BURINEX Tablet (2019)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
| Εκδότης | KARO PHARMA AB |
|---|---|
| Διεύθυνση | Box 16184, 103 24 Stockholm, Sweden |
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Περιεχόμενα
Name of the medicinal product
Burinex 5 mg Tablets.
Qualitative and quantitative composition
Each tablet contains 5 mg of Bumetanide. <u>Excipient with known effect:</u> Each tablet contains 92 mg lactose monohydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. A white, flat, circular, uncoated, bevelled-edge tablet marked with a score line and 5 mg on one face. The score line is only to facilitate breakup for ease of swallowing and not to divide into ...
Therapeutic indications
Burinex 5 mg Tablets are indicated in adults in the management of oedema due to congestive heart failure, hepatic cirrhosis and renal disease, including nephrotic syndrome, where high dose diuretic is ...
Posology and method of administration
Posology The dose should be carefully adjusted according to response. As a general rule, dosage should be started at 5 mg daily and then increased by 5 mg every 12-24 hours until the required response ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Severe electrolyte depletion. Persisting anuria. Hepatic encephalopathy including coma.
Special warnings and precautions for use
Hepatic Impairment Caution is advised if bumetanide is to be administered to patients with severe hepatic impairment. Hypotension Caution should be exercised when bumetanide is used in patients with hypotension. ...
Interaction with other medicinal products and other forms of interaction
Dose adjustment of hypoglycaemic agents may be necessary in patients with diabetes mellitus. Digitalis glycosides Hypokalaemia increases the sensitivity to digitalis glycosides which might result in digitalis ...
Fertility, pregnancy and lactation
Pregnancy Bumetanide may cause harmful pharmacological effects during pregnancy, to the foetus or to the newborn child. Bumetanide should not be used during pregnancy unless the clinical condition of the ...
Effects on ability to drive and use machines
Bumetanide has no or negligible direct influence on the ability to drive and use machines. However, the patient should be informed that dizziness may occur during treatment and take this into account while ...
Undesirable effects
The estimation of the frequencyof undesirable effects is based on a pooled analysis of data from clinical studies and spontaneous reporting. Based on pooled data from clinical studies including more than ...
Overdose
In high doses and during long-term treatment loop diuretics may cause electrolyte imbalance, dehydration and polyuria. Symptoms of electrolyte imbalance include dry mouth, thirst, weakness, lethargy, drowsiness, ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Sulphonamides, plain <b>ATC code:</b> C03CA02 Bumetanide is a potent loop diuretic. Bumetanide exerts an inhibiting effect on the reabsorption mechanism of salts in the ...
Pharmacokinetic properties
Bumetanide is nearly totally absorbed from the gastro-intestinal tract. After peroral administration, a bioavailability of between 80‑95% is observed. Diuresis begins within ½‑1 hour with a peak effect ...
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
Maize starch Lactose monohydrate Povidone Polysorbate 80 Colloidal anhydrous silica Agar powder Talc Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Keep the blisters in the outer carton in order to protect from light. Store below 25°C.
Nature and contents of container
PVC/aluminium blister packs of 14 (physicians sample), 30 and 56 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
KARO PHARMA AB, Box 16184, 103 24 Stockholm, Sweden
Marketing authorization number(s)
PA22650/001/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 01 April 1978 Date of latest renewal: 01 April 2008
Date of revision of the text
March 2019
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