Rocephin 250mg powder for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ceftriaxone sodium

Available from:

Roche Products Ltd

ATC code:

J01DD04

INN (International Name):

Ceftriaxone sodium

Dosage:

250mg

Pharmaceutical form:

Powder for solution for injection

Administration route:

Intramuscular; Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010201; GTIN: 5000471005370

Patient Information leaflet

1
uk-pl-rocephin-clean-171025-2g-1g-250mg
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROCEPHIN 2 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION
ROCEPHIN 1 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION
ROCEPHIN 250 MG POWDER FOR SOLUTION FOR INJECTION
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 Rocephin is and what it is used for
2.
What you need to know before you are given Rocephin
3.
How Rocephin is given
4.
Possible side effects
5.
How to store Rocephin
6.
Contents of the pack and other information
1.
WHAT ROCEPHIN IS AND WHAT IT IS USED FOR
Rocephin 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
_. _
Rocephin 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 adults and children
including newborn babies
from 15 days of age.

to prevent infections during surgery.
2.
WH

Summary of Product characteristics

OBJECT 1
ROCEPHIN 250MG POWDER FOR SOLUTION FOR
INJECTION
Summary of Product Characteristics Updated 30-Jan-2018 | Roche
Products Limited
1. Name of the medicinal product
Rocephin 2 g Powder for solution for injection or infusion.
Rocephin 1 g Powder for solution for injection or infusion.
Rocephin 250 mg Powder for solution for injection.
2. Qualitative and quantitative composition
Rocephin 2 g powder for solution for injection or infusion.
Each bottle contains 2 g ceftriaxone as ceftriaxone sodium.
Rocephin 1 g powder for solution for injection or infusion
Each vial contains 1 g ceftriaxone as ceftriaxone sodium.
Rocephin 250 mg powder for solution for injection
Each vial contains 250 mg ceftriaxone as ceftriaxone sodium.
Excipient with known effect:
Rocephin contains approximately 83 mg (3.6 mmol) of sodium per gram of
ceftriaxone.
3. Pharmaceutical form
2 g powder for solution for injection or infusion
1 g powder for solution for injection or infusion
Powder for solution for injection or infusion.
250 mg powder for solution for injection
Powder for solution for injection.
White to yellowish-orange crystalline powder.
4. Clinical particulars
4.1 Therapeutic indications
Rocephin 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 infections
Gonorrhoea
Syphilis
Bacterial endocarditis
Rocephin may be used:
For treatment of acute exacerbations of chronic obstructive pulmonary
disease in adults
For treatment of disseminated Lyme borreliosis (early (stage II) and
late (stage III)) in adults and children
including neonates from 15 days of age
For Pre-operative prophylaxis of surgical site infections
In the management of neutropenic patients with fever that is suspected
to be due to a bacterial infection