Nasal Care / Vasoconstrictors

Septanazal for children 0.5 mg / 50 mg nasal spray 10ml 1’s

Brands: KRKA, d.d., Novo Mesto (Slovenia)

$7.30

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Septanazal for children 0.5 mg / 50 mg nasal spray 10ml 1's quantity

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7d34a5e20e0b

Brands:: KRKA, d.d., Novo Mesto (Slovenia)

Description

Trade name
of Septanazal® for children
of Septanazal® for adults
the International unlicensed name
Is not present

the Dosage form
nasal spray of 0.5 mg / 50 mg, 10 ml
nasal spray of 1 mg / 50 mg, 10 ml

Structure
of 1 ml of drug contain
Septanazal® for children
active agents: xylomethazolinum a hydrochloride of 0.5 mg,
dekspantenol 50 mg
of Septanazal® for adults
active agents: xylomethazolinum hydrochloride of 1 mg,
dekspantenol 50 mg
excipients: potassium dihydrophosphate, dinatrium phosphate dodecahydrate, water

the Transparent colourless liquid purified the Description

Pharmacotherapeutic group
Nasal drugs. Antikongestanta and other nasal drugs for topical administration. Sympathomimetics in a combination with other drugs (excepting glucocorticosteroids). Xylomethazolinum in a combination with other drugs.
The ATX R01AB06 code

the Pharmacological

Xylomethazolinum Pharmacokinetics properties a hydrochloride
Data of pharmacokinetic researches of use of xylomethazolinum of a hydrochloride for the person are absent. In certain cases, at intranasal introduction, the absorbed amount of xylomethazolinum of a hydrochloride can cause system effects on the central nervous system and a cardiovascular system.
Dekspantenol Dekspantenol is absorbed by skin and enzymatically is oxidized in an organism, also as well as on skin, in pantothenic acid. Vitamin is transported in the form of the connecting proteins in blood plasma. Pantothenic acid participates in quality of a key component of coenzyme A which is formed everywhere in an organism.
More detailed researches of metabolism on skin and mucous membranes are absent. 60 – 70% of orally received dose of a dekspantenol are removed with urine, 30-40% excrements.
A pharmacodynamics
of Septanazal® – the rhinologic drug representing a combination of alpha sympathomimetics with a vitamin analog for topical administration on a mucous membrane of a nose. Xylomethazolinum has vasoconstrictive effect owing to what eliminates hypostasis of a mucous membrane. Dekspantenol is derivative pantothenic acid – vitamin, promotes healing of wounds and

Xylomethazolinum hydrochloride a hydrochloride – derivative an imidazole protects mucous membranes of Xylomethazolinum, is an alpha and adrenergic sympathomimetic. It has vasoconstrictive effect owing to what eliminates hypostasis of a mucous membrane. The beginning of action usually comes in 5 – 10 min., its manifestation is simplification of nasal breath owing to elimination of hypostasis and improvement of a conclusion

of Dekspantenol Dekspantenol discharges (D-(+)-pantotenilovy alcohol) is an alcohol analog of pantothenic acid and, thanks to intermediate conversion, pantothenic acid has such  biological activity, as well as. Only D-panthenol is biologically active (dekspantenol). Pantothenic acid and its salts are water-soluble vitamins which, as well as coenzyme A, participate in many metabolic processes, including assistance in synthesis of protein and kortikoid and also in producing antibodies. Coenzyme And also participates in formation of lipids to which secretion of sebaceous glands belongs, it has important protective function, and plays a role in acetylation of aminosugars which are the main construction material for various mucopolysaccharides. Dekspantenol renders protective properties of an epithelium and promotes healing of wounds.

Indications
of Septanazal® for adults / Septanazal® for children is shown:
– for reduction of a rhinedema in rhinitises and
as maintenance therapy for healing of injuries
of a mucous membrane of a nose,
– for relief of symptoms of vasomotorial rhinitis,
– for treatment of disturbances of nasal breath after surgical
interventions in a nasal cavity.

A route of administration and doses
the Dosage
the Usual dose of the drug Septanazal® for adults makes one injection in each nostril to 3 times a day, as required.
The dosage depends on individual sensitivity to drug and clinical performance.
Duration of treatment is no more than 7 days. Repeated use is possible only after a break in several days.
Children
At children aged up to 12 years should use drug under supervision of adults.
If after 3 days of treatment the improvement did not occur or deterioration in symptoms is observed, clinical it has to be reconsidered.
To children 6 years
the Usual dose of the drug Septanazal® for adults at children aged from 6 years are aged more senior and are more senior makes one injection in each nostril to 3 times a day. Concerning treatment duration at children, it is necessary to consult with the doctor always.
Use of the drug Septanazal® for adults is contraindicated to children under 6 years.
To children aged from 2 up to 6 years
the Usual dose of the drug Septanazal® for children at children aged from 2 up to 6 years makes one injection in each nostril to 3 times a day. Concerning treatment duration at children, it is necessary to consult with the doctor always.
Use of the drug Septanazal® for children is contraindicated to children under 2 years.
A route of administration
At first it is necessary to remove a protective cover from the spray
Before the first use or if spray was not used during the long span, it is necessary to press several times on a raspylitelny head, small drops will not appear yet.

The tip of the spray should be entered, whenever possible, vertically into one nostril and once to press on a spray head. The patient during dispersion needs to inhale softly through a nose. If necessary the procedure should be repeated for other nostril.

