Dafraclav Suspension, Oral 228

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Amoxicillin , Clavulanic acid

Available from:

Dafra Pharma GmbH, SWITZERLAND

ATC code:

Antibacterials for systemic use, Combinations of

INN (International Name):

Amoxicillin and Clavulanic acid

Dosage:

228

Pharmaceutical form:

Suspension, Oral

Manufactured by:

BILIM PHARMACEUTICALS, TURKEY

Product summary:

Physical description: Cream-white coloured, raspberry coloured, homogeneous powder mixture; Local technical representative: Harleys (T) Limited (4194)

Authorization status:

Registered/Compliant

Authorization date:

2020-11-07

Patient Information leaflet

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

Summary of Product characteristics

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