AUGMENTIN 1G INJECTION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

AMOXICILLIN AS SODIUM; CLAVULANIC ACID AS POTASSIUM CLAVULANATE

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

J01CR02

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJ/INF

Composition:

AMOXICILLIN AS SODIUM 1000 MG; CLAVULANIC ACID AS POTASSIUM CLAVULANATE 200 MG

Administration route:

I.V

Prescription type:

Required

Manufactured by:

SMITHKLINE BEECHAM PHARMACEUTICALS, UK

Therapeutic group:

AMOXICILLIN AND ENZYME INHIBITOR

Therapeutic area:

AMOXICILLIN AND ENZYME INHIBITOR

Therapeutic indications:

Augmentin is indicated for the treatment of the following infections in adults and children: severe infections of the ear, nose and throat (such as mastoiditis, peritonsillar infections, epiglottitis, and sinusitis when accompanied by severe systemic signs and symptoms), acute exacerbations of chronic bronchitis (adequately diagnosed), community acquired pneumonia. cystitis, pyelonephritis, Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis, bone and joint infections, in particular osteomyelitis, intra-abdominal infections, female genital infections. Prophylaxis against infections associated with major surgical procedures in adults, such as those involving the: gastrointestinal tract, pelvic cavity, head and neck, biliary tract surgery.

Authorization date:

2012-08-31

Patient Information leaflet

ץרמ
2018
:ןודנה
AUGMENTIN 250MG TABLETS
AUGMENTIN 500MG TABLETS
AUGMENTIN 875MG TABLETS
AUGMENTIN SUSPENSION 250MG/5ML
AUGMENTIN SUSPENSION 400MG/5ML
AUGMENTIN ES 600MG/5ML
AUGMENTIN 500MG INJECTION
INJECTION
AUGMENTIN 1GR
ה/דבכנ ה/אפור
,ה/דבכנ ת/חקור
ג תרבח
ןיילקתימסוסקל
( מ"עב לארשי
GSK
לש ןכרצלו אפורל םינולעה ןוכדע לע
עידוהל תשקבמ )
ןודנבש ןיטנמגוא ירישכת
ב
וז העדוה
םילולכ
םייונישה
םייתוהמה
ב
.ןכרצל ןולעבו אפורל ןולע
ולעב
םנשי םינ
.םיפסונ םייוניש
היוותה
לארשיב רישכתל המושרה :
AUGMENTIN 250MG TABLETS:
Augmentin is indicated for the treatment of the following infections
in adults and children :
• Acute bacterial sinusitis (adequately diagnosed)
• Otitis media infection
• Acute pharyngitis
• Cystitis
• Pyelonephritis
• Skin and soft tissue infections in particular cellulitis, animal
bites, severe dental abscess with
spreading cellulitis.
AUGMENTIN 500 MG TABLETS , AUGMENTIN 875MG TABLETS AND AUGMENTIN
SUSPENSION 250MG/5ML:
Augmentin is indicated for the treatment of the following infections
in adults and children :
• Acute bacterial sinusitis (adequately diagnosed)
• Otitis media infection
• Acute exacerbations of chronic bronchitis (adequately diagnosed)
• Community acquired pneumonia
• Cystitis
• Pyelonephritis
• Skin and soft tissue infections in particular cellulitis, animal
bites, severe dental abscess with
spreading cellulitis.
• Bone and joint infections, in particular osteomyelitis.
AUGMENTIN SUSPENSION 400MG/5ML:
Augmentin is indicated for the treatment of the following infections
in adults and children:
• Acute bacterial sinusitis (adequately diagnosed)
• Acute otitis media
• Acute exacerbations of chronic bronchitis (adequately diagnosed)
• Community acquired pneumonia
• Cystitis
• Pyelonephritis
• Skin and soft tissue infections in particular cellulitis

Summary of Product characteristics

AUGMENTIN 500 MG INJECTION
AUGMENTIN 1G INJECTION
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL
PRODUCT
Augmentin 500 mg Injection
Augmentin 1 g Injection
2.
QUALITATIVE AND QUANTITATIVE
COMPOSITION
Augmentin 500 mg Injection
500 mg/100 mg powder for solution for injection/infusion
Each vial contains sodium amoxicillin equivalent to 500 mg amoxicillin
and potassium
clavulanate equivalent to 100 mg of clavulanic acid.
The sodium content of each vial is 31.4 mg (1.4 mmol).
The potassium content of each vial is 19.6 mg (0.5 mmol), which at
less than 39 mg (1 mmol) is
considered essentially ‘potassium-free’.
Augmentin 1 g Injection
1000 mg/200 mg powder for solution for injection/infusion
Each vial contains sodium amoxicillin equivalent to 1000 mg
amoxicillin and potassium
clavulanate equivalent to 200 mg
of clavulanic acid.
The sodium content of each vial is 62.9 mg (2.7 mmol). The
potassium content of each vial is 39.3 mg (1.0 mmol). For the
full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
500 mg/100 mg powder for solution for
injection/infusion
Powder for solution for
injection
/
infusion.
Vials containing a white to off-white sterile powder.
1000 mg/200 mg powder for solution for
injection/infusion
Powder for solution for
injection
/
infusion.
Vials containing a white to off-white sterile powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
Augmentin is indicated for the treatment of the following infections
in adults and children (see sections 4.2,
4.4 and 5.1):
•
Severe infections of the ear, nose and throat (such as mastoiditis,
peritonsillar infections,
epiglottitis, and sinusitis when accompanied by severe systemic signs
and symptoms)
•
Acute exacerbations of chronic bronchitis (adequately diagnosed)
•
Community acquired pneumonia
•
Cystitis
•
Pyelonephritis
•
Skin and soft tissue infections in particular cellulitis, animal
bites, severe dental abscess with
spreading cellulitis
•
Bone and joint infections, in particular osteomyelitis
•
Intra-abdominal i