PENTACARINAT 300MG POWDER FOR SOLUTION FOR INJECTION/INFUSION

Active substance: PENTAMIDINE ISETIONATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Pentacarinat® 300mg powder for
solution for injection/infusion
Pentamidine isetionate

Is this leaflet hard to see or read? Phone 01483
505515 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

i

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 medicine if:
You have liver or kidney problems
You have high or low blood pressure
You have a slow heartbeat (bradycardia), an uneven heartbeat or
any other heart problems
You have a high or low blood sugar level
You have a low white blood cell count - signs include an unexplained
infection or fever
You have anaemia (look pale or feel tired)
You have unusual bruising or your blood takes a long time to clot
You have asthma, other breathing problems, or had a collapsed
lung (pneumothorax) in the past
You smoke

- You have unusual salt levels in your blood, especially if you have low
levels of potassium (‘hypokalaemia’) or magnesium (‘hypomagnesaemia’).
Blood tests will have shown this.
If you are not sure if any of the above apply to you, talk to your doctor
or pharmacist before having Pentacarinat 300mg.
Taking other medicines
If you have to go to a doctor, dentist or hospital for any reason,
tell them that you are taking Pentacarinat powder. Also tell
your doctor or pharmacist if you are taking or have recently
taken any other medicine. This includes medicines you buy without
a prescription, including herbal medicines. This is because Pentacarinat
powder and some medicines can affect the way each other work.
In particular, tell your doctor if you are taking any of the following:
• Medicines for mood or thought problems called ‘phenothiazines’ (such
as chlorpromazine and pericyazine)
• Medicines for depression called ‘tricyclic antidepressants’ (such as
amitriptyline)
• Anti-histamines called terfenadine and astemizole - used for allergies
• Antibiotics such as erythromycin or quinolones (includes ciprofloxacin)
• Halofantrine - used for malaria
• Foscarnet - used for viral infections
These medicines may cause an uneven heartbeat (seen on your ECG)
called ‘QT prolongation’. Pentacarinat 300mg can increase the chance
of this happening.
Tests
Before you are given Pentacarinat powder, your doctor will check your
blood pressure, heart and blood.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if:
• You are pregnant, plan to get pregnant, or think you may be pregnant.
Miscarriage has been reported during the first three months of
pregnancy
• You are breast-feeding or planning to breast-feed
Ask your doctor or pharmacist for advice before taking any medicine
if you are pregnant or breast-feeding.
Driving and using machines
You may feel dizzy, tired, light headedness or faint or have
muscle spasms and twitches whilst taking Pentacarinat powder.
If this happens, do not drive or use any tools or machines.
3. How Pentacarinat powder is given
How Pentacarinat powder is given
• Pentacarinat powder will usually be given to you by a doctor or
nurse at a clinic or in a hospital
• It will be given either by injection or by inhalation using a nebuliser
• If you feel the effect of your medicine is too weak or too strong, do
not change the dose yourself, but ask your doctor
1) Having this medicine as an injection
• A doctor or nurse will mix Pentacarinat powder with water
for injections. If given into a vein, they will dilute it further
in another liquid.
• You must lie down when you are given a Pentacarinat
powder injection.
• Your doctor will decide how much to give you. The dose
depends on your weight.


IMPORTANT INFORMATION

Pentacarinat 300mg powder for solution
for injection/infusion
®

Pentamidine isetionate
Technical information for the administration of Pentacarinat
300mg powder for solution for injection/infusion
There is limited information available on the effects of this product
on people who handle it.
It is therefore recommended that the following precautions are taken
when the solution is administered by nebuliser:1. Dissolve the powder in water as described below: Use a vertical
laminar flow cabinet if available.
2. When patients are using nebulisers always make sure that they are
in a well ventilated room. This room should not be used for any
other purpose whilst the procedure is in progress.
3. Only staff wearing adequate protective clothing (see 7 below) should
be in the room when nebulisers are being used.
4. A nebuliser which is fitted with a filter to minimise loss of the drug
to the atmosphere e.g. "Respirgard II”, modified “Acorn System 22”
or an equivalent device should be used.
5. Use a suitable exhaust tube which vents directly through a window
to the external atmosphere if possible. Care should be taken to
ensure that passers-by will not be exposed to the exhaust.
6. Make sure that the patient is wearing a well-fitting mask and the
air flow to the nebuliser is turned off before the mask is removed.
7. Masks of nominal protection factor 10 , goggles and gloves should
be worn by all healthcare personnel administering nebulised
pentamidine preparations. Once the system has been set up, staff
should not stay in the room where pentamidine is being nebulised
unless there is a particular clinical need.
8. Children, pregnant women and staff with a history of asthma should
avoid coming into contact with nebulised pentamidine. Women of
child-bearing potential should also avoid exposure to the drug unless
they are taking adequate contraceptive precautions.
9. Staff should ensure that they are adequately vaccinated against
tuberculosis.
If PENTACARINAT is used in the home, other members of the household
should not be in the same room as the patient during nebulisation and

