Furosemide 10mg/ml Solution for Injection or Infusion (25ml vial)

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

FUROSEMIDE

Prieinama:

Pinewood Laboratories Limited Ballymacarbry, Clonmel, Co. Tipperary, Ireland

ATC kodas:

C03CA01

INN (Tarptautinis Pavadinimas):

FUROSEMIDE 10 mg/ml

Vaisto forma:

SOLUTION FOR INJECTION/INFUSION

Sudėtis:

FUROSEMIDE 10 mg/ml

Recepto tipas:

POM

Gydymo sritis:

DIURETICS

Autorizacija statusas:

Withdrawn

Leidimo data:

2015-03-12

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
FUROSEMIDE 10MG/ML SOLUTION FOR INJECTION OR INFUSION
Furosemide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
-
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.
The active ingredient in this medicine is furosemide. This is the new
name for frusemide. The
ingredient itself has not changed.
The name of your medicine is Furosemide 10mg/ml solution for Injection
or Infusion. In the rest of
this leaflet it is called Furosemide Injection.
WHAT IS IN THIS LEAFLET:
1.
What Furosemide Injection is and what it is used for
2.
What you need to know before you are given Furosemide Injection
3.
How Furosemide Injection should be given
4.
Possible side effects
5.
How to store Furosemide Injection
6.
Contents of the pack and other information
1.
WHAT FUROSEMIDE INJECTION IS AND WHAT IT IS USED FOR
Furosemide is one of a group of medicines called diuretics. A diuretic
helps get rid of excess fluid in
the body by causing more urine to be passed. Furosemide Injection is
used to remove excess fluid
from the body. It may also be used when your kidneys are not
functioning properly and not producing
normal amounts of urine.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FUROSEMIDE INJECTION
YOU SHOULD NOT BE GIVEN FUROSEMIDE IF:
•
you are allergic to furosemide or any of the other ingredients of this
medicine (listed in section 6).
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips,
face, throat or tongue
•
you are allergic to amiloride, sulfonamides or sulphonamide
derivatives, such as sulfadiazine or
cotrimoxazole
•
you have a low blood volume or are dehydrated (with or without
accompanying low blood pressure).
•
you have too lit

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Furosemide 10mg/ml Solution for Injection or Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 10mg of furosemide. Each 25ml vial contains 250mg of
furosemide.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection or infusion
The solution is colourless or almost colourless.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Furosemide 10mg/ml Injection is a diuretic indicated for use when a
prompt
and effective diuresis is required. The intravenous formulation is
appropriate
for use in emergencies or when oral therapy is precluded. Indications
include
cardiac, pulmonary, hepatic and renal oedema.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: intramuscular or intravenous use.
_Adults _
Intravenous furosemide must be injected or infused slowly; a rate of 4
mg per
minute must not be exceeded. In patients with severe impairment of
renal
function (serum creatinine>5 mg/dl), it is recommended that an
infusion rate
of 2.5 mg per minute is not exceeded.
Intramuscular administration must be restricted to exceptional cases
where
neither oral nor intravenous administration are feasible. It must be
noted that
intramuscular injection is not suitable for the treatment of acute
conditions
such as pulmonary oedema.
To achieve optimum efficacy and suppress counter-regulation, a
continuous
furosemide infusion is generally to be preferred to repeated bolus
injections.
Where continuous furosemide infusion is not feasible for follow-up
treatment
after one or several acute bolus doses, a follow-up regimen with low
doses
given at short intervals (approximately four hours) is to be preferred
to a
regimen with higher bolus doses at longer intervals.
Doses of 20 to 50 mg intramuscularly or intravenously may be given
initially.
If larger doses are required, they should be given by 20 mg increments
and not
given more often than every two hours. If doses greater than 50 mg are
required it is recomm