Инструкция по применению VALEKLOR
Содержание инструкции
VALECLOR 250 mg/5 ml GRANULATED FOR ORAL SUSPENSION
Cefaclor
PHARMACOTHERAPEUTIC CATEGORY
Oral antibiotic (cephalosporins).
THERAPEUTIC INDICATIONS
Treatment of the following infections caused by sensitive germs:
- Infections of the respiratory tract, such as pneumonia, bronchitis, exacerbations of chronic bronchitis, pharyngitis and tonsillitis.
- Otitis media (bacterial origin inflammatory processes affecting the middle ear).
- Skin and soft tissue infections.
- Urinary tract infections, including pyelonephritis and cystitis.
- Sinusitis.
- Gonococcal urethritis.
- CONTRAINDICATIONSCefaclor is contraindicated in patients with known allergy to cephalosporins and other components of the product. The oral suspension granules contain sucrose, therefore if your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.
PRECAUTIONS FOR USE
Before starting therapy with cefaclor, it is recommended to investigate previous reactions of
hypersensitivity to cephalosporins and penicillins. In case of allergic reactions, the admini-
stration of the drug must be interrupted and the patient appropriately treated.
There have been patients who have had severe reactions (including anaphylaxis) following the
administration of penicillins or cephalosporins including Cefaclor, IgE mediated reactions that
usually manifest at the skin, gastrointestinal, respiratory and cardiovascular level.
Symptoms may include: severe and sudden hypotension, acceleration and slowing of the
heart rate, unusual fatigue or weakness, anxiety, agitation, dizziness, loss of co-
sciousness, difficulty breathing or swallowing, generalized itching especially at
the soles of the feet and palms of the hands, hives with or without angioedema (skin areas
swollen and itchy located more frequently at the extremities, external genitalia and face,
especially in the region of the eyes and lips), redness of the skin especially in-
around the ears, cyanosis, profuse sweating, nausea, vomiting, cramp-like abdominal pains,
diarrhea.
Since during treatment with broad-spectrum antibiotics (including macrolides, semi-synthetic penicillins
and cephalosporins) the appearance of pseudomembranous colitis is possible, its
onset must be kept in mind during the treatment with these drugs.
Cefaclor should be administered with caution to patients with severely impaired renal function.
In these cases, the dosage should be lower than generally recommended.
Broad-spectrum antibiotics should be administered with caution to subjects who have
previously experienced intestinal disorders, due to the possibility of developing antibiotic-associated colitis.
Prolonged use of cefaclor may lead to a proliferation of non-sensitive germs; if
during therapy with cefaclor a bacterial superinfection occurs, it must be appropriately
treated.
Use in neonates
The efficacy and tolerability of cefaclor in neonates less than one month of age are unknown.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, even
those without a prescription.
There is evidence of partial cross-allergenicity between penicillins and cephalosporins.
After cefaclor administration, false positive reactions to urinary glucose may occur
with both Benedict and Fehling solutions and with Clinitest, but not with Tes
- Tape (urine glucose test strips, Lilly). Positivity of Coombs' tests (sometimes false) has been reported during treatment with cephalosporins. Renal elimination of cefaclor is inhibited by probenecid (a drug for gout able to fa- vor the elimination of uric acid). SPECIAL WARNINGSCefaclor does not affect the ability to drive or operate machinery.
Use during pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
The tolerability of Cefaclor during pregnancy has not been sufficiently proven.
In pregnant women, the drug should be used only when necessary and under
direct medical supervision.
Small amounts of Cefaclor have been found in breast milk after the administration of
single doses of 500 mg. Caution is recommended during breastfeeding.
KEEP OUT OF THE REACH OF CHILDREN.
DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Cefaclor is administered orally and can be taken independently of meals.
Adults:250 mg every 8 hours; in more severe infections, higher dosages may be necessary. The maximum recommended dose is 2 g per day.
For the treatment of acute gonococcal urethritis in both sexes, a single administration of 3 g of cefaclor is recommended, possibly in association with 1 g of probenecid.
Children: 20 mg/kg per day in divided doses every 8 hours; in more severe infections (such as
otitis media), a dosage of 40 mg/kg per day is recommended up to a maximum daily dose
of 1 g.
