CHARLYN 2 мг/2 мл Раствор для небулайзера
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Инструкция по применению KARLYN
C h a r l y n
2 mg/2ml solution for nebulization
Flunisolide
Generic drug
COMPOSITION
1 single-dose container of 2 ml contains:
Active ingredient: Flunisolide 2 mg
Excipients: propylene glycol, sodium chloride, sodium citrate, citric acid, water for injections.
PHARMACEUTICAL FORM AND PACKAGING
Solution for nebulization.
Box of 15 single-dose containers of 2 ml of 2 mg/2ml solution
PHARMACOTHERAPEUTIC CATEGORY
Anti-inflammatory, antiasthmatic glucocorticoid.
A.I.C. HOLDER
S.F. GROUP S.r.l.
Via Tiburtina, 1143
00156 Rome - Italy
MANUFACTURERS AND FINAL CONTROLLERS
COC Farmaceutici
Via Modena 15 - S. Agata Bolognese (Bologna)
THERAPEUTIC INDICATIONS
Allergic diseases of the respiratory tract: bronchial asthma, chronic asthmatic bronchitis: chronic and
seasonal rhinitis.
CONTRAINDICATIONS
Individual hypersensitivity to the active ingredient and to the excipients of the product. Active or
quiescent pulmonary tuberculosis. Bacterial, viral or fungal infections.
Generally contraindicated in pregnancy and breastfeeding. (See Special warnings)
PRECAUTIONS FOR USE
Flunisolide, like all corticosteroids, should be used with caution, if not avoided, in patients with
active or quiescent tuberculosis infections of the respiratory tract, or with untreated infections from fungi, from
bacteria or viruses or with herpes simplex in the eyes.
Due to the inhibitory effect exerted by corticosteroids on the cicatricial processes, it is appropriate to use
flunisolide with caution in patients with previous or recent nasal trauma, with nasal septal ulcer or with
recurrent epistaxis. Although nosebleeds have been rarely reported, it is advisable to check, especially
for prolonged treatments, the possible change in the microbial flora of the upper airways, establishing, if
necessary, a covering therapy.
The effect of CHARLYN, as for all corticosteroids administered by inhalation, is not immediate.
Therefore, it should be kept in mind that CHARLYN is not effective in ongoing asthma crises and that it is
advisable to adhere to a regular use of the product for several days:
In case of prolonged and high-dose topical use, it is good to keep in mind the possibility of inhibition of the
surrenal activity and atrophy of the mucous membranes, although no absorption of the
product sufficient to produce general effects has been demonstrated in clinical experience. In patients with marked nasal congestion or with abundant
secretions, a preliminary treatment with topical vasoconstrictors may be indicated to allow the aerosol
to come into contact with the mucosa. Rarely, a series of psychological and
behavioral effects can occur, including psychomotor hyperactivity, sleep disturbances, anxiety, depression,
aggression, behavioral disorders (especially in children). It is important to take the dose as
before consulting the doctor.
DRUG AND OTHER INTERACTIONS
Not known.
SPECIAL WARNINGS
The use of CHARLYN is reserved for adults.
The use of the product, especially if prolonged, can lead to sensitization phenomena and
exceptionally to the classic systemic undesirable effects of the drug.
In this case, treatment should be discontinued and appropriate therapy instituted. Every time corticosteroids are used, it should be kept in mind that they can mask some symptoms of infection and that new infectious processes can occur during
their use. The transfer from systemic steroid therapy to therapy with flunisolide must be carried out with caution if there is reason to suspect
the presence of altered adrenal functions: abrupt discontinuation of systemic treatment is, in
generally, to be avoided. The conduct of treatment in patients already under systemic corticosteroid therapy requires
particular precautions and close medical supervision, given that the reactivation of the functional
surrenals, suppressed by prolonged systemic corticosteroid therapy, is slow. It is in any case necessary
that the disease is relatively "stabilized" with systemic treatment.
Initially CHARLYN should be administered continuing systemic treatment, subsequently this should be
progressively reduced by controlling the patient at regular intervals and modifying the dosage of
CHARLYN according to the results obtained. During periods of stress or severe asthma attack, patients,
undergoing this transition, should have supplementary steroid treatment. In these
patients periodic checks of the corticosurrenal function should also be carried out, including
measurements of morning cortisol levels in resting conditions.
In steroid-dependent patients, a gradual and controlled transition from oral to
endobronchial topical therapy is recommended. The effect of CHARLYN, as for all corticosteroids administered by inhalation, is not immediate. It should therefore be kept in mind that CHARLYN is not effective in ongoing asthma crises and that it is advisable to adhere to a regular use of the product for several days. It is important that the
dose of inhaled corticosteroids is brought to the minimum effective dose for asthma control and that it is
reviewed regularly. In fact, possible systemic effects, such as adrenal suppression, even acute, growth retardation
in children and adolescents, reduced bone mineral density, cataracts and glaucoma,
can occur following treatment with inhaled corticosteroids at high doses for prolonged periods.
