Amoxil 500mg powder for solution for injection vials

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Amoxicillin sodium

Commercializzato da:

GlaxoSmithKline UK Ltd

Codice ATC:

J01CA04

INN (Nome Internazionale):

Amoxicillin sodium

Dosaggio:

500mg

Forma farmaceutica:

Powder for solution for injection

Via di somministrazione:

Intravenous; Intramuscular

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 05010103; GTIN: 5010005051650

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOXIL VIALS FOR INJECTION
500 MG AND 1 G
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 having:

Urine tests (glu

Scheda tecnica

OBJECT 1
AMOXIL VIALS FOR INJECTION 500MG
Summary of Product Characteristics Updated 17-Jan-2018 |
GlaxoSmithKline UK
1. Name of the medicinal product
Amoxil Vials for Injection 500 mg
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 regarding prolonged therapy)