КЛОРАЦЕР 750 мг Модифицированные таблетки
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Инструкция по применению KLORATSER
NAME OF THE MEDICINAL PRODUCT
CLORAZER 750 mg modified-release tablets
Cefaclor
COMPOSITION
Each tablet contains:
Active ingredient:cefaclor monohydrate equivalent to cefaclor 750 mg
Excipients:
Mannitol, methylhydroxypropylcellulose, hydroxypropylcellulose, acrylic acid copolymer,
stearic acid, magnesium stearate, blue coloring mixture, propylene glycol.
PHARMACEUTICAL FORM
Modified-release tablets of 750 mg for oral use.
PHARMACOTHERAPEUTIC CATEGORY
CLORAZER is a broad-spectrum antibiotic for oral administration belonging to the
cephalosporin class.
HOLDER OF THE MARKETING AUTHORISATION
Biomed Pharma S.r.l.,
Via Colla 6/3,
17014 Cairo Montenotte (SV)
PRODUCED AND CONTROLLED BY
FACTA FARMACEUTICI S.p.A.
Via Laurentina Km 24,730 - 00040 Pomezia (RM)
THERAPEUTIC INDICATIONS
CLORAZER is indicated for the treatment of the following infections caused by susceptible germs:
Acute bronchitis and exacerbation of chronic bronchitis.
Pharyngitis and tonsillitis.
Uncomplicated lower urinary tract infections.
Skin and soft tissue infections.
CONTRAINDICATIONS
Hypersensitivity to cefaclor or cephalosporin antibiotics, or to any other components.
PRECAUTIONS FOR USE
There have been patients who have experienced severe reactions (including anaphylaxis) following
administration of penicillins or cephalosporins including cefaclor, IgE-mediated reactions that usually
manifest at the skin, gastrointestinal, respiratory and cardiovascular levels. Symptoms may include:
severe and sudden hypotension, acceleration and slowing of the heart rate, unusual fatigue or
weakness, anxiety, agitation, dizziness, loss of consciousness, difficulty 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.
Before initiating therapy with CLORAZER, careful investigation should be made as to whether
the patient has had previous hypersensitivity reactions to cephalosporins,
penicillins or other drugs. If an allergic reaction to
CLORAZER occurs, discontinue administration of the drug.
Treatment with broad-spectrum antibiotics, including CLORAZER, alters the normal flora of the
colon and causes an increase in the number of clostridia. Various studies have shown that
a toxin produced by Clostridium difficileis the main cause of severe diarrhea
associated with antibiotic therapy, including pseudomembranous colitis. Colitis
pseudomembranous has been reported with the use of broad-spectrum antibiotics (including
macrolides, semi-synthetic penicillins and cephalosporins); therefore, it is important to consider
this diagnosis in patients who develop diarrhea during antibiotic therapy.
Cases of mild colitis usually respond to discontinuation of the drug alone. In
cases of moderate or severe severity, appropriate therapeutic measures should be taken, which
should include performing appropriate bacteriological studies and administering
fluids, electrolytes and proteins.
If the colitis does not improve after discontinuation of the drug or if the symptoms are not severe, oral
vancomycin is the treatment of choice.
As with other antibiotics, during treatment with CLORAZER, the possible emergence of resistant
microorganisms should be considered, which may result in a
superinfection for which appropriate measures must be taken.
INTERACTIONS
The extent of absorption of CLORAZER decreases if antacids containing magnesium hydroxide or
aluminum are administered within one hour of taking the antibiotic, while H2-blockers do not alter
the rate and extent of CLORAZER absorption.
Similarly to other beta-lactam antibiotics, the renal excretion of cefaclor (and
presumably CLORAZER) is inhibited by the administration of probenecid (a drug
used to promote uric acid excretion); no other significant interactions with drugs have been observed
during clinical studies.
SPECIAL WARNINGS
CLORAZER has no effects on the ability to drive and operate machinery.
Carcinogenesis, mutagenesis, impairment of fertility
No studies have been conducted in animals to assess the potential for carcinogenicity or
mutagenicity of CLORAZER.
Reproduction studies have revealed no evidence of impaired fertility.
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 CLORAZER during labor and delivery has not been studied; therefore, the drug
should only be administered if clearly needed.
The effects of CLORAZER on the nursing infant are unknown. Caution is recommended when using the
drug during breastfeeding.
Use in children
The efficacy and tolerability of CLORAZER in children has not been well established.
DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
CLORAZER is administered orally and can be taken independently of
meals. However, concomitant intake of food increases the absorption of
CLORAZER. The tablets must be taken whole, and therefore not broken, crushed
or chewed.
