Rocephin 1 g powder and solvent for IM injection only

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lidocaine Hydrochloride Monohydrate; Ceftriaxone sodium

Available from:

Roche Products (Ireland) Ltd

ATC code:

J01DD04

INN (International Name):

Lidocaine Hydrochloride Monohydrate; Ceftriaxone sodium

Dosage:

1 gram(s)

Pharmaceutical form:

Powder and solvent for solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

ceftriaxone

Authorization status:

Marketed

Authorization date:

2005-05-06

Patient Information leaflet

1
IE_PIL_Rocephin-1g- solvent IM only_01 March 2023_Clean
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROCEPHIN
® 1 G POWDER AND SOLVENT FOR IM INJECTION ONLY
ceftriaxone (as ceftriaxone sodium)
lidocaine (as lidocaine hydrochloride)
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 administered by injection into a muscle in a solution
containing lidocaine, which reduces the
pain associated with the injection.
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
includi

Summary of Product characteristics

Health Products Regulatory Authority
06 April 2023
CRN00DHHJ
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rocephin 1 g powder and solvent for IM injection only
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder contains 1 g ceftriaxone as ceftriaxone sodium.
Each 1 ml of solvent contains 10 mg of lidocaine hydrochloride,
corresponding to 35 mg of lidocaine hydrochloride per 3.5 ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for IM injection.
Powder: White to yellowish-orange crystalline powder.
Solvent: A clear colourless solution.
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
In the treatment of patients with bacteraemia that occurs in
association with, or is suspected to be associated with, any of the
infections listed above
Rocephin should be co-administered with other antibacterial agents
whenever the possible range of causative bacteria would
not fall within its spectrum (see section 4.4).
Consideration should be given to official guidelines on the
appropriate use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose depends