AmBisome

Main information

  • Trade name:
  • AmBisome 50 mg Powder for injection
  • Dosage:
  • 50 mg
  • Pharmaceutical form:
  • Powder for injection
  • Units in package:
  • Vial, glass, 1 vial, 20mL, 50 mg
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • North China Pharmaceutical Huasheng Co., Ltd

Documents

Localization

  • Available in:
  • AmBisome 50 mg Powder for injection
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • AmBisome is indicated for:· prophylaxis in liver transplant patients at risk of systemic Candida, Aspergillus and Cryptococcus infections, and for · the treatment of systemic fungal infections caused by organisms susceptible to Amphotericin B. AmBisome is indicated for empirical treatment of presumed fungal infections in febrile neutropaenic patients whose fever has failed to respond to broad spectrum antibiotic treatment. AmBisome is indicated for the treatment of visceral leishmaniasis. Clinical studies of efficacy in visceral leishmaniasis are limited to Leishmania infantum.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 7576
  • Authorization date:
  • 23-06-1995
  • Last update:
  • 27-09-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

AmBisome CMI (10 September 2014) Page 1 of 3

Consumer Medicine

Information

AmBisome

®

(liposomal

amphotericin) for injection

Please read this leaflet carefully

before you start to take your

medicine,

even

if

you

have

taken this medicine before.

medicine

your

doctor

prescribed

called

AmBisome

for Injection. This

is the brand name of a drug called

liposomal amphotericin.

This leaflet is only a summary of

information. Ask your doctor or

pharmacist

have

questions or are not sure about

your treatment with AmBisome.

They

will

have

more

detailed

information.

WHAT IS AMBISOME USED

FOR AND HOW DOES IT

WORK?

AmBisome contains

amphotericin

which

antibiotic that belongs to a group

of medicines called antifungals.

used

help

body

overcome

serious

fungal

infections

either

killing

fungus or stopping it spreading.

Amphotericin is also used to treat

disease

which

rare

Australia called leishmaniasis.

WHAT DO I NEED TO

KNOW BEFORE AND

WHILE TAKING THE

MEDICINE?

should

always

follow

advice

given

your

doctor or pharmacist. This leaflet

is not a substitute for things that

your doctor or pharmacist tell you

or should tell you, based on your

individual circumstances.

DO NOT TAKE AmBisome

IF YOU:

have

ever

reaction

amphotericin

other

ingredient in the injection. For

information on ingredients, see

the section headed

“What is

in AmBisome?”

If you have not done so already,

it is important to tell your doctor

or pharmacist immediately about

the following things, which may

have particular relevance to your

treatment.

Medical problems.

Tell your

doctor

pharmacist

presently have, or have ever

had,

medical

problems

especially

following:

kidney disease

liver disease

diabetes

Current medicines.

Tell your

doctor or pharmacist about any

other

medicines

currently taking, whether they

prescription

non-

prescription medicines.

In particular, tell your doctor of

pharmacist if you are taking any

of the following medicines (not

all brand names included):

anticancer agents

(chemotherapy)

digoxin (e.g. Lanoxin

flucytosine (e.g. Ancotil

cortisone-like medicine

(e.g. hydrocortisone,

betamethasone,

dexamethasone,

prednisolone,

methylprednisolone)

corticotrophin (e.g.

Acthargel)

dipyridamole (e.g.

Persantin

Other

medicines.

While

taking AmBisome do not take

any other medicines, whether

they are prescription or non-

prescription medicines unless

they

have

been

approved

recommended by a doctor or

pharmacist. Before any doctor

or pharmacist gives you any

other

medicines,

make

sure

they know you are receiving

treatment with AmBisome.

Allergies.

Tell your doctor or

pharmacist if you are sensitive

or allergic to:

amphotericin

any of the ingredients listed

under

“What is in

AmBisome?”

any foods, dyes or

preservatives

any other medicines

Pregnancy.

Tell your doctor

pharmacist

pregnant

become

pregnant

while

receiving

treatment

with

AmBisome.

Breast-feeding.

Tell

your

doctor or pharmacist if you are

breast-feeding or if you want

start

breast-feeding

whilst

taking AmBisome.

AmBisome CMI (10 September 2014) Page 2 of 3

HOW DO I TAKE

AMBISOME PROPERLY?

AmBisome is to be administered

only by or under the supervision

of your doctor.

AmBisome must be reconstituted

using

Water

Injection

then

filtered

using

5-micron

filter into the correct amount of

5% Glucose Injection. It is given

as a long running infusion (e.g. a

slow injection via a “drip” into a

vein).

WHAT ABOUT THE SIDE

EFFECTS?

Like other medicines AmBisome

may cause side effects. If they

occur

most

minor

temporary. However, some side

effects

serious

require medical attention.

Check

with

your

doctor

immediately

have

problems

while

taking

AmBisome, even if you do not

think the problems are connected

with the medicine or if the effects

are not listed in this leaflet. Your

doctor will be able to tell you

what to do.

Before you begin treatment with

AmBisome, it is advised you and

your doctor talk about the good

this medicine can do as well as

the risks of using it.

Common side effects.

nausea and vomiting

rash

mild headaches

Less

common

side

effects.

following

side

effects

have been reported:

back pain

joint pain and bone pain

fever, chills

chest tightness

kidney problems

liver problems

Check

with

your

doctor

pharmacist if you experience or

do not understand any of the side

effects described above.

The above list is

not

a complete

list of all possible side effects.

Other side effects not listed above

occur

some

patients.

Also, as with any medicine, there

may be other effects which are

not yet known. If you notice any

other

effects,

check

with

your

doctor.

WHAT IF I TAKE TOO

MUCH AMBISOME?

Severe

side

effects

AmBisome

more

likely

occur at high doses, particularly

receive

overdose.

Symptoms

AmBisome

overdose include the side effects

listed above, but are usually of a

more severe nature.

As AmBisome is most likely to

be given to you in hospital under

the supervision of your doctor, it

very

unlikely

that

will

receive an overdose. However, if

experience

severe

side

effects

tell

your

doctor

immediately.

WHAT ABOUT STORING

AMBISOME?

important

store

your

medicine

properly.

Guidelines

for proper storage include:

Keep out of reach of children.

keep

medicine after the expiry date

marked on the packet.

Store AmBisome below 25 °C.

AmBisome can only be obtained

with a prescription.

REMEMBER THIS

MEDICINE IS FOR YOU.

Never

give

it

to

anyone

else

even

if

his

or

her

symptoms

seem to be the same as yours.

WHAT IS IN AMBISOME?

Each

injection

contains

amphotericin equivalent to 50 mg

amphotericin

plus

hydrogenated

phosphatidylcholine,

cholesterol,

distearoylphosphatidylglycerol

sodium

salt),

alpha

tocopherol,

sucrose

sodium

succinate hexahydrate.

AUST R 53783

SPONSOR

Australia

Gilead Sciences Pty Ltd

Level 6, 417 St Kilda Road

Melbourne, Victoria 3004

New Zealand

Gilead Sciences (NZ)

c/- PricewaterhouseCoopers

Level 8 Pricewaterhousecoopers

Tower

188 Quay Street

Auckland 1010

AmBisome CMI (10 September 2014) Page 3 of 3

AmBisome

registered

trademark

licensed

Gilead

Sciences Pty. Limited.

Date

Preparation:

September 2014

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