DALACIN C PHOSPHATE STERILE

Parenteral (IM or IV administration) - ‘see Method of administration’ below. 2 g/day in two, three or four equal doses. 7 g/day in two, three or four equal doses. 2 g in a single one-hour infusion. For more serious infections, these doses may have to be increased.

8 g daily have been given intravenously to adults. Alternatively, the drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV infusion. Treatment for infections caused by beta-haemolytic streptococci should be continued for at least 10 days to guard against subsequent rheumatic fever or glomerulonephritis.

Paediatric population (over 1 month in age) Serious infections: 15-25 mg/kg/day in three or four equal doses. Clindamycin should be dosed based on total body weight regardless of obesity. More severe infections: 25-40 mg/kg/day in three or four equal doses.

In severe infections it is recommended that children be given no less than 300 mg/day regardless of body weight. Elderly patients The half-life, volume of distribution and clearance, and extent of absorption after administration of clindamycin phosphate are not altered by increased age.

Analysis of data from clinical studies has not revealed any age-related increase in toxicity. Dosage requirements in elderly patients should not be influenced, therefore, by age alone. See Precautions for other factors which should be taken into consideration.

Method of administration Parental (IM or IV administration). This medicine should be used undiluted for IM administration. This medicine must be diluted prior to IV administration and should be infused over at least 10-60 minutes. Dilution for IV use and IV infusion rates The concentration of clindamycin in diluent for infusion should not exceed 18 mg per ml and INFUSION RATES SHOULD NOT EXCEED 30 MG PER MINUTE.

The usual infusion rates are as follows:

Dose Diluent Time 300 mg 600 mg 900 mg 1200 mg 50 ml 50 ml 50-100 ml 100 ml 10 min 20 min 30 min 40 min

The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency.

The frequency grouping is defined using the following convention:

Very common (≥1/10); Common (≥ 1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥ 1/10,000 to <1/1,000); Very Rare (< 1/10,000); and Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

System Organ Class Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1 000 to <1/100 Rare ≥ 1/10 000 to <1/1 000 Very Rare < 1/10 000 Not Known (cannot be estimated from available data) Infections and Infestations pseudomembran ous colitis*# vaginal infection* Blood and Lymphatic System Disorders agranulocytosis*, neutropenia*, thrombocytopenia*, leukopenia*, eosinophilia Immune System Disorders anaphylactic shock*, anaphylactoid reaction*, anaphylactic reaction*, Kounis syndrome*, hypersensitivity* Nervous System Disorders dysgeusia Cardiac Disorders cardio- respiratory arrest †§, Vascular Disorders thrombophlebitis † hypotension† § Gastrointestinal Disorders diarrhoea, nausea, abdominal pain, vomiting, oesophageal ulcers, oesophagitis Hepatobiliary Disorders jaundice* Skin and Subcutaneous Tissue Disorders rash maculopapular urticaria erythema multiforme, pruritus toxic epidermal necrolysis (TEN)*, Stevens-Johnson syndrome (SJS)*, System Organ Class Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1 000 to <1/100 Rare ≥ 1/10 000 to <1/1 000 Very Rare < 1/10 000 Not Known (cannot be estimated from available data) drug reaction with eosinophilia and systemic symptom (DRESS)*, acute generalised exanthematous pustulosis (AGEP)*, dermatitis exfoliative*, dermatitis bullous*, cutaneous vasculitis*, rash morbilliform*, symmetrical drug- related intertriginous and flexural exanthema* Renal and urinary disorders acute kidney injury# General Disorders and Administrative Conditions pain†, injection site abscess† injection site irritation†* Investigations liver function test abnormal * ADR identified post-marketing.

Warnings This medicine contains benzyl alcohol (see section 2). The preservative benzyl alcohol may cause hypersensitivity reactions. Intravenous administration of benzyl alcohol has been associated with serious adverse events, and death in paediatric patients including neonates (“gasping syndrome”).

Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome”, the minimum amount of benzyl alcohol at which toxicity may occur is not known.

Benzyl alcohol containing formulations should only be used in neonates if it is necessary and if there are no alternatives possible. Premature and low-birth weight neonates may be more likely to develop toxicity. Benzyl alcohol containing formulations should not be used for more than 1 week in children under 3 years of age unless necessary.

It is important to consider the total quantity of benzyl alcohol received from all sources, and high volumes should be used with caution and only if necessary, especially in patients with liver or kidney impairment, as well as in pregnant or breast-feeding women, because of the risk of accumulation and toxicity (metabolic acidosis).

Severe hypersensitivity reactions, including severe skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalised exanthematous pustulosis (AGEP), and Kounis syndrome have been reported in patients receiving clindamycin therapy.

8). This medicine should only be used in the treatment of serious infections. In considering the use of the product, the practitioner should bear in mind the type of infection and the potential hazard of the diarrhoea which may develop, since cases of colitis have been reported during, or even two or three weeks following, the administration of clindamycin.

1. 6).