ROCEPHIN 1 Grams Pdr+Solv for Soln for Inj
Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Foglio illustrativo
(PIL)
06-07-2017
Scheda tecnica
(SPC)
28-02-2018
Principio attivo:
CEFTRIAXONE SODIUM
Commercializzato da:
Roche Products Limited
Codice ATC:
J01DD04
INN (Nome Internazionale):
CEFTRIAXONE SODIUM
Dosaggio:
1 Grams
Forma farmaceutica:
Pdr+Solv for Soln for Inj
Tipo di ricetta:
Product subject to prescription which may not be renewed (A)
Area terapeutica:
Third-generation cephalosporins
Stato dell'autorizzazione:
Authorised
Data dell'autorizzazione:
2005-05-06
Foglio illustrativo
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 including newborn
babies from 15 days of age.
● to prevent infections during surgery.
2.
WHAT YOU NEED TO KNOW BEFORE
YOU ARE GIVEN ROCEPHIN
YOU MUST NOT BE GIVEN ROCEPHIN IF:
● You are allergic to ceftriaxone or any of
the other ingredie
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Scheda tecnica
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rocephin 1g 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.
Excipient with known effect:
Rocephin contains approximately 83 mg (3.6 mmol) of sodium per gram of
ceftriaxone.
For a 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
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