Ceftriaxone 250mg powder for solution for injection vials

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Osta kohe

Laadi alla Infovoldik (PIL)
01-10-2021
Laadi alla Toote omadused (SPC)
14-12-2021

Toimeaine:

Ceftriaxone sodium

Saadav alates:

Bowmed Ibisqus Ltd

ATC kood:

J01DD04

INN (Rahvusvaheline Nimetus):

Ceftriaxone sodium

Annus:

250mg

Ravimvorm:

Powder for solution for injection

Manustamisviis:

Intravenous; Intramuscular

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 05010201; GTIN: 5060130130126

Infovoldik

                                PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CEFTRIAXONE 250 MG, 1G, 2G POWDER FOR SOLUTION FOR INJECTION OR
INFUSION
Ceftriaxone (as Ceftriaxone Sodium)
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.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if their
signs of illness are the same as yours.
• 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 Ceftriaxone injection is and what it is used for
2. What you need to know before you are given Ceftriaxone injection
3. How Ceftriaxone injection is given
4. Possible side effects
5. How to store Ceftriaxone injection
6. Contents of the pack and other information
The name of your medicine is “Ceftriaxone Powder for Solution for
Injection or Infusion” (referred to as
Ceftriaxone injection throughout this leaflet).
1. WHAT CEFTRIAXONE INJECTION IS AND WHAT IT IS USED FOR
Ceftriaxone is an antibiotic given to adults and children (including
newborn babies). It works by killing bacteria
that cause infections. It belongs to a group of medicines called
cephalosporins
_. _
Ceftriaxone injection is used
to treat infections of:
• the brain (meningitis).
• the lungs.
• the middle ear.
• the abdomen and abdominal wall (peritonitis).
• the urinary tract and kidneys.
• bones and joints.
• the skin or soft tissues.
• the blood.
• the heart.
It can be given:
• to treat specific sexually transmitted infections (gonorrhoea and
syphilis).
• to treat patients with low white blood cell counts (neutropenia)
who have fever due to bacterial infection.
• to treat infections of the chest in adults with chronic
bronchitis.
• to treat Lyme disease (caused by tick bites) in adu
                                
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Toote omadused

                                OBJECT 1
CEFTRIAXONE 250MG POWDER FOR
SOLUTION FOR INJECTION VIALS
Summary of Product Characteristics Updated 21-Jun-2022 | 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
Ceftriaxone 250mg powder for solution for injection
2. Qualitative and quantitative composition
Each vial contains 298.25mg Ceftriaxone sodium equivalent to 250mg
Ceftriaxone
Also contains approximately 21 mg (0.9 mmol) sodium.
3. Pharmaceutical form
Powder for solution for injection
A white or almost white powder
4. Clinical particulars
4.1 Therapeutic indications
Ceftriaxone is indicated for the treatment of the following infections
in adults and children including term
neonates (from birth):
• Bacterial Meningitis
• Community acquired pneumonia
• Hospital acquired pneumonia
• Acute otitis media
• Intra-abdominal infections
• Complicated urinary tract infections (including pyelonephritis)
• Infections of bones and joints
• Complicated skin and soft tissue infect
                                
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