Medicinal Products

DALACINE 900 mg 900 mg / 6 mL

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

Injectable solution
Box of 1 ampoule of 6 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 900 mg 900 mg / 6 mL Solution for injection Box of 1 ampoule of 6 ml

Dosage

Cure

· Adults: 600 to 2400 mg / 24 hours, in 2, 3 or 4 administrations;

· Children: 15 to 40 mg / kg / 24 hours, in 3 or 4 administrations.

Prophylactic treatment

Antibiotic prophylaxis should be short-term, usually limited to the intraoperative period, sometimes 24 hours, but never more than 48 hours.

· For all surgeries except ENT surgery and appendectomy: injection of 600 mg IV at anesthetic induction, followed by reinjection of the same dose every 4 hours, until the end of the procedure .

· For appendectomy, a single dose is sufficient.

· For ENT oncological surgery, an injection of 600 mg every 6 hours for 24 hours, without exceeding 48 hours.

Administration mode

· Intramuscular route
Intramuscular administration of more than 600 mg at one time is not recommended.

· Intravenous way

Never administer IV directly and always dilute beforehand in an isotonic solution of sodium chloride or glusose.

The dilution volume and the minimum duration of infusion will be determined according to the dose administered as follows:

dose

dilution volume

minimum duration of infusion

300 mg

50 ml

10 minutes

600 mg

50 ml

20 minutes

900 mg

50 - 100 ml

30 minutes

1200 mg

100 ml

40 minutes

The concentration of clindamycin should not exceed 18 mg / ml and the injection rate should not exceed 30 mg / min.

Against indications

This medicine should never be used:

· If you are allergic to lincomycin or clindamycin

· In children under 3 years, due to the presence of benzyl alcohol

· Breastfeeding (see section on Pregnancy and breastfeeding ).

Side effects Dalacine 900 MG

Hematological and lymphatic system disorders:

· Neutropenia, leukopenia, agranulocytosis, thrombocytopenic purpura, eosinophilia.

Nervous system disorders:

· Dysgeusia.

Gastrointestinal disorders:

· Abdominal pain, diarrhea, antibiotic associated colitis (potentially fatal in very rare cases) (see Warnings and Precautions section ).

· Nausea, vomiting.

Skin and subcutaneous tissue disorders:

· Rare cases of erythema multiforme, Stevens-Johnson syndrome or Lyell.

Pruritus, rash, urticaria, maculopapular eruptions, rare cases of desquamative eruptions and erythroderma; very rare cases of acute generalized exanthematous pustulosis (PEAG) (see Warnings and Precautions for Use section ).

Immune system disorders:

· Hypersensitivity reactions such as angioedema and anaphylaxis in some penicillin-allergic subjects (see Warnings and Precautions section ).

Hepatobiliary disorders:

· A few cases of jaundice and liver function disorders (transaminases) without any direct relationship between the administration of clindamycin and hepatic dysfunction could be established.

General disorders and administration site defects:

· After intravenous administration too fast (see section Dosage and method of administration ), rare cases of hypotension or even cardiac arrest.

· Following intramuscular administration, clindamycin is generally well tolerated.

· Some cases of thrombophlebitis.

These reactions can be reduced by performing deep intramuscular injections and avoiding the permanent use of catheters.

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