Amoksiklav 156.25mg/5ml powder for oral suspension

Država: Armenija

Jezik: engleski

Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivni sastojci:

amoxicillin (amoxicillin trihydrate), clavulanic acid (potassium clavulanate)

Dostupno od:

Sandoz GmbH

ATC koda:

J01CR02

INN (International ime):

amoxicillin (amoxicillin trihydrate), clavulanic acid (potassium clavulanate)

Doziranje:

125mg/5ml+ 31,25mg/5ml

Farmaceutski oblik:

powder for oral suspension

Jedinice u paketu:

7.88g powder containing 100ml amber glass bottle and a 5ml dosing syringe

Tip recepta:

Prescription

Status autorizacije:

Registered

Datum autorizacije:

2022-09-23

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Trade name of the medicinal product:
AMOKSIKLAV® 156.25 MG/5 ML POWDER FOR ORAL SUSPENSION
AMOKSIKLAV® 312.5 MG/5 ML POWDER FOR ORAL SUSPENSION
International nonproprietary name: 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, nurse or
pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Amoksiklav is and what it is used for
2. What you need to know before you take Amoksiklav
3. How to take Amoksiklav
4. Possible side effects
5. How to store Amoksiklav
6. Contents of the pack and other information
1. WHAT AMOKSIKLAV IS AND WHAT IT IS USED FOR
Amoksiklav 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.
Amoksiklav is used in adults and children to treat the following
infections:

middle ear and sinus infections

respiratory tract infections

urinary tract infections

skin and soft tissue infections including dental infections

bone and joint infections
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMOKSIKLAV
DO NOT TAKE AMOKSIKLAV:

if you are allergic (hypersensitive) 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 (hypersensitivity) reaction to
any other antibi

Svojstava lijeka

Amoxicillin, clavulanic acid powder for oral suspension
156.25 mg / 5 mL, 312.5 mg / 5 mL
Page 1
Amoxicillin_Clavulanic acid_oral_v04_11_2017
September 2021
SPC Amoksiklav POS 156_312 Kundl (CIS+AM) ENG_17.9.2021
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
AMOKSIKLAV® 156.25 MG/5 ML POWDER FOR ORAL SUSPENSION
AMOKSIKLAV® 312.5 MG/5 ML POWDER FOR ORAL SUSPENSION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
International non-proprietary name: amoxicillin, clavulanic acid.
Each 5 ml of Amoksiklav 156.25 mg/5 ml oral suspension contains 125 mg
of amoxicillin in the
form of amoxicillin trihydrate and 31.25 mg of clavulanic acid in the
form of potassium
clavulanate.
Each 5 ml of Amoksiklav 312.5 mg/5 ml oral suspension contains 250 mg
of amoxicillin in the
form
of
amoxicillin
trihydrate
and
62.5
mg
of
clavulanic
acid
in
the
form
of
potassium
clavulanate.
For the list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral suspension (white to cream coloured powder).
After reconstitution the suspension is homogeneous, white to cream
coloured.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amoksiklav 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.
Amoxicillin, clavulanic acid powder for oral suspension
156.25 mg / 5 mL, 312.5 mg / 5 mL
Page 2
Amoxicillin_Clavulanic acid_oral_v04_11_2017
September 2021
SPC Amoksiklav POS 156_312 Kundl (CIS+AM) ENG_17.9.2021
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Doses are expressed throughout