Rocephin 250mg vials

देश: माल्टा

भाषा: अंग्रेज़ी

स्रोत: Medicines Authority

सक्रिय संघटक:

CEFTRIAXONE

थमां उपलब्ध:

Roche Products Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

ए.टी.सी कोड:

J01DD05

INN (इंटरनेशनल नाम):

CEFTRIAXONE 250 mg

फार्मास्यूटिकल फॉर्म:

POWDER FOR SOLUTION FOR INJECTION

रचना:

CEFTRIAXONE 250 mg

प्रिस्क्रिप्शन प्रकार:

POM

चिकित्सीय क्षेत्र:

ANTIBACTERIALS FOR SYSTEMIC USE

प्राधिकरण का दर्जा:

Withdrawn

प्राधिकरण की तारीख:

2006-03-14

सूचना पत्रक

PLEASE READ ALL OF THIS LEAFLET
CAREFULLY BEFORE YOU START HAVING
THIS MEDICINE.
• Keep this leaflet. You may need to read
it again.
• If you have any further questions,
ask your doctor or nurse.
• If any of the side effects become serious
or troublesome, or if you notice any
side effects not listed in this leaflet,
please tell your doctor or nurse.
IN THIS LEAFLET:
1. What Rocephin is and what it is used
for
2. Before you are given Rocephin
3. How Rocephin will be given
4. Possible side effects
5. How Rocephin is stored
6. Further information
1. WHAT ROCEPHIN IS AND WHAT
IT IS USED FOR
Rocephin contains a medicine called
ceftriaxone. This belongs to a group of
medicines called antibiotics.
• Rocephin is used to treat infections
caused by bacteria.
• It can be used to treat
infections in different
parts of the body
including the lungs
(pneumonia), blood
(septicaemia), skin,
other soft body parts
(tissues), bone,
and for infections
such as meningitis
and gonorrhoea
(a sexually
transmitted
infection).
• It can be used to treat infections in
people with low numbers of white blood
cells (neutropenia).
• It can also be given before and after
operations to stop infections from
happening.
It works by stopping the bacteria
from growing properly. This causes
the bacteria to die.
2. BEFORE YOU ARE GIVEN ROCEPHIN
YOU MUST NOT BE GIVEN ROCEPHIN IF:
• You are allergic (hypersensitive)
to ceftriaxone (the only ingredient
in Rocephin).
• You are allergic to antibiotics called
‘cephalosporins’. These include
cefalexin, cefaclor and cefuroxime.
• You have had a SUDDEN OR SEVERE
allergic reaction to penicillin or
similar antibiotics (such as amoxicillin
or flucloxacillin). The signs include
sudden swelling of the throat or face
which might make it difficult to
breathe or swallow, sudden swelling
of the hands, feet and ankles, and a
severe rash that develops quickly.
• You are allergic to lidocaine and
you are to be given Rocephin as an
injection into a

उत्पाद विशेषताएं

1 
SUMMARY OF PRODUCT CHARACTERISTICS 

1.

NAME OF THE MEDICINAL PRODUCT 
Rocephin 250mg vials. 

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each 250mg vial contains 250mg ceftriaxone as 298.3mg hydrated disodium ceftriaxone. 

3.

PHARMACEUTICAL FORM 
Powder for solution for injection. 
. 
4.

CLINICAL PARTICULARS 
4.1 
THERAPEUTIC INDICATIONS 
Ceftriaxone  is  indicated  for  the  treatment  of  the  following  infections  when  known  or  likely  to  be 
due  to  one  or  more  susceptible  micro-organisms  (see  section  _5.1_)  and  when  parenteral  therapy  is 
required: 

Pneumonia. 
septicaemia. 
Meningitis. 
Bone, skin and soft tissue infections.  
Infections in neutropenic patients. 
Gonorrhoea. 
Peri-operative prophylaxis of infections associated with surgery. 

Treatment may be started before the results of susceptibility tests are known. 

Consideration should be given to official guidance on the appropriate use of antibacterial agents. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Rocephin may be administered by deep intramuscular injection, slow intravenous injection, or as a 
slow  intravenous  infusion,  after  reconstitution  of  the  solution  according  to  the  directions  given 
below. Diluents containing calcium, (e.g. Ringer’s solution or Hartmann’s solution), should not be 
used  to  reconstitute  ceftriaxone  vials  or  to  further  dilute  a  reconstituted  vial  for  IV  administration 
because  a  precipitate  can  form.  Precipitation  of  ceftriaxone-calcium  can  also  occur  when 
ceftriaxone  is  mixed  with  calcium-containing  solutions  in  the  same  IV  administration  line. 
Therefore,  ceftriaxone  and  calcium-containing  solutions  must  not  be