Pentacarinat 300mg powder for solution for injection vials

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Pentamidine isetionate

Mevcut itibaren:

Sanofi

ATC kodu:

P01CX01

INN (International Adı):

Pentamidine isetionate

Doz:

300mg

Farmasötik formu:

Powder for solution for injection

Uygulama yolu:

Inhalation; Intramuscular; Intravenous

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 05040800; GTIN: 5035074112316

Bilgilendirme broşürü

_I_
PENTACARINAT
®
300MG POWDER FOR
SOLUTION FOR INJECTION/INFUSION
PACKAGE LEAFLET: INFORMATION FOR THE USER
Pentamidine isetionate
IMPORTANT INFORMATION
Pentamidine isetionate
PENTACARINAT
® 300MG POWDER FOR SOLUTION
FOR INJECTION/INFUSION
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE [phone] FOR HELP
READ ALL OF THIS LEAFLET CAREFULLY BEFORE TAKING THIS
MEDICINE.
• Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
yours.
• If any of the side effects gets serious, or if you notice any side
effects
not listed in this leaflet, please tell your doctor or your
pharmacist.
IN THIS LEAFLET:
1. What Pentacarinat powder is and what it is used for
2. Before you use Pentacarinat powder
3. How to use Pentacarinat powder
4. Possible side effects
5. How to store Pentacarinat powder
6. Further information
1. WHAT PENTACARINAT IS AND WHAT IT IS USED FOR
The name of your medicine is Pentacarinat 300mg powder for solution
for injection/infusion (called Pentacarinat powder in this leaflet).
Pentacarinat powder contains a medicine called pentamidine isetionate.
Pentacarinat powder can be used to:
• Treat or help prevent a lung infection called ‘Pneumocystis
carinii
Pneumonia (PCP). It often happens in people with the HIV virus.
• Treat diseases of the skin or organs caused by parasites
(Leishmania
and Trypanosoma gambiense).
2. BEFORE YOU HAVE PENTACARINAT POWDER
DO NOT HAVE THIS MEDICINE IF:
X You are allergic (hypersensitive) to pentamidine isetionate
or any of the ingredients of this medicine (see Section 6:Further
information).
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of the lips, face, throat and tongue.
Do not have this medicine if the above applies to you.
TAKE SPECIAL CARE WITH PENTACARINAT POWDER
CHECK WITH YOUR DOCTOR OR YOUR PHARMACIST BEFORE HAVING
THIS

Ürün özellikleri

OBJECT 1
PENTACARINAT 300MG
Summary of Product Characteristics Updated 23-May-2014 | SANOFI
1. Name of the medicinal product
Pentacarinat 300mg Powder for Solution for Injection/Infusion
2. Qualitative and quantitative composition
Pentamidine Isetionate 300 mg (Equivalent to 172.4 mg pentamidine
base)
3. Pharmaceutical form
Powder for reconstitution
Sterile, white to almost white powder for use after reconstitution
4. Clinical particulars
4.1 Therapeutic indications
Pentamidine is indicated in the treatment of:
• Pneumonia due to Pneumocystis carinii (PCP)
• Cutaneous leishmaniasis
• Early phase African sleeping sickness caused by Trypanosoma
gambiense.
• Prevention of Pneumocystis carinii pneumonia in patients infected
by the human immunodeficiency
virus (HIV) who have experienced a previous episode of PCP.
4.2 Posology and method of administration
All indications can be treated by deep intramuscular injection or
intravenous injection.
Pentamidine powder is reconstituted before use with Water for
Injections. For intravenous use the
required dose of pentamidine isetionate is diluted further in 50-250ml
of glucose intravenous infusion or
0.9% (normal) Sodium Chloride Injection.
The following dosage regimens are recommended for adults, children and
infants.
TREATMENT:
_Pneumocystis carinii pneumonia: _
The preferred route of administration is by slow IV infusion, 4 mg/kg
bodyweight of pentamidine
isetionate once daily for at least 14 days. The IM route is not
recommended for the treatment of PCP.
_Leishmaniasis_
Cutaneous: 4 mg/kg bodyweight, every other day for 3 doses by IM or IV
injection.
_Trypanosomiasis : _
4mg/kg bodyweight of pentamidine isetionate per day for 7 days. The
preferred route is by deep IM
injection. Otherwise slow IV infusion over 60-120 minutes may be used.
PREVENTION:
In the prophylaxis of P. carinii pneumonia, administration is by the
inhalation route; the adult dosage is
300 mg every 4 weeks or 150mg every 2 weeks.
Dissolve the contents of one pentacarinat vial (300 mg pentamidine
i