Country: নাইজেরিয়া
ভাষা: ইংরেজি
সূত্র: NAFDAC (National Agency for Food and Drugs Administration and Control)
Dafra Pharma GmbH
AMOXICILLIN 200MG,CLAVULANIC ACID 28MG
BILIM PHARM CERKEZKOY ISLETMESI 59501 CERKEZKOY/TEKIRDAY,TURKEY
DAFRACLAV® is indicated in the treatment of the following infections caused by the microorganisms indicated below. Upper respiratory tract infections (including otitis media and sinusitis), due to beta-lactamase producing strains of Haemophilus influenzae and Moraxella catarrhalis. Lower respiratory tract infections, due to beta-lactamase producing strains of Haemophilus influenzae and Moraxella catarrhalis. Skin and Skin Structure infections, due to beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli and Klebsiella spp. Urinary tract infections. Since DAFRACLAV® contains amoxicillin, it can be used in the treatment of infections caused by bacteria susceptible to ampicillin. Additionally, if in a mixed infection a microorganisms is susceptible to ampicillin and the other which is a beta-lactamase producer is susceptible to DAFRACLAV®, such an infection can be treated by the administration of DAFRACLAV® alone, addition of another antibiotic is not required.
DAFRACLAV® BD 200/28 mg POWDER FOR ORAL SUSPENSION contains 200 mg amoxicillin equivalent of amoxicillin trihydrate and potassium clavulanate equivalent to 28 mg clavulanic acid activity per 5 ml of suspension as active ingredients. Each cardboard box contains 1 bottle of 70 ml. Bottle containing enough powder mixture to give 70 ml suspension after reconstitution with water. Supplied with a measure spoon. Other pharmaceutical forms available: - Dry powder DAFRACLAV® BD 400/57 mg Forte Oral Suspension, 70 ml - DAFRACLAV® 625 mg Filmcoated tablet (15 tablets) - DAFRACLAV® 1 g Filmcoated tablet (10 tablets).
PATIENT INFORMATION LEAFLET DAFRACLAV ® 200/28 Amoxicillin + Clavulanic Acid POWDER FOR PEDIATRIC ORAL SUSPENSION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION. Keep this leaflet. You may need to read it again. IF YOU HAVE ANY FURTHER QUESTIONS, ASK YOUR DOCTOR OR PHARMACIST. This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child’s. 1. WHAT IS DAFRACLAV® 200/28 AND WHAT IT IS USED FOR Dafraclav® 200/28 contains amoxicillin and clavulanic acid (ATC code: J01CR02). These are antibiotics, working by killing bacteria that cause infections. Amoxicillin belongs to the group of “penicillins”. Clavulanic acid prevents amoxicillin from being inactivated by enzymes produced by the bacteria. Dafraclav® 200/28 is used in the treatment of the following infections: respiratory tract infections (including middle ear and sinus infections), skin and skin structure infections (including dental infections), urinary tract infections. 2. WHAT YOU NEED TO KNOW BEFORE YOU GIVE YOUR CHILD DAFRACLAV® 200/28 _DO NOT GIVE YOUR CHILD DAFRACLAV® 200/28 IF IT _ is allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of Dafraclav® 200/28 (listed in section 6), has ever had a severe allergic (hypersensitive) reaction to any other antibiotic; this can include a skin rash or swelling of the face or neck, has ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic. _TAKE SPECIAL CARE WITH DAFRACLAV® 200/28 IF YOUR CHILD _ has glandular fever (infectious mononucleosis), has liver or kidney problems, is not passing water regularly. If you are not sure if any of the above apply to your child, talk to your doctor or pharmacist before giving Dafraclav® 200/28. _SPECIAL WARNINGS AND PRECAUTIONS FOR USE _ inflammation of the large intestine has been re সম্পূর্ণ নথি পড়ুন
DAFRACLAV® 200/28 MG PEDIATRIC POWDER FOR ORAL SUSPENSION 1. QUALITATIVE AND QUANTITATIVE COMPOSITION Dafraclav® BD 200/28 mg POWDER FOR ORAL SUSPENSION contains 200 MG AMOXICILLIN equivalent of amoxicillin trihydrate and potassium clavulanate equivalent to 28 MG CLAVULANIC ACID activity per 5 ML of suspension as active ingredients. 2. PHARMACEUTICAL FORM Each cardboard box contains 1 bottle of 70 ml. Bottle containing enough powder mixture to give 70 ml suspension after reconstitution with water. Supplied with a measure spoon. OTHER PHARMACEUTICAL FORMS AVAILABLE: Dry powder Dafraclav® BD 400/57 mg Forte Oral Suspension, 70 ml; Dafraclav® 625 mg Filmcoated tablet (15 tablets); Dafraclav® 1 g Filmcoated tablet (10 tablets). 3. CLINICAL PARTICULARS 3.1 THERAPEUTIC INDICATIONS: Dafraclav® is indicated in the treatment of the following infections caused by the microorganisms indicated below. _UPPER RESPIRATORY TRACT INFECTIONS (INCLUDING OTITIS MEDIA _ _AND SINUSITIS), _ due to beta-lactamase producing strains of Haemophilus influenzae and Moraxella catarrhalis. _LOWER _ _RESPIRATORY _ _TRACT _ _INFECTIONS, _ due to beta-lactamase producing strains of Haemophilus influenzae and Moraxella catarrhalis. _SKIN AND SKIN STRUCTURE INFECTIONS_, due to beta- lactamase producing strains of Staphylococcus aureus, Escherichia coli and Klebsiella spp. _ URINARY _ _TRACT INFECTIONs. _Since Dafraclav® contains amoxicillin, it can be used in the treatment of infections caused by bacteria susceptible to ampicillin. Additionally, if in a mixed infection a microorganisms is susceptible to ampicillin and the other which is a beta-lactamase producer is susceptible to Dafraclav®, such an infection can be treated by the administration of Dafraclav® alone, addition of another antibiotic is not required. Since in vitro Streptococcus pneumoniae is more susceptible to amoxicillin compared to ampicillin and penicillin, Streptococcus pneumoniae strains that are moderately susceptible to penicillin and ampicillin in microbiological tes সম্পূর্ণ নথি পড়ুন