Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Alcohol: Enhanced hypotensive effect. Orthostatic hypotension, associated with diuretics, may be enhanced.                                                                      Furosemide 10mg/ml Injection is generally well tolerated.

Aldesleukin: Enhanced hypotensive effect.                                                        Metabolism and nutrition disorders: The most common side-effect is fluid and electrolyte imbalance including hyponatraemia, hypokalaemia, hypochloraemic Anaesthetics, general: Enhanced hypotensive effects.                                             alkalosis, hypotension and increased calcium excretion.

Anion-exchange resins: Colestyramine and colestipol markedly reduce the                          As with other diuretics, electrolytes and water balance may be disturbed as a result absorption of furosemide. Administer two to three hours apart.                                   of diuresis after prolonged therapy. Furosemide leads to increased excretion of sodium and chloride and consequently water. In addition, excretion of other Anti-arrhythmics: Toxicity of amiodarone, disopyramide, flecainide and quinidine is              electrolytes (in particular potassium, calcium and magnesium) is increased.
increased if hypokalaemia occurs. Action of lidocaine and mexilitine is antagonised              Symptomatic electrolyte disturbances and metabolic alkalosis may develop in the by hypokalaemia.                                                                                 form of a gradually increasing electrolyte deficit or, e.g. where higher furosemide Page No. 1
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Barcode Information:



Barcode Scan Report:
Packing: 2ml Amp                                                                                 Plant Location : Injectable Country: Israel                                                                                  Language : English Ref. Code Creation/Blockage Note:                                                                Artwork Control Key No.: “Controlled Copy” Holder (1)                                           (2)                       (3)                            (4)                             (5) Date: 31/03/21
 doses are administered to patients with normal renal function, acute severe                      A sustained diuretic effect is seen in the newborn, possibly due to immature tubular electrolyte losses.                                                                              function.
Warning signs of electrolyte disturbances include increased thirst, dry mouth, headache, hypotension, drowsiness, confusion, muscle cramps, tetany, muscle                5.3 Preclinical safety data weakness, disorders of cardiac rhythm and gastrointestinal symptoms.
Not applicable
Increased calcium excretion in infants and new-borns has been associated with reports of decreased bone mineral content, rickets, fractures and renal                    6.    Pharmaceutical particulars calcification. Hypocalcaemic tetany has also been reported in hypoparathyroid patients. Nephrocalcinosis / Nephrolithiasis may develop in premature infants.             6.1 List of excipients 
Pre-existing metabolic alkalosis (e.g. in decompensated cirrhosis of the liver) may              Sodium Chloride be aggravated by furosemide treatment.                                                           Sodium Hydroxide Hydrochloric Acid
Thiamine deficiency with prolonged treatment, particularly in congestive heart                   Water for injections failure and the elderly.
6.2 Incompatibilities
Furosemide may cause hyperuricaemia and precipitate attacks of gout in some patients.                                                                                        Furosemide may precipitate out of solution in fluids of low pH (e.g. dextrose solutions).
Serum cholesterol and triglyceride levels may rise during furosemide treatment.
During long term therapy they will usually return to normal within six months.                   Furosemide Baxter 20mg/2ml may be mixed with neutral and weak alkaline solution with pH between 7 and 10, such as:
Nervous system disorders: Syncope, rarely, paraesthesiae may occur.
0.9%w/v Sodium Chloride solution
Ear and labyrinth disorders: tinnitus and deafness, although usually transitory, may occur in rare cases, (usually with large parenteral doses and rapid administration               0.9%w/v Sodium Chloride and 5%w/v glucose solution or in patients with hypoproteinaemia or renal impairment). Rarely deafness may be permanent, particularly if furosemide has been given to patients taking other                 Compound sodium lactate intravenous infusion ototoxic drugs.
After dilution: chemical and physical in-use stability has been demonstrated for 24 Eye disorders: Blurred vision, yellow vision.                                                    hours at 25ºC protected from light.

