Augmentin Intravenous 1.2g powder for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amoxicillin sodium; Potassium clavulanate

Available from:

GlaxoSmithKline UK Ltd

ATC code:

J01CR02

INN (International Name):

Amoxicillin sodium; Potassium clavulanate

Dosage:

1000mg ; 200mg

Pharmaceutical form:

Powder for solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010103; GTIN: 5010004032384

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
AUGMENTIN INTRAVENOUS
CO-AMOXICLAV (AMOXICILLIN AND CLAVULANIC ACID)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
If you get any side effects, talk to your doctor or nurse. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1
What Augmentin is and what it is used for
2
What you need to know before you have Augmentin
3
How Augmentin is given
4
Possible side effects
5
How to store Augmentin
6
Contents of the pack and other information
1
WHAT AUGMENTIN IS AND WHAT IT IS USED FOR
Augmentin is an antibiotic and works by killing bacteria that cause
infections. It contains
two different medicines called amoxicillin and clavulanic acid.
Amoxicillin belongs to a
group of medicines called “penicillins” that can sometimes be
stopped from working
(made inactive). The other active component (clavulanic acid) stops
this from
happening.
Augmentin is used in adults and children to treat the following
infections:
•
severe ear, nose and throat infections
•
respiratory tract infections
•
urinary tract infections
•
skin and soft tissue infections including dental infections
•
bone and joint infections
•
intra-abdominal infections
•
genital organ infections in women.
Augmentin is used in adults and children to prevent infections
associated with major
surgical procedures.
2
WHAT YOU NEED TO KNOW BEFORE YOU HAVE AUGMENTIN
YOU SHOULD NOT HAVE AUGMENTIN:
•
if you are allergic to amoxicillin, clavulanic acid, penicillin or any
of the other
ingredients of this medicine (listed in section 6).
•
if you have ever had a severe allergic reaction to any other
antibiotic. This can
include a skin rash or swelling of the face or throat.
•
if you have ever had liver problems or jaundice (yellowing of the
skin) when takin

Summary of Product characteristics

OBJECT 1
AUGMENTIN INTRAVENOUS
Summary of Product Characteristics Updated 07-Mar-2018 |
GlaxoSmithKline UK
1. Name of the medicinal product
Augmentin Intravenous
2. Qualitative and quantitative composition
Each vial contains sodium amoxicillin equivalent to 500mg amoxicillin
and potassium clavulanate
equivalent to 100 mg of clavulanic acid.
Excipients with known effect
Sodium 31.4 mg (1.4 mmol) per vial.
Potassium 19.6 mg (0.5 mmol) per vial.
Each vial or bottle contains sodium amoxicillin equivalent to 1000 mg
amoxicillin and potassium
clavulanate equivalent to 200mg of clavulanic acid.
Excipients with known effect
Sodium 62.9 mg (2.7 mmol) per vial.
Potassium 39.3 mg (1.0 mmol) per vial.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
500 mg/100 mg powder for solution for injection or infusion
Powder for solution for injection or infusion.
Vials containing a white to off-white sterile powder.
1000 mg/200 mg powder for solution for injection or infusion
Powder for solution for injection or infusion.
Vials or bottles containing a white to off-white sterile powder.
4. Clinical particulars
4.1 Therapeutic indications
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 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.
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