Furosemide Solution for Inj/Inf 10mg/ml (20mg/2ml)

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

FUROSEMIDE

Beschikbaar vanaf:

Wockhardt UK Limited

ATC-code:

C03CA01

INN (Algemene Internationale Benaming):

FUROSEMIDE

farmaceutische vorm:

SOLUTION FOR INJECTION/INFUSION

Samenstelling:

FUROSEMIDE 10 mg/ml

Prescription-type:

POM

Therapeutisch gebied:

DIURETICS

Autorisatie-status:

Authorised

Autorisatie datum:

2015-03-12

Bijsluiter

_París 1 - 7, Nave 2, Pol. Ind. Cova Solera, 08191 Rubí - Barcelona
- España_
_Tlf. 93 697 04 12 - Fax [phone] ● diseño&preimpresión:
[e-mail] ● www.graficas-agarcia.com_
PRUEBA _PROOF_
nº 1
_FECHA DATE_
ARTWORK _ARTWORK_
REIG JOFRÉ
PROSPECTO _LEAFLET_
FUROSEMIDE 10 mg / ml
REF. _REF._
B10248-04
SUSTITUYE _REPLACES_
B10248-03
MEDIDAS _FORMAT_
297 x 420 mm
PLEGADO _FOLD_
148,5 x 46,6 mm
MATERIAL _MATERIAL_
Specialprint 40 gr
PLANO _LAYOUT LEAFLET_
-
LAETUS _LAETUS_
-
TIPOGRAFÍA _FONT_
Helvética
8 pt
COLORES _COLORS PRINT_
1/1
Negro
CLIENTE _CUSTOMER_
REIG JOFRÉ
OBSERVACIONES_ OBSERVATIONS_
-
22/02/2013
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again while you are
receiving your treatment.
-
If you have any further questions, please ask your doctor or nurse.
-
This medicine has been prescribed for you. Do not pass it onto others.
It may harm them, even if their symptoms
are the same as yours.
-
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor
or pharmacist.
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.
IN THIS LEAFLET:
1. What furosemide injection is and what it is used for
2. Before you are given furosemide injection
3. How furosemide injection should be given
4. Possible side effects
5. How to store furosemide injection
6. Further information
1.
WHAT FUROSEMIDE INJECTION IS AND WHAT IT IS USED FOR
Furosemide belongs to a group of medicines called loop diuretics which
are used to get rid of excess water from the
body.
Furosemide injection is used to get rid of excess fluid from the body,
which has accumulated due to problems with
the heart, lungs, liver or kidneys. It is used in emergency situations

Productkenmerken

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 2ml ampoule contains 20mg 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.
Page
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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 require