Very rare cases of acute adrenal crises have been reported in children exposed to doses higher than those
recommended (approximately 1000 mcg/day) for prolonged periods (several months or years). The symptoms of adrenal insufficiency are initially nonspecific and include anorexia, abdominal pain, weight loss,
fatigue, headache, nausea, vomiting: specific symptoms in case of treatment with inhaled corticosteroids
include hypoglycemia with reduced state of consciousness and/or convulsions.
Situations that could potentially determine an adrenal crisis are: trauma, surgical interventions,
infections and rapid reduction of the dosage. Patients receiving high doses should be
closely evaluated and the dose gradually reduced. Monitoring of adrenal reserve may also be
necessary.
The recommended doses should not be exceeded. An eventual increase, in fact, in addition to not improving the therapeutic efficacy
of the product, entails the risk of systemic effects from absorption.
Pregnancy and breastfeeding.
The product is not recommended in the first three months of pregnancy: in the further period and during
breastfeeding the product should be administered only in cases of actual need and under strict control of the
doctor.
The product is not contraindicated in subjects affected by celiac disease.
For those who engage in sports activity: the use of the drug without therapeutic necessity constitutes doping and may
anyway determine positivity to anti-doping tests.
DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Adults
Half the content of a single-dose container of CHARLYN 2 mg/2ml twice a day CHARLYN does not
must be diluted.
As is known, the administration of drugs in solution by means of electric nebulizers involves a residue
of solution that, adhering to the walls of the ampoule or on the bottom, is not delivered. Taking this into account
it is necessary, in preparation, to consider the need to integrate the non-deliverable part.
OVERDOSE
The administration of large quantities of flunisolide in a short period of time can determine the
suppression of hypothalamic-pituitary-adrenal function. In this case, the administered dose must be
immediately reduced to the recommended dose.
UNDESIRABLE EFFECTS
Only some patients, with very sensitive airways, have presented cough and hoarseness: sometimes a mild transient burning of the nasal mucosa can occur. Rarely, fungal infections have been observed in the mouth or throat that have disappeared rapidly after appropriate local therapy. These infections
can be prevented or minimized if patients rinse their mouths thoroughly after each administration. Other undesirable effects observed are: nasal irritation, epistaxis, nasal congestion, rhinorrhea, sore throat, hoarseness and irritation of the oral cavity and pharynx. If severe, these undesirable effects may require discontinuation of therapy.
Only in case of inappropriate use can occur, even if to a limited extent, the typical effects of
corticosteroids administered by systemic route. The most common undesirable effect found in cortico-dependent patients was the appearance of nasal congestion and nasal polyps, due precisely to the reduction
of systemic corticosteroid therapy. Patients should nevertheless be kept under close control in the event of prolonged treatments, in order to promptly ascertain the eventual appearance of systemic manifestations
(osteoporosis, peptic ulcer, signs of secondary corticosurrenal insufficiency such as hypotension and weight loss) in order to avoid in the latter event serious incidents from acute hyposurrenalism.
At high doses used for long periods, adrenal suppression, growth retardation may occur
in children and adolescents, reduced bone mineral density, cataracts and glaucoma.
Report any undesirable effects to your doctor or pharmacist, even if they are not listed above.
Undesirable effects that may occur, with unknown frequency, are psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, behavioral disorders (especially in children).
EXPIRY AND STORAGE
See the expiry date indicated on the packaging. This date refers to the product in intact packaging
correctly stored.
Storage: Store the product in its original packaging to protect it from light.
Warning: do not use the product beyond the expiry date indicated on the packaging. Use the product
within 12 hours of first opening the single-dose container. The excess product should be discarded. After
opening the aluminum pouch, the product must be used within one month: the excess product
should be discarded.
KEEP OUT OF REACH AND SIGHT OF CHILDREN
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- Страна регистрации
- Форма выпускаSolution for nebulization, 2 MG/2 ML
- Код АТХR03BA03
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги KARLYNФорма выпуска: Solution for nebulization, 0.1%Действующее вещество: flunisolideПроизводитель: S.F. GROUP S.R.L.Отпускается по рецептуФорма выпуска: Solution for nebulization, 0.1%Действующее вещество: flunisolideПроизводитель: PIAM FARMACEUTICI S.P.A.Отпускается по рецептуФорма выпуска: Solution for nebulization, 0.1%Действующее вещество: flunisolideПроизводитель: GENETIC S.P.A.Отпускается по рецепту
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Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
KARLYN требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество KARLYN — flunisolide. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
KARLYN производится компанией S.F. GROUP S.R.L.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения KARLYN с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить KARLYN в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (flunisolide) включают AERFLU, AEROLID, ASMAFLU. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
