Furosemide 10 mg/ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Furosemide

Available from:

hameln pharma gmbh

ATC code:

C03CA01

INN (International Name):

Furosemide

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Therapeutic area:

furosemide

Authorization status:

Marketed

Authorization date:

2020-09-25

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FUROSEMIDE 10 MG/ML SOLUTION FOR INJECTION
furosemide
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 or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
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 is 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 Injection contains a medicine called furosemide, belongs to
a group of medicines called
diuretics (water tablets).
Furosemide Injection can be used to help you lose extra water in your
body very quickly. It is given
when you cannot take a tablet or when you have a lot of extra water in
your body. It is often used
when you have too much water around your heart, lungs, liver or
kidneys.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FUROSEMIDE INJECTION
YOU MUST NOT BE GIVEN FUROSEMIDE INJECTION:
•
If you are allergic to Furosemide Injection or any of the other
ingredients of this medicine
(listed in section 6). If you are allergic to a group of medicines
called sulfonamides (e.g. Co-
Trimoxazole, sulfadiazine) or sulfonamide derivatives and amiloride
you may also be allergic to
this injection.
•
If you are dehydrated, your blood volume is low (you may feel dizzy,
faint or have pale skin) or
you are unable to pass urine.
•
If you have low levels of potassium or sodium or an imbalance of
chemicals in your blood
(shown in a blood test).
•
If you have severe liver problems (cirrhosis) that are affecting your
consciousness.
•
If you previously received certain medicines that have damage

Summary of Product characteristics

Health Products Regulatory Authority
18 January 2024
CRN00DT54
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Furosemide 10 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution contains 10 mg furosemide (10 mg/ml).
Each 2 ml of solution contains 20 mg furosemide (10 mg/ml).
Each 4 ml of solution contains 40 mg furosemide (10 mg/ml).
Each 5 ml of solution contains 50 mg furosemide (10 mg/ml).
Each 25 ml of solution contains 250 mg furosemide (10 mg/ml).
Excipient(s) with know effect:
This medicinal product contains a maximum 4 mg sodium per 1 ml of
solution.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Furosemide 10mg/ml solution for injection is clear colourless to
slightly brownish yellow solution, free from visible particles.
pH 8.0-9.3
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Furosemide 10 mg/ml solution for 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
Posology
_Adults_
Doses of 20 to 50 mg intramuscularly or intravenously may be given
initially. If larger doses are required, they should be given
increasing by 20 mg increments and not given more often than every two
hours. If doses greater than 50 mg are required it is
recommended that they be given by slow intravenous infusion. The
recommended maximum daily dose of furosemide
administration is 1,500 mg.
_Elderly_
The dosage recommendations for adults apply, but in the elderly
furosemide is generally eliminated more slowly. Dosage
should be titrated until the required response is achieved.
_Paediatric population_
Parenteral doses for children range from 0.5 to 1.5 mg/kg body weight
daily up to a maximum total daily dose of 20 mg.
Method of administration
Furosemide 10 mg/ml so