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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefaclor monohydrate, Quantity: 53.72 mg/mL (Equivalent: cefaclor, Qty 50 mg/mL)

Available from:

Viatris Pty Ltd

INN (International Name):

cefaclor monohydrate

Pharmaceutical form:

Oral Liquid, powder for

Composition:

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

Administration route:

Oral

Units in package:

75mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ACLOR 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 tract 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. ACLOR appears to be as effective as phenoxymethyl penicillin in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of ACLOR 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.

Product summary:

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

Authorization status:

Registered

Authorization date:

2004-05-20

Patient Information leaflet

ACLOR(R)
1
ACLOR(R)
_cefaclor monohydrate_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Aclor. 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 Aclor 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 THIS
MEDICINE.
You may need to read it again.
WHAT ACLOR IS USED FOR
Aclor contains cefaclor monohydrate
as the active ingredient.
It is used to treat infections caused by
bacteria in different parts of the
body, including infections of the:
*
ears, nose, throat and tonsils
(upper respiratory tract)
*
chest and lungs (lower
respiratory tract)
*
bladder and kidneys (urinary
tract)
*
skin.
This medicine belongs to a group of
antibiotics called cephalosporins.
These antibiotics work by killing the
bacteria that are causing your
infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ACLOR HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is only available with
a doctor's prescription.
There is no evidence that it is
addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE ACLOR IF YOU HAVE EVER
HAD AN ALLERGIC REACTION TO:
*
any medicine containing cefaclor
monohydrate
*
other cephalosporins
*
any of the ingredients listed at the
end of this leaflet.
DO NOT TAKE ACLOR IF YOU HAVE HAD A
SERIOUS ALLERGIC REACTION TO
PENICILLIN.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty breathing;
swelling of the face, lips, tongue or
other parts of the body; rash, itching
or hives on the skin.
DO NOT GIVE THIS MEDICINE TO A CHILD
UNDER THE AGE OF ONE MONTH.
Safety and effectiveness in children
younger than one month have not
been established.
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINT

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
ACLOR
_cefaclor (as monohydrate) powder for oral liquid _
1
NAME OF THE MEDICINE
Cefaclor (as monohydrate)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL of ACLOR powder for oral liquid upon reconstitution contains
125 mg or 250 mg of cefaclor (as
monohydrate) as the active ingredient.
Excipients of known effect: sugars
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
ACLOR 125 mg/5 mL and 250 mg/5 mL powder for oral liquids are pink
free-flowing dry powders. After
constitution, a red coloured suspension with a characteristic
strawberry odour is formed.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ACLOR 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. ACLOR appears to be as effective
as phenoxymethylpenicillin 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
ACLOR is administered orally.
DIRECTIONS FOR RECONSTITUTION OF ACLOR
125 mg/5 mL - add 60 mL of water in two portions to the dry mixture in
the bottle. Shake well after each
addition.
250 mg/5 mL - add 45 mL of water in two portions to the dry mixture in
the bottle. Shake well after each
addition.
ACLOR – PRODUCT INFORMATION
2