The following dosage regimens are recommended:
- Pharyngitis, tonsillitis and skin and tissue infections: 375 mg 2 times a day.
- Uncomplicated lower urinary tract infections: 375 mg 2 times a day.
- Bronchitis: 375 mg 2 times a day. In more severe infections, higher doses may be necessary (750 mg 2 times a day). In the treatment of infections caused by S. pyogenes(group A streptococci), therapy with CLORAZER should be continued for up to 10 days.
OVERDOSE
Signs and symptoms:may include nausea, vomiting, epigastric discomfort and diarrhea; the
severity of gastric and diarrheal disorders is related to the dose taken. If other symptoms are present,
these are likely to be secondary to a pre-existing underlying condition, an
allergic reaction or another toxic state.
Treatment:in the treatment of overdose, consider the possibility of overdose
due to multiple drugs, drug interactions or unusual pharmacokinetics in the patient.
Ensure adequate ventilation and perfusion of the patient's airways.
Carefully monitor and maintain the patient's vital signs (heart rate and blood pressure), blood gas
analysis, serum electrolytes, etc. within acceptable limits.
Intestinal absorption of drugs may be reduced by administering activated charcoal, which in many
cases is more effective than induced vomiting or gastric lavage; therefore, activated charcoal should
be considered as an alternative or addition to gastric emptying. Repeated administration of activated
charcoal may facilitate the elimination of other drugs that may have been absorbed.
It is necessary to protect the patient's airways when gastric emptying or the use of activated charcoal is performed.
It is not known whether forced diuresis, peritoneal dialysis, hemodialysis or hemoperfusion with
charcoal is beneficial to the patient in the treatment of CLORAZER overdose.
TO OBTAIN APPROPRIATE CLARIFICATIONS ON THE USE OF THE MEDICINAL PRODUCT
CONTACT YOUR DOCTOR OR PHARMACIST.
UNDESIRABLE EFFECTS
Adverse reactions considered relatable to treatment with CLORAZER are the
following: Allergic reactions: hypersensitivity reactions (1.5%) have been observed
including morbilliform rashes (1%); itching, urticaria and positive Coombs test occur in less than 1
in 200 treated patients. Generalized reactions called "serum-like diseases” have also been reported,
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. “Serum-like disease” 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, transient hepatitis and cholestatic jaundice have been
rarely observed. Other manifestations: angioedema (abnormal fluid retention
in tissues, of allergic origin), 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 certainty is lacking
regarding correlation with treatment: Central nervous system: rarely reversible hyperactivity,
restlessness, insomnia, mental confusion, hypertonia (increased muscle tone), hallucinations, feeling
of instability and dizziness, drowsiness. Digestive system:
mild increases in the values of transaminases (SGOT and SGPT) or alkaline phosphatase. Hemolymphatic system: transient lymphocytosis, leukopenia and, rarely, hemolytic anemia, aplastic anemia, agranulocytosis and reversible neutropenia. Rare reports of increased
prothrombin time, with or without clinical consequences (e.g. bleeding), have been
reported in patients receiving cefaclor and Warfarin sodium (antithrombotic drug) concurrently.
Genitourinary system: slight increases in azotemia, creatinine and alterations in urine analysis.
undesirable.
IF YOU EXPERIENCE ANY UNDESIRABLE EFFECTS - EVEN DIFFERENT
FROM THOSE DESCRIBED - THE PATIENT IS INVITED TO REPORT THEM TO
HIS DOCTOR OR PHARMACIST.
Expiry date: see the expiry date indicated on the packaging.
This date refers to the product in intact packaging, stored correctly.
WARNING: DO NOT USE THE MEDICINAL PRODUCT AFTER THE EXPIRY DATE
INDICATED ON THE PACKAGING
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF
CHILDREN
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- Страна регистрации
- Форма выпускаModified-release tablet, 750 MG
- Код АТХJ01DC04
- 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 KLORATSERФорма выпуска: Granules for oral suspension, 250 MG/5 MLДействующее вещество: cefaclorОтпускается без рецептаФорма выпуска: Granules for oral suspension, 250 MG/5 MLДействующее вещество: cefaclorПроизводитель: S.F. GROUP S.R.L.Отпускается без рецепта
Аналоги KLORATSER в других странах
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Аналог KLORATSER в Польша
Аналог KLORATSER в Испания
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Часто задаваемые вопросы
KLORATSER требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество KLORATSER — cefaclor. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
KLORATSER производится компанией BIOMED 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 KLORATSER 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 KLORATSER 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, KLIAKEF, MAKOVAN. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
