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RIFADIN INFUSION 600MG

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Children: The usual paediatric regimen is a single daily
dose of up to 20mg/kg bodyweight; the total daily dose
should not normally exceed 600mg.
Leprosy: The recommended daily dose is 10 mg/kg.
Usual daily dose:
Patients weighing less than 50 kg - 450 mg.
Patients weighing 50 kg or more - 600 mg.
Alternatively, 600 mg doses of rifampicin may be given
once per month.
In the treatment of leprosy, rifampicin should always be
used in conjunction with at least one other antileprosy drug.
Brucellosis, Legionnaires Disease or serious staphylococcal
infections:
Adults: The recommended daily dose is 600 - 1200mg
given in 2 to 4 divided doses, together with another
antibacterial agent with similar properties to prevent
the emergence of resistant strains.
Impaired liver function: A daily dose of 8mg/kg should
not be exceeded in patients with impaired liver function.
Use in the elderly: In elderly patients, the renal
excretion of rifampicin is decreased proportionally with
physiological decrease of renal function; due to
compensatory increase of liver excretion, the serum
terminal half-life is similar to that of younger patients.
However, as increased blood levels have been noted in one
study of rifampicin in elderly patients, caution should be
exercised in using rifampicin in such patients, especially if

Rifadin® 600mg Infusion
Rifampicin

Technical Leaflet - Rifadin® 600mg Infusion
The following information is extracted from the SPC.
Technical information for the preparation and
administration of Rifadin 600mg Infusion.
1. NAME OF THE MEDICINAL PRODUCT
Rifadin for Infusion 600mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Rifampicin 600mg
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lyophilisate (for reconstitution prior to use) and
accompanying ampoule of solvent.
4.2. Posology and method of administration
Treatment with Rifadin for Infusion should include
concomitant use of other appropriate antibacterials to
prevent the emergence of resistant strains of causative
organism.
Tuberculosis:
Adults: A single daily administration of 600mg given by
intravenous infusion over 2 to 3 hours has been found
to be effective and well tolerated for adult patients.
Serum concentrations following this dosage regimen
are similar to those obtained after 600mg by mouth.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rifadin 600mg Infusion
rifampicin
Is this leaflet hard to see or read?
Phone 0845 372 7101 for help
Important things you need to know about
Rifadin Infusion
• You must keep taking it until your doctor tells you to stop.
• If you are having any other medicines, including
medicines you have bought from the pharmacy or shop,
you must make sure your doctor knows
• Rifadin Infusion makes all your body fluids an orange or
red colour. Do not worry - this is normal and not harmful
• If you get a temperature, are sick, begin to feel more
unwell, lose your appetite or have yellowing of the skin,
gums or eyes, you must talk to your doctor straight away
Read the rest of this leaflet carefully before you start
having 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 to
others. It may harm them, even if their symptoms are the
same as 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 pharmacist.
In this leaflet:
1. What Rifadin Infusion is and what it is used for
2. Before you have Rifadin Infusion
3. How Rifadin Infusion is given
4. Possible side effects
5. How to store Rifadin Infusion
6. Further information

1. What Rifadin Infusion is and what
it is used for

i

Rifadin Infusion contains a medicine called rifampicin. It
belongs to a group of medicines called anti-infectives. It
works by killing the bacteria that cause infections.
Rifadin Infusion is used to treat the following bacterial
infections when medicines can not be given by mouth:
• Tuberculosis (also known as TB) alongside other medicines
• Leprosy alongside other medicines
• Brucellosis alongside other medicines
• Legionnaires Diseases alongside other medicines
• Other serious bacterial infections

2. Before you have Rifadin Infusion

Do not have Rifadin Infusion if:
X You are allergic (hypersensitive) to
- rifampicin
- any of the other ingredients of the Rifadin Infusion (see
Section 6: Further information)
Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or
tongue
X You have yellowing of the skin and eyes (jaundice)
X You are taking saquinavir or ritonavir for an HIV infection
(see ‘Taking other medicines’ section below)
Do not have if any of the above apply to you. If you are not
sure, talk to your doctor, nurse or pharmacist before having
Rifadin Infusion.
Take special care with Rifadin Infusion
Check with your doctor or pharmacist before
having this medicine if:
▲ You have liver problems
▲ You have any kidney problems and if you are having more
than 600mg rifampicin per day
▲ You have diabetes. Your diabetes may become more difficult
to control while taking this medicine
▲ You feel numb or weak in your arms and legs (peripheral
neuropathy)
▲ You are under weight or malnourished
▲ You have a rare blood problem called ‘porphyria’
▲ You wear contact lenses. Having Rifadin Infusion may
permanently stain soft contact lenses
▲ The person having this medicine is a child
▲ You are aged 65 years or older
If you are not sure if any of the above apply to you, talk to
your doctor or pharmacist before having Rifadin Infusion.
Blood Tests
Your doctor will need to check your blood before you are
given this medicine. This will help your doctor know if any
changes happen to your blood after having this medicine.
You may also need to have regular blood tests to check how
your liver is working.