the room should be adequately ventilated at the end of each
administration. If other occupants remain in the room they may
experience effects such as eye irritation, facial numbness or difficulty in
breathing. They are also at risk of contracting other lung infections.
PRESENTATION
A sterile white powder supplied in single dose vials containing 300mg
pentamidine isetionate.
DOSAGE AND ADMINISTRATION
Dosage by the inhalation route
For the treatment of PCP the recommended dosage is 600mg
pentamidine isetionate (2x300mg vials) daily for 3 weeks.
For the prevention of recurring cases of PCP the dosage is 300mg
pentamidine isetionate administered as a single inhalation every 4 weeks.
Dosage by the intravenous route
The following dosage regimens are recommended for adults, children
and infants:
Treatment of PCP: Pentamidine isetionate 4 mg/kg bodyweight daily
for at least 14 days, preferably by slow intravenous infusion.
Elderly No specific dosage recommendations.
Dosage in renal failure (creatinine clearance <10ml/min): A
modified dosage regimen is recommended - see data sheet for details.
Dosage in hepatic impairment No information available.
Administration by inhalation
Solutions should be prepared as described below and then used
immediately.
Treatment of PCP: Dissolve the contents of 2 x 300mg vials (600mg
pentamidine isetionate) in 6ml of Water for Injections.
Prevention of recurring PCP: Dissolve the contents of one vial (300mg
pentamidine isetionate) in 4-6ml of Water for Injections.
The freshly prepared solution should be administered by inhalation
using a suitable nebuliser such as a “Respirgard II”, modified “Acorn
System 22” or an equivalent device. This should be fitted with either
a portable compressor or piped oxygen at a flow rate of 6-10
litres/minute.
The optimal particle size for alveolar deposition is between 1 and 2
microns.
A suitable, well-fitted one-way system should be employed such that
the nebuliser stores the aerosolised drug during exhalations and
disperses exhaled pentamidine into a reservoir. A filter should be fitted
to the exhaust line to reduce atmospheric pollution.

How much Pentacarinat is given
The usual dose of pentacarinat powder for adult, children and infants
for the following illnesses is:
Lung Infection by PCP
• 4 mg for each kg of body weight, once each day for 14 days
• If you have kidney problems, your doctor may give you this
medicine less often
• The dose is given by a slow infusion (drip) into a vein
Infection of the organs by Leishmania
• 3 to 4 mg for each kg of your body weight, on every other day
• The dose is given by injection into your muscles
• A maximum of 10 injections may be given
Infection of the skin by Leishmania
• 3 to 4 mg for each kg of your body weight,
once or twice each week
• The dose is given by injection into your muscles until the infection
has cleared
Infection by Trypanosoma gambiense
Dose for adults, children and infants is:
• 4 mg for each kg of your body weight, once each day or on every
other day
• The dose is given by injection into your muscles or by a slow
infusion (drip) into a vein
• A total of between 7 and 10 injections are given
2) Having this medicine by inhalation
This medicine has been prescribed only for you
• It is dangerous for other people to be exposed to this medicine
• This means that other people should not be in the same room when
you are using the nebuliser.
• The medicine is put in the nebuliser
• Air or oxygen is piped into the nebuliser
• This turns the medicine into a fine mist or spray
• This spray is then inhaled into your lungs
The usual dose of pentacarinat powder for the following illnesses is:
To treat Pneumocystis carinii Pneumonia (PCP)
Dose for adults, children and infants is:
• Inhalation of the spray from 2 bottles once each day for 3 weeks
To stop further attacks of Pneumocystis carinii Pneumonia (PCP)
Dose for adults only is:
• Inhalation of the spray from 1 bottle every 4 weeks
• or
• Inhalation of half a bottle every 2 weeks
If you have more Pentacarinat powder than you should
If you have too much of this medicine, talk to doctor or go to a hospital
straight away. Too much Pentacarinat powder can cause problems
with your heart.
If you forget to visit your doctor to have your medicine
Contact your doctor straight away to arrange another appointment as
soon as possible.
If you stop taking Pentacarinat powder
Do not stop having your medicine without talking to your doctor. You
should not stop having Pentacarinat Powder just because you feel
better. This is because the infection may come back again or get worse.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4 Possible side effects
Like all medicines, Pentacarinat powder can cause side effects, although
not everybody gets them. Your doctor will closely check for any possible
side effects.
Stop having and speak to your doctor or nurse or go to a hospital
straight away if you notice any of the following side effects - you
may need urgent medical treatment:
• If you have an allergic reaction. The signs may include: a rash,
swallowing or breathing problems, swelling of your lips, face, throat
or tongue
• If you have severe skin reactions. Signs include blistering or bleeding
of the skin around the lips, eyes, mouth, nose and genitals. Also flulike symptoms and fever. This may be something called ‘StevensJohnson syndrome’
• Low blood pressure (hypotension). Signs include feeling dizzy, lightheaded or fainting