Vascular disorders: Furosemide may cause a reduction in blood pressure which, if                 From a microbiological point of view, the product should be used immediately. If not pronounced, may cause signs and symptoms such as impairment of concentration                     used immediately, in-use storage times and conditions prior to use are the and reactions, lightheadedness, sensations of pressure in the head, headache,                    responsibility of the user.
dizziness, drowsiness, weakness, disorders of vision, dry mouth, orthostatic hypotension. The diuretic action of furosemide may lead to or contribute to hypovolaemia and dehydration, especially in elderly patients. Severe fluid                 6.3 Shelf life depletion may lead to haemoconcentration with a tendency for thromboses to develop.                                                                                         24 months.

Immune system disorders: Hypersensitivity reactions, that may include skin                 6.4 Special precautions for storage rashes, photosensitivity, vasculitis, fever, urticaria and interstitial nephritis occur rarely but when these occur treatment should be withdrawn. Severe anaphylaxis                    Store below 25º c. Protect from light.
or anaphylactoid reactions (e.g with shock) may also occur rarely and necessitate immediate withdrawal of furosemide treatment.                                              6.5   Nature and contents of container 
Endocrine disorders: Glucose tolerance may decrease with furosemide. In                          Furosemide Baxter 20 mg/2 ml Injection is available as 2 ml glass ampoules patients with diabetes mellitus this may lead to a deterioration of metabolic control            containing 2 ml of solution.
with hyperglycaemia and glycosuria; latent diabetes mellitus may also become                     5 Glass Ampoules are packed in 1 Open Tray Blister.
manifest.
1) Such 1 Tray is packed in 1 carton with leaflet- Pack of 5
Gastrointestinal disorders: side-effects of a minor nature such as nausea, or                    2) Such 2 Tray is packed in 1 carton with leaflet- Pack of 10 gastric upset (vomiting and diarrhoea) may occur but are not usually severe                      3) Such 3 Tray is packed in 1 carton with leaflet- Pack of 25 enough to necessitate withdrawal or treatment. Pancreatitis is more common at high doses.                                                                                      * Not all pack size may be marketed 
Blood and lymphatic system disorders: In rare cases, thrombocytopenia,                     6.6 Special precautions for disposal and other handling leucopenia, agranulocytosis, eosinophilia, aplastic anaemia or haemolytic anaemia may develop. Bone marrow depression necessitates withdrawal of                           None treatment.
7.    Manufacturer
Hepatobiliary disorders: In isolated cases, intrahepatic cholestasis, an increase in liver transaminases, or cholestatic jaundice has been reported. Hepatic                          Baxter Pharmaceuticals India Private Limited encephalopathy in patients with hepatocellular insufficiency may occur.                          Vasana-Chacharwadi, Ahmedabad-382 213, India.
Pregnancy, puerperium and perinatal conditions: If furosemide is administered to premature infants during the first weeks of life, it may increase the risk of              8.    Marketing authorisation holder persistence of patent ductus arteriosus.
David Margalit & Co. Ltd.
Renal and urinary disorders: Increased production of urine may provoke or                        P.O Box 16666, Tel Aviv 6116601 aggravate complaints in patients with an obstruction of urinary outflow. Thus, acute retention of urine with possible secondary complications may occur, for example,           9.    Marketing authorisation number in patients with bladder-emptying disorders, prostatic hyperplasia or narrowing of the urethra. As with other diuretics, treatment with furosemide may lead to                      157-93-34378 transitory increases in blood creatinine and urea levels.
Revised in March 2021
Skin and subcutaneous tissue disorders: Skin and mucous membrane reactions may occasionally occur, e.g. itching, urticarial, other rashes or bullous lesions, erythema multiforme, bullous pemphigoid, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, purpura, AGEP (acute generalized exanthematous pustulosis) and DRESS (Drug rash with eosinophilia and systemic symptoms).
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General disorders and administration site conditions: malaise. Following intramuscular injection, local reactions such as pain may occur.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il