CROMin FOTO s.n.c.
GRAFICA - FOTOCOMPOSIZIONE

TYPE OF MATERIAL:

LEAFLET

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines. This includes
medicines you buy without a prescription, including herbal
medicines. This is because Rifadin Infusion can affect the
way some other medicines work. Also some medicines can
affect the way Rifadin Infusion work.
In particular, do not have this medicine, and tell your
doctor, if you are taking:
• Saquinavir or ritonavir used for HIV infection
The following medicines can make Rifadin Infusion
work less well:
• Antacids used for indigestion. Have Rifadin Infusion at
least 1 hour before taking antacids
• Other medicines used for TB such as P-aminosalicyclic
acid (PAS). PAS and Rifadin Infusion should be taken at
least 8 hours apart
Tell your doctor if you are having any of the following
medicines:
Heart and blood medicines
• Medicines for high blood pressure
• Medicines for heart problems or to control your heartbeat
• Medicines used to thin the blood such as warfarin
• Medicines used to lower cholesterol
• Water tablets (diuretics) such as eplerenone
Mental health, epilepsy and motor neurone medicines
• Medicines for thought disorders known as ‘antipsychotics’
such as haloperidol
• Medicines to calm or reduce anxiety (hypnotics, anxiolytics)
• Medicines to help you sleep (barbiturates)
• Medicines used for epilepsy such as phenytoin
• Some medicines used for depression such as amitriptyline
and nortriptyline
• Riluzole - used for motor neurone disease
Medicines for infections and the immune system
• Some medicines used for viral infections such as
indinavir, efavirenz, amprenavir, nelfinavir, atazanavir,
lopinavir and neviparine
• Medicines used for fungal infections
• Medicines used for bacterial infections (antibiotics)
• Medicines used for lowering your immune system such
as ciclosporin, sirolimus and tacrolimus
• Praziquantel - used for tapeworm infections
• Atovaquone - used for pneumonia
Hormone and cancer medicines
• Some hormone medicines (estrogen, systemic
hormones, progestogens) used for contraception or
some types of cancer such as ethinyloestradiol,
levonorgestrel or dydrogesterone
• Some hormone medicines (anti-estrogens) used for
breast cancer or endometriosis such as tamoxifen,
toremifene and gestrinone
• Some medicines used for cancer (cytotoxics) such as
imatinib
• Levothyroxine (thyroid hormone) used for thyroid
problems
• Irinotecan - used for cancer
Pain, inflammation and gout medicines
• Non-steroidal anti-inflammatory drugs (NSAIDS) such as
etoricoxib, aspirin and indometacin
• Medicines used for pain such as codeine, morphine,
fentanyl or pethidine
• Corticosteroids used for inflammation such as
hydrocortisone, betamethasone and prednisolone
• Methadone - used for heroin withdrawal
Other medicines
• Medicines used for diabetes
• Medicines used to relax muscles before surgery
(anaesthetics) such as halothane
• Some medicines used for feeling sick or being sick such
as ondansetron and aprepitant
• Quinine - used for malaria
• Theophylline - used for wheezing or difficulty in breathing
Pregnancy and breast-feeding
Talk to your doctor before having this medicine if you are
pregnant, plan to get pregnant or think you are pregnant.
Rifadin Infusion may make the contraceptive “pill” work less
well. This means you should change to a different type of
contraception. Instead, you must use a reliable barrier
method of contraception such as condoms or the “coil” while
having Rifadin Infusion. If you have any questions or are
unsure about this talk to your doctor or pharmacist.
You should not breast-feed if you are having
Rifadin Infusion. This is because small amounts
may pass into the mothers’ milk. If you are breastfeeding or planning to breast feed, talk to your
doctor or pharmacist before taking any medicine.

89027190
(int. version 2)

DESCRIPTION:

89027190

VERSION:

2 a

13 DIC 2013

COUNTRY:

RIFADIN 600 mg

MIN. FONT SIZE: CODE:

8 pt

Via G. Tartini, 2- 2 0 15 8 - M I L A N O
Tel. 02.375787 • e-mail: crominfoto@tiscali.it

Taking other medicines

UK
OLD CODE:

DIMENSION mm:

89025327 160 x 420

COLOURS N°:

1

COLOUR 1:

REFLEX BLUE

LOGO VERSION:

//

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there is evidence of liver function impairment.
When patients are able to accept oral medication, they
should be transferred to Rifadin Capsules or Syrup (for
further information on these products see their
summaries of product characteristics).
6.