After each use the tip of the spray should be wiped with a tissue and a cover back to insert on the spray

Side effects
Infrequently (≥ 1/1.000, to & lt, 1/100):
– hypersensitivity reactions (Quincke’s edema, skin rash, an itching)
it is rare (≥ 1/10.000, to & lt, 1/1.000):
– tachycardia, arterial hypertension
Very seldom (& lt, 1/10.000):
– the concern, insomnia, fatigue (drowsiness, sedation),
a headache, hallucinations (especially at children)
– arrhythmia
– repeated congestion, nasal bleeding
– spasms (especially at children)
is not known (it cannot be estimated on the available data):
– burning or dryness mucous a nose, sneezing

of the Contraindication
– hypersensitivity to active agents or others
– drug components
– dry rhinitis (rhinitis sicca)
– transsphenoidal hypophysectomy in the anamnesis or other surgical interventions influencing a firm meninx
– Septanazal® for adults is contraindicated to children up to 6 years
– Septanazal® for children is contraindicated to children up to 2 years

Medicinal interactions
of Xylomethazolinum a hydrochloride
Simultaneous use of Septanazala® for adults / Septanazala® for children with monoamine oxidase inhibitors of type of Tranylcyprominum or the tricyclic antidepressants and drugs increasing arterial blood pressure can lead to increase in arterial blood pressure owing to influence of these active agents on a cardiovascular system
Simultaneous use of drug with medicines for topical or system treatment of flu and with drugs for the cold and cough containing sympathomimetics (for example pseudoephedrine, ephedrine, Phenylephrinum, oxymetazoline, xylomethazolinum, tramazolin, naphazoline, tuaminogeptan),
Dekspantenol
Dannye about interaction of a dekspantenol with other medicines can cause additional effects on a cardiovascular system and the central nervous system are absent.

Can apply the special instructions This Medicine with care only after careful risk assessment and advantages in the following cases:
– patients receive treatment by monoamine oxidase inhibitors (MAO) and
other drugs which potentially increase arterial
blood pressure,
– increase in intraocular pressure, especially closed-angle glaucoma,
– serious cardiovascular diseases (for example
coronary heart disease, arterial hypertension),
– a pheochromocytoma,
– disbolism (for example, a hyperthyroidism, diabetes),
– a porphyria,
– a prostate hyperplasia.
Before use to clean the nasal courses.
In chronic rhinitis drug can be used only under observation of the doctor in connection with danger of developing of a mucosal atrophy of a nose.
Prolonged use and overdose of sympathomimetic antistagnant means can lead to a reactive hyperemia of a mucous membrane of a nasal cavity. This side effect can lead to obstruction of airways that, in turn, compels the patient repeatedly or even constantly to use drug. It can cause chronic hypostasis (medicamentous rhinitis) or even a nose mucosal atrophy.
In not sharp cases it is possible to stop administration of sympathomimetic drug in one nostril and when the complication decreases, to continue treatment by introduction to other nostril to keep, at least, partially nasal breath.
It is necessary to avoid hit of medicine in eyes
in case of the wrong use or use of excess amount of spray, absorption of xylomethazolinum can cause system side effects, especially in children (cardiovascular and neurologic side effects).
Simultaneous use of drug with medicines for topical or system treatment of flu and with drugs for the cold and cough containing sympathomimetics (for example pseudoephedrine, ephedrine, Phenylephrinum, oxymetazoline, xylomethazolinum, tramazolin, naphazoline, tuaminogeptan) is not recommended in order to avoid the increased risk of development of possible cardiovascular and neurologic side effects.
Only one person has to use each packing to avoid infection.
Pregnancy and a lactation
of Septanazal® for взрослых/Септаназал® it is not necessary to apply to children during pregnancy as the sufficient data concerning hydrochloride xylomethazolinum use by pregnant women no.
Септаназал® for взрослых/Септаназал® it is not necessary to apply to children in the period of a lactation as it is not known whether the hydrochloride in breast milk is allocated xylomethazolinum.
Features of influence of medicine on ability to run the vehicle or potentially dangerous
Septanazal® mechanisms for adults / Septanazal® for children does not affect ability of control of motor transport and other mechanisms when using according to the instruction.

Xylomethazolinum overdose a hydrochloride
the Clinical picture of intoxication derivatives of an imidazole can be various as phases of stimulation can alternate with the periods of suppression of the central nervous system and a cardiovascular system
Symptoms: spasms and a coma, bradycardia, an apnoea, arterial hypertension and also arterial hypotension, concern, the excited state, hallucinations, decrease in body temperature, fatigue, drowsiness, a miosis, a mydriasis, perspiration, fever, pallor, cyanosis, nausea, tachycardia, bradycardia, heart arrhythmia, cardiac arrest, arterial hypertension, shocklike hypotension, a fluid lungs, disturbances of breath and an apnoea.
Treatment: in cases of heavy overdose the intensive hospital treatment is shown. Prescribing of activated carbon (adsorbent), sodium sulfate (laxative) or gastric lavage (in case of large numbers) should be carried out immediately as xylomethazolinum is quickly soaked up. For a lowering of arterial pressure it is possible to appoint the non-selective antagonist of alpha adrenoceptors. Angiotonic agents are contraindicated. If necessary – decrease in body temperature, anticonvulsant therapy and oxygen inhalation.

The form of release and packing
On 10 ml of drug place in plastic bottles with the raspylitelny valve and a protective cap.
1 bottle together with the instruction for medical use in the state and Russian languages is placed in a pack from cardboard.

To Store storage conditions at a temperature not over 25 ºС.
To store out of children’s reach!

A period of storage
2 years, the use period after opening of a bottle – 3 months.
Not to apply after expiry date.

Prescription status
Without prescription

the Producer
of KRK, of. The place is new, Slovenia
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