Amoxicillin Delbert 500 mg, powder for solution for injection or infusion

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Amoxicillin sodium

Saatavilla:

Laboratoires DELBERT

ATC-koodi:

J01CA; J01CA04

INN (Kansainvälinen yleisnimi):

Amoxicillin sodium

Annos:

500 milligram(s)

Lääkemuoto:

Powder for solution for injection/infusion

Terapeuttinen alue:

Penicillins with extended spectrum; amoxicillin

Valtuutuksen tilan:

Not marketed

Valtuutus päivämäärä:

1977-04-01

Pakkausseloste

[DELBERT Logo]
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOXICILLIN DELBERT 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 Amoxicillin Delbert 500 mg is and what it is used for
2.
What you need to know before you use Amoxicillin Delbert 500 mg
3.
How to take Amoxicillin Delbert 500 mg
4.
Possible side effects
5.
How to store Amoxicillin Delbert 500 mg
6.
Contents of the pack and other information
1 WHAT AMOXICILLIN DELBERT 500 MG IS AND WHAT IT IS USED FOR
WHAT AMOXICILLIN DELBERT 500 MG IS
Amoxicillin is an antibiotic. The active ingredient is amoxicillin.
This belongs to a group of medicines called
‘penicillin’.
WHAT AMOXICILLIN DELBERT 500 MG IS USED FOR
Amoxicillin is used to treat infections caused by bacteria in
different parts of the body.
Amoxicillin is usually used for urgent treatment of severe infection
or if patients cannot take amoxicillin by
mouth.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMOXICILLIN DELBERT 500 MG
DO NOT TAKE AMOXICILLIN DELBERT 500 MG :
•
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 use Amoxicillin Delbert 500 mg if any of the above apply. If
you are not sure, talk to your doctor,
pharmacist or nurse before using Amoxicillin Delbert 500 mg .
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Amoxicillin
Delbert 500 mg if you:
•
have glandular fever (fever, sore throat, swollen glands

Valmisteyhteenveto

Health Products Regulatory Authority
18 May 2023
CRN00DHKD
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amoxicillin Delbert 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
Amoxicillin Delbert 500 mg 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
Amoxicillin Delbert 500 mg 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 Amoxicillin Delbert 500 mg 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
Health Products Regulatory Authority
18 May 2023
CRN00DHKD
Page 2 of 14
The duration of therapy should be determined by the type of infection
and the response o