PHARMACEUTICAL PARTICULARS

6.1. List of excipients
Sodium sulfoxylate formaldehyde
Sodium hydroxide
Solvent
Water for Injections.

6.6. Special precautions for disposal
Not applicable.
7.

6.3. Shelf life
Unopened vial of lyophilisate:
Unopened ampoule of solvent:
Reconstituted Solution:

4 years
5 years
6 hours

6.4. Special precautions for storage
Store below 25°C.

3. How Rifadin Infusion is given
Rifadin Infusion is given by a doctor or nurse. This is because
it needs to be given as a slow drip into a vein (infusion).
How much is given
If you are not sure why you are being given Rifadin Infusion
or have any questions about how much Rifadin Infusion is
being given to you, speak to your doctor or nurse.
Tuberculosis (TB)
• The usual dose is:
• Adults: A single daily dose of 600mg given over
2 - 3 hours
• Children: Up to 20mg per kilogram of body weight
each day. The maximum dose is 600mg each day
Leprosy
• Your doctor may prescribe a monthly or daily dose
• Patients weighing less than 50kg: A single daily dose of
450mg
• Patients weighing more than 50kg: A single daily dose
of 600mg
Brucellosis, Legionnaires Disease or other serious
bacterial infections
• The amount you are given will depend on how severe
your infection is
• Adults: 600mg to 1200mg each day. The dose is given
in 2 to 4 divided doses.
Elderly patients
Your doctor may need to monitor you more closely
People with Liver problems
You should not be given any more than 8mg per kilogram of
body weight each day
If you are given more Rifadin Infusion than you should
Your doctor will carefully calculate how much Rifadin
Infusion you should get. Therefore it is unlikely your doctor
or nurse will give you too much of this medicine. But, if you
think that you have been given too much or too little Rifadin
Infusion, tell your doctor or nurse.
You may feel sick (nausea), be sick (vomiting), have stomach
pain, itching or a headache. You may also feel tired, sleepy,
dizzy or light-headed. Other signs of having too much
includes swelling of the face, eyes or eyelids, slurring of
speech, difficulty breathing, fast heartbeat, uneven
heartbeats, fits and heart attack.
If you miss a dose of Rifadin Infusion
Your doctor or nurse will have instructions on when to give
you this medicine. It is unlikely that you will not be given the
medicine as it has been prescribed. However, if you think you
may have missed a dose, then talk to your doctor or nurse.
Tests
Having Rifadin Infusion may affect the results of some blood
tests. In particular, tests for folate, vitamin B12 and liver
function. If you are going to have a blood test, it is important
to tell your doctor that you are having Rifadin Infusion.

4. Possible side effects
Like all medicines, Rifadin Infusion can cause side effects,
although not everybody gets them.
Tell a nurse or doctor straight away if you notice any of
the following serious side effects:
• You have an allergic reaction. The signs may include: a
rash, swallowing or breathing problems, wheezing,
swelling of your lips, face, throat or tongue
• You have a fever and yellowing of the skin or whites of the
eyes, feel tired, weak or generally unwell, loss of appetite
(anorexia), feeling sick (nausea), being sick (vomiting).
These may be early signs of liver problems
• You get blistering, peeling, bleeding, scaling or fluid filled
patches on any part of your skin. This includes your lips,
eyes, mouth, nose, genitals, hands or feet. You may have
a serious skin problem
• You bruise more easily than usual. Or you may have a
painful rash of dark red spots under the skin which do not
go away when you press on them (purpura). This could be
because of a serious blood problem
• You have chills, tiredness, unusually pale skin colour,
shortness of breath, fast heartbeat or dark coloured urine.
This could be signs of a serious type of anaemia
• You have blood in your urine or an increase or decrease in
amount of urine you produce. You may also get swelling,
especially of the legs, ankles or feet. This may be caused
by serious kidney problems
• You have a sudden severe headache. This could be a sign
of bleeding in the brain
• Shortness of breath and wheezing
• You get confused, sleepy, cold clammy skin, shallow or
difficult breathing, a racing heartbeat or your skin is paler
than normal. These could be signs of shock
• You get more infections more easily than normal. Signs
include fever, sore throat or mouth ulcers. This could be
because you have a low number of white blood cells

TYPE OF MATERIAL:

LEAFLET

MARKETING AUTHORISATION NUMBER
PL 04425/0051
DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
th
th
7 December 1982 / 28 January 1994

Via G. Tartini, 2- 2 0 15 8 - M I L A N O
Tel. 02.375787 • e-mail: crominfoto@tiscali.it
AZIENDA CERTIFICATA UNI EN ISO 9001:2008

