Package leaflet: Information for the patient

Furosemidum Neupharm, 10 mg/ml, solution for injection
Furosemidum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor, pharmacist or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Leaflet contents

What Furosemidum Neupharm is and what it is used for
Important information before using Furosemidum Neupharm
How to use Furosemidum Neupharm
Possible side effects
How to store Furosemidum Neupharm
Contents of the pack and other information

1. What Furosemidum Neupharm is and what it is used for

Furosemidum Neupharm, 10 mg/ml, solution for injection belongs to a group of medicines called diuretics (water tablets).
Furosemidum Neupharm, 10 mg/ml, solution for injection is indicated when oral administration of furosemide does not produce sufficient urine output or when oral administration is not possible.
Furosemidum Neupharm is indicated:

in the presence of fluid retention in tissues (oedema) and/or ascites caused by heart or liver disease,
in the presence of fluid accumulation in tissues (oedema) caused by kidney diseases,
in the presence of fluid accumulation in tissues (oedema) caused by burns,
in cases of fluid accumulation in lung tissue (pulmonary oedema) (e.g. in acute heart failure),
as an adjunctive agent in cases of fluid accumulation in brain tissue (cerebral oedema),
in cases of low urine output (oliguria) occurring due to pregnancy-induced hypertension (gestosis), possibly after correction of fluid deficits (oedema and/or arterial hypertension in gestosis are not indications!),
in cases of severely elevated blood pressure which may lead to life-threatening conditions (hypertensive crisis).

How does Furosemidum Neupharm, 10 mg/ml, solution for injection work?
Furosemidum Neupharm promotes the excretion of a larger amount of water (urine) than usual.
When excess water is not removed from the body, it may place an additional burden on the heart, blood vessels, lungs, kidneys or liver.

2. Important information before using Furosemidum Neupharm

When not to use Furosemidum Neupharm

if the patient is allergic to furosemide, sulfonamides (possible cross-allergy with furosemide), or any of the other ingredients of this medicine (listed in section 6);
if the patient has renal failure with oliguria, despite administration of furosemide;
if the patient is in hepatic coma or pre-comatose states associated with hepatic encephalopathy;
in cases of severe hypokalemia;
in cases of severe hyponatremia;
in cases of hypovolemia or dehydration;
if the patient is breastfeeding (see also section "Pregnancy, breastfeeding and fertility").

Do not use Furosemidum Neupharm if any of the above conditions apply to the patient.
If in doubt, discuss this with a doctor or nurse before starting treatment with Furosemidum Neupharm.
Warnings and precautions
Before starting treatment with Furosemidum Neupharm, discuss this with a doctor, pharmacist, or nurse:

if the patient has very low blood pressure;
if the patient is elderly, takes other medicines that may lower blood pressure, or has other medical conditions that may be associated with a risk of low blood pressure;
in case of diabetes or previously undiagnosed diabetes (overt or latent diabetes); regular monitoring of blood glucose (sugar) levels is necessary;
if the patient has gout; in such cases, regular monitoring of blood uric acid levels is required;
if the patient has urinary tract obstruction (e.g. due to benign prostatic hyperplasia, hydronephrosis, or ureteral stenosis);
in case of decreased protein levels in blood, e.g. in nephrotic syndrome (protein loss, lipid metabolism disorders, and fluid retention), careful dose adjustment is necessary;
if the patient has rapidly progressing kidney dysfunction associated with severe liver disease, e.g. cirrhosis (hepatorenal syndrome);
if the patient has circulatory disorders in the brain or coronary arteries, due to the particular risk of significant, undesirable drop in blood pressure.

