DALACINE 600 mg

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

Injectable solution
box of 1 ampoule of 4 ml
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 healing

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

· ENT,

· Bronchopulmonary,

· Stomatological,

· Cutaneous,

· Genital,

· Osteoarticulars,

· Post-surgical abdominal,

· Septicemia,
with the exception of meningeal infections, even with susceptible germs, due to insufficient diffusion of this antibiotic into the CSF.

In prophylaxis

For patients allergic to beta-lactams, prophylaxis of post-operative infections in:

· Neurosurgery

· Mesocolic digestive surgery in combination with an aminoglycoside;

ORL oncological surgery with opening of the oropharyngeal tract in association with an aminoglycoside;

· Gynecological surgery in association with an aminoglycoside;

· Limb amputation in association with an aminoglycoside.

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

Dosage DALACINE 600 mg solution for injection 1 ampoule of 4 ml

In healing

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

· ENT,

· Bronchopulmonary,

· Stomatological,

· Cutaneous,

· Genital,

· Osteoarticulars,

· Post-surgical abdominal,

· Septicemia,
with the exception of meningeal infections, even with susceptible germs, due to insufficient diffusion of this antibiotic into the CSF.

In prophylaxis

For patients allergic to beta-lactams, prophylaxis of post-operative infections in:

· Neurosurgery

· Mesocolic digestive surgery in combination with an aminoglycoside;

ORL oncological surgery with opening of the oropharyngeal tract in association with an aminoglycoside;

· Gynecological surgery in association with an aminoglycoside;

· Limb amputation in association with an aminoglycoside.

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 3, due to the presence of benzyl alcohol

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

Side effects Dalacine 600 Mg

The table below lists adverse reactions from 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
Heart conditions		Cardiac arrest , Hypotension
Vascular disorders	thrombophlebitis *
Gastrointestinal disorders	Pseudo-membranous colitis *	Diarrhea, Nausea			Abdominal pain vomiting
Hepatobiliary disorders	Abnormal liver function tests				icterus
Skin and subcutaneous tissue disorders	Maculopapular eruptions	Erythema multiforme itching Urticaria			Toxic epidermal necrolysis (Lyell syndrome), Steven Johnson syndrome, Exfoliative dermatitis, Bullous dermatosis, Morbilliform eruptions, Acute generalized exanthematous pustulosis (PEAG)
General disorders and administration site conditions		pain, Abscess			Irritations at the injection site *

* 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.