ARGENTO 0.5% Назальные капли, раствор

Содержание инструкции

1. Argento proteinato Marco Viti children 0.5% nasal and ear drops, solution, adults 1% nasal and ear drops, solution, adults 2% nasal and ear drops, solution

Argento proteinato Marco Viti nasal and ear drops, solution
Marco Viti Farmaceutici S.p.A.

Argento proteinato Marco Viti children 0.5% nasal and ear drops, solution, adults 1% nasal and ear drops, solution, adults 2% nasal and ear drops, solution

Pharmacotherapeutic category
Other rhinology preparations

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.

Precautions for use
Avoid concomitant use with papain-based products (see Interactions).
Follow the recommended doses and methods of use.
Silver proteinate, if accidentally ingested or if used for a long period at excessive doses, can
determine toxic phenomena (see Overdose).

Interactions
Inform your doctor or pharmacist if you have recently taken any other medicines, including those without
prescription.
Silver proteinate solution may interact with papain-based products. Papain is a proteolytic enzyme,
belonging to the class of hydrolases, extracted from the unripe fruit of the papaya (Carica
papaya).
Concomitant use of silver proteinate and papain may inhibit the enzymatic action of papain.

Special warnings
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine

Pregnancy
There are no adequate data regarding the use of silver proteinate in pregnant women. Silver
proteinate should not be used during pregnancy unless absolutely necessary.

Breastfeeding
There are no adequate data regarding the use of silver proteinate during breastfeeding. Silver proteinate should not
be used during breastfeeding unless absolutely necessary.

Effects on ability to drive and operate machinery
Silver proteinate does not impair the ability to drive vehicles or operate machinery.

Dosage, method and duration of administration
Administer 1-2 drops in each nostril or in the ear canal 2-3 times a day.

Overdose
The medicine, if accidentally ingested or if used in excessive doses, can determine toxic phenomena.
In case of overdose, high concentrations of silver in the plasma and discoloration of the skin may occur.
In addition, systemic symptoms such as hepatotoxicity, cardiomyopathy, amnesia and
confused speech may occur.

Argento proteinato Marco Viti nasal and ear drops, solution
Marco Viti Farmaceutici S.p.A.
Prolonged daily ingestion of silver proteinate can determine irreversible neurotoxicity, with
myoclonic status epilepticus, up to determining coma and, finally, death.
An accumulation of silver in the skin, mucous membranes, membranes and eyes, due to ingestion or
absorption of even small amounts, can determine the appearance of argyria. Argyria is characterized by
a discoloration of the skin from gray to dark blue, due to the binding of silver with various proteins and the
consequent production of pigments.
In case of accidental ingestion/assumption of an excessive dose of silver proteinate, immediately notify
your doctor or go to the nearest hospital.
IF YOU HAVE ANY DOUBTS ABOUT THE USE OF SILVER PROTEINATE MARCO VITI, CONTACT YOUR DOCTOR OR
PHARMACIST.

Undesirable effects
Like all medicines, silver proteinate can cause side effects, although not everyone will experience them.
The following are the undesirable effects of silver proteinate. There are not enough data available to
establish the frequency of the individual effects listed.

Skin and subcutaneous tissue disorders
Dermatitis
Rash
Burning
Skin irritation
Skin discoloration
Hypersensitivity reactions
Argyria (see Overdose)

If any of these side effects worsen, or if you notice any side effect

Shelf life and storage
Expiry date: see the expiry date indicated on the packaging
The expiry date refers to the medicine in intact packaging, correctly stored.
After first opening, the medicine must be used within 30 days.
After this period, any remaining medicine must be discarded.
WARNING: do not use the medicine after the expiry date indicated on the packaging.

Storage conditions
Keep the bottle tightly closed in the original packaging to protect the medicine from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

Keep the medicine out of the reach and sight of children.
Argento proteinato Marco Viti nasal and ear drops, solution
Marco Viti Farmaceutici S.p.A.

Composition
Argento proteinato Marco Viti children 0.5% nasal and ear drops, solution
100 g of solution contains:

Active ingredient: silver proteinate g 0.5

Excipients:purified water, disodium phosphate dodecahydrate, monobasic potassium phosphate, bronopol.
Argento proteinato Marco Viti adults 1% nasal and ear drops, solution
100 g of solution contains:

Active ingredient: silver proteinate g 1.0

Excipients:purified water, disodium phosphate dodecahydrate, monobasic potassium phosphate, bronopol.
Argento proteinato Marco Viti adults 2% nasal and ear drops, solution
100 g of solution contains:

Active ingredient: silver proteinate g 2.0

Excipients:purified water, disodium phosphate dodecahydrate, monobasic potassium phosphate, bronopol.

Pharmaceutical form and content
Nasal and ear drops, solution.
Bottle with dropper cap containing 10 ml

MARKETING AUTHORISATION HOLDER
Marco Viti Farmaceutici S.p.A.
Via Mentana, 38 – 36100 Vicenza

RESPONSIBLE MANUFACTURER FOR BATCH RELEASE
Zeta Farmaceutici S.p.A.
Via Galvani, 10 – 36066 Sandrigo (VI)
Or
Marco Viti Farmaceutici S.p.A.
Via Tarantelli, 13/15 – 22076 Mozzate (CO)
AIFA determination of 06 March 2012