Keflor

देश: न्यूज़ीलैंड

भाषा: अंग्रेज़ी

स्रोत: Medsafe (Medicines Safety Authority)

सक्रिय संघटक:

Cefaclor monohydrate 26.86 mg/mL equivalent to cefaclor 25 mg/mL

थमां उपलब्ध:

Viatris Limited

डोज़:

125 mg/5mL

फार्मास्यूटिकल फॉर्म:

Granules for oral suspension

रचना:

Active: Cefaclor monohydrate 26.86 mg/mL equivalent to cefaclor 25 mg/mL Excipient: Dimeticone Erythrosine Methylcellulose Sodium laurilsulfate Starch Strawberry flavour 052312 AP0551 Sucrose Xanthan gum

प्रिस्क्रिप्शन प्रकार:

Prescription

चिकित्सीय संकेत:

Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated micro-organisms: Lower respiratory infections, including pneumonia caused by S. pneumoniae, H. influenzae (including both ampicillin-sensitive and ampicillin-resistant strains), and S. pyogenes (Group A beta- haemolytic streptococci), M.catarrhalis, acute bronchitis, and acute exacerbations of chronic bronchitis. Upper respiratory infections, including pharyngitis and tonsillitis caused by S. pyogenes (Group A beta-haemolytic streptococci) and M. catarrhalis. Otitis media caused by S. pneumoniae, H. influenzae (including both ampicillin-sensitive and ampicillin-resistant strains) staphylococci, and S. pyogenes (Group A beta-haemolytic streptococci), and M. catarrhalis. Skin and soft-tissue infections caused by Staphylococcus aureus (including ?-lactamase producing strains), S. pyogenes (Group A beta-haemolytic streptococci) and Staphylococcus epidermidis (including ?-lactamase producing strains). Urinary tract infections, including pyelonephritis and cystitis caused by E. coli, P, mirabilis, Klebsiella sp" and coagulase-negative staphylococci. Note: Cefaclor has been found to be effective in both acute and chronic urinary tract infections; sinusitis; gonococcal urethritis. Skin and skin structure infections caused by Staphylococcus aureus and S. pyogenes (group A beta-haemolytic streptococci). Sinusitis. Gonococcal urethritis, but appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor. Therapy may be started while awaiting the results of these studies. Once these results become available, antimicrobial therapy should be adjusted accordingly.

उत्पाद समीक्षा:

Package - Contents - Shelf Life: Bottle, plastic, HDPE - 100 mL - 24 months from date of manufacture stored at or below 25°C 14 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

प्राधिकरण की तारीख:

2019-07-03

सूचना पत्रक

Page 1 of 3
NEW ZEALAND CONSUMER MEDICINE INFORMATION
KEFLOR
_CEFACLOR, GRANULES FOR ORAL SUSPENSION, 125 MG PER 5 ML _
_ _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking KEFLOR.
This leaflet answers some common
questions about KEFLOR.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking KEFLOR
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT KEFLOR IS
USED FOR
KEFLOR is used to treat infections
in different parts of the body caused
by bacteria. KEFLOR can be used
to treat infections of the
•
ear, nose, throat and tonsils
•
chest and lungs
•
skin
•
bladder and kidneys
•
sinuses
•
urethra
KEFLOR contains the active
ingredient cefaclor_._ It is an antibiotic
that belongs to a group of
medicines called cephalosporins.
It works by killing the bacteria that
are causing your infection.
KEFLOR will not work against
infections caused by viruses, such
as colds or flu.
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor’s prescription.
This medicine is not addictive.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
BEFORE YOU TAKE
KEFLOR
_WHEN YOU MUST NOT TAKE _
_IT _
DO NOT TAKE KEFLOR IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
cefaclor
•
any of the ingredients listed
at the end of this leaflet
•
any other similar medicines
(such as antibiotics that
belong to cephalosporins or
penicillins).
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezing
or difficulty breathing; swelling
of the face, lips, tongue or other
parts of

उत्पाद विशेषताएं

Page 1 of 9
NEW ZEALAND DATA SHEET
KEFLOR
1. PRODUCT NAME
KEFLOR, 125 mg per 5 mL, granules for oral suspension.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 26.86 mg cefaclor monohydrate (equivalent to 25 mg
cefaclor).
Excipient with known effect: sucrose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Pink free-flowing powder blend with a characteristic strawberry odour.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
Cefaclor is indicated in the treatment of the following infections
when caused by susceptible strains
of the designated micro-organisms:
•
Lower respiratory infections, including pneumonia caused by _S.
pneumoniae_, _H. influenzae _
(including both ampicillin-sensitive and ampicillin-resistant
strains), and _S. pyogenes _(Group
A beta-haemolytic streptococci), _M._c_atarrhalis, _acute_
_bronchitis, and acute exacerbations of
chronic bronchitis.
•
Upper respiratory infections, including pharyngitis and tonsillitis
caused by _ S_. _ pyogenes _
(Group A beta-haemolytic streptococci) and _M. _c_atarrhalis. _
Note:
Penicillin
is
the usual
medicine of
choice
in
the treatment and prevention of
streptococcal infections, including the prophylaxis of rheumatic
fever. Amoxicillin has been
recommended
by
The American
Heart
Association as the
standard
regimen for the
prophylaxis of bacterial endocarditis for dental, oral, and upper
respiratory tract procedures,
with Penicillin V a rational and acceptable alternative in the
prophylaxis against beta-
haemolytic streptococcal bacteriaemia in this setting. Cefaclor is
generally effective in the
eradication of streptococci from the nasopharynx; however, substantial
data establishing the
efficacy of cefaclor in the subsequent prevention of rheumatic fever
or bacterial endocarditis
are not available at present.
•
Otitis media caused by _S. pneumoniae, H. influenzae _(including both
ampicillin-sensitive and
ampicillin-resistant strains) staphylococci, and _ S. pyogenes _
(Group A beta-haemolytic
streptococci),