Alternative dosage: in otitis media and pharyngitis, the total daily dose can be
administered in divided doses every 12 hours.
Instructions for use
| n Up to 8 kg | From 8 to 16 kg | From 16 to 21 kg | Over 21 kg | |
| g 3 times a day unit dose (measuring spoon or syringe) | e 100 mg (2 ml) | 200 mg (4 ml) | 250 mg (5 ml) | 300 mg (6 ml) |
In pharyngitis and otitis media, the total daily dose can be administered in divided doses every 12 hours. As an example, the following scheme referring to the daily dose of 40 mg/kg is reported:
| Up to 8 kg | From 8 to 16 kg | From 16 to 21 kg | Over 21 kg | |
| 2 times a day unit dose (measuring spoon or syringe) | 150 mg (3 ml) | 300 mg (6 ml) | 400 mg (8 ml) | c a 500 mg (10 ml) |
The tables refer to the maximum daily dose of 40 mg/kg; the doses of 20 mg/kg
per day correspond to half of the values reported above.
Instructions for use of VALECLOR 250 mg/5 ml GRANULATED FOR ORAL SUSPENSION:
- shake the bottle well before adding water to promote dispersion of the granules;
- then add water up to the level indicated by the arrow on the label;
- cap and shake well until the suspension becomes homogeneous; the volume will decrease
below the level indicated by the arrow; - add water again to bring the volume back to the level indicated by the arrow on the label;
- shake well until a uniform suspension is obtained.
If prepared according to these instructions, 5 ml of the suspension will contain 250 mg of ce-
faclor.
Shake the suspension well before each administration.
OVERDOSE
In case of accidental ingestion/intake of an excessive dose of VALECLOR, immediately
inform your doctor or go to the nearest hospital.
Signs and symptoms: may include nausea, vomiting, epigastric discomfort and diarrhea, the severity
of which is related to the dose taken. If other symptoms are present, they are likely to be se-
condary to a pre-existing condition, an allergic reaction or another toxic state.
Treatment:always keep in mind the possibility that the overdose is caused by multiple
drugs, by drug interactions or by the particular pharmacokinetics in the patient.
Gastric lavage is not necessary when the patient has not ingested a dose of cefaclor 5
times higher than the recommended dose.
The patient should be carefully monitored, controlling in particular the state of the airways as-
suring ventilation and perfusion, vital signs (heart rate and blood pressure), blood gas analysis, serum electrolytes, etc.
Intestinal absorption may be reduced by administering activated charcoal, which, in many cases,
is more effective than induced vomiting or gastric lavage. Therefore, consider charcoal as
an alternative or addition to gastric emptying. Carefully check the patient's airways during gastric emptying
and when using charcoal.
It is not known whether forced diuresis, peritoneal dialysis, hemodialysis or hemoperfusion with car-
bon are beneficial to the patient.
UNDESIRABLE EFFECTS
Like all medicines, VALECLOR can cause side effects, although not everyone
experiences them.
Adverse reactions considered related to treatment with cefaclor are as follows:
Allergic reactions: hypersensitivity reactions (1.5%) including
morbilliform rashes (1%); itching, hives and positive Coombs' test are observed in less than
1 in 200 treated patients.
Serum-like disease-like reactions, characterized by the presence of erythema multiforme, skin rash and other manifestations affecting
the skin accompanied by arthritis and/or arthralgia (inflammatory or painful joint disorders), with or without fever, have also been reported. Serum-like disease-like reactions occur
more often during and after a cycle of treatment with cefaclor, and more frequently in
children than in adults.
Signs and symptoms appear a few days after the start of therapy and disappear a few days
after its conclusion. Antihistamines and corticosteroids promote healing. No
serious complications have been observed.
More severe hypersensitivity reactions (such as Stevens-Johnson syndrome, toxic epidermal necrolysis and anaphylaxis) have been observed rarely.
Gastrointestinal manifestations: can occur in approximately 2.5% of patients, even
with the appearance of diarrhea.
Pseudomembranous colitis can be observed during and after antibiotic treatment.
Nausea and vomiting are rarely observed. With some penicillins and other cephalosporins, rare-
ly transient hepatitis and cholestatic jaundice have been observed.