In patients with impaired urination (e.g. due to benign prostatic hyperplasia), Furosemidum Neupharm should be used only if free urine flow is ensured, because sudden onset of urine flow may lead to urinary incontinence (urinary retention).
Furosemidum Neupharm causes increased excretion of sodium and chlorides, and consequently of water.
Excretion of other electrolytes (especially potassium, calcium, and magnesium) is also increased. Since disturbances in water and electrolyte balance due to increased electrolyte excretion are frequently observed during treatment with Furosemidum Neupharm, regular monitoring of serum electrolyte concentrations is recommended.
During prolonged treatment with Furosemidum Neupharm, regular monitoring of serum electrolyte concentrations (especially potassium, sodium, and calcium), bicarbonates, creatinine, urea, and uric acid, as well as blood glucose levels, is necessary.
Particular caution is required in patients at high risk of developing electrolyte imbalances or increased fluid loss (e.g. due to vomiting, diarrhea, or excessive sweating). Hypovolemia or dehydration and other significant electrolyte or acid-base imbalances should be corrected. This may require temporary discontinuation of Furosemidum Neupharm.
Underlying diseases (e.g. cirrhosis, heart failure), concomitant medications, and diet may influence the potential development of electrolyte imbalances.
Weight loss caused by increased diuresis should not exceed 1 kg per day, regardless of the volume of urine excreted.
In nephrotic syndrome, the dose of the medicinal product should be carefully adjusted due to increased risk of adverse effects.
The injection solution should not be administered together with other medicines in the same syringe.
Ensure that the pH of the ready-to-use injection solution is between slightly alkaline and neutral (pH not less than 7). Acidic solutions should not be used, as precipitation of the active substance may occur.
Concomitant use with risperidone
In placebo-controlled studies with risperidone in elderly patients with dementia, higher mortality was observed in patients treated concomitantly with furosemide and risperidone compared to patients treated with risperidone alone or furosemide alone. Therefore, caution is required, and the physician should consider the risks and benefits of such combination or concomitant use with other potent diuretics before initiating treatment. Dehydration should be avoided.
There is a possibility of exacerbation or activation of systemic lupus erythematosus, a disease in which the immune system attacks the body's own cells and tissues.
Children
In premature infants, particularly careful monitoring is required due to the risk of developing nephrocalcinosis or kidney stones.
Renal function should be monitored and renal ultrasound examinations should be performed.
In premature infants with respiratory distress syndrome, diuretic treatment with Furosemidum Neupharm in the first weeks of life may increase the risk that the fetal vascular shunt bypassing the pulmonary circulation (patent ductus arteriosus Botalli) will not close.
Anti-doping control
Use of Furosemidum Neupharm may lead to positive results in anti-doping tests. Moreover, inappropriate use of Furosemidum Neupharm as a doping agent may pose a health risk to the patient.
Furosemidum Neupharm and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
In particular, inform the doctor if the patient is taking any of the following medicines:

Anti-inflammatory and antiallergic drugs, such as glucocorticosteroids (cortisone), carbenoxolone (used in the treatment of gastric ulcers), or laxatives (used to treat constipation), when used with Furosemidum Neupharm, may lead to increased potassium loss with a concurrent risk of potassium deficiency. Large amounts of liquorice have the same effect as carbenoxolone.
Anti-inflammatory drugs (including non-steroidal anti-inflammatory drugs, NSAIDs, e.g. indomethacin and acetylsalicylic acid) may reduce the effectiveness of Furosemidum Neupharm. In patients who develop reduced blood volume or dehydration during furosemide treatment, concomitant administration of NSAIDs may cause acute kidney failure.
Probenecid (used in the treatment of gout), methotrexate (used in the treatment of certain cancers and severe arthritis), and other drugs that, like furosemide, are significantly excreted via tubular secretion in the kidneys, may reduce the effectiveness of Furosemidum Neupharm.
It has been reported that concomitant administration of phenytoin (used in the treatment of epilepsy) reduces the effectiveness of furosemide.

The following medicines may increase the risk of adverse effects during treatment with Furosemidum Neupharm:

