AMOXICILLIN B&B amoxicillin (as trihydrate) 250 mg/5 mL powder for oral suspension bottle pack

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

amoxicillin trihydrate, Quantity: 57.4 mg/mL (Equivalent: amoxicillin, Qty 50 mg/mL)

Disponibbli minn:

Micro Labs Pty Ltd

Għamla farmaċewtika:

Suspension, powder for

Kompożizzjoni:

Excipient Ingredients: sorbitol; sodium benzoate; saccharin sodium; disodium edetate; xanthan gum; silicon dioxide; Flavour

Rotta amministrattiva:

Oral

Unitajiet fil-pakkett:

Amoxicillin powder for oral suspension packed in bottle of 150mL along with 28mm screw cap

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

It is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms:,Note: Therapy should be guided by bacteriological studies, including sensitivity tests, and by clinical response. However, in emergency cases where the causative organism has not been identified, therapy with amoxicillin may be useful. Clinical judgement will decide whether combination with another antibiotic would provide a sufficiently broad spectrum of activity pending sensitivity test results.,Skin and Skin Structure: Staphylococcus, non-penicillinase producing; Streptococcus; E.coli,Respiratory (Acute and Chronic): H.influenzae, Streptococcus; S.pneumoniae; staphylococcus, non-penicillinase-producing; E.coli,Genitourinary Tract (complicated and uncomplicated, Acute and Chronic): E.coli, P.mirabilis and S.faecalis.,Gonorrhoea: N.gonorrhoeae (non-penicillinase producing).,Prophylaxis of endocarditis: [Trade name] may be used for the prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with a prosthetic heart valve or those who have previously had endocarditis.

Sommarju tal-prodott:

Visual Identification: Unconstituted powder: white to pale yellow free flowing powder. Reconstituted: pale yellow to yellow coloured suspension with fruity aromatic odor.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2019-04-08

Karatteristiċi tal-prodott

1
AUSTRALIAN PRODUCT INFORMATION - AMOXICILLIN B&B (AMOXICILLIN
TRIHYDRATE)
1.
NAME OF THE MEDICINE
Amoxicillin trihydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
When reconstituted, every 5 ml of oral suspension contains amoxicillin
trihydrate equivalent
to 125 mg amoxicillin (25 mg per ml) for strength 125mg/5mL Oral
suspension
When reconstituted, every 5 ml of oral suspension contains amoxicillin
trihydrate equivalent
to 250 mg amoxicillin (50 mg per ml) for strength 250mg/5mL Oral
suspension.
Amoxicillin B&B contains the inactive ingredients Sodium benzoate and
sorbitol.
For the full list of excipients, see Section 6.1 List of excipients
3.
PHARMACEUTICAL FORM
Dry Powder for oral suspension.
White to pale yellow free flowing powder for Oral suspension, which
when constituted with
water forms Pale yellow to yellow colored suspension with fruity
aromatic odor.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
It is indicated for the treatment of the following infections due to
susceptible strains of
sensitive organisms:
Note: Therapy should be guided by bacteriological studies, including
sensitivity tests, and by
clinical response. However, in emergency cases where the causative
organism has not been
identified, therapy with amoxicillin may be useful. Clinical judgement
will decide whether
combination with another antibiotic would provide a sufficiently broad
spectrum of activity
pending sensitivity test results.
Skin and Skin Structure: Staphylococcus, non-penicillinase producing;
Streptococcus; _E.coli_
(see Section 5.1 Pharmacodynamic Properties (Microbiology)).
2
Respiratory
(Acute
and
Chronic):
_H.influenzae_,
Streptococcus;
_S.pneumoniae_;
staphylococcus,
non-penicillinase-producing;
_E.coli _
(see
Section
5.1
Pharmacodynamic
Properties (Microbiology)).
Genitourinary Tract (complicated and uncomplicated, Acute and
Chronic): _ E.coli_, (see
Section 5.1 Pharmacodynamic Properties (Microbiology)), _P.mirabilis
and S.faecalis. _
Gonorrhoea: _N.gonorrhoeae_ (non-penicillinase producing).
Prophylaxis of e