day. The dose for all treatment in children should not exceed 1,500 mg.
How do you measure the dose?
1) This medicine is provided with a 10 ml syringe, marked on each 0.25 ml. It comes with an adapter that fits the bottle.
2) Shake the bottle well before use and remove the child-resistant cap.
3) Insert the adapter into the neck of the bottle.
4) Place the end of the syringe into the adapter.
5) Turn the bottle down with the throat.
6) Pull the plunger to measure the dose you need.
7) If there are large bubbles in the syringe, slowly push the plunger back into the syringe. This will return the drug back to the bottle. Repeat step 6 again.
8) Turn the bottle upright, remove the syringe, leave the adapter in the bottle and close the bottle.
Ask your doctor or pharmacist if you need any advice on how to measure the medicine.
Giving the medicine with the syringe:
1) Make sure the child is in an upright position.
2) Place the tip of the syringe gently into the child's mouth. Point the tip of the syringe toward the inside of the cheek.
3) Slowly push down on the syringe plunger: Do not spay quickly. The drug will fall into the mouth of the child.
4) Give the child time to swallow the medicine.
Cleaning and storage of the syringe:
1) Pull the plunger out of the syringe and wash the two parts by holding under hot running water.
2) Dry both parts. Insert the plunger back into the syringe. Keep it in a safe place along with the medicine. Once you have given your child the last dose of medicine, wrap the syringe in a newspaper sheet and put it in the trash can.
How to prepare the medicine?
Shake the dust container well. Using the syringe (supplied in the box), add the specified amount of boiled and chilled water (X mL) to the powder. The exact amount of water depends on the size of the bottle and is added as described below:
Due to loss of application, a larger volume of suspension is prepared.
Azibi 20 mg / ml:
For 20 ml of suspension (400 mg), add 11 ml of water.
Azib 40 mg / ml:
For 15 ml (600 mg) of the prepared suspension: add 9.0 ml of water.
For 22.5 ml (900 mg) of the prepared suspension: add 12.5 ml of water.
For 30 ml (1.200 mg) of the prepared suspension: add 16.0 ml of water.
For 37.5 ml (1.500 mg) of the prepared suspension: add 19.0 ml of water.
After adding the indicated amount of water, close the package, invert it so that the powder is mixed with water and shake vigorously until a homogeneous suspension is obtained.
If you have taken more Azibot than you should
If you / your child take too much Azibot, you may not feel well. Tell your doctor, contact your nearest emergency center immediately. Take the rest of your medicine with you. Symptoms of overdose may include severe nausea, vomiting and diarrhea and reversible hearing loss.
If you forget to take Azibot
Do not take a double dose to make up for the missed dose. If you forget to take the dose, it should be taken as soon as you remember. However, if it is almost time for the next dose, skip the forgotten dose and continue taking the rest of the medicine as usual.
If you stop taking Azibito
Do not stop treatment before the scheduled time.
Even when you start to feel better, it is important for you to continue taking your medicine for as long as your doctor has told you.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them. They are usually mild to moderate and stop at the end of treatment.
If you get any of the following side effects, stop taking the medicine and tell your doctor as soon as possible or go to the nearest emergency center. You may have a rare severe allergic reaction to the medicine:
Swelling of the hands, legs, ankles, face, lips, mouth or throat;
Problems with swallowing or breathing;
Serious skin reactions including Stevens-Johnson syndrome (severe skin rash) and other severe skin rashes that may cause blistering or peeling (toxic epidermal necrolysis);
Severe, persistent diarrhea, especially if there is blood or mucus (this may be pseudomembranous colitis, inflammation of the intestine).
Other reported side effects are:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Impaired (vomiting), abdominal pain, malaise (nausea);
Changes in the number of white blood cells;
Changes in some other blood tests (lowering of bicarbonates in the blood).
Uncommon (may affect up to 1 in 100 people):
Thrush (Candidiasis) - fungal infection of the mouth and vagina;
Pneumonia, bacterial throat infection, inflammation of the gastrointestinal tract, respiratory disorders, inflammation of the lining of the nose;
Changes in white blood cells (leucopenia, neutropenia, eosinophilia);
Swelling of the eyelids, face or lips (angioedema), allergic reactions;
Lack of appetite (anorexia);
Nervousness, difficulty falling asleep (insomnia);
Feeling dizzy, drowsiness (somnolence), change in taste perception (change in taste), feeling tingling or numbness (paresthesia);
Hearing disorders, dizziness (vertigo);
You feel palpable;
Sudden wheezing, bleeding from the nose;
Constipation, gas, indigestion (dyspepsia), inflammation of the lining of the stomach (gastritis), difficulty in swallowing (dysphagia), abdominal bloating, dry mouth, stomach gas burning, mouth ulcers, hypersecretion of the salivary glands ;
Rash, pruritus, urticaria, dermatitis, dry skin, abnormal increased sweating (hyperhidrosis);
Degenerative joint diseases (osteoarthritis), muscle aches, back pain in the neck;
Difficult urination (dysuria), kidney pain;
Uterine bleeding at irregular intervals (metrorrhagia), testicular disorder;
Edema, weakness, general malaise, facial swelling, chest pain, fever, pain, peripheral edema;
Deviations of laboratory values (eg blood or liver test
How to store Azibiot?
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture.
This medicinal product does not require any special storage conditions.
Bottles of 15 ml, 20 ml and 22.5 ml suspension:
After dilution, the product should be used within 5 days. Store below 25 ° C.
Bottles of 30 ml and 37.5 ml of suspension:
After dilution, the product should be used within 10 days. Store below 25 ° C.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Does Azibot Contain?
The active substance is azithromycin (azithromycin).
Azibi 20 mg / ml powder for oral suspension 1 ml of the oral suspension contains 20 mg of azithromycin (as azithromycin dihydrate).
Azibib 40 mg / ml powder for oral suspension 1 ml of oral suspension contains 40 mg of azithromycin (as azithromycin dihydrate).
The other ingredients are sucrose, hydroxypropylcellulose, tribasic sodium phosphate, anhydrous (E339), xanthan gum, colloidal anhydrous silica, banana flavor (sucrose, maltodextrin, gum arabic, aromatic substances), wild cherry flavor sucrose, maltodextrin, gum arabic, aromatics) and vanilla flavor (maltodextrin, flavor, natural flavoring). See point 2 "Azibito contains sucrose and sodium".
What does Azibito look like and what does the package contain?
The powder for the oral suspension is white to off-white, which, after reconstitution with water, produces a homogeneous suspension of pale yellow to brownish-yellow color with a characteristic banana flavor and wild cherry flavor.
Azibib 20 mg / ml is available in cartons of 16.38 g of powder to make 20 ml of oral suspension (400 mg azithromycin) per carton.
Azib 40 mg / ml is available in cartons of:
12.6 g powder for preparation of 15 ml oral suspension (with 600 mg azithromycin) in a bottle;
18.9 g powder to make 22.5 ml oral suspension (with 900 mg azithromycin) in a bottle;
25.2 g powder to make 30 ml oral suspension (1200 mg azithromycin) in a bottle;
31.5 g powder to make 37.5 ml oral suspension (with 1500 mg azithromycin) in a bottle.
The packs are provided with a 10 ml PE / PP syringe for oral administration, graduated with 0.25 ml increment with an adapter.
The reconstituted suspension contains an excess of 5 ml to ensure full dose delivery.
Not all pack sizes may be marketed.
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