PENICILLIN VK Film-coated tablet (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Penicillin VK Tablets 250 mg. Phenoxymethylpenicillin 250 mg Film-Coated Tablets.
Qualitative and quantitative composition
Each tablet contains 250 mg phenoxymethylpenicillin (as phenoxymethylpenicillin potassium). For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet.
Therapeutic indications
For use in the treatment of mild to moderately severe infections caused by penicillin sensitive organisms. Consideration should be given to official guidance on the appropriate use of antibacterial agents. ...
Posology and method of administration
Posology Adults The dosage is 250-500 mg every six hours. Elderly The dosage is as for adults. The dosage should be reduced if renal function is markedly impaired. Prophylactic Use The dosage is 250 mg ...
Contraindications
Phenoxymethylpenicillin is contraindicated in patients with known penicillin hypersensitivity. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics e.g. cephalosporins. ...
Special warnings and precautions for use
Phenoxymethylpenicillin should be given with caution to patients with a history of allergy, especially to other drugs. Phenoxymethylpenicillin should also be given cautiously to cephalosporin-sensitive ...
Interaction with other medicinal products and other forms of interaction
As penicillins like phenoxymethylpenicillin are only active against proliferating microorganisms, phenoxymethylpenicillin should not be combined with bacteriostatic antibiotics such as tetracycline, erythromycin, ...
Pregnancy and lactation
Pregnancy Animal studies with phenoxymethylpenicillin potassium have shown no teratogenic effects. Phenoxymethylpenicillin potassium has been in extensive clinical use and suitability in human pregnancy ...
Effects on ability to drive and use machines
None known.
Undesirable effects
Hypersensitivity Potential allergic reactions include urticaria, angioneurotic oedema, erythema multiforme, exfoliative dermatitis, fever, joint pain, serum sickness-like reactions, haemolytic anaemia, ...
Overdose
A large overdose may cause nausea, vomiting and diarrhoea. Rarely major motor seizures may occur. There is no known antidote. Symptomatic and supportive therapy is recommended. It is advisable to monitor ...
Pharmacodynamic properties
Mechanism of action Phenoxymethylpenicillin is a broad spectrum beta-lactam antibiotic with bactericidal action against Gram-positive bacteria and Gram-negative cocci. Its antimicrobial action is similar ...
Pharmacokinetic properties
Absorption Phenoxymethylpenicillin is stable under acidic conditions so it can be administered by oral route. Phenoxymethylpenicillin is rapidly, but incompletely absorbed after oral administration and ...
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of this SPC.
List of excipients
Tablet core: Magnesium stearate Talc (E553b) Macrogol 6000 Povidone (E1201) Maltodextrin Tablet coating: Titanium dioxide (El71) Hypromellose (E464) Talc (E553b)
Incompatibilities
There are no known incompatibilities.
Shelf life
Shelf life: This medicinal product as packaged for sale has a shelf life of two years.
Special precautions for storage
The following applies to the storage of Penicillin VK Tablets 250 mg/Phenoxymethylpenicillin 250 mg Film-Coated Tablets: "Do not store above 25°C" Store in the original packaging (when packaged in blisters) ...
Nature and contents of container
The 250 mg film coated tablets are presented in the following containers: Amber glass bottles with polyethylene twist off closures containing 50 or 100 tablets. Polypropylene containers with polyethylene ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Tyrol, Austria
Marketing authorization number(s)
PL 04520/0005
Date of first authorization / renewal of the authorization
26<sup>th</sup> November 1998 (latest renewal date)
Date of revision of the text
22/02/2017
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