5. How to store Rifadin Infusion
Keep this medicine in a safe place where children cannot see
or reach it.
Do not use Rifadin Infusion after the expiry date which is
stated on the carton and label. The expiry date refers to the
last day of that month.
Store below 25°C
Medicines should not be disposed of via waterwaste 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 Rifadin Infusion contains:
• Once the solvent and powder have been mixed, each
10ml solution contains 600mg of the active substance,
rifampicin.
• The other ingredients are sodium sulfoxyformaldehyde,
sodium hydroxide, water for injections
What Rifadin Infusion look like and contents of the pack
Rifadin Infusion is presented as a 20ml clear glass vial
containing 600mg rifampicin and a 10ml clear glass
ampoule containing the solvent.
Marketing Authorisation Holder
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Tel: 0845 372 7101
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 required
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 12/2013
89027190
© Sanofi 1982 - 2013

89027190
(int. version 2)

89027190

2 a

13 DIC 2013

COUNTRY:

RIFADIN 600 mg
VERSION:

UK
OLD CODE:

DIMENSION mm:

89027190

• You have bleeding from your nose, ear, gums, throat, skin
or stomach. Signs may include a feeling of tenderness and
swelling in your stomach, purple spots on your skin and
black or tar-like stools
Talk to your doctor straight away if you notice any of the
following serious side effects:
• Mental problems with unusual thoughts and strange
visions (hallucinations)
• Severe watery diarrhoea that will not stop and you are
feeling weak and have a fever. This may be something
called ‘Pseudomembranous colitis’
• Flu-like symptoms including chills, fever, headache,
dizziness and bone pains
Tell your doctor as soon as possible if you have any of
the following side effects:
• Water retention (oedema) which may cause swollen face,
stomach, arms or legs
• Muscle weakness or pain or loss of muscle reflexes
• Dizziness, feel lightheaded and faint especially when you
stand or sit up quickly (due to low blood pressure)
• Swollen fingers, toes or ankles
• Being unable to concentrate, feeling nervous, irritable or
depressed
• Feeling very tired and weak or difficulty sleeping (insomnia)
• Short-term memory loss, anxiety, being less alert or
responsive
• Wasting of muscles or other body tissues
• Weight loss, night sweats and fever. These could be signs
of a blood condition called eosinophilia
• Feeling sick or being sick
Tell your doctor or pharmacist if any of the following
side effects get serious or lasts longer than a few days:
• Skin flushing or itching
• Irregular periods
• Loss of appetite (anorexia)
• Headache
• Diarrhoea or stomach discomfort
• Pain, redness or swelling at the site of injection
Other side effects you should discuss with your doctor if
you are concerned about them
• You notice an orange or reddish colour in your urine, sweat,
phlegm (sputum), saliva or tears. This is quite common and
you need not worry. However, the red colour may permanently
stain soft contact lenses. The red colour in tears may last for
some time after you have stopped having Rifadin Infusion.
Blood tests
• A blood test may show changes in the way the liver is working
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet.
United Kingdom
You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting, The Medicines Authority, Post-Licensing
Directorate, 203 Level 3, Rue D'Argens, GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
By reporting side effects you can help provide more
information on the safety of this medicine.

DESCRIPTION:

MIN. FONT SIZE: CODE:

8 pt

8.

10. DATE OF REVISION OF THE TEXT
11/2013

Driving and using machines
You may feel dizzy or faint, have problems with vision or
have other side effects that could affect your ability to drive
while having this medicine. If this happens, do not drive or
use any tools or machines.
Important information about some of the ingredients of
Rifadin Infusion
Rifadin Infusion contains:
• Sodium: The infusion contains less than 1 mmol sodium
(23 mg) per daily dose and is essentially ‘sodium-free’.

GRAFICA - FOTOCOMPOSIZIONE

MARKETING AUTHORISATION HOLDER
Aventis Pharma Ltd
trading as Marion Merrell or Aventis Pharma
One Onslow Street
Guildford
Surrey
GU1 4YS
UK

9.

6.2 Incompatibilities
Compatibilities: Rifadin for Infusion is compatible with
the following infusion solutions for up to 6 hours:
Glucose 5%, Saline Solution.
Incompatibilities: Rifadin for Infusion is incompatible
with the following: Perfudex, Sodium Bicarbonate 5%,
Sodium Lactate 0.167M, Ringer Acetate with Glucose.

CROMin FOTO s.n.c.

6.5. Nature and contents of container
20ml clear neutral glass vial sealed with butyl rubber
stopper and aluminium/plastic “flip-off” cap (colour
coded blue) containing 600mg Rifampicin and 10ml
clear glass ampoule containing solvent.
Pack size: combination of 1 vial of lyophilisate and
1 ampoule of solvent.

89025327 160 x 420

COLOURS N°: COLOUR 1:

1

REFLEX BLUE

LOGO VERSION:

//

Expand Transcript

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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