Imipenem+Cilastatin RBX
국가: 뉴질랜드
언어: 영어
출처: Medsafe (Medicines Safety Authority)
환자 정보 전단 유효 성분:
Cilastatin sodium 530.7mg equivalent to 500 mg cilastatin; Imipenem monohydrate 530.1mg equivalent to 500 mg imipenem
제공처:
Douglas Pharmaceuticals Limited
INN (International Name):
Cilastatin sodium 530.7 mg (equivalent to 500 mg cilastatin)
복용량:
500mg/500mg
약제 형태:
Powder for injection
구성:
Active: Cilastatin sodium 530.7mg equivalent to 500 mg cilastatin Imipenem monohydrate 530.1mg equivalent to 500 mg imipenem Excipient: Sodium bicarbonate
패키지 단위:
Bottle, glass, Type 1 clear, 10 x 100mL infusion bottle, with bromobutyl rubber plug, PP filp-off seal, 1 L
수업:
Prescription
처방전 유형:
Prescription
Manufactured by:
Sun Pharmaceutical Industries Ltd
치료 징후:
Indicated for the treatment of the following infections due to susceptible organisms: · Intra-abdominal infections · Lower respiratory tract infections · Gynaecological infections · Septicaemia · Genitourinary tract infections · Bone and joint infections · Skin and soft tissue infections · Endocarditis Indicated for the treatment of mixed infections caused by susceptible strains of aerobic and anaerobic bacteria. The majority of these mixed infections are associated with contamination by faecal flora or flora originating from the vagina, skin and mouth. In these mixed infections, Bacteroides fragilis is the most commonly encountered anaerobic pathogen and is usually resistant to aminoglycosides, ephalosporins and penicillins. However, Bacteroides fragilis is usually susceptible to imipenem and cilastatin combination. Imipenem and cilastatin combination has demonstrated efficacy against many infections caused by aerobic and anaerobic gram-positive and gram-negative bacteria resistant to the cephalosporins, including cefazolin, cefoperazone, cephalothin, cefoxitin, cefotaxime, moxalactam, cefamandole, ceftazidime and ceftriaxone. Similarly, many infections caused by organisms resistant to aminoglycosides (gentamicin, amikacin, tobramycin) and/or penicillins (ampicillin, carbenicillin, penicillin-G, ticarcillin, piperacillin, azlocillin, mezlocillin) responded to treatment imipenem and cilastatin. IMIPENEM+CILASTATIN RBX is not indicated for the treatment of meningitis.
제품 요약:
Package - Contents - Shelf Life: Bottle, glass, Type 1 clear, 100mL infusion bottle, with bromobutyl rubber plug and PP filp-off seal - 1 dose units - 24 months from date of manufacture stored at or below 25°C - Bottle, glass, Type 1 clear, 100mL infusion bottle, with bromobutyl rubber plug, PP filp-off seal - 10 dose units - 24 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, Type 1 clear 30mL vial, chlorobutyl rubber plug, PP flip-off lid - 1 dose units - 36 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, Type 1 clear, chlorobutyl rubber plug, 22mL vial with transfer set - 1 dose units - 24 months from date of manufacture stored at or below 25°C
승인 날짜:
2011-06-07
환자 정보 전단
IMIPENEM+CILASTATIN RBX
®
_imipenem/cilastatin sodium _
500 mg/500 mg Powder for Solution for Infusion
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about IMIPENEM+CILASTATIN
RBX. It does not contain all the available information. It does not take the place of
talking to your doctor or pharmacist. All medicines have risks and benefits. Your
doctor has weighed the risks of you using IMIPENEM+CILASTATIN RBX against
the benefits he or she expects it will have for you. If you have any concerns about
being given this medicine, ask your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
WHAT IMIPENEM+CILASTATIN RBX IS USED FOR
IMIPENEM+CILASTATIN RBX is an antibiotic which is used to treat serious
infections caused by bacteria (germs). These infections may occur in many
different parts of the body. IMIPENEM+CILASTATIN RBX is sometimes given in
addition to other antibiotics. IMIPENEM+CILASTATIN RBX works by killing the
bacteria causing the infection.
BEFORE YOU ARE GIVEN IMIPENEM+CILASTATIN RBX
WHEN YOU MUST NOT BE GIVEN IT
Do not use IMIPENEM+CILASTATIN RBX if you have an allergy to the active
ingredients imipenem/cilastatin sodium or any of the ingredients listed at the end
of this leaflet.
BEFORE YOU ARE GIVEN IT
Your doctor must know about all of the following before you are given
IMIPENEM+CILASTATIN RBX, if you have or have had:
• any allergies to other antibiotics, in particular, penicillins and cephalosporins
• allergies to any other substances, such as foods, preservatives, or dyes If you
have any of these allergies you may be allergic to IMIPENEM+CILA
전체 문서 읽기
제품 특성 요약
1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
IMIPENEM+CILASTATIN RBX 500 mg/500 mg powder for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each container contains 530.1 mg of imipenem monohydrate (equivalent
to 500 mg imipenem)
and 530.7 mg of cilastatin sodium (equivalent to 500 mg cilastatin).
EXCIPIENT(S) WITH KNOWN EFFECT
Each container contains sodium bicarbonate (equivalent to 37.5 mg (1.6
mEq) sodium). For the
full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Imipenem is a light tan to white, nonhygroscopic, ultraviolet
light-sensitive, crystalline
compound which is sparingly soluble in water, and slightly soluble in
methanol.
Cilastatin is an off-white to yellowish-white, hygroscopic, amorphous
compound which is very
soluble in water or methanol.
IMIPENEM+CILASTATIN RBX for intravenous use is supplied as a white to
pale yellow sterile
powder. The reconstituted solution is clear (however variations in
colour from colourless to
yellow do not affect the potency of the product).
IMIPENEM+CILASTATIN RBX for intramuscular use is not available in New
Zealand.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
The activity of IMIPENEM+CILASTATIN RBX against an unusually broad
spectrum of pathogens
makes it particularly useful in the treatment of polymicrobic mixed
aerobic/anaerobic infections
as well as initial therapy prior to the identification of the
causative organisms.
IMIPENEM+CILASTATIN RBX is indicated for the treatment of the
following infections due to
susceptible organisms:
•
Intra-abdominal infections
•
Lower respiratory tract infections
•
Gynaecological infections
•
Septicaemia
•
Genitourinary tract infections
2 | P a g e
•
Bone and joint infections
•
Skin and soft tissue infections
•
Endocarditis
IMIPENEM+CILASTATIN RBX is indicated for the treatment of mixed
infections caused by
susceptible strains of aerobic and anaerobic bacteria. The majority of
these mixed infections are
associated with contamination by faecal flora or flora originatin
전체 문서 읽기
