NEPHROTRANS Gastro-resistant capsule (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Nephrotrans 500 mg gastro-resistant capsules, soft.

2. Qualitative and quantitative composition

Each capsule contains 500 mg sodium hydrogen carbonate. Excipients with known effect: sorbitol, soya-bean oil and propylene glycol. Each capsule contains 50 mg sorbitol, 15 mg soya-bean oil and ...

3. Pharmaceutical form

Opaque, russet and white, elongated oval gastro-resistant capsule, soft with approximate size of 22 mm (length) and 7.8 mm (diameter).

4.1. Therapeutic indications

For the treatment of metabolic acidosis and for maintenance treatment against recurrence of metabolic acidosis in adults with chronic renal impairment.

4.2. Posology and method of administration

Posology The dosage depends on the severity of metabolic acidosis, based on the results of blood gas analysis or determination of serum bicarbonate. The mean dosage is 3 to 5 g sodium hydrogen carbonate ...

4.3. Contraindications

Hypersensitivity to the active substance, soya, peanuts, or to any of the excipients listed in section 6.1. Metabolic alkalosis Hypokalaemia Hypernatraemia Low sodium diet

4.4. Special warnings and precautions for use

The effect of Nephrotrans 500 mg should initially be monitored at intervals of at least one to two weeks (e.g. by pH measurement, standard bicarbonate, alkali reserve), especially at higher doses. Plasma ...

4.5. Interaction with other medicinal products and other forms of interaction

Due to the increase in pH levels in the stomach and intestines, absorption and excretion of weak acids and bases may be affected. This applies, for example, to sympathomimetics, anticholinergics, tricyclic ...

4.6. Fertility, pregnancy and lactation

Pregnancy and breast-feeding There is no experience with the use of Nephrotrans 500 mg in pregnancy and breast-feeding. In principle, there are no objections to the use of sodium hydrogen carbonate in ...

4.7. Effects on ability to drive and use machines

Nephrotrans 500 mg has no influence on the ability to drive and use machines.

4.8. Undesirable effects

The following frequencies are used for the evaluation of adverse reactions: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), ...

4.9. Overdose

In the event of an absolute or relative overdose (e.g. in renal impairment), even oral administration of sodium hydrogen carbonate can lead to alkalosis with dizziness, muscle weakness, fatigue, cyanosis, ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: antacids with sodium bicarbonate ATC code: A02AH Sodium hydrogen carbonate is a salt whose essential pharmacological properties result from its physiological role ...

5.2. Pharmacokinetic properties

In one study, absorption of orally administered sodium hydrogen carbonate in the form of gastro-resistant capsules versus IV administration was studied by measuring the acid-base status and renal Na+ elimination. ...

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. ...

6.1. List of excipients

Yellow beeswax, hydrogenated soya-bean oil, partially hydrogenated soya-bean oil, refined rapeseed oil, soya lecithin, iron oxide (E172), titanium dioxide (E171), glycerol 85%, gelatin, partially dehydrated ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from light.

6.5. Nature and contents of container

Boxes containing capsules in PVC/PVDC clear blisters sealed to aluminium foil. Packs with 100 gastro-resistant capsules, soft. Hospital packs with 500 gastro-resistant capsules, soft. Not all pack sizes ...

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Medice Arzneimittel Pütter GmbH & Co. KG, Kuhloweg 37, 58638 Iserlohn, Germany

8. Marketing authorization number(s)

PL 11243/0045

9. Date of first authorization / renewal of the authorization

17/04/2020

10. Date of revision of the text

14/10/2020

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