Amoxicillin Actavis

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Amoxicillin trihydrate 60.26 mg/mL equivalent to 50 mg/mL Amoxicillin, on reconstitution;  

Available from:

Actavis New Zealand Limited

INN (International Name):

Amoxicillin trihydrate 60.26 mg/mL (= 50 mg/mL Amoxicillin, on reconstitution)

Dosage:

250 mg/5mL

Pharmaceutical form:

Powder for oral suspension

Composition:

Active: Amoxicillin trihydrate 60.26 mg/mL equivalent to 50 mg/mL Amoxicillin, on reconstitution   Excipient: Carmellose sodium Citric acid Colloidal silicon dioxide Erythrosine Essence BTM DM 7020A Purified talc Sodium benzoate Sucrose

Prescription type:

Prescription

Manufactured by:

Zhuhai United Laboratories Co Ltd

Therapeutic indications:

Amoxicillin is indicated for the treatment of infections due to susceptible organisms. Amoxicillin may be useful in instituting therapy prior to bacteriology; however bacteriological studies to determine the causative organisms and their sensitivity to Amoxicillin should be determined. Amoxicillin may be used for the prevention of bacteraemia, associated with procedures such as dental extraction, in patients at risk of developing bacterial endocarditis.

Product summary:

Package - Contents - Shelf Life: Bottle, glass, 60 ml amber glass with Silver coloured aluminium closure and wad in carton - 18 g - 24 months unopened stored at or below 25°C protect from light 10 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Bottle, glass, 60 ml amber glass with LDPE tamper-evident closure in carton - 18 g - 24 months unopened stored at or below 25°C protect from light 10 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Bottle, glass, 60 ml amber glass with PP tamper-evident closure in carton - 18 g - 24 months unopened stored at or below 25°C protect from light 10 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Bottle, glass, 100 ml amber glass with silver aluminium closure and wad in carton - 30 g - 24 months unopened stored at or below 25°C protect from light 10 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Bottle, glass, 100 ml amber glass with LDPE tamper-evident closure in carton - 30 g - 24 months unopened stored at or below 25°C protect from light 10 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Bottle, glass, 100 ml amber glass with PP tamper-evident closure in carton - 30 g - 24 months unopened stored at or below 25°C protect from light 10 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Bottle, plastic, White HDPE with screw cap - 100 mL - 24 months from date of manufacture stored at or below 25°C protect from light 10 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

2012-02-22

Patient Information leaflet

NEW ZEALAND CONSUMER MEDICINE INFORMATION
AMOXICILLIN ACTAVIS
Amoxicillin Oral Suspension BP 125mg/5mL and 250mg/5mL
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you give AMOXICILLIN ACTAVIS
to your
child.
This leaflet answers some common questions about AMOXICILLIN ACTAVIS.
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 using
AMOXICILLIN ACTAVIS against the benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT AMOXICILLIN ACTAVIS IS USED FOR
AMOXICILLIN ACTAVIS contains the active ingredient amoxicillin, which
belongs to
the penicillin group of antibiotics.
AMOXICILLIN ACTAVIS is used to treat a range of infections caused by
bacteria.
These may be infections of the chest (pneumonia), tonsils
(tonsillitis), sinuses
(sinusitis), inner ear (otitis media), urinary and genital tract or
skin and fleshy tissues.
AMOXICILLIN ACTAVIS works by killing the bacteria that cause these
infections.
AMOXICILLIN ACTAVIS can also be used to prevent infection.
Your child’s doctor may have prescribed AMOXICILLIN ACTAVIS for
another reason.
Ask your doctor if you have any questions about why AMOXICILLIN
ACTAVIS has
been prescribed for your child.
This medicine is available only with a doctor's prescription.
BEFORE YOU GIVE AMOXICILLIN ACTAVIS
_ _
_WHEN YOU MUST NOT USE IT _
1
Do not give AMOXICILLIN ACTAVIS if:
•
your child is allergic to penicillin or similar types of antibiotics
such as
cephalosporins. If your child has ever had an allergic reaction (such
as a rash)
when taking an antibiotic, tell the doctor before any AMOXICILLIN
ACTAVIS is
given.
•
your child has ever had an allergic reaction to amoxicillin or any of
the ingredients
listed toward the end of this leaflet.
If you are not sure whether you should st

Summary of Product characteristics

NEW ZEALAND DATA SHEET
AMOXICILLIN ACTAVIS
Amoxicillin Oral Suspension BP
PRESENTATION
_POWDER FOR ORAL SUSPENSION 125MG/5ML_
_ _
60ML: Light pink coloured granular powder to prepare 60ml oral
suspension. When
reconstituted as directed, produces 60mL of pink coloured suspension
with each
5mL containing Amoxicillin Trihydrate BP equivalent to amoxicillin
125mg.
100ML: Light pink coloured granular powder to prepare 100ml oral
suspension.
When reconstituted as directed, produces 100mL of pink coloured
suspension with
each 5mL containing Amoxicillin Trihydrate BP equivalent to
amoxicillin 125mg.
_POWDER FOR ORAL SUSPENSION 250MG/5ML _
60ML: Light pink coloured granular powder to prepare 60ml oral
suspension. When
reconstituted as directed, produces 60mL of pink coloured suspension
with each
5mL containing Amoxicillin Trihydrate BP equivalent to amoxicillin
250mg.
100ML: Light pink coloured granular powder to prepare 100ml oral
suspension.
When reconstituted as directed, produces 100mL of pink coloured
suspension with
each 5mL containing Amoxicillin Trihydrate BP equivalent to
amoxicillin 250mg.
USES
_ACTIONS _
Amoxicillin is a semi-synthetic aminopenicillin of the beta-lactam
group of antibiotics
which exerts a bactericidal effect against many Gram-positive and
Gram-negative
microorganisms. Amoxicillin is not effective against beta-lactamase
producing
organisms.
_INDICATIONS _
Treatment of Infection: Amoxicillin is indicated in the treatment of
infections due to
susceptible organisms.
Amoxicillin may be useful in instituting therapy prior to
bacteriology; however
bacteriological studies to determine the causative organisms and their
sensitivity to
amoxicillin should be performed.
Prophylaxis for endocarditis: amoxicillin may be used for the
prevention of
bacteraemia, associated with procedures such as dental extraction, in
patients at risk
of developing bacterial endocarditis.
_PHARMACODYNAMIC PROPERTIES _
Amoxicillin is a semisynthetic aminopenicillin of the beta-lactam
group of antibiotics.
It has a broad spectrum