Amoxicillin Sodium 500mg Powder for solution for injection

Krajina: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktívna zložka:

AMOXICILLIN

Dostupné z:

Pinewood Laboratories Limited Ballymacarbry, Clonmel, Co. Tipperary, Ireland

ATC kód:

J01CA04

INN (Medzinárodný Name):

AMOXICILLIN 500 mg

Forma lieku:

POWDER FOR SOLUTION FOR INJECTION

Zloženie:

AMOXICILLIN 500 mg

Typ predpisu:

POM

Terapeutické oblasti:

ANTIBACTERIALS FOR SYSTEMIC USE

Stav Autorizácia:

Withdrawn

Dátum Autorizácia:

2019-08-06

Príbalový leták

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOXICILLIN SODIUM 250 MG, 500 MG AND 1000 MG POWDER FOR SOLUTION FOR
INJECTION
Sodium Amoxicillin (referred to as Amoxicillin in the remainder of the
leaflet)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 is and what it is used for
2. What you need to know before you are given Amoxicillin
3. How Amoxicillin is given
4. Possible side effects
5. How to store Amoxicillin
6. Contents of the pack and other information
1. WHAT AMOXICILLIN IS AND WHAT IT IS USED FOR
The name of your medicine is Amoxicillin Sodium Powder for Solution
for Injection. The vials
contain a medicine called sodium amoxicillin.
This belongs to a group of medicines called ‘penicillin’.
WHAT AMOXICILLIN IS USED FOR
Amoxicillin is used to treat infections caused by bacteria in
different parts of the body.
Amoxicillin Powder for Solution for Injection 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 ARE GIVEN AMOXICILLIN INJECTION
YOU SHOULD NOT BE GIVEN AMOXICILLIN
• if you are allergic to amoxicillin or penicillin. There are no
other ingredients in this medicine (see
section 6).
• if you have had an allergic reaction to any antibiotic. This can
include a skin rash or swelling of
the face or throat.
• if you have previously been told that your infection cannot be
treated with amoxicillin or
ampicillin.
You should not be given Amoxicillin if any of the above applies to
you. If you are not sure speak to
your doctor, nurse or pharmacist.
WARNINGS AND PRECAUTIONS
Talk to you doctor , pharmacist or nurse before y

Súhrn charakteristických

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amoxicillin Sodium 500mg Powder for Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Amoxicillin equivalent to Amoxicillin Ph Eur 500mg
3.
PHARMACEUTICAL FORM
Powder for solution for injection.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amoxicillin 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 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 that is selected to treat an individual
infection should take into
account:
2
• 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 regarding prolonged therapy). ADULTS AND CHILDREN ≥ 40 KG
INDICATION*
DOSE*
Severe infections of the ear, nose and throat
(such as mastoiditis peritonsillar infections,
epiglottis and sinusitis when accompanied by
severe systemic signs and symptoms
750 mg