PERFORMER 250 mg /5 Ml Granules For Oral Suspension
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Інструкція із застосування PERFORMER
Зміст інструкції
PERFORMER 250mg/5ml GRANULATED FOR ORAL SUSPENSION
cefaclor (monohydrate)
| Up to 8 Kg | From 8 to 16 Kg | From 16 to 21 Kg | Over 21 Kg | |
| 3 times a day single dose (measuring spoon or syringe) | a 100 mg (2 ml) | l 200 mg (4 ml) | 250 mg (5 ml) | 300 mg (6 ml) |
| a Up to 8 Kg | From 8 to 16 Kg | From 16 to 21 Kg | Over 21 Kg | |
| 2 times a day single dose (measuring spoon or syringe) | i 150 mg (3 ml) | 300 mg (6 ml) | 400 mg (8 ml) | 500 mg (10 ml) |
PERFORMER 750 mg MODIFIED-RELEASE TABLETS
cefaclor (monohydrate)
PHARMACOTHERAPEUTIC CATEGORY
Oral antibiotic, belonging to the class of cephalosporins.
THERAPEUTIC INDICATIONS
PERFORMER 750 mg modified-release tablets is indicated for the treatment of more severe forms
of the following infections:
- acute bronchitis and exacerbation of chronic bronchitis;
- pharyngitis and tonsillitis;
- skin and soft tissue infections;
- uncomplicated lower urinary tract infections.
CONTRAINDICATIONS
Hypersensitivity to the active ingredient or to any of the excipients and to other cephalosporins or penicillins.
PRECAUTIONS FOR USE
Before initiating therapy with PERFORMER, careful investigation must be carried out to determine if the patient has
had previous reactions of hypersensitivity to cephalosporins, penicillins or other drugs.
There have been patients who have experienced severe reactions (including anaphylaxis) following the administration
of penicillins or cephalosporins including Cefaclor, IgE-mediated reactions that usually manifest at the level
of the skin, gastrointestinal, respiratory and cardiovascular systems.
Symptoms may include: severe and sudden hypotension, acceleration and slowing of the heartbeat,
unusual fatigue or weakness, anxiety, agitation, dizziness, loss of consciousness, difficulty in
breathing or swallowing, generalized itching especially on the soles of the feet and palms of the
hands, urticaria with or without angioedema (swollen and itchy skin areas located more frequently
on the extremities, external genitalia and face, especially in the region of the eyes and lips), redness
of the skin especially around the ears, cyanosis, profuse sweating, nausea, vomiting, cramp-like abdominal
pain, diarrhea.
If an allergic reaction to PERFORMER should occur, discontinue administration of the
drug. Treatment with broad-spectrum antibiotics, including PERFORMER, alters the normal flora
of the colon and determines a numerical increase of clostridia.
It has been demonstrated by various studies that a toxin produced by Clostridium difficile is the main cause of
severe diarrhea associated with antibiotic therapy, including pseudomembranous colitis.
Therefore, it is important to consider this diagnosis in patients who develop diarrhea during therapy with
these antibiotics.
As with other antibiotics, during treatment with PERFORMER, the possible emergence of resistant microorganisms must be considered
which may result in a superinfection for which appropriate measures must be taken.
Use in newborns
Efficacy and tolerability in children have not been well established.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, even those
available without a prescription.
The extent of absorption of PERFORMER decreases if antacids containing magnesium hydroxide or aluminum are administered within one hour of taking the antibiotic
while H-blockers do not
alter the rate and extent of PERFORMER absorption.
After administration of Cefaclor, falsely positive results for urinary glucose may occur
with Benedict and Fehling solutions and with Clinitest but not with Tes-Tape (urine glucose test strip, Lilly).
Similarly to other beta-lactamics, the renal excretion of PERFORMER is inhibited by the administration of
probenecid; no other significant drug interactions were observed during clinical studies.
SPECIAL WARNINGS
Use during pregnancy and breastfeeding
There are no specific and well-controlled studies in pregnant women and, since animal reproduction studies
are not always predictive of the response in humans, this drug should be used during pregnancy
only if clearly necessary.
The use of PERFORMER 750 during labor and delivery has not been studied; therefore the drug
should be administered only in case of ascertained need.
Small amounts of Cefaclor have been found in breast milk after the administration of
single doses of 500 mg. Caution is recommended during breastfeeding.
Effects on ability to drive and operate machinery
PERFORMER has no effects on the ability to drive and operate machinery.
DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
PERFORMER is administered orally and can be taken independently of meals.
However, simultaneous intake of food increases the absorption of PERFORMER. The tablets
must be taken whole, and therefore not broken, crushed or chewed.
The following dosage regimens are recommended:
- pharyngitis, tonsillitis and skin and soft tissue infections: 750 mg 2 times a day.
- uncomplicated lower urinary tract infections: 750 mg 2 times a day.
- bronchitis: 750 mg 2 times a day. In the treatment of infections caused by S. pyogenes (group A streptococci) therapy with PERFORMER should be continued for up to 10 days.
