CILICAINE V phenoxymethylpenicillin (as benzathine) 150mg/5mL oral liquid, suspension bottle

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

phenoxymethylpenicillin benzathine, Quantity: 40.27 mg/mL (Equivalent: phenoxymethylpenicillin, Qty 30 mg/mL)

Disponible depuis:

Viatris Pty Ltd

DCI (Dénomination commune internationale):

phenoxymethylpenicillin benzathine

forme pharmaceutique:

Oral Liquid, suspension

Composition:

Excipient Ingredients: sodium propyl hydroxybenzoate; sodium methyl hydroxybenzoate; butylated hydroxyanisole; polysorbate 80; xanthan gum; sucrose; purified water; sodium citrate dihydrate; potassium sorbate; citric acid; Flavour

Mode d'administration:

Oral

Unités en paquet:

100mL

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

Treatment of mild to moderately severe infections due to penicillin sensitive staphylococci, pneumococci, gonococci and haemolytic streptococci infections. Therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. For prophylactic use in recurrent streptococcal infections including the prevention of recurrence following rheumatic fever and/or Sydenham's chorea and to prevent bacterial endocarditis in patients with rheumatic fever and/or congenital heart disease who are about to undergo dental or upper respiratory surgery or instrumentation. Note: Oral penicillin should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower intestinal tract surgery, sigmoidoscopy or complications of childbirth.

Descriptif du produit:

Visual Identification: beige, dense, viscous creamy suspension, apricot flavour; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Statut de autorisation:

Registered

Date de l'autorisation:

2010-06-09

Notice patient

CILICAINE
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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 CILICAINE V?
CILICAINE V contains the active ingredient phenoxymethylpenicillin
benzathine. CILICAINE V is used to treat infections in different
parts of the body caused by bacteria.
For more information, see Section 1. Why am I using CILICAINE V? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CILICAINE V?
Do not use if you have ever had an allergic reaction to CILICAINE V 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
CILICAINE V? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CILICAINE V 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 CILICAINE V?
•
Your doctor will tell you how much CILICAINE V 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 CILICAINE V?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CILICAINE V?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
CILICAINE V.
•
If the symptoms of your infection do not improve within a few days, or
if they become worse, tell your
doctor.
•
If you develop itching with swelling of skin rash or difficulty
breathing while you are taking CILICAINE V
do not take any more and contact your doctor immediately.
THINGS YOU
SHOULD NOT DO
•
Do not take CILICAINE V 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 medic

Résumé des caractéristiques du produit

AUSTRALIAN PRODUCT INFORMATION
CILICAINE
® V
_Phenoxymethylpenicillin (as benzathine) oral suspension _
1
NAME OF THE MEDICINE
Phenoxymethylpenicillin (as benzathine)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL of oral liquid suspension contains 150 mg of
phenoxymethylpenicillin (as benzathine) as the active
ingredient.
Excipients with known effect: hydroxybenzoates, sorbates, sugars and
soya bean products.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
CILICAINE V 150 mg/5 mL oral liquid suspension is a beige, dense,
viscous creamy suspension and apricot
flavoured.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of mild to moderately severe infections due to penicillin
sensitive staphylococci, pneumococci,
gonococci and haemolytic streptococci infections. Therapy should be
guided by bacteriological studies,
including sensitivity tests, and by clinical response.
For prophylactic use in recurrent streptococcal infections including
the prevention of recurrence following
rheumatic fever and/or Sydenham’s chorea and to prevent bacterial
endocarditis in patients with rheumatic
fever and/or congenital heart disease who are about to undergo dental
or upper respiratory surgery or
instrumentation.
Note: Oral penicillin should not be used as adjunctive prophylaxis for
genitourinary instrumentation or
surgery, lower intestinal tract surgery, sigmoidoscopy or
complications of childbirth.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
250 mg to 500 mg every four to six hours, preferable one hour before
food. The dosage should be determined
according to sensitivity of the organisms and severity of the
infection.
Prevention of recurrence following rheumatic fever: 250 mg twice a day
continuously.
CHILDREN
_Infants and small children_ -
15 to 50 mg/kg in three to six divided doses. If not calculated by
bodyweight the
following dosage schedule may be used.
•
UP TO 1 YEAR:
60 mg every six hours.
•
1 TO 5 YEARS:
120 mg every six hours.
•
6 TO 12 YEARS:
120 to