Co-amoxiclav 125mg/31mg/5ml oral suspension sugar free

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Kupi sada

Preuzimanje Uputa o lijeku (PIL)
07-06-2018
Preuzimanje Svojstava lijeka (SPC)
07-06-2018

Aktivni sastojci:

Potassium clavulanate; Amoxicillin trihydrate

Dostupno od:

Viatris UK Healthcare Ltd

ATC koda:

J01CR02

INN (International ime):

Potassium clavulanate; Amoxicillin trihydrate

Doziranje:

6.25mg/1ml ; 25mg/1ml

Farmaceutski oblik:

Oral suspension

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 05010103

Uputa o lijeku

                                PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CO-AMOXICLAV 125 MG/31.25 MG/5 ML POWDER FOR ORAL SUSPENSION
CO-AMOXICLAV 250 MG/62.5 MG/5 ML POWDER FOR ORAL SUSPENSION
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 or pharmacist.
-
This medicine is usually prescribed for a baby or child. Do not pass
it on to others. It may harm them,
even if their signs of illness are the same as your child’s.
-
If your child gets any side effects talk to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet. See section 4.
If you are an adult who has been given this medicine, this information
applies to you.
WHAT IS IN THIS LEAFLET
1.
What Co-amoxiclav is and what it is used for
2.
What you need to know before you give Co-amoxiclav
3.
How to give Co-amoxiclav to your child
4.
Possible side effects
5.
How to store Co-amoxiclav
6.
Contents of the pack and other information
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, babies and children to treat the
following infections:
• middle ear and sinus infections
• respiratory tract infections
• urinary tract and kidney infections
• skin and soft tissue infections including animal bites and dental
infections
• bone and joint infections.
You must talk to a doctor if your child does not feel better or if
your child feels worse after 14 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU GIVE CO-AMOXICLAV
DO NOT GIVE CO-AMOXICLAV TO YOUR CHILD IF:
•
your chi
                                
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Svojstava lijeka

                                OBJECT 1
CO-AMOXICLAV 125 MG/31.25 MG/5 ML POWDER FOR
ORAL SUSPENSION
Summary of Product Characteristics Updated 03-Jan-2018 | Generics UK
T/A Mylan
1. Name of the medicinal product
Co-amoxiclav 125 mg/31.25 mg/5 ml Powder for Oral Suspension
2. Qualitative and quantitative composition
5 ml reconstituted suspension contains:
Amoxicillin trihydrate 143.50 mg corresponding to 125 mg amoxicillin
Potassium clavulanate 37.2 mg corresponding to 31.25 mg clavulanic
acid
Excipients with known effect:
Each 5 ml reconstituted suspension contains 8.5 mg aspartame (E951),
small amounts of sorbitol (E420),
dextrose and maltodextrin (glucose).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for oral suspension
Off-white powder or off-white suspension once reconstituted.
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).
• 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, animal
bites, severe dental abscess with spreading
cellulitis.
• Bone and joint infections, in particular osteomyelitis.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 Posology and method of administration
Posology
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 patient as shown below.
The use of alternative presentations of Co-amoxiclav (_e.g._
                                
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