Concomitant use of certain cardiac glycosides (e.g. digoxin) may increase myocardial sensitivity to these cardiac drugs in patients who develop potassium or magnesium deficiency during treatment with Furosemidum Neupharm. There is an increased risk of cardiac arrhythmias (ventricular arrhythmias, including torsade de pointes) when used concomitantly with certain drugs that may cause ECG changes (prolonged QT interval syndrome) (e.g. terfenadine - an antiallergic drug, certain antiarrhythmic drugs of class I and III) and in the presence of electrolyte imbalances.
In case of concomitant use of Furosemidum Neupharm with high doses of analgesics (salicylates), adverse effects associated with salicylate use may be intensified.
Furosemidum Neupharm may intensify the harmful effects of nephrotoxic drugs (e.g. aminoglycoside antibiotics, cephalosporins, polymyxins). In patients taking Furosemidum Neupharm and high doses of certain cephalosporins simultaneously, worsening of kidney function may occur.
Ototoxic effects (hearing damage) caused by antibiotics used to treat infections (e.g. aminoglycosides such as kanamycin, gentamicin, tobramycin) and other ototoxic drugs may be increased during concomitant administration of Furosemidum Neupharm. Hearing disturbances may be irreversible. Therefore, concomitant use of the above-mentioned drugs should be avoided.
Concomitant use of cisplatin (an anticancer drug) and Furosemidum Neupharm may lead to hearing damage. Furosemidum Neupharm should be administered with particular caution, as it may intensify the nephrotoxic effects of cisplatin.
Concomitant administration of Furosemidum Neupharm and lithium (an antidepressant used in mood disorders) may intensify the cardiotoxic and neurotoxic effects of lithium. Therefore, careful monitoring of serum lithium levels is recommended in patients receiving both furosemide and lithium.
If Furosemidum Neupharm is used concomitantly with other antihypertensive drugs (especially ACE inhibitors or angiotensin II receptor antagonists), diuretics, or drugs with hypotensive effects, a greater reduction in blood pressure should be expected. Significant lowering of blood pressure with shock and worsening of kidney function (in some cases acute kidney failure) has been observed, particularly when an ACE inhibitor (e.g. lisinopril) or an angiotensin II receptor antagonist (e.g. losartan) is administered for the first time or for the first time in high doses. Therefore, if possible, treatment with Furosemidum Neupharm should be temporarily discontinued or the dose reduced for 3 days before initiating

administration of ACE inhibitors or angiotensin II receptor antagonists, or before
increasing their dose.

Furosemidum Neupharm may reduce renal elimination of probenecid (used in the treatment of gout), methotrexate (used in the treatment of certain cancers and severe arthritis), and other drugs that, like furosemide, are significantly excreted via tubular secretion in the kidneys. In case of high-dose treatment, this may lead to increased blood levels of the drug and increased risk of adverse effects.
The effects of theophylline (an asthma medication) or muscle relaxants (curare derivatives) may be intensified during treatment with Furosemidum Neupharm.
The effects of drugs lowering blood glucose (antidiabetic drugs, e.g. metformin and insulin) or drugs increasing blood pressure (sympathomimetics, e.g. epinephrine, norepinephrine) may be reduced during concomitant administration of Furosemidum Neupharm.
Caution is required in patients treated with risperidone (used in the treatment of psychiatric disorders); the physician should consider the risks and benefits of combined or concomitant treatment with risperidone and Furosemidum Neupharm or other potent diuretics.
Concomitant use of thyroid hormones (e.g. L-thyroxine) and high doses of furosemide may affect thyroid hormone levels. Therefore, in patients receiving this combination of drugs, thyroid hormone levels should be monitored.

Other interactions

Concomitant use of cyclosporine A (used to prevent transplant rejection) and Furosemidum Neupharm is associated with an increased risk of arthritis due to furosemide-induced elevation of serum uric acid levels and impaired renal excretion of uric acid caused by cyclosporine.
In patients at high risk of kidney damage due to contrast agents, worsening of kidney function occurred more frequently after contrast imaging using X-rays in patients treated with Furosemidum Neupharm than in high-risk patients who received only intravenous fluids for hydration before contrast imaging.
In isolated cases, intravenous administration of Furosemidum Neupharm may cause hot flushes, sweating, anxiety, nausea, elevated blood pressure, and rapid heartbeat (tachycardia) within 24 hours after administration of chloral hydrate. Therefore, concomitant use of Furosemidum Neupharm and chloral hydrate is not recommended.

Furosemidum Neupharm with food and drink
Large amounts of liquorice combined with Furosemidum Neupharm may lead to increased potassium loss.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine.
Furosemidum Neupharm may be used during pregnancy only if the physician considers it necessary, as furosemide crosses the placental barrier.
Furosemide passes into breast milk and may inhibit lactation. Therefore, breastfeeding women should not use Furosemidum Neupharm. If necessary, breastfeeding should be discontinued.
Driving and operating machinery
Even when used as intended, this medicine may affect reaction ability, impairing the ability to drive vehicles, operate machinery, or perform potentially dangerous activities. The risk is higher at the beginning of treatment, when increasing the dose, during changes in medication, and when combined with alcohol.
Furosemidum Neupharm contains sodium
This medicine contains 3.7 mg of sodium (main component of table salt) per ml. This corresponds to 0.2% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Furosemidum Neupharm

