Amoxil Vials 500 mg, powder for solution for injection or infusion

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Amoxicillin sodium

Pieejams no:

GlaxoSmithKline (Ireland) Limited

ATĶ kods:

J01CA; J01CA04

SNN (starptautisko nepatentēto nosaukumu):

Amoxicillin sodium

Deva:

500 milligram(s)

Zāļu forma:

Powder for solution for injection/infusion

Receptes veids:

Product subject to prescription which may not be renewed (A)

Ārstniecības joma:

Penicillins with extended spectrum; amoxicillin

Autorizācija statuss:

Not marketed

Autorizācija datums:

1977-04-01

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOXIL VIALS 500 MG
POWDER FOR SOLUTION FOR INJECTION OR INFUSION
AMOXICILLIN
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.
WHAT IS IN THIS LEAFLET
1.
What Amoxil is and what it is used for
2.
What you need to know before you take Amoxil
3.
How to take Amoxil
4.
Possible side effects
5.
How to store Amoxil
6.
Contents of the pack and other information
1 WHAT AMOXIL IS AND WHAT IT IS USED FOR
WHAT AMOXIL IS
Amoxil is an antibiotic. The active ingredient is amoxicillin. This
belongs to a group of medicines called
‘penicillin’.
WHAT AMOXIL IS USED FOR
Amoxil is used to treat infections caused by bacteria in different
parts of the body.
Amoxil Powder for Solution for Injection or Infusion is usually used
for urgent treatment of severe infection
or if patients cannot take Amoxil by mouth.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMOXIL
DO NOT TAKE AMOXIL:

if you are allergic to amoxicillin, penicillin or any of the other
ingredients of this medicine (listed in
section 6).

if you have ever had an allergic reaction to any antibiotic. This can
include a skin rash or swelling of the
face or throat.
Do not take Amoxil if any of the above apply. If you are not sure,
talk to your doctor, pharmacist or nurse
before taking Amoxil.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Amoxil if you:

have glandular fever (fever, sore throat, swollen glands and extreme
tiredness)

have kidney problems

are not urinating regularly.
If you are not sure if any of the above apply to you, talk to your
doctor, pharmacist or nurse before taking
Amoxil.
BLOOD AND URINE TESTS
If you are havi

Produkta apraksts

Health Products Regulatory Authority
17 June 2021
CRN00C087
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amoxil Vials 500 mg, powder for solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains amoxicillin sodium equivalent to 500 mg amoxicillin
Excipient with known effect
Sodium 32 mg (1.37 mmol) per vial.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
Vials containing a white to off-white sterile powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amoxil 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

Community acquired pneumonia

Acute cystitis

Acute pyelonephritis

Severe dental abscess with spreading cellulitis

Prosthetic joint infections

Lyme disease

Bacterial meningitis

Bacteremia that occurs in association with, or is suspected to be
associated with, any of the infections listed above
Amoxil is also indicated for the treatment and prophylaxis of
endocarditis.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose of Amoxil 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 duration of therapy should be determined by the type of infection
and the response of the patient, and should generally
be as short as possible. Some infections require longer periods of
treatment (see section 4.4 regardin