Co-amoxiclav 500mg/100mg powder for solution for injection vials

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Amoxicillin sodium; Potassium clavulanate

Tillgänglig från:

Bowmed Ibisqus Ltd

ATC-kod:

J01CR02

INN (International namn):

Amoxicillin sodium; Potassium clavulanate

Dos:

500mg ; 100mg

Läkemedelsform:

Powder for solution for injection

Administreringssätt:

Intravenous

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 05010103; GTIN: 5060130130089

Bipacksedel

_PACKAGE LEAFLET: INFORMATION FOR THE USER_
Co-amoxiclav 500mg/100mg & 1000mg/200mg
Powder for solution for injection or infusion
Amoxicillin/clavulanic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4
1. WHAT CO-AMOXICLAV IS AND WHAT IT IS USED FOR
Co-amoxiclav 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.
Co-amoxiclav 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.
Co-amoxiclav is also used in adults and children to prevent infections
associated with major surgical procedures.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CO-AMOXICLAV
YOU SHOULD NOT BE GIVEN CO-AMOXICLAV:
• if
you
are
allergic
(hypersensitive)
to
amoxicillin,
clavulanic
acid
or
penicillin
• if you have ever had a severe allergic (hypersensitive) reaction
to any other
antibiotic. This can include a skin rash or swelling of the face or
neck
• if you have ever had liver problems or jaundice (yellowing of the
skin) when
taking an antibiotic.
YOU SHOULD NOT BE GIVEN CO-AMOXICLAV IF ANY OF THE ABOVE APPLY TO
YOU.
If you are not sure, talk to your doctor, pharmacist or nurse before
you are
given Co-amoxiclav.
W

Produktens egenskaper

OBJECT 1
CO-AMOXICLAV 500MG/100MG POWDER FOR SOLUTION
FOR INJECTION VIALS
Summary of Product Characteristics Updated 11-Dec-2017 | Bowmed
Ibisqus Limited
1. Name of the medicinal product
Co-amoxiclav 500mg/100mg powder for solution for injection or
infusion.
2. Qualitative and quantitative composition
Each vial contains:
Amoxicillin 500 mg (as amoxicillin sodium).
Clavulanic acid 100 mg (as clavulanate potassium).
3. Pharmaceutical form
Powder for solution for injection or infusion
Glass vial containing white powder
4. Clinical particulars
4.1 Therapeutic indications
Co-amoxiclav 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.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 Posology and method of administration
Doses are expressed throughout in terms of amoxicillin/clavulanic acid
content except when doses are
stated in terms of an individual component.
The dose of Co-amoxiclav that is selected to treat an individual
infection should take into account:
• The expected pathogens and their likely susceptibility to
antibacterial agents (see section 4.4)
• The severity and the site of the infection
• The age, weight and renal function of the p