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Furosemidum Neupharm is administered by a doctor or nurse as an injection into a vein
(intravenously) or as an injection into a muscle (intramuscularly).
Dosage
Dosage should be individually adjusted, especially after successful treatment. Always use
the lowest dose that achieves the desired effect.
Unless otherwise directed, the following dosage recommendations apply to adults:
Adults and elderly patients
Fluid retention (oedema) and/or ascites due to heart or liver disease:
The initial dose of Furosemidum Neupharm is 2–4 ml (equivalent to 20–40 mg
of furosemide) administered intravenously. In cases of persistent oedema, if necessary,
the dose may be repeated at appropriate intervals until diuresis begins.
Oedema due to kidney disease:
The initial dose of Furosemidum Neupharm is 2–4 ml (equivalent to 20–40 mg
of furosemide) administered intravenously. In cases of persistent oedema, if necessary,
the dose may be repeated at appropriate intervals until diuresis begins.
In patients with nephrotic syndrome, dosage should be carefully selected due to the risk
of increased adverse effects.
Oedema due to burns:
The daily and/or single dose of Furosemidum Neupharm may range from 4 to 10 ml
(equivalent to 40–100 mg of furosemide); exceptionally, in cases of impaired kidney function,
the dose may reach up to 25 ml (equivalent to 250 mg of furosemide). Intravascular volume
reduction should be corrected before administering Furosemidum Neupharm.
Pulmonary oedema (fluid accumulation in lung tissue, e.g. in acute heart failure):
Use in combination with other therapeutic agents. The initial dose of Furosemidum
Neupharm is 2–4 ml (equivalent to 20–40 mg of furosemide) administered intravenously.
If diuresis does not occur, repeat the dose after 30–60 minutes, and if necessary, administer
a double dose.
As an adjunctive agent in cerebral oedema (fluid accumulation in brain tissue):
The daily and/or single dose of Furosemidum Neupharm may range from 4 to 10 ml
(equivalent to 40–100 mg of furosemide); in exceptional cases with impaired kidney function,
the recommended dose may be up to 25 ml (equivalent to 250 mg of furosemide).
Reduced urine output (oliguria) due to pregnancy complications (gestosis):
This is the most restrictive indication!
Intravascular volume reduction should be corrected before administering Furosemidum
Neupharm. The daily dose of Furosemidum Neupharm may range from 1 to 10 ml (equivalent to 10–
100 mg of furosemide).
Oedema and/or arterial hypertension occurring during gestosis are not indications for
the use of Furosemidum Neupharm!
Hypertensive crisis:
2 to 4 ml of Furosemidum Neupharm (equivalent to 20–40 mg of furosemide),
together with other medicinal agents.
Use in children
Unless otherwise directed, in infants and children under 15 years of age, Furosemidum
Neupharm should be administered parenterally only exceptionally, in life-threatening conditions.
The average daily dose is 0.5 mg of furosemide per kg of body weight. In exceptional cases,
the dose may reach up to 1 mg of furosemide per kg of body weight administered intravenously.
This medicine should always be used as directed by a doctor, pharmacist, or nurse. In case
of doubt, consult your doctor, pharmacist, or nurse.
Use of a higher than recommended dose of Furosemidum Neupharm
If a higher than recommended dose of Furosemidum Neupharm is used, contact your doctor
or pharmacist immediately for advice. Depending on the severity of overdose, the doctor may
decide on additional measures that may be required. Symptoms of acute or chronic overdose
depend on the degree of salt and fluid loss.
Overdose may lead to hypotension and circulatory disturbances upon changing from a lying
to a standing position, electrolyte imbalances (reduced potassium, sodium, and chloride levels),
or increased blood pH (alkalosis).
In case of significant fluid loss, dehydration may occur, leading to reduced circulating blood volume,
circulatory collapse, and blood concentration (haemoconcentration) with a tendency to thrombosis.
Rapid loss of water and electrolytes may result in confusion.
For any further questions regarding the use of this medicine, consult your doctor or pharmacist.
Blood tests
Your doctor may recommend blood tests to check whether the levels of certain electrolytes
in the blood are within normal limits.
If you have any further doubts regarding the use of this medicine, consult your doctor,
pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The frequency of adverse effects is defined according to the following criteria:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Frequency not known: frequency cannot be estimated from the available data

Disorders of the blood and lymphatic system
Common: haemoconcentration (in case of excessive urine output).
Uncommon: decreased number of blood platelets (thrombocytopenia).
Rare: increased number of certain white blood cells (eosinophilia), decreased number of white blood cells (leukopenia).
Very rare: anaemia caused by increased breakdown of red blood cells (haemolytic anaemia), anaemia caused by impaired blood formation in the bone marrow (aplastic anaemia), marked decrease in certain white blood cells with tendency to infections and severe general symptoms (agranulocytosis).
Signs suggestive of agranulocytosis may include: fever with chills, mucosal lesions and sore throat.

