Proveblue 5mgml Solution for Injection

국가: 말레이시아

언어: 영어

출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

유효 성분:

Methylene Blue (Methylthioninium Chloride)

제공처:

PHARM-D SDN. BHD.

INN (국제 이름):

Methylene Blue (Methylthioninium Chloride)

패키지 단위:

10 ml

Manufactured by:

CENEXI

제품 특성 요약

1
PACKAGE INSERT – PROVEBLUE
®
5 MG/ML, SOLUTION FOR
INJECTION
1.
NAME OF THE MEDICINAL PRODUCT
Proveblue
®
(Methylthioninium chloride) 5 mg/ml solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 5 mg methylthioninium chloride.
Each 10 ml ampoule contains 50 mg methylthioninium chloride.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection (injection)
Clear dark blue solution with a pH value between 3.0 and 4.5
Osmolality is usually between 10 and 15 mOsm/kg.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Proveblue
®
is indicated:

for the treatment of drug and chemical products-induced
methaemoglobinaemia

as a dye in diagnostic procedures such as fistula detection

for the delineation of certain body tissues during surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Proveblue
®
may be administered orally or by intravenous (IV) injection.
In the treatment of acute methaemoglobinaemia, the IV route of
administration is usually preferred
because it provides a more rapid onset of effect.
Adults and children: In the treatment of methaemoglobinaemia,
methylene blue is administered
intravenously as the 0.5 % solution in doses of 1 to 2 mg per kg
bodyweight injected over a period
of 5 minutes. A repeat dose may be given after one hour if required. A
maximum dose of 7mg/kg
bodyweight is recommended.
The use of methylene blue is not recommended in infants under 4
months of age.
A dose of 5 mg/kg diluted in 500 mL of glucose 5% infused over 1 hour
has been used
successfully to stain and identify the parathyroid glands.
For the treatment of acute methaemoglobinaemia, Proveblue
®
should not be diluted with sodium
chloride 0.9% (saline) as precipitation may occur (due to presence of
chloride ions which have
been shown to reduce the solubility of methylene blue).
2
A suitable dilution for oral dosing would be 10-20 mL of the 0.5 %
solution diluted to 100-200 mL
with water for injections. The high volume is suggested to r