Amoxicillin 250mg powder for solution for injection vials

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Amoxicillin sodium

Disponible desde:

Bowmed Ibisqus Ltd

Código ATC:

J01CA04

Designación común internacional (DCI):

Amoxicillin sodium

Dosis:

250mg

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: 5060130130409

Información para el usuario

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOXICILLIN 250MG, 500MG OR 1G,
POWDER FOR SOLUTION FOR INJECTION OR INFUSION
Amoxicillin
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 Injection is and what it is used for
2. What you need to know before you are given Amoxicillin Injection
3. How Amoxicillin Injection is given
4. Possible side effects
5. How to store Amoxicillin Injection
6. Contents of the pack and other information
The name of your medicine is “Amoxicillin 250mg, 500mg, 1g Powder
for Solution for Injection or
Infusion” (referred to as
AMOXICILLIN INJECTION
throughout this leaflet).
1. WHAT AMOXICILLIN INJECTION IS AND WHAT IT IS USED FOR
WHAT AMOXICILLIN INJECTION IS
Amoxicillin Injection is an antibiotic. The active ingredient is
amoxicillin. This belongs to a group of
medicines called ‘penicillins’.
WHAT AMOXICILLIN INJECTION IS USED FOR
Amoxicillin Injection is used to treat infections caused by bacteria
in different parts of the body.
Amoxicillin 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 MUST NOT BE GIVEN AMOXICILLIN INJECTION:
•
if you are allergic to amoxicillin or penicillin
•
if you have ever had an allergic reaction to any antibiotic. This can
include a skin rash or
swelling of the face or throat.
You must not be given Amoxicillin Injection if any of the above apply.
If you are not sure, talk to your doctor, pharmacist or nurse before
you are given Amoxicillin
Injection.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse be

Ficha técnica

OBJECT 1
AMOXICILLIN 250MG POWDER FOR
SOLUTION FOR INJECTION VIALS
Summary of Product Characteristics Updated 15-Oct-2019 | Bowmed
Ibisqus Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Amoxicillin 250 mg, powder for solution for injection or infusion
2. Qualitative and quantitative composition
Each vial contains amoxicillin sodium equivalent to 250 mg
amoxicillin.
3. Pharmaceutical form
Powder for solution for injection or infusion.
Glass vial containing white or almost white powder.
4. Clinical particulars
4.1 Therapeutic indications
Amoxicillin is indicated for the treatment of the following infections
in adults and children (see section
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
•