Dalacin C Phosphate solution for injection 150mg/ml, 2 ml x 1 ampoule — Made in Belgium — Free Delivery

Product description

The active ingredient of the preparation Dalacin C Phosphate is clindamycin, a semi-synthetic antibiotic that is synthesized from lincomycin by replacing the 7- (R) hydroxyl group with 7- (S) -chlorogroup.

Indications for use

Clindamycin is indicated for the treatment of severe infections caused by susceptible strains of gram-positive aerobic microorganisms, such as streptococci, pneumococci, and staphylococci, or susceptible anaerobic bacteria.

Upper respiratory tract infections: chronic sinusitis caused by anaerobic strains. Clindamycin can be used to treat some cases of chronic suppurative otitis media or as an adjunctive therapy in combination with antibiotics active against aerobic gram-negative microorganisms. The indications do not apply to infections caused by H. influenzae. Clindamycin can be used to treat recurrent pharyngotonsillitis.

Lower respiratory tract infections, including infectious exacerbation of chronic bronchitis and pneumonia.

Severe infections of the skin and soft tissues caused by sensitive microorganisms.

Bone and joint infections, including osteomyelitis and septic arthritis.

Severe gynecological infections, including pelvic inflammatory disease. Clindamycin monotherapy can also be used for Chlamydia trachomatis cervicitis.

Intra-abdominal infections, including peritonitis and abdominal abscesses.

Septicemia and endocarditis. In isolated cases of septicemia and / or endocarditis caused by susceptible microorganisms, an appropriate response to clindamycin has been obtained. However, antibacterial preparations are predominantly used to treat these infections.

Dental infections, including periodontal abscess and periodontitis.

Toxoplasmic encephalitis in AIDS patients. Clindamycin can be used in combination with pyrimethamine in patients with intolerance to standard treatment.

Pneumocystis jirovecii pneumonia in AIDS patients. Clindamycin can be used in combination with primaquine in patients with intolerance to standard treatment.

Severe malaria.

Prevention of endocarditis in patients with penicillin allergy / hypersensitivity.

Prevention of wound infection during surgery in the head and neck area. Clindamycin phosphate, dissolved in saline, can be used for intraoperative irrigation of the surgical site.

Prevention of peritonitis and intra-abdominal abscesses after perforation and post-traumatic contamination when used simultaneously with aminoglycoside antibiotics (gentamicin or tobramycin).

As with all antibiotics, information on the prevention of local resistance and the official guidelines for antibiotic prescribing should be consulted before prescribing clindamycin.

Contraindications

Hypersensitivity to the active substance, lincomycin or excipients specified in the "Composition" section.

Infectious meningitis.

Method of administration and dosage

Doses.

The method of administration and dose should be determined according to the severity of the infection, the condition of the patient and the sensitivity of the microorganism that causes the disease.

When administered, clindamycin phosphate should be used undiluted.

Phosphate must be diluted before clindamycin is administered.

Adults (intravenous or intramuscular). For the treatment of intra-abdominal infections, infections of the pelvic organs in women and other severe infections, the standard dose of clindamycin phosphate is 2400-2700 mg (2, 3 or 4 injections in equal doses) and, as a rule, is used in combination with an acceptable antibiotic active against gram-negative aerobic microorganisms.

For less complicated infections caused by more sensitive microorganisms, a response to treatment can be observed when using low doses: 1200-1800 mg per day (3 or 4 injections in equal doses).

Doses of up to 4800 mg daily have been used successfully for adults.

The use of a single intramuscular dose over 600 mg is not recommended.

Treatment of pelvic inflammatory disease: clindamycin phosphate 900 mg every 8:00 in combination with an acceptable antibiotic active against gram-negative microorganisms (for example gentamicin, 2 mg / kg first dose and then 1.5 mg / kg every 8:00), patients with normal renal function. This treatment should be continued for at least 4 days. With the appearance of clinical signs of improvement, treatment should be continued for another 2 days. Next, you should go to the oral administration of clindamycin hydrochloride at a dose of 1800 mg per day (in divided doses) until the end of the full course of treatment, which is 10-14 days.

Children aged 1 month and older (intravenously or intramuscularly). The preparation is prescribed at a dose of 20-40 mg / kg per day in 3 or 4 injections in equal doses).

The use of the preparation Dalacin C Phosphate for children under 3 years of age is indicated only if necessary (see Section "Peculiarities of use").

Patients with impaired renal and / or liver function. There is no need for dose adjustment in patients with impaired renal function. Hemodialysis and peritoneal dialysis are ineffective in removing clindamycin from the blood.

