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

Available from:

Viatris Pty Ltd

Pharmaceutical form:

Oral Liquid, powder for

Composition:

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

Administration route:

Oral

Units in package:

75mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

2021-02-17

Patient Information leaflet

CECLOR
®
C
E
C
L
O
R
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING CECLOR?
CECLOR contains the active ingredient cefaclor. CECLOR is used to
treat infections caused by bacteria in different parts of the
body. For more information, see Section 1. Why am I using CECLOR? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CECLOR?
Do not use if you have ever had an allergic reaction to CECLOR or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
CECLOR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CECLOR and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE CECLOR?
•
Your doctor will tell you how much CECLOR you need to take.
•
This will depend on the type of infection you have.
More instructions can be found in Section 4. How do I use CECLOR? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CECLOR?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
CECLOR.
•
Tell your doctor if the symptoms of your infection do not improve
within a few days, or if they become
worse.
•
If you become pregnant while taking this medicine, tell your doctor
immediately.
THINGS YOU
SHOULD NOT DO
•
Do not take CECLOR to treat any other complaints unless your doctor
tells you to.
•
Do not give your medicine to anyone else, even if they have the same
condition as you.
•
Do not stop taking your medicine or lower the dosage without checking
with your doctor.
DRIVING
OR USING
MACHINES
•
Be careful driving or operating machinery until you know how CECLOR
affects you.
LOOKING AFTER
YOUR MEDIC

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
CECLOR®
_cefaclor (as monohydrate) powder for oral liquid _
1
NAME OF THE MEDICINE
Cefaclor (as monohydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL of CECLOR 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
CECLOR 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
CECLOR 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. CECLOR 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
CECLOR is administered orally.
DIRECTIONS FOR RECONSTITUTION OF CECLOR
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.
CECLOR – PRODUCT INFORMATION
ADULTS