Immune system disorders
Uncommon: allergic skin and mucosal reactions (see "Skin and subcutaneous tissue disorders").
Rare: severe anaphylactic and anaphylactoid reactions, such as anaphylactic shock.
Frequency not known: exacerbation or activation of systemic lupus erythematosus.

Metabolism and nutrition disorders (see: "Warnings and precautions")
Very common: electrolyte imbalance (including symptomatic), dehydration and hypovolaemia (especially in elderly patients), increased blood triglyceride levels.
Common: hyponatraemia and hypochloraemia (especially if sodium chloride intake is restricted), hypokalaemia (especially with concomitant reduced potassium intake and/or increased potassium loss, e.g. due to vomiting or chronic diarrhoea); increased blood cholesterol levels, increased blood uric acid levels and gout attacks.
Uncommon: decreased glucose tolerance and hyperglycaemia. In patients with diagnosed diabetes, this may lead to deterioration of metabolic control. Latent diabetes may become apparent.
Rare: tetany or cardiac arrhythmias following hypomagnesaemia.
Frequency not known: hypocalcaemia, hypomagnesaemia, metabolic alkalosis, pseudobartter syndrome (kidney dysfunction associated with abuse and/or prolonged use of furosemide, characterised by increased blood pH, decreased sodium levels, and low blood pressure).
Common symptoms of sodium deficiency include: apathy, calf cramps, loss of appetite, weakness, drowsiness, vomiting and disorientation.
Symptoms of potassium deficiency may include: muscle weakness, discomfort in limbs (e.g. tingling, numbness or painful burning), paralysis, vomiting, constipation, excessive gas accumulation in the intestines, excessive urination, excessive thirst with increased fluid intake, and irregular pulse (e.g. disturbances in generation and conduction of impulses in the heart). Severe potassium loss may lead to intestinal paralysis (paralytic ileus) or disturbances of consciousness and even coma.
Calcium deficiency may rarely cause neuromuscular hyperexcitability (tetany).
Magnesium deficiency has rarely been associated with tetany or cardiac arrhythmia.

Nervous system disorders
Common: hepatic encephalopathy in patients with liver failure.
Rare: skin tingling or numbness (paraesthesiae).
Frequency not known: dizziness, fainting and loss of consciousness, headache.

Ear and labyrinth disorders
Uncommon: hearing disturbances, mainly reversible, particularly in patients with renal failure or hypoproteinaemia (reduced blood protein levels, e.g. in nephrotic syndrome) and/or in case of too rapid intravenous injection. Deafness (sometimes irreversible).
Rare: tinnitus.

Vascular disorders
Very common (after intravenous administration): hypotension, including orthostatic syndrome.
Rare: vasculitis.
Frequency not known: thrombosis (particularly in elderly patients). Excessive urine output may lead to circulatory problems (potentially progressing to circulatory collapse), especially in elderly patients and children, manifesting mainly as headache, dizziness, blurred vision, dry mouth and thirst, hypotension and orthostatic hypotension.

Gastrointestinal disorders
Uncommon: nausea.
Rare: vomiting, diarrhoea.
Very rare: acute pancreatitis.

Hepatobiliary disorders
Very rare: intrahepatic cholestasis (bile stasis causing yellowing of the skin or dark urine), increased aminotransferase activity.

Skin and subcutaneous tissue disorders
Uncommon: itching, urticaria, rash, bullous dermatitis, erythema multiforme, pemphigoid, exfoliative dermatitis, purpura, photosensitivity.
Frequency not known: Stevens-Johnson syndrome (formation of blisters and skin peeling around lips, eyes, oral cavity, nose and genital organs, flu-like symptoms, fever), toxic epidermal necrolysis (sloughing off of large skin areas with exposure of dermis), acute generalised exanthematous pustulosis (acute febrile drug eruption), drug reaction with eosinophilia and systemic symptoms (so-called DRESS syndrome), lichenoid reactions (oral mucosal ulcers).

