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Local antibiotic treatment in acute states of congestion in the context of rhinitis, sinusitis, rhinofaryngitis.
It is a symptomatic treatment of short duration.
framycetin. sulphate i.e. 7800 - Naphazolin. Nitra 0.5 mg - Phenylhydrargyr. Nitra 0.02 mg - Natr. citras - Acid. Citric. monohydric. - Natr. chlorid. - Aqua purific. q.s. ad 1 ml.
Unit Dose: - by spraying : mcl ± 140, ± 1090 IU or framycetin and 70 mcg nafazoline nitrate - per drop: mcl ± 50 or ± 390 IU framycetin nafazoline nitrate and 25 mcg.
Dose and method of use:
Adults: 2 or 3 drops of solution 1 ; spray in each nostril, 4 to 5 times a day.
Not more than 15 drops or 5 sprays per day.
Children older than 7 years: 1 or 2 drops of solution in each nostril, 3 to 4 times a day.
Not more than 8 drops per day.
The treatment should last no longer than 10 days.
This is a medicine, 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.
Individual sensitivity to one of the components of Sofraline, especially for the group of antibiotics aminosiden and sympathomimetic amines.
not use in children younger than 7 years given the presence of nafazoline.
MAO inhibitors (risk of hypertensive surge) .
Given the presence of an alpha-adrenoceptor caution in hypertension, heart disease (ischemic heart disease or tachyarrhythmias) and hyperthyroidism.
Not use for a long time (over more than 10 days), because there is a risk of rebound and iatrogenic rhinitis.
aminosiden The concomitant administration of other potentially ototoxic or nephrotoxic substances should be avoided (see section 'Interactions').
Caution is advised in elderly and in patients with preexisting renal impairment or hearing impairment.
Pregnancy and lactation:
Sofraline is contraindicated during the first three months of pregnancy (teratogenic potential risk), at the end of pregnancy and lactation, given the presence of a sympathomimetic (reactions in the newborn, such as insomnia, agitation, tachycardia).
Following the use of nafazoline.
Local reactions: feeling of dry nose, burning and stinging.
Systemic side effects: headache, insomnia and palpitations may occur with prolonged use in high doses or when used in normal doses by susceptible individuals, such as elderly.
Potential systemic effects, especially in newborns, young children and elderly as a result of penetration by the inflamed mucosa and absorption in the gastrointestinal tract, without a direct parallel between the two phenomena exists.
Prolonged or misuse can hyperaemia and secondary atrophic rhinitis cause.
Although the doses amino side , which are administered through the nose, extremely low, we mention below, but the side effects of treatment in higher doses, with aminosiden:
In the literature of the deterioration of hearing and equilibrium organ following administration of aminosiden described.
Elderly patients are susceptible to these effects, and patients with preexisting hearing impairment.
Cases of nephrotoxicity with aminosiden were reported. There was an increase in serum urea determined, but usually it was normal again soon or immediately after treatment stop put.
The cases of renal failure, following administration of aminosiden were reported, were usually related to a high dose or a prolonged treatment, pre-existing renal disease, hemodynamic disturbances or association with other nephrotoxic products. The nephrotoxicity may be potentiated by certain drugs (see 'Interactions').
It was shown that the potential nephrotoxicity of cephalosporins and cefaloridine especially in the presence of aminosiden may increase. If this combination is given, it is recommended to monitor renal function.
Elderly are also more exposed to kidney damage.
3.) Cases of neuromuscular blockade and respiratory paralysis have been reported with administration of aminosiden to patients during anesthesia myorelaxantia type of curare had been given.
4.) There were also effects on the central nervous system and described cases of peripheral neuropathy.
If used correctly there is no risk of overdose.
Incorrect use (prolonged and / or frequent use) or by accidental ingestion, especially in young children, would nafazoline nitrate in the blood can be absorbed and cause signs of overdose. These signs are: headache, nausea, insomnia, heart palpitations, hypertension, bradycardia, hypothermia, sedation, coma, respiratory depression.
Consideration of a possible overdose in the hospital: gastric lavage (as soon as possible), prolonged respiratory assistance if necessary, and symptomatic treatment.
Potential toxic doses - in children: about 7 to 8 mg nafazoline (± 0.4 mg / kg) - in adults: from about 8 mg nafazoline.
The concomitant administration of nafazoline and monoamine oxidase inhibitors is contraindicated. After discontinuation of treatment with monoamine oxidase inhibitors should be an interval of two weeks must be taken given the risk of hypertensive run against.
The presence of nafazoline is Sofraline best not used together with preparations that sympathomimetic contain, or antihypertensives, including beta blockers.
The combination with ototoxic or nephrotoxic substances are not recommended: other aminosiden, cephalosporins, vancomycin, amphotericin B, polymyxin, cisplatin, loop diuretics (furosemide, ethacrynezuur), curariserende substances ciclosprine.
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This is a medecine available without a prescription.. Do not use long without medical advice. Read the instructions carefully. Keep this medicine out of the reach of children. Keep the manual as it contains important information. Ask for advice from your doctor or pharmacist. Consult your doctor if adverse reactions.