• Low blood sugar level (hypoglycaemia). Signs include feeling nervous,
shaky or sweaty
• Low numbers of white cells in your blood (leucopenia) - signs include
an unexplained infection or fever
• You bruise or bleed more easily than usual. This could be because
of a blood disorder (thrombocytopenia).
• Kidney failure - changes in the way your kidneys are working. These
would show up in the results of some blood or urine tests. You may
also notice signs such as swollen ankles, passing less water (urine)
than usual, low back pain
• If you have low levels of calcium in your blood (‘hypocalcaemia’).
• Inflammation of the pancreas (pancreatitis). Signs include severe
stomach pain - which may reach through to the back
• Uneven or fast heart beat
Tell your doctor straight away if you have any of the following
side effects:
• Yellowing of the skin and eyes
• Flushing or fainting
• Feeling dizzy, tired or faint. This may be due to low blood pressure
when standing up
• Chest pain, cough, wheezing, shortness of breath or difficulty
breathing
• Feeling sick (nausea), being sick (vomiting) or stomach pain
• Blood in your urine
• Muscle spasm, muscle twitch or pins and needles
• Pain, or a lump or abscess at the site where you were given the
injection
• Rash
• Increased thirst or needing to go to the toilet more often
• Change in the way things taste or a loss of appetite
• Fever
• Unexplained muscle pain, tenderness or weakness
Tell your doctor straight away if you notice any side effects not
listed in this leaflet.
5 How to store Pentacarinat powder
Keep this medicine in a safe place where children cannot see or
reach it. Store below 30°C, do not refrigerate. Once the powder has
been mixed with liquid, store it in a fridge at 2-8°C. Use within 24
hours. Concentrated solution for inhalation or intramuscular routes:
Use immediately. Do not use the medication after the expiry date
which is stated on the carton and on the vial label after EXP. The
expiry date refers to the last day of that month. Medicines should
not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
6 Further information
What Pentacarinat 300mg powder for solution for injection/infusion
contains
• Each small glass bottle (vial) contains 300mg the active substance,
Pentamidine isetionate (equivalent to 172.4 mg pentamidine
base).
What Pentacarinat powder looks like and content of the pack
Pentacarinat powder is a white or almost white plug of lyophilised
powder contained in a glass vial. Pentacarinat powder is supplied in
cartons containing 5 glass vials. Each vial contains a single dose of
Pentacarinat powder for solution for injection/infusion.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey,
GU1 4YS, UK - Tel: 01483 505515 / Fax: 01483 535432
Email: uk-medicalinformation@sanofi.com
Manufacturer
SANOFI-AVENTIS S.P.A.
Loc. Valcanello
03012 Anagni (FR)
ITALY
This leaflet does not contain all the information about your medicine.
If you have any questions or are not sure about anything, ask your
doctor or pharmacist.
This leaflet was last revised in 10/2012
© Sanofi, 1997 - 2012
89025622


