Amoxicillin 500mg powder for solution for injection vials

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Amoxicillin sodium

Disponible desde:

Wockhardt UK Ltd

Código ATC:

J01CA04

Designación común internacional (DCI):

Amoxicillin sodium

Dosis:

500mg

formulario farmacéutico:

Powder for solution for injection

Vía de administración:

Intravenous; Intramuscular

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 05010103; GTIN: 5012727902555

Información para el usuario

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 you

Ficha técnica

OBJECT 1
AMOXICILLIN SODIUM FOR INJECTION
Summary of Product Characteristics Updated 10-Jan-2018 | Wockhardt UK
Ltd
1. Name of the medicinal product
Amoxicillin Sodium 250mg Powder for Solution for Injection
Amoxicillin Sodium 500mg Powder for Solution for Injection
Amoxicillin Sodium 1g Powder for Solution for Injection
2. Qualitative and quantitative composition
Sodium Amoxicillin equivalent to Amoxicillin Ph Eur 250mg
Sodium Amoxicillin equivalent to Amoxicillin Ph Eur 500mg
Sodium Amoxicillin equivalent to Amoxicillin Ph Eur 1g
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:
• 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 requir