Medicinal Products

DALACINE 150 mg

Generic drug of the therapeutic class: Infectiology - Parasitology
Active ingredients: Clindamycin
laboratory: Pfizer Pfe France

capsule
box of 12
All forms

Indication

They arise from the antibacterial activity and pharmacokinetic characteristics of clindamycin. They take into account both the clinical studies that the drug has given and its place in the range of antibacterial products currently available.

In curative:

They are limited to severe infections, due to germs defined as sensitive in their manifestations:

· ENT,

· Bronchopulmonary,

· Stomatological,

· Cutaneous,

· Genital,

· Osteoarticulars,

· Post-surgical abdominal,

· Septicemic.

With the exception of meningeal infections, even with sensitive germs, because of insufficient diffusion of this antibiotic in the CSF.

In prophylaxis:

Prophylaxis of infectious endocarditis during dental care and upper airways during ambulatory care for beta-lactam allergy.

Official recommendations concerning the appropriate use of antibacterials should be taken into account.

Dosage DALACINE 150 mg capsule box of 12

They arise from the antibacterial activity and pharmacokinetic characteristics of clindamycin. They take into account both the clinical studies that the drug has given and its place in the range of antibacterial products currently available.

In curative:

They are limited to severe infections, due to germs defined as sensitive in their manifestations:

· ENT,

· Bronchopulmonary,

· Stomatological,

· Cutaneous,

· Genital,

· Osteoarticulars,

· Post-surgical abdominal,

· Septicemic.

With the exception of meningeal infections, even with sensitive germs, because of insufficient diffusion of this antibiotic in the CSF.

In prophylaxis:

Prophylaxis of infectious endocarditis during dental care and upper airways during ambulatory care for beta-lactam allergy.

Official recommendations concerning the appropriate use of antibacterials should be taken into account.

Against indications

This medicine should never be used:

· In case of hypersensitivity to the active substance clindamycin and lyncomycin or to any of the excipients listed under Composition

· In children under 6, due to the pharmaceutical form,

If breastfeeding (see section Pregnancy and breast-feeding ).

Side effects Dalacine

The table below lists adverse reactions identified in clinical trials and post-marketing surveillance by organ-class system and frequency.

According to the organ classification system, adverse reactions are listed below in order of frequency and then by clinical importance using the following categories: very common ((≥1 / 10), frequent (≥1 / 100 to <1 / 10), uncommon (≥1 / 1000 to <1/100), rare (≥1 / 10000 to <1/1000), very rare (<1/10000), indeterminate frequency (can not be estimated on the basis of available data).

Table of adverse effects

Organ-class system

Frequent ≥ 1/100 to <1/10

Uncommon ≥ 1/1000 to <1/100

Rare ≥ 1/10000 to <1/1000

Very rare <1/10000

Not known (can not be estimated from the available data)

Infections and infestations

Vaginal infection

Blood and lymphatic system disorders

Agranulocytosis, Leukopenia, Neutropenia, Thrombocytopenia,

eosinophilia

thrombocytopenic purpura

Immune system disorders

Hypersensitivity reactions such as angioedema and anaphylaxis in some people with penicillin allergy *;

DRESS syndrome

(drug hypersensitivity syndrome with eosinophilia and systemic symptoms)

Nervous system disorders

dysgeusia

Gastrointestinal disorders

Diarrhea, abdominal pain

Pseudo-membranous colitis *

Nausea, Vomiting

Esophagitis, esophageal ulcer

Hepatobiliary disorders

Abnormal liver function tests

icterus

Skin and subcutaneous tissue disorders

Maculopapular rash, Urticaria

Toxic epidermal necrolysis

(Lyell's syndrome),

Stevens Johnson syndrome,

Exfoliative dermatitis, Bullous dermatosis, Morbilliform eruptions, Acute generalized exanthematous pustulosis (PEAG),

Erythema multiforme,

itching

* See section Warnings and precautions for use

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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