AMBISOME FOR INJECTION 50 mgvial

Šalis: Singapūras

kalba: anglų

Šaltinis: HSA (Health Sciences Authority)

Veiklioji medžiaga:

Amphotericin B

Prieinama:

GILEAD SCIENCES SINGAPORE PTE. LTD.

ATC kodas:

J02AA01

Dozė:

50 mg/vial

Vaisto forma:

INJECTION, POWDER, FOR SOLUTION

Sudėtis:

Amphotericin B 50 mg/vial

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

Prescription Only

Pagaminta:

GILEAD SCIENCES INC

Autorizacija statusas:

ACTIVE

Leidimo data:

2002-07-15

Pakuotės lapelis

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Timabak,
eye drop solution
Timolol
1. NAME OF MEDICINAL PRODUCT
TIMABAK 0.25%, eye drop solution
TIMABAK 0.50%, eye drop solution
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION
Timolol
...........................................................0.250 g
In the form of timolol maleate .............0.343 g
For 100 ml of solution
Timolol
...........................................................0.500 g
In the form of timolol maleate .............0.685 g
For 100 ml of solution
See section 6.1 for the complete list of
excipients.
3. PHARMACEUTICAL FORM
Eye drop solution.
Clear colourless liquid.
4. CLINICAL PARTICULARS
4.1. Clinical indications
Intra-ocular hypertension.
Chronic wide-angle glaucoma.
4.2. Dosage and route of administration
Ophthalmic route.
Dosage
It is recommended to start the treatment by
instilling 1 drop of TIMABAK 0.25% in the
afflicted eye twice daily.
In cases of insufficient effectiveness, 1 drop
of the higher concentration TIMABAK 0.50%
should be used twice daily in the afflicted
eye.
If they deem necessary, the ophthalmologist
can combine TIMABAK with one or more
other anti-glaucoma treatments (ocular and/
or other route of administration).
However, it is not recommended to combine
two beta-blocking eye drop solutions (see
section 4.4).
The other eye drop solutions should be
administered at least 15 minutes before
TIMABAK.
In any case, it may take several weeks before
ocular pressure returns to normal with
TIMABAK eye drops. An assessment of the
treatment should also include measurement
of the intraocular eye pressure after
approximately 4 weeks of treatment.
In certain cases, a daily administration of just
1 drop of TIMABAK eye drops may prove
sufficient, in particular when the intraocular
pressure is maintained at satisfactory levels.
The systemic passage may be reduced by
nasolacrimal occlusion or by closing the
eyelids for 2 minutes. This method may help
to reduce systemic side effects and increase
local effectiveness.
Replacement of a previous treatment
When TIMABAK is used

Prekės savybės

1
AMBISOME

(AMPHOTERICIN B) LIPOSOME FOR INJECTION
DESCRIPTION
AmBisome for Injection is a sterile, non-pyrogenic lyophilized product
for intravenous infusion. Each
vial contains 50 mg of amphotericin B, USP, intercalated into a
liposomal membrane consisting of
approximately 213 mg hydrogenated soy phosphatidylcholine; 52 mg
cholesterol, NF; 84 mg
distearoylphosphatidylglycerol; 0.64 mg alpha tocopherol, USP;
together with 900 mg sucrose, NF;
and 27 mg disodium succinate hexahydrate as buffer. Following
reconstitution with Sterile Water for
Injection, USP, the resulting pH of the suspension is between 5-6.
AmBisome is a true single bilayer liposomal drug delivery system.
Liposomes are closed, spherical
vesicles created by mixing specific proportions of amphophilic
substances such as phospholipids and
cholesterol so that they arrange themselves into multiple concentric
bilayer membranes when
hydrated in aqueous solutions. Single bilayer liposomes are then
formed by microemulsification of
multilamellar vesicles using a homogenizer. AmBisome consists of these
unilamellar bilayer
liposomes with amphotericin B intercalated within the membrane. Due to
the nature and quantity of
amphophilic substances used, and the lipophilic moiety in the
amphotericin B molecule, the drug is an
integral part of the overall structure of the AmBisome liposomes.
AmBisome contains true liposomes
that are less than 100 nm in diameter. A schematic depiction of the
liposome is presented below.
Note: Liposomal encapsulation or incorporation into a lipid complex
can substantially affect a drug’s
functional properties relative to those of the unencapsulated drug or
non-lipid associated drug. In
addition, different liposomal or lipid-complex products with a common
active ingredient may vary from
one another in the chemical composition and physical form of the lipid
component. Such differences
may affect the functional properties of these drug products.
Amphotericin B is a macrocyclic, polyene, antifungal antibiotic
produced from a strain of