PHOSEX Tablet (2011)
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Περιεχόμενα
1. Name of the medicinal product
Phosex 1000 mg tablet.
2. Qualitative and quantitative composition
1 tablet contains. Calcium Acetate 1000 mg (calcium acetate anhydrous 986.36 mg) equivalent to 250 mg calcium. For a full list of excipients see Section 6.1.
3. Pharmaceutical form
Tablet. Oval yellow tablet embossed “PHOS-EX” on one side with a score-line on the reverse.
4.1. Therapeutic indications
Correction of hyperphosphataemia associated with chronic renal failure in patients undergoing dialysis.
4.2. Posology and method of administration
For oral use. Initially one tablet 3 times a day. The tablet should be swallowed whole with a meal to achieve the maximal phosphate binding effect. Where the patient cannot swallow the tablets whole they ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients. Hypercalcaemia.
4.4. Special warnings and precautions for use
The use of phosphate binders in renal failure should be in conjunction with dietary advice regarding phosphate intake and methods of dialysis appropriate to the patient. The dose will need to be adjusted ...
4.5. Interaction with other medicinal products and other forms of interaction
Calcium interacts with several drugs: The absorption of antibiotics such as ciprofloxacin, enoxacin, norfloxacin, tetracyclines (PO) can be affected and consequently, the intake of Phosex should be made ...
4.6. Pregnancy and lactation
No data available. It is not known whether Phosex can cause foetal effects when administered during pregnancy or whether it can affect reproductive capacity. Phosex should only be administered to pregnant ...
4.7. Effects on ability to drive and use machines
No effects on the ability to drive and use machines have been observed.
4.8. Undesirable effects
Uncommon (0.1% - 1%) Undesirable effects are nausea, vomiting, diarrhoea and constipation. Hypercalcaemia can occur and the serum levels of total and ionised calcium should be monitored. Mild hypercalcaemia ...
4.9. Overdose
Overdose with calcium substances may lead to soft tissue calcifications.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs for treatment of hyperkalaemia and hyperphosphataemia <b>ATC code:</b> V03AE Phosphate binder. Calcium ions of calcium acetate interact with and bind to phosphates ...
5.2. Pharmacokinetic properties
Calcium acetate is not indicated for systemic availability. The residual acetate will be metabolised through bicarbonate, which will be further excreted via normal metabolic routes. The amount of calcium ...
5.3. Preclinical safety data
No specific studies are available on Phosex calcium acetate tablets.
6.1. List of excipients
Macrogol 8000 Sodium starch glycolate (type A) Calcium stearate Lemon meringue flavour containing lemon oil, citral, aldehyde C-9, lime oil, orange oil, vanillin, ethyl vanillin, malto-dextrin, tricalcium ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C. Store Phosex in the original container and keep the container tightly closed in order to protect from moisture.
6.5. Nature and contents of container
White HDPE bottles with polypropylene caps. Package size: bottle with 50, 100, 180, 200, 500 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Pharmacosmos A/S, Roervangsvej 30, DK-4300 Holbaek, Denmark
8. Marketing authorization number(s)
PL 18380/0003
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 29 June 2001 Date of last renewal: 22 December 2007
10. Date of revision of the text
October 2011
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