CLINDAMYCIN INJECTIONS

Երկիր: Իսրայել

Լեզու: անգլերեն

Աղբյուրը: Ministry of Health

Ակտիվ բաղադրիչ:

CLINDAMYCIN AS PHOSPHATE

Հասանելի է:

RAFA LABORATORIES LTD

ATC կոդը:

J01FF01

Դեղագործական ձեւ:

SOLUTION FOR INJECTION

Կազմը:

CLINDAMYCIN AS PHOSPHATE 150 MG/ML

Կառավարման երթուղին:

I.M, I.V

Ռեկվիզորի տեսակը:

Required

Պատրաստված է:

RAFA LABORATORIES LTD, JERUSALEM

Թերապեւտիկ խումբ:

CLINDAMYCIN

Թերապեւտիկ տարածք:

CLINDAMYCIN

Թերապեւտիկ ցուցումներ:

The treatment of infections caused by susceptible anaerobic bacteria.

Հաստատման ամսաթիվը:

2020-10-31

Տեղեկատվական թերթիկ

)תוחיטב עדימ( הרמחה לע העדוה
)תוחיטב עדימ( הרמחה לע העדוה :ל חולשל(
(
[e-mail]
ךיראת :
9
ב ילוי
2015
:תילגנאב רישכת םש
CLINDAMYCIN INJECTIONS
:םושיר ירפסמ
120
48
30032
םושירה לעב םש :
מ"עב אפר תודבעמ
אפורל ןולעב
אפורל ןולעב
ןולעב קרפ
)םייקה טסקטה תמועל םייתועמשמה
םייונישה ןומיס ללוכ( שדח טסקט
4.4 SPECIAL
WARNINGS AND
PRECAUTION FOR
USE
WARNINGS
This product contains benzyl alcohol (10 mg/ml as preservative).
Intravenous
administration of the preservative benzyl alcohol has been associated
with
serious adverse events, and death in paediatric patients including
neonates
characterized by central nervous system depression, metabolic
acidosis,
gasping respirations, cardio-vascular failure and haematological
anomalies
(“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. Use only
if it is
necessary and if there are no alternatives possible. If given in high
volumes, it
should be used with caution and preferably for short term treatment in
subjects
with liver or kidney impairment because of the risk of accumulation
and toxicity
(metabolic acidosis) due to benzoic acid (a metabolite of benzyl
alcohol).
Premature and low-birth weight infants may be more likely to develop
toxicity.
Benzyl Alcohol containing products should not be used in pre-term or
full-term
neonates unless strictly necessary.
Benzyl alcohol can cross the placenta and clindamycin should only be
used
during pregnancy if clearly needed (see section 4.6).
…
4.5 INTERACTION
WITH OTHER
MEDICINAL
PRODUCTS AND
OTHER FORMS OF
INTERACTION
…
Vitamin K antagonists
Increased coagulation tests (PT/INR) and/or bleeding have

Ապրանքի հատկությունները

1
DOCTOR LEAFLET
1. NAME OF THE MEDICINAL PRODUCT
Clindamycin Injections
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 150 mg clindamycin (as phosphate).
Each ampoule of 4 ml contains 600 mg clindamycin (as phosphate).
Excipients with known effect:
Each ml of solution contains 10 mg of benzyl alcohol.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for IV or IM Injection.
Clear, almost colourless, sterile solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of infections caused by susceptible anaerobic
bacteria.
Clindamycin does not penetrate the blood/brain barrier in
therapeutically effective quantities.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology_ _
Parenteral (IM or IV administration).
Clindamycin Injections MUST be diluted prior to IV administration and
should be infused over at
least 10-60 minutes.
_Adults _
Serious infections: 600mg-1.2 g/day in two, three or four equal doses.
More severe infections: 1.2-2.7 g/day in two, three or four equal
doses.
Single IM injections of greater than 600 mg are not recommended nor is
administration of more
than 1.2 g in a single one-hour infusion.
For more serious infections, these doses may have to be increased. In
life-threatening situations,
doses as high as 4.8 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.
_ _
_Pediatric population _
_Children (over 1 month of age)_:
Serious infections: 15-25 mg/kg/day in three or four equal doses.
2
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 no