Patients with moderate to severe hepatic impairment exhibited a prolonged elimination half-life of clindamycin. If clindamycin is applied every 8:00, accumulation occurs in isolated cases. Therefore, dose reduction cannot be considered necessary.

Dosage for specific indications.

Toxoplasmic encephalitis in AIDS patients.

Dalacin C Phosphate should be used at a dose of 600-1200 mg every 6:00 for 2 weeks, then 300-600 mg orally in capsules every 6:00. Typically, a full course of treatment lasts 8 to 10 weeks. Within 8-10 weeks, pyrimethamine should be administered orally at a dose of 25-75 mg per day. Together with high doses of pyrimethamine, folic acid should be used at a dose of 10-20 mg per day.

Pneumocystis jirovecii pneumonia in AIDS patients.

The preparation is used by intravenous infusion at a dose of 600-900 mg every 6:00 or 900 mg every 8:00 for 21 days in combination with primaquine at a dose of 15-30 mg per day for 21 days.

Severe malaria.

Adults. Quinidine gluconate: loading dose is 10 mg / kg for 1-2 hours, then - 0.02 mg / kg / min, continuous infusion for at least 24 hours (an alternative dosing regimen is given in the instructions for medical use of quinidine). When the parasite density reaches <1% and the patient is able to administer preparations orally, it is necessary to supplement the treatment with oral quinine at the dose indicated above and oral clindamycin at a dose of 20 mg of active ingredient / kg / day (the dose is divided into 3 applications per day within 7 days).

If the patient is unable to administer preparations orally, a loading dose of clindamycin should be administered, which is 10 mg of active ingredient / kg, then 5 mg of active ingredient / kg every 8:00. Rapid administration should be avoided. It is necessary to switch to oral administration of clindamycin (the dose for oral administration is given above) as soon as the patient can use the preparations orally. The course of treatment lasts 7 days.

Children. Quinidine gluconate: same mg / kg dose and recommendations as for adults and oral clindamycin 20 mg active ingredient / kg / day (dose divided into 3 applications per day for 7 days). If the patient is unable to administer preparations orally, administer a loading dose of clindamycin of 10 mg active ingredient / kg, followed by 5 mg of active ingredient / kg every 8:00. Avoid rapid administration. Switch to clindamycin in the appropriate dosage form (oral dose indicated above) as soon as the patient is able to administer the preparations orally. The course of treatment lasts 7 days.

Prevention of endocarditis in patients sensitive to penicillin.

As an alternative treatment, if parenteral administration is required, 600 mg of clindamycin phosphate should be administered 1:00 before the procedure.

Prevention of infections during surgery in the head and neck area.

900 mg of clindamycin phosphate, dissolved in 1000 ml of saline, is used to flush the affected area during surgery in the head and neck area before closing the wound.

Mode of application.

Dilution and infusion rate for intravenous administration.

The concentration of clindamycin in a diluted state should not exceed 18 mg / ml, and the infusion rate should not exceed 30 mg / min (see Section "Adverse Reactions"). The infusion rates are shown below:

Intravenous infusion at doses exceeding 1200 mg per hour is not recommended.

Unused medicinal product or waste should be disposed of in accordance with local regulations.

Overdose

Clindamycin toxicity is not dose related. Overdose does not cause specific symptoms. Hemodialysis and peritoneal dialysis are ineffective in removing clindamycin from serum.

Compound

active substance: clindamycin;

1 ml clindamycin phosphate 150 mg (corresponds to clindamycin base)

Excipients: benzyl alcohol, sodium edetate, water for injection.

Storage conditions

Store at a temperature not exceeding 25 ° C, out of the reach of children.

Shelf life is 2 years.

Incompatibility

The following preparations  are physically incompatible with clindamycin phosphate solution for injection ampicillin, sodium phenytoin, barbiturates, aminophylline, calcium gluconate, magnesium sulfate, sodium ceftriaxone and ciprofloxacin.

Compatibility.

Solutions of clindamycin phosphate in 5% dextrose in water and sodium chloride solution, in which the following antibiotics are added at a standard concentration, remain stable for at least 24 hours: amikacin sulfate, aztreones, cefamandole nafate, cefazolin sodium, cefotaxime sodium, cefoxitin sodium , ceftazidime sodium, ceftizoxime sodium, gentamicin sulfate, netromycin sulfate, piperacillin, and tobramycin.

The compatibility and stability of these mixtures may vary depending on concentration and other conditions.