Nesivine is indicated for the symptomatic treatment of nasal congestion, eg rhinitis acuta, eustachitis or otitis media, and as adjuverende treatment in sinusitis.
Qualitative and quantitative composition:
Nesivine 0.01% and 0.01% sine Nesivine conservans: oxymetazoline HCl 0.1 mg / ml .
Nesivine 0.025% and 0.025% Nesivine sine conservans: oxymetazoline HCl 0.25 mg / ml.
Nesivine 0.05% and Nesivine 0, 05% sine conservans: oxymetazoline HCl 0.5 mg / ml.
For excipients see List of excipients.
Nose drops and nasal spray - solution.
Posology and method of administration:
Nesivine 0.01% / 0.025% / 0.05% contain the preservative benzalkonium chloride.
Nesivine 0.01% / 0.025% / 0.05% sine conservans contain no preservatives.
Nesivine should not exceed 7 days administered without medical advice.
Between each use of Nesivine should always 5 to 6 hours expire.
Nesivine 0.01% Baby for babies from 0 to 2 years.
1st to 4th week of life.
2 to 3 times a day 1 drop of solution in each nostril instillation. The maximum dose is 1 drop at a time and 3 drops per day in each nostril.
From the 5th to the 52nd week of life.
2 to 3 times per day 1 to 2 drops of solution in each nostril instillation. The maximum dose is 2 drops 3 times per day in each nostril.
Children from 1 to 2 years.
2 to 3 times daily 1 to 2, drops of solution in each nostril instillation. The maximum dose is 8 drops per day in each nostril.
The following method proved to be equally effective: according to age 1 or 2 drops of 0.01% Nesivine baby on a cotton wad and it drops the nose cleaning.
Nesivine 0.025% Pediatrics for children from 2 to 6 years.
2 to 3 times daily or 1 spray 1 to 2 drops of solution in each nostril apply.
The maximum dose is 1 spray 2 or 3 drops each time and 6 drops or sprays in each nostril daily.
Nesivine 0.05% for adults and children over 7 years.
2 to 3 times daily or 1 spray 1 to 2 drops of the solution applied in the nostrils.
Usually only the nasal spray Nesivine 0.05% 1 only once a day to use, if necessary, the spray still 2 to 3 times per day used. The maximum dose is 1 spray 2 or 3 drops each time and 6 drops or sprays in each nostril daily. Nesivine
1 ml solution (all strengths) contains approximately 20 drops.
By spraying Nesivine nasal spray (spray and doseerspray) is approximately 45 mg (± 25%) solution Fri, 1 drop Nesivine nose drops (with the dropping pipette) solution is about 50 mg.
The nasal spray (spray and doseerspray) is Nesivine effective than the dose administered to the nose drops, spray 1 is therefore equivalent to 1 or 2 drops.
When prolonged or excessive use is a risk of atrophy of the nasal mucosa as well as strong reactive hyperemia when the force decreases.
This is a drug, no prolonged use without medical advice, keep away from children, read the leaflet carefully. Ask your doctor or pharmacist. In case of side effects, contact your doctor.
Rhinitis sicca, oxymetazoline and hypersensitivity to sympathomimetic amines or any of the other ingredients have contraindications.
Special warnings and precautions for use:
Nesivine 0.01% use in babies from 0 to 2 years.
Nesivine Pediatrics only 0.025% use in children aged 2 to 6 years.
Nesivine 0.05% use only in adults and children over 7 years.
Nesivine should not be administered more than 7 days without medical advice.
Caution is advised when used in elderly and in cases of serious cardiovascular disease (eg coronary heart disease, hypertension), metabolic disorders (thyrotoxicosis, diabetes), patients treated with monoamine oxidase inhibitors and other drugs that can increase blood pressure, increased intra - -ocular pressure (especially in narrow-angle glaucoma) and pheochromocytoma.
Pregnancy and lactation:
during pregnancy and lactation, the use of Nesivine not recommended.
Local irritation may occur with sneezing, a dry sensation in the mouth and throat. In rare cases, restlessness, insomnia, fatigue, headache and avoid reactive hyperemia. And excessive or prolonged use may again occur congestion (rebound effect) or a drug-induced rhinitis (drug induced rhinitis). It can also lead to atrophy and weaken the effect of the nasal mucosa. For intranasal use topical overdose may rarely cause systemic sympathomimetic effects such as heart palpitations, tachycardia and increased blood pressure.
Effects on ability to drive and the ability to use machines:
Systemic effects in cardiovascular events can not be excluded after prolonged administration or ingestion of oxymetazoline in higher doses than the recommended dose. In such cases, the ability to drive or operate machinery decreased.
Emergency measures, symptoms and antidotes.
After an accidental overdose or taken orally, the following symptoms occur: mydriasis, nausea, vomiting, cyanosis, fever, spasms, tachycardia, arrhythmias, hypovolemic shock, cardiac arrest, hypertension, pulmonary edema, respiratory disorders and mental disorders.
also may possibly inhibit the central nervous drowsiness, drop in body temperature, bradycardia, shock -like hypotension, apnea and coma occur.
Symptoms may occur after accidental oral ingestion of 0.1 to 0.2 mg / kg benzylimidazolines (eg oxymetazoline, xylometazoline).
Therapeutic measures after overdose.
symptomatic treatment should be performed.
List of excipients:
Quantity benzalkonium chloride.
Baby Nesivine 0.01%, nose drops
0.10 mg / ml
Pediatrics Nesivine 0.025%, nose drops
0.15 mg / ml
0.025% Nesivine Pediatrics, nasal spray
0.15 mg / ml
Nesivine 0.05%, nose drops
0.15 mg / ml
(= 0.15 mg / g 1.015)
Nesivine 0.05%, nasal spray, and spray doseerspray
0.15 mg / ml The
sine conservans contain are not benzalkonium chloride .
Nesivine 0.01% / 0.025% / 0.05%.
Disodium - Benzalkonium chloride - Monosodium phosphate dihydrate - Disodiumhydrogenphosphate dodecahydrate - Sodium Hydroxide - Water for injection.
Nesivine 0.01% conservans sine / sine conservans 0.025% / 0.05% sine conservans.
Sodium hydroxide - Sodium dihydrogen - Disodiumhydrogenphosphate dodecahydrate - Water for injection.
Interaction with other medicinal products and other forms of interaction:
Nesivine and concurrent use of MAO inhibitors may cause hypertensive crises. This risk also exists if Nesivine is administered less than 14 days after using an MAO inhibitor. A potentialisering of the alpha-adrenergic stimulation is possible in case of Nesivine combined with other products containing sympathomimetic amines, and with no ß 1 -selective beta-blockers.
Given the small amount of the product used and the very low absorption (3.5% of the intranasal dose), these interactions are unlikely.
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