Also a suitable exhaust tube should be used which vents directly
through a window to the external atmosphere if possible. Care should
be taken to ensure that passers-by will not be exposed to the exhaust.
Administration by the intravenous route
In order to reduce the incidence of sudden, severe hypotension,
PENTACARINAT should be administered parenterally only by slow
intravenous infusion with the patient lying down. Bolus intravenous
injections should be avoided if possible and should never be given
rapidly.
PENTACARINAT must be reconstituted only with Water for Injections.
The reconstituted solution may be further diluted for intravenous
infusion using either Glucose Intravenous Infusion 5% w/v or 0·9%
(Normal) Sodium Chloride Injection. It must not be mixed or diluted
with any other injection solutions.
For slow intravenous infusion the contents of one vial (300mg pentamidine
isetionate) should be dissolved in a known volume (3-5ml) of Water for
Injections. The dose calculated for an individual patient may then be
diluted further in 50-250ml of Glucose Intravenous Infusion 5% w/v or
0·9% (Normal) Sodium Chloride Injection. The resulting solution containing
pentamidine isetionate should be infused over a period of at least 60
minutes with the patient remaining supine under close medical supervision.
PRECAUTIONS
PENTACARINAT should be used with particular caution in patients with
hepatic and/or renal dysfunction, hypertension or hypotension,
hyperglycaemia or hypoglycaemia, leucopenia, thrombocytopenia or
anaemia.
Fatalities due to severe hypotension, hypoglycaemia, acute pancreatitis
and cardiac arrhythmias have been reported in patients treated with
pentamidine isetionate, by both the intramuscular and intravenous
routes. Baseline blood pressure should be established and patients
should receive the drug lying down. Blood pressure should be closely
monitored during administration and at regular intervals until treatment
is concluded.
Therefore patients receiving PENTACARINAT by inhalation should be
closely monitored for the development of severe adverse reactions.
Pentamidine isetionate may prolong the QT interval. Cardiac arrhythmias
indicative of QT prolongation, such as Torsades de Pointes, have been
reported in isolated cases with administration of pentamidine isetionate.
Therefore, pentamidine isetionate should be used with care in patients
with coronary heart disease, a history of ventricular arrhythmias,
uncorrected hypokalaemia and or hypomagnesaemia, bradycardia

(<50 bpm), or during concomitant administration of pentamidine
isetionate with QT prolonging agents.
Particular caution is necessary if the QTc exceeds 500 msec whilst
receiving pentamidine isetionate therapy, continuous cardiac monitoring
should be considered in this case.
Should the QTc- interval exceed 550 msec then an alternative regimen
should be considered.
Laboratory monitoring: The following tests should be carried out
before, during and after treatment by the i.v. route:
(I) Blood urea nitrogen and serum creatinine daily during therapy.
(II) Complete blood and platelet counts daily during therapy.
(III) Fasting blood glucose measurements daily during therapy, and at
regular intervals after completion of therapy. Hyperglycaemia and
diabetes mellitus, with or without preceding hypoglycaemia have
occurred up to several months after cessation of therapy.
(IV) Liver function tests (LFTs) including serum bilirubin, alkaline
phosphatase, aspartate aminotransferase (AST/SGOT) and alanine
aminotransferase (ALT/SGPT). If baseline measurements are normal
and remain so during therapy, test weekly thereafter.
When there is baseline elevation in LFTs and/or LFTs increase during
therapy, continue monitoring weekly unless the patient is on other
hepatotoxic agents, when monitoring every 3-5 days is appropriate.
(V) Serum calcium, test weekly.
(VI) Urine analysis and serum electrolytes daily during therapy.
(VII) Electrocardiograms at regular intervals.
PHARMACEUTICAL PRECAUTIONS
This product should be reconstituted in a fume cupboard.
Store the dry product below 30°C.
Store dilute reconstituted solutions between 2-8°C and discard all
unused portions within 24 hours of preparation.
Concentrated solutions for administration by the inhalation route
should be used immediately.
After reconstitution with Water for Injections, PENTACARINAT should
not be mixed with any injection solution other than Glucose Intravenous
Infusion 5% w/v and 0·9% (Normal) Sodium Chloride Injection.
FURTHER INFORMATION
Further information is available on request.
PENTACARINAT is a Trade Mark of the Aventis group.
“Acorn System 22” is a Trade Mark of Medic-Aid and “Respirgard II”
is a Trade Mark of Marquest, Medical Products Inc.
89025622
Date of revision: 10/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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