Ceftazidime 1g powder for solution for injection vials

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Hent Indlægsseddel (PIL)
01-05-2021
Hent Produktets egenskaber (SPC)
14-03-2017

Aktiv bestanddel:

Ceftazidime pentahydrate

Tilgængelig fra:

Bowmed Ibisqus Ltd

ATC-kode:

J01DD02

INN (International Name):

Ceftazidime pentahydrate

Dosering:

1gram

Lægemiddelform:

Powder for solution for injection

Indgivelsesvej:

Intramuscular; Intravenous

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 05010201; GTIN: 5060130131345

Indlægsseddel

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFTAZIDIME 500, 1G, POWDER FOR SOLUTION FOR INJECTION
CEFTAZIDIME 2G, POWDER FOR SOLUTION FOR INJECTION/INFUSION
Ceftazidime
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
• 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 Ceftazidime Injection is and what it is used for
2. What you need to know before you are given Ceftazidime Injection
3. How Ceftazidime Injection is given
4. Possible side effects
5. How to store Ceftazidime Injection
6. Contents of the pack and other information
The name of your medicine is “Ceftazidime powder for solution for
injection or infusion” (referred to as
CEFTAZIDIME INJECTION
throughout this leaflet).
1. WHAT CEFTAZIDIME INJECTION IS AND WHAT IT IS USED FOR
Ceftazidime is an antibiotic used in adults and children (including
newborn babies). It works by killing
bacteria that cause infections. It belongs to a group of medicines
called cephalosporins
_. _
CEFTAZIDIME IS USED TO TREAT SEVERE BACTERIAL INFECTIONS OF
:
• the lungs or chest
• the lungs and bronchi in patients suffering from cystic fibrosis
• the brain (meningitis)
• the ear
• the urinary tract
• the skin and soft tissues
• the abdomen and abdominal wall (peritonitis)
• the bones and joints.
Ceftazidime can also be used:
• to prevent infections during prostate surgery in men
• to treat patients with low white blood cell counts (neutropenia)
who have a fever due to a bacterial infection.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CEFTAZIDIME INJECTION
YOU MUST NOT BE GIVEN CEFTAZIDIME INJECTION:
• IF YOU ARE ALLERGIC
to
CEFTAZIDIME
or the other ingredient of this medicine (see section 6).
• if you have had a
SEVERE ALLERGIC REACTIO
                                
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Produktets egenskaber

                                OBJECT 1
CEFTAZIDIME 1G POWDER FOR SOLUTION
FOR INJECTION VIALS
Summary of Product Characteristics Updated 11-Dec-2017 | 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
Ceftazidime 1g Powder for Solution for Injection
2. Qualitative and quantitative composition
Each vial contains 1g Ceftazidime (as pentahydrate)
Also contains sodium carbonate anhydrous (equivalent to 52mg sodium)
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for solution for injection
A white to cream-coloured powder.
4. Clinical particulars
4.1 Therapeutic indications
Ceftazidime is indicated for the treatment of the infections listed
below in adults and children including
neonates (from birth).
• Nosocomial pneumonia
• Broncho-pulmonary infections in cystic fibrosis
• Bacterial meningitis
• Chronic suppurative otitis media
• Malignant otitis externa
• Complicated urinary tract infections
• Complicated skin and soft tissue infections

                                
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