CEFTRIAXONE HOSPIRA 1 Grams Pdr for Soln for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CEFTRIAXONE SODIUM

Available from:

Hospira UK Limited

ATC code:

J01DD04

INN (International Name):

CEFTRIAXONE SODIUM

Dosage:

1 Grams

Pharmaceutical form:

Pdr for Soln for Injection

Prescription type:

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

Therapeutic area:

Third-generation cephalosporins

Authorization status:

Authorised

Authorization date:

2014-09-19

Patient Information leaflet

Page 1 of 9
PFLEET 2016-0022545
PACKAGE LEAFLET: INFORMATION FOR THE USER
REMIFENTANIL 1 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INJECTION/INFUSION
REMIFENTANIL 2 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INJECTION/INFUSION
REMIFENTANIL 5 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INJECTION/INFUSION
Remifentanil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT IMFORMATION 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 of the side effects talk to your doctor, pharmacist or
nurse. This includes any side effects
not listed in this leaflet, see section 4.
WHAT IS IN THIS LEAFLET:
1.
What Remifentanil is and what it is used for
2.
What you need to know before you use Remifentanil
3.
How to use Remifentanil
4.
Possible side effects
5.
How to store Remifentanil
6.
Contents of the pack and other information
1.
WHAT REMIFENTANIL IS AND WHAT IT IS USED FOR
Remifentanil
belongs to a group called opioids. It differs from other medicines in
this group by its very
quick onset and very short duration of action.
-
Remifentanil may be used to stop you feeling pain before or while you
are having an operation.
-
Remifentanil may be used to relieve pain while you are under
controlled mechanical ventilation in
an Intensive Care Unit (for patients 18 years of age and over).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE REMIFENTANIL
DO NOT USE REMIFENTANIL
-
if you are allergic (hypersensitive) to remifentanil, any of the other
ingredients of this medicine
(see list of ingredients in Section 6) or fentanyl derivates (such as
alfentanil, fentanyl, sufentanil).
An allergic reaction may include rash, itching, difficulty of
breathing or swelling of the face, lips,
throat or tongue. You may know this from earlier experience
-
as injection i

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ceftriaxone Hospira 1g powder for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 g ceftriaxone as 1.193 g ceftriaxone sodium.
Ceftriaxone Hospira 1 g contains approximately 3.6 mmol (82.8 mg)
sodium.
3 PHARMACEUTICAL FORM
Powder for Solution for Injection
Almost white or yellowish, slightly hygroscopic, crystalline 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 track infections (including pyelonephritis).
Infections of bone and joints.
Complicated skin and soft tissue infections.
Gonorrhoea.
Syphilis.
Bacterial Endocarditis.
Ceftriaxone 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.
Ceftriaxone 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 guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose depends on the severity, susceptibility, site and type of
infection and on the age and hepato-renal function of
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