POTABA Powder for oral solution (2022)
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Περιεχόμενα
1. Name of the medicinal product
Potaba 3 g Powder Sachets. Potassium para-aminobenzoate 3 g Powder Sachets.
2. Qualitative and quantitative composition
Each sachet contains 3 g potassium para-aminobenzoate.
3. Pharmaceutical form
Powder for oral solution. Each sachet contains 3 g white/off-white powder.
4.1. Therapeutic indications
Potassium para-aminobenzoate 3 g powder is indicated for the treatment of Peyronies disease and scleroderma in adults.
4.2. Posology and method of administration
Posology One sachet containing 3 g Potassium para-aminobenzoate powder should be taken orally, four times daily. Paediatric population The safety of Potassium para-aminobenzoate 3 g powder in children ...
4.3. Contraindications
Hypersensitivity to the active substance potassium para-aminobenzoate, para-substituted aromatic amines (e.g. benzocaine, procaine, ethyl parahydroxybenzoate) or to any of the excipients listed in section ...
4.4. Special warnings and precautions for use
Hypersensitivity reactions Potassium para-aminobenzoate 3 g powder must be discontinued immediately if signs or symptoms of hypersensitivity reactions develop (including, but not limited to, severe rash ...
4.5. Interaction with other medicinal products and other forms of interaction
Sulfonamides will be inactivated by Potassium para-aminobenzoate 3 g powder since aminobenzoate is preferentially taken up by bacteria. Methotrexate is displaced from plasma protein binding by aminobenzoate. ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of potassium para-aminobenzoate in pregnant women. Potassium para-aminobenzoate 3 g powder is not recommended during pregnancy. Breastfeeding ...
4.7. Effects on ability to drive and use machines
Potassium para-aminobenzoate 3 g powder has no or negligible influence on the ability to drive and use machines. If patients experience confusion, lethargy or weakness they should not drive until such ...
4.8. Undesirable effects
The following convention has been utilised for the classification of undesirable effects: Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare ...
4.9. Overdose
No particular problems are expected following overdose with Potassium para- aminobenzoate 3 g powder. Symptomatic and supportive therapy should be given as appropriate.
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other dermatological preparations, Other dermatologicals <b>ATC code:</b> D11AX23 Mechanism of action Potassium para-aminobenzoate is considered a member of the Vitamin ...
5.2. Pharmacokinetic properties
Absorption Aminobenzoate is well absorbed after oral administration. Oral administration of 3 g Potassium para-aminobenzoate to healthy volunteers resulted in maximum plasma levels of 29-74 μg/mL after ...
5.3. Preclinical safety data
In-vitro bacterial tests with para-aminobenzoate revealed no mutagenic potential. There are no long-term tests for carcinogenic potential. Adequate reproductive toxicity tests are not available for potassium ...
6.1. List of excipients
None in this presentation.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Do not store above 25°C. Store in the original packaging.
6.5. Nature and contents of container
Cardboard outer containing 40 foil laminate sachets.
6.6. Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Neon Healthcare Ltd., 8 The Chase, John Tate Road, Hertford, SG13 7NN, United Kingdom
8. Marketing authorization number(s)
PL 45043/0044
9. Date of first authorization / renewal of the authorization
28/04/1981 / 16/01/2004
10. Date of revision of the text
10/11/2022
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