Silver proteinate nova argentia nasal drops and ear drops, children's solution 0.5% nasal drops and ear drops solution bottle 10 ml
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CHILDREN 0.5% NASAL AND EAR DROPS SOLUTION BOTTLE 10 ML
- Package Leaflet -
- Directions - What itis and what it is used for
This medicine contains the active substance silver proteinate, which inhibits the growth of bacteria and kills them.
PROTEINIZED SILVER NOVA ARGENTIA is indicated for the treatment of infections caused by bacteria (antiseptic) of the nasal mucosa and the outer ear (ear canal) and as a decongestant of the mucosa of the nose.
Talk to your doctor if you do not feel better or if you feel worse after a few days. - Contraindications - What you need to know before taking the medicine
DO not use NOVA ARGENTIA protected SILVER
- if you are allergic to silver proteinate or any of the other ingredients of this medicine (listed in section 6). - Special warnings and precautions for use - Warnings and precautions
Talk to your doctor or pharmacist before using Proteinate NOVA ARGENTIA SILVER.
Avoid the simultaneous use of products based on a substance called papain (see section Other medicines and protected SILVER NOVA ARGENTIA).
Use this medicine at the recommended doses and in the manner recommended in this leaflet.
This medicinal product, if ingested accidentally or if used for long periods of time at excessive doses, may cause toxic effects (see section If you use more NOVA ARGENTIA PROTEINATE SILVER than you should). - Interactions -
- Side Effects - Possible Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Talk to your doctor if you experience any of the following side effects -
Frequency not known (whose frequency cannot be defined on the basis of the available data) -
- skin irritations, dermatitis, rashes, burning;
- alteration of skin colour (skin discolouration);
- allergic reactions (hypersensitivity reactions);
- skin colouring from grey to dark blue (argyria).
Reporting of undesirable effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at - https - //www.aifa.gov.it/content/segalazionireazioni-avverse.
By reporting side effects you can help provide more information about the safety of this medicine.
- Directions - What itis and what it is used for
- Recommendations on how to store - Store the bottle tightly closed in the original packaging to protect from light.
- Active ingredients - PROTEINATED SILVER NOVA ARGENTIA 0.5% nasal and ear drops, solution 100 g of solution contain - Active ingredient - Proteinated silver 0.50 g. PROTEINIZED SILVER NOVA ARGENTIA 1% nasal and ear drops, solution 100 g of solution contain - Active ingredient - 1.00 g proteinated silver. PROTEINIZED SILVER NOVA ARGENTIA 2% nasal and ear drops, solution 100 g of solution contain - Active ingredient - 2.00 g proteinated silver. For the full list of excipients see section 6.1.
- Excepents - Excipients - dibasic sodium phosphate, monobasic potassium phosphate, bronopol, purified water.
- Therapeutic Indications - Decongestant and antiseptic of the nasal mucosa and antiseptic of the ear canal.
- Contraindications - Hypersensitivity to the active substance or to any of the excipients.
- Posology - Adults and children Administer 1-2 drops into each nostril or ear canal 2-3 times a day.
- Warnings - Avoid concomitant use with papain products (see section 4.5). Follow the recommended doses and methods of use. Proteinated silver, if accidentally ingested or if used for a long period at excessive doses, can cause toxic phenomena (see section 4.9). Important information about some excipients - The presence of bronopol may cause local skin reactions (e.g. contact dermatitis)
- Interactions - Proteinated silver solution may interact with papain-based products. Papain is a proteolytic enzyme, belonging to the class of hydrolases, which is extracted from the immature fruit of papaya (Carica papaya). The concomitant use of silver proteinate and papain could inhibit the enzymatic action of papain.
- Undesirable effects - Below are the undesirable effects of proteinated silver, organized according to the MedDRA systemic organ classification. There are insufficient data to establish the frequency of the individual listed effects. Skin and subcutaneous tissue disorders Dermatitis Rash Burns Skin irritation Skin discolouration Hypersensitivity reactions Argyria (see section 4.9) Reporting of suspected adverse reactions Reporting of suspected adverse reactions occurring after authorisation of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions through the national reporting system at - www.aifa.gov.it/content/segalazioni-reazioni-avverse.
- Overdose - In case of overdose, high concentrations of silver in the plasma and skin discoloration may occur. In addition, systemic symptoms such as hepatotoxicity, cardiomyopathy, amnesia, and confused speech may occur. Prolonged daily ingestion of silver proteinate may result in irreversible neurotoxicity, with myoclonic status epilepticus, leading to coma and eventually death. An accumulation of silver in the skin, mucous membranes, membranes and eyes, due to ingestion or absorption of even small amounts, can cause the appearance of argyria. Argyria is characterised by a colouring of the skin from grey to dark blue, due to the binding of silver with different proteins and the consequent production of pigments.
- Pregnancy - Pregnancy There are no adequate data regarding the use of proteinated silver in pregnant women. Proteinized silver should not be used during pregnancy, unless absolutely necessary. Lactation There are no adequate data regarding the use of proteinated silver in lactation. Proteinized silver should not be used during breastfeeding, unless absolutely necessary.
| Marca | NOVA ARGENTIA |
|---|---|
| MISAN | 030459010 |
| Casa farmaceutica | NOVA ARGENTIA Srl IND. FARM |
| Tipo | FARMACO GENERICO |
| Sintomi | Naso |
| is used for | VARI |
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