Other manifestations:angioedema (abnormal fluid retention in allergic origin tissues), eosinophilia, genital itching, vaginal candidiasis, vaginitis and, rarely, thrombocytopenia and
reversible interstitial nephritis.
Cases of hemolytic anemia have been reported following treatment with cephalosporins.
Effects for which the correlation with treatment is uncertain.
Central nervous system: rarely reversible hyperactivity, restlessness, insomnia, confusion
mental, hypertonia (increased muscle tone), hallucinations, feeling of instability and bar-
collapsing, drowsiness.
Digestive system: mild increases in the values of transaminases (SGOT and SGPT) or alkaline phosphatase.
Hemolymphatic system: transient lymphocytosis, leukopenia and, rarely, aplastic anemia, agra-
nulocytosis and reversible neutropenia. There have been rare reports of increased prothrombin time, with or without clinical consequences (e.g. bleeding), in patients who were receiving cefaclor and Warfarin sodium (antithrombotic drug) simultaneously.
Genitourinary system: mild increases in azotemia, creatinine and alterations
of urine analysis.
If any of these side effects worsen, or if you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
SHELF LIFE AND STORAGE
SHELF LIFE: SEE THE EXPIRY DATE REPORTED ON THE PACKAGING.
THE EXPIRY DATE REFERS TO THE PRODUCT IN INTEGRAL PACKAGING,
CORRECTLY STORED.
ATTENTION: DO NOT USE THE MEDICINE AFTER THE EXPIRY DATE REPORTED
ON THE PACKAGING.
Once prepared, the suspension must be stored in the refrigerator between 2° and 8° C and consumed within 14 days.
MEDICINES SHOULD NOT BE DISPOSED OF VIA DRAINAGE AND DOMESTIC WASTE.
ASK YOUR PHARMACIST HOW TO DISPOSE OF MEDICINES YOU NO LONGER USE.
THIS WILL HELP TO PROTECT THE ENVIRONMENT.
KEEP THE MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN.
COMPOSITION
VALECLOR 250 mg/5 ml GRANULATED FOR ORAL SUSPENSION
5 ml of suspension contains:
Active ingredient:
Cefaclor monohydrate eq. to Cefaclor: 250 mg
Excipients:
dimethicone 350, xanthan gum, pregelatinized starch, cherry aroma, sodium lauryl sulfate,
methylcellulose 15, sucrose.
PHARMACEUTICAL FORM AND CONTENT
Granules for oral suspension. Bottle of 100 ml
MARKETING AUTHORISATION HOLDER AND MANUFACTURER
Siar Pharma S.r.l.
Via Verdi, 33
Bussero (Milan)
Manufacturer
ACS DOBFAR S.p.A.
Via Laurentina KM. 24.730
00071 Pomezia (RM)
Italy
DRUG:.
- Страна регистрации
- Форма выпускаGranules for oral suspension, 250 MG/5 ML
- Код АТХJ01DC04
- Действующее вещество
- Отпускается по рецептуНет
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги VALEKLORФорма выпуска: Modified-release tablet, 750 MGДействующее вещество: cefaclorПроизводитель: BIOMED PHARMA S.R.L.Отпускается по рецептуФорма выпуска: Granules for oral suspension, 250 MG/5 MLДействующее вещество: cefaclorОтпускается без рецепта
Аналоги VALEKLOR в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог VALEKLOR в Польша
Аналог VALEKLOR в Испания
Врачи онлайн по VALEKLOR
Обсудите применение VALEKLOR и возможные следующие шаги — по оценке врача.
Получите рецепт на VALEKLOR онлайн
Заполните форму за 2 минуты
Расскажите о симптомах, истории болезни и нужном препарате.
Выберите врача или мы назначим
Выберите специалиста или мы подберём ближайшего доступного врача.
Врач рассматривает ваш случай
Обычно в течение 30 минут. Может задать уточняющие вопросы в чате.
Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
VALEKLOR не требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество VALEKLOR — cefaclor. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
VALEKLOR производится компанией SIAR PHARMA 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 VALEKLOR 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 VALEKLOR 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 (cefaclor) включают KEFAKLOR EG, KLORATSER, KLIAKEF. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