Musculoskeletal and connective tissue disorders
Frequency not known: cases of rhabdomyolysis have been reported, often associated with severe hypokalaemia (see: "When not to use Furosemidum Neupharm").

Renal and urinary disorders
Very common: increased blood creatinine levels.
Common: increased urine volume.
Rare: tubulointerstitial nephritis.
Frequency not known: increased urinary sodium concentration, increased urinary chloride concentration, increased blood urea levels, symptoms of urinary tract obstruction (e.g. in patients with benign prostatic hyperplasia, hydronephrosis and ureteral stenosis) up to urine retention (anuria) with secondary complications, nephrocalcinosis and/or urolithiasis in preterm infants (see: "Warnings and precautions"), renal failure (see: "Furosemidum Neupharm and other medicines").

Congenital disorders, familial and genetic disorders
Frequency not known: increased risk of patent ductus arteriosus (persistent arterial duct of Botalli) failing to close if preterm infants are treated with furosemide during the first weeks of life.

General disorders and administration site conditions
Rare: fever.
Frequency not known: following intramuscular injection, local reactions such as pain may occur.
If an adverse effect occurs suddenly or develops rapidly, inform your doctor immediately, as some adverse effects of this medicine may be life-threatening. The doctor will decide what measures should be taken and whether treatment can be continued.
Do not re-administer Furosemidum Neupharm if any signs of hypersensitivity reaction occur.
If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.

Reporting of adverse effects
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Furosemidum Neupharm

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: Expiry (EXP) and on the ampoule after: EXP. The expiry date refers to the last day of the stated month.
There are no special requirements regarding storage temperature of the medicinal product.
Store the ampoules in the outer packaging to protect from light. Do not store in a refrigerator and do not freeze.
Do not use this medicine if visible particles or discolouration are present in the injection solution. The solution may be used only when it is clear, colourless or slightly yellowish.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.
Information on the storage of the diluted medicinal product is provided in section 6 "Information intended exclusively for healthcare professionals".

6. Contents of the packaging and other information

What Furosemidum Neupharm contains

The active substance is furosemide. One 2 ml ampoule of injection solution contains 21.3 mg of sodium furosemide (equivalent to 20 mg of furosemide).
The other ingredients (excipients) are: sodium chloride, sodium hydroxide, water for injections.

What Furosemidum Neupharm looks like and contents of the pack
Furosemidum Neupharm is a clear, colourless or slightly yellowish injection solution.
Furosemidum Neupharm is available in packs containing 5 and 50 ampoules, each containing 2 ml.
Marketing authorisation holder and importer
Marketing authorisation holder
Neupharm Sp. z o.o.
ul. Ługowa 85
96-320 Mszczonów
Poland
Tel. No.: +48 22 49 21 301
Importer
SciencePharma Sp. z o.o.
ul. Chełmska 30/34
00-725 Warsaw
Poland

Information intended exclusively for medical professionals.

Preparation of the medicinal product for administration
For single use only. Use immediately after first opening.
The medicinal product Furosemidum Neupharm must not be mixed with injection/infusion solutions that are acidic or slightly acidic and have a pronounced buffer capacity in the acidic range. In such mixtures, the pH shifts toward the acidic range, causing the poorly soluble furosemid to precipitate as a crystalline deposit. It is essential to ensure that the pH of the ready-to-use injection solution is within the slightly alkaline to neutral range (pH not less than 7).
The product may be diluted with sodium chloride 0.9% solution for injection (dilution ratio 1:9), which, in composition, represents a physiological solution similar to blood plasma.
As an aqueous solution, it mixes easily and ensures safe administration of the diluted solution into the bloodstream.
Furosemidum Neupharm diluted to 1 mg/ml is compatible with 0.9% NaCl infusion solution for 12 hours at 25°C±2°C, when protected from light.
Before administration, the solution should be visually inspected for the presence of particulate matter and discoloration.
The solution may be used only if it is clear, colorless or slightly yellowish, and contains no visible particles.
Any unused product or waste material derived from it should be disposed of in accordance with local regulations.
Stability after dilution
Chemical and physical stability has been demonstrated in 0.9% sodium chloride solution for 12 hours at 25°C±2°C, when protected from light.
From a microbiological standpoint, unless the method of opening/reconstitution/dilution precludes the risk of microbiological contamination, the product should be used immediately. If the medicinal product is not used immediately, the user is responsible for the storage conditions and duration during use.

Furosemide neupharm