KEFLOR cefaclor 250mg/5mL (as monohydrate) powder for oral liquid bottle

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

cefaclor monohydrate, Quantity: 52.45 mg/mL (Equivalent: cefaclor, Qty 50 mg/mL)

Disponible des:

Alphapharm Pty Ltd

formulario farmacéutico:

Oral Liquid, powder for

Composición:

Excipient Ingredients: methylcellulose; sodium lauryl sulfate; dimeticone 350; xanthan gum; erythrosine; sucrose; pregelatinised starch; Flavour

Vía de administración:

Oral

Unidades en paquete:

75mL

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

KEFLOR is indicated for the treatment of the following types of infections caused by or likely to be caused susceptible organisms: Lower respiratory infections, including pneumonia, bronchitis and exacerbations of chronic bronchitis. Upper respiratory infections, including pharyngitis, tonsillitis and otitis media. Skin and skin structure infections. Urinary tract infections, including pyelonephritis and cystitis. NOTE: 1. Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. KEFLOR appears to be effective as phenoxymethul penicillin in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. 2. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organisms to cefaclor.

Resumen del producto:

Visual Identification: A pink free-flowing dry powder. After constitution a red coloured suspension with a characteristic strawberry odour.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Estat d'Autorització:

Licence status A

Data d'autorització:

1997-02-19

Informació per a l'usuari

KEFLOR
_cefaclor monohydrate suspension_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Keflor.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. 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, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your 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
(upper respiratory tract)
•
chest and lungs (lower respiratory
tract)
•
bladder and kidneys (urinary
tract)
•
skin.
Your doctor may have prescribed
Keflor for another reason. Ask your
doctor if you have any questions
about why Keflor has been
prescribed for you.
Keflor is an antibiotic that belongs to
a group of medicines called
cephalosporins. These medicines
work by killing the bacteria that are
causing your infection.
Keflor will not work against
infections caused by viruses, such as
colds or flu.
Keflor is available only with a
doctor's prescription.
There is no evidence that Keflor is
addictive.
BEFORE YOU TAKE KEFLOR
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE KEFLOR IF YOU ARE
ALLERGIC TO MEDICINES CONTAINING:
•
CEFACLOR MONOHYDRATE
•
ANY OTHER CEPHALOSPORIN
•
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
Some of the symptoms of an allergic
reaction may include skin rash,
itching or hives, swelling of the face,
lips or tongue, which may cause
difficulty in swallowing or breathing,
wheezing or shortness of breath.
DO NOT TAKE KEFLOR IF YOU HAVE HAD
A SEVERE ALLERGIC REACTION TO
PENICILLIN.
DO NOT GIVE THIS MEDICINE TO A CHILD
UNDER THE AGE OF 1 MONTH.
Safety and effectiveness in children
younger than 1 month have not been
establish

Fitxa tècnica

AUSTRALIAN PRODUCT INFORMATION
KEFLOR
_Cefaclor monohydrate powder for oral suspension _
1
NAME OF THE MEDICINE
Cefaclor monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Keflor contains cefaclor monohydrate, equivalent to 125 mg or 250 mg
of cefaclor per 5 mL upon
reconstitution.
Excipients with known effect: Sugars as sucrose.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
KEFLOR 125 mg/5 mL is a powder for oral suspension. The powder is a
pink free-flowing dry powder. After
reconstitution, it is a red coloured suspension with a characteristic
strawberry odour.
KEFLOR 250 mg/5 mL is a powder for oral suspension. The powder is a
pink free-flowing dry powder. After
reconstitution, it is a red coloured suspension with a characteristic
strawberry odour.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Keflor is indicated for the treatment of the following types of
infections caused by or likely to be caused by
susceptible organisms:
•
Lower respiratory infections, including pneumonia, bronchitis and
exacerbations of chronic
bronchitis.
•
Upper respiratory infections, including pharyngitis, tonsillitis and
otitis media.
•
Skin and skin structure infections.
•
Urinary tract infections, including pyelonephritis and cystitis.
NOTE:
1.
Penicillin is the usual drug of choice in the treatment and prevention
of streptococcal infections,
including the prophylaxis of rheumatic fever. Keflor appears to be as
effective as phenoxymethyl
penicillin in the eradication of streptococci from the nasopharynx;
however, substantial data
establishing the efficacy of cefaclor in the subsequent prevention of
rheumatic fever are not
available at present.
2.
Appropriate culture and susceptibility studies should be performed to
determine susceptibility of the
causative organism to cefaclor.
4.2
DOSE AND METHOD OF ADMINISTRATION
Keflor is administered orally.
DIRECTIONS FOR RECONSTITUTION OF KEFLOR FOR ORAL SUSPENSION
125 MG/5 ML
- Add 60 mL of water in two portions to the dry mixtur