Instructions for use
PERFORMER is administered orally and can be taken independently of meals. The
tablets must be taken whole, and therefore not broken, crushed or chewed.
OVERDOSE
Signs and symptoms:
Toxic symptoms resulting from PERFORMER overdose may include nausea, vomiting, gastrointestinal
disturbances and diarrhea.
Treatment:
In addition to general measures that may be required, intestinal absorption
may be reduced by emesis, gastric lavage or administration of activated charcoal.
Forced diuresis, peritoneal dialysis, hemodialysis or hemoperfusion have not been shown to be beneficial
in accelerating the elimination of PERFORMER.
In case of accidental ingestion/intake of an excessive dose of PERFORMER, immediately
inform your doctor or go to the nearest hospital.
UNDESIRABLE EFFECTS
Like all medicines, PERFORMER can cause side effects, although not everyone will
experience them.
After oral administration of PERFORMER in clinical studies, a low number of side effects were observed (with an incidence rate generally less than 1%), most of which were
mild and transient.
Gastrointestinal manifestations: diarrhea, nausea, vomiting and dyspepsia.
Allergic manifestations: rash, urticaria and itching have been reported. In controlled clinical studies, on 3,272 patients treated with PERFORMER, a serum sickness-like reaction (0.03%) was found, characterized by the appearance of erythema multiforme, rash and other
manifestations affecting the skin accompanied by arthritis/arthralgia, with or without fever. These manifestations
more often occur during or after a course of treatment with Cefaclor and have been observed more
frequently in children than in adults. Signs and symptoms usually appear a few days
after the start of therapy and disappear a few days after the end of treatment. Antihistamines and corticosteroids
promote healing. No serious complications have been observed.
Lymphatic and circulatory system: eosinophilia.
Genitourinary system: vaginal candidiasis and vaginitis.
The following adverse events, whose causal relationship with the drug is however uncertain, have been observed in
patients treated with PERFORMER: headache, dizziness, drowsiness, transient increases in transaminases
and alkaline phosphatase, transient azotemia and creatininemia, transient
thrombocytopenia, leukopenia, lymphocytosis, neutropenia and abnormalities of urine examination.
In patients treated with Cefaclor, the following have been observed sometimes: erythema multiforme, fever, anaphylaxis (more
frequent in patients with a history of allergy to penicillin). Stevens-Johnson syndrome, positive
direct Coombs test, genital itching, toxic epidermal necrolysis, reversible interstitial nephritis,
altered liver function including cholestasis, increased prothrombin time in patients
receiving Cefaclor and Warfarin simultaneously, reversible hyperactivity, nervousness, insomnia, confused state, hypertonia, aplastic anemia, agranulocytosis and hemolytic anemia.
Treatment with broad-spectrum antibiotics can alter the intestinal bacterial flora, sometimes leading
to manifestations of pseudomembranous colitis.
Anaphylactoid reactions may be represented by isolated manifestations, including angioedema,
asthenia, edema (both facial and of the limbs), dyspnea, paresthesia, syncope and vasodilation.
If any of the side effects worsen, or if you notice any side effect
SHELF LIFE AND STORAGE
Shelf life: see the expiry date printed on the packaging.
The expiry date refers to the product in intact packaging, correctly stored.
Caution: do not use the medicine after the expiry date printed on the packaging.
Store at a temperature below 25°C.
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.
COMPOSITION
Each tablet contains:
Active ingredient: Cefaclor monohydrate eq. to Cefaclor 750 mg
Excipients: Hypromellose, mannitol, povidone, magnesium stearate, colloidal silica, propylene glycol, titanium
dioxide.
PHARMACEUTICAL FORM AND CONTENT
Modified-release tablets in a pack of 6 and 12 tablets.
MARKETING AUTHORISATION HOLDER
PIAM Farmaceutici S.p.A. – Via Padre G. Semeria, 5 – 16131 Genoa
MANUFACTURER
FACTA Farmaceutici S.p.A. – Via Laurentina Km 24,730 – Pomezia (ROME)
April 2012
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- Країна реєстрації
- Лікарська формаGranules for oral suspension, 250 MG/5 ML
- Код АТХJ01DC04
- Діюча речовина
- Потрібен рецептНі
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до PERFORMERЛікарська форма: Modified-release tablet, 750 MGДіюча речовина: cefaclorВиробник: BIOMED PHARMA S.R.L.Потрібен рецептЛікарська форма: Granules for oral suspension, 250 MG/5 MLДіюча речовина: cefaclorРецепт не потрібен
Аналоги PERFORMER в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог PERFORMER у Польща
Аналог PERFORMER у Іспанія
Лікарі онлайн щодо PERFORMER
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на PERFORMER онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
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Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
PERFORMER не потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у PERFORMER — cefaclor. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
PERFORMER виробляється компанією PIAM FARMACEUTICI S.P.A.. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування PERFORMER з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати PERFORMER у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (cefaclor) включають KEFAKLOR EG, KLORATSER, KLIAKEF. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
