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OCTREOTIDE 50 MICROGRAMS/ML SOLUTION FOR INJECTION

Active substance(s): OCTREOTIDE ACETATE / OCTREOTIDE ACETATE

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PH - 151

'ROWTH HORMONE SECRETING PITUITARY TUMOURS MAY
SOMETIMES EXPAND AND CAUSE PROBLEMS 4ELL YOUR DOCTOR
IF YOU EXPERIENCE ANY PROBLEMS WITH YOUR EYES OR SIGHT
PACKAGE LEAFLET:
INFORMATION FOR THE USER

Read all of this leaflet carefully before you start
using this medicine.
s +EEP THIS LEAFLET 9OU MAY NEED TO READ IT AGAIN
s )F YOU HAVE ANY FURTHER QUESTIONS ASK YOUR DOCTOR
OR PHARMACIST
s )F 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 Octreotide is and what it is used for
2. Before Octreotide is used
3. How to use Octreotide
4. Possible side effects
5. How to store Octreotide
6. Further information
08 October 2014

1

WHAT OCTREOTIDE IS AND WHAT IT IS
USED FOR

/CTREOTIDE IS A SYNTHETIC FORM OF A HORMONE CALLED
SOMATOSTATIN WHICH OCCURS NATURALLY IN THE BODY )T
HELPS STOP THE RELEASE OF SOME HORMONES INCLUDING
GROWTH HORMONE IN THE BODY

Version:

2

/CTREOTIDE IS USED
s 4O TREAT ACROMEGALY
!CROMEGALY IS A CONDITION WHERE THE BODY PRODUCES
TOO MUCH GROWTH HORMONE 4HE LEVEL OF GROWTH
HORMONE CONTROLS THE GROWTH OF TISSUES ORGANS AND
BONES 4OO MUCH HORMONE MEANS THE SIZE OF BONES
AND TISSUES ESPECIALLY IN THE HANDS AND FEET IS
LARGER THAN NORMAL 4HE SYMPTOMS OF ACROMEGALY
INCLUDE HEADACHE EXCESSIVE PERSPIRATION NUMB
HANDS AND FEET TIREDNESS AND JOINT PAIN )N MOST
CASES THE OVERPRODUCTION OF GROWTH HORMONE IS
CAUSED BY AN ENLARGEMENT IN THE PITUITARY GLAND A
PITUITARY ADENOMA 
/CTREOTIDE IS USED TO TREAT PEOPLE WITH ACROMEGALY
s WHEN OTHER TYPES OF TREATMENT FOR ACROMEGALY
SURGERY OR RADIOTHERAPY ARE NOT SUITABLE OR
HAVE NOT WORKED
s AFTER RADIOTHERAPY TO COVER THE INTERIM PERIOD
UNTIL THE RADIOTHERAPY BECOMES FULLY EFFECTIVE
s BEFORE SURGERY ON THE PITUITARY GLAND

4AKING OTHER MEDICINES
0LEASE TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING
OR HAVE RECENTLY TAKEN ANY OF THE FOLLOWING MEDICINES
INCLUDING MEDICINES OBTAINED WITHOUT A PRESCRIPTION
s )NSULIN OR OTHER DRUGS FOR DIABETES
s #ICLOSPORIN A DRUG USED AFTER A TRANSPLANT
s #IMETIDINE A DRUG USED TO REDUCE STOMACH ACID
s "ROMOCRIPTINE A DRUG USED IN 0ARKINSONS DISEASE
OR IN ACROMEGALY OR TO SUPPRESS BREAST MILK
s -EDICINES TO CONTROL BLOOD PRESSURE BETA BLOCKERS
OR CALCIUM CHANNEL BLOCKERS OR AGENTS TO CONTROL
FLUID AND ELECTROLYTE BALANCE DIURETICS
s -EDICINES METABOLISED BY THE LIVER FOR EXAMPLE
CARBAMAZEPINE A DRUG USED IN PSYCHIATRIC DISORDERS
EPILEPSY TRIGEMINAL NEURALGIA AND NEUROPATHY
DIGOXIN MEDICINE FOR CERTAIN HEART PROBLEMS AND
WARFARIN A DRUG USED TO THIN THE BLOOD AND
TERFENADINE TO RELIEVE ALLERGIC SYMPTOMS 
0LEASE TELL YOUR DOCTOR OR HOSPITAL PHARMACIST IF YOU
ARE TAKING OR HAVE RECENTLY TAKEN ANY OTHER MEDICINES
INCLUDING MEDICINES OBTAINED WITHOUT A PRESCRIPTION
Pregnancy and breast-feeding
!SK YOUR DOCTOR OR PHARMACIST FOR ADVICE BEFORE
TAKING ANY MEDICINES 9OU SHOULD NOT USE /CTREOTIDE
IF YOU ARE PREGNANT UNLESS YOU HAVE BEEN TOLD BY YOUR
DOCTOR THAT IT IS ABSOLUTELY NECESSARY FOR YOU TO DO SO
9OU SHOULD NOT BREAST FEED YOUR INFANT WHILST
RECEIVING TREATMENT WITH OCTREOTIDE UNLESS YOU HAVE
BEEN TOLD TO DO SO
$RIVING AND USING MACHINES
/CTREOTIDE MAY MAKE YOU FEEL DIZZY )F THIS HAPPENS
DO NOT DRIVE OR OPERATE MACHINERY 2EMEMBER THAT IF
YOU ARE UNWELL YOUR ABILITY TO OPERATE MACHINERY
MAY BE AFFECTED
)MPORTANT INFORMATION ABOUT SOME OF THE
ingredients of Octreotide
/CTREOTIDE  MICROGRAMSML  MICROGRAMSML
AND  MICROGRAMSML 3OLUTION FOR INJECTION OR
#ONCENTRATE FOR SOLUTION FOR INFUSION CONTAINS LESS
THAN  MMOL SODIUM PER DOSE IE ESSENTIALLY
hSODIUM FREEv

TEVA UK Ref:

231-30-61204-B LEA OCTREOTIDE A/S SOLN TEVAH
/THER 3PECIAL 7ARNINGS
s 4ELL YOUR DOCTOR IF YOUR STOMACH OR BOWEL
SYMPTOMS GET WORSE
s /CTREOTIDE SHOULD ONLY BE USED IN PREGNANCY IF
CLEARLY NEEDED 4ELL YOUR DOCTOR IF YOU ARE PREGNANT
OR WANT TO BECOME PREGNANT
s 4O RELIEVE STOMACH OR BOWEL SYMPTOMS ASSOCIATED s 7OMEN OF CHILD BEARING POTENTIAL MUST USE AN
with certain tumours known as
EFFECTIVE CONTRACEPTIVE METHOD DURING TREATMENT
@GASTROENTEROPANCREATIC TUMOURS RARE TUMOURS OF
WITH /CTREOTIDE
THE STOMACH BOWELS OR PANCREAS
/VERPRODUCTION OF SPECIFIC HORMONES AND OTHER
3 HOW TO USE OCTREOTIDE
RELATED NATURAL SUBSTANCES CAN BE CAUSED BY SOME
RARE CONDITIONS OF THE STOMACH BOWELS OR
!LWAYS USE /CTREOTIDE EXACTLY AS YOUR DOCTOR HAS
PANCREAS 4HIS UPSETS THE NATURAL HORMONAL
TOLD YOU 9OU SHOULD CHECK WITH YOUR DOCTOR OR
BALANCE OF THE BODY AND RESULTS IN A VARIETY OF
PHARMACIST IF YOU ARE UNSURE OF ANYTHING
SYMPTOMS SUCH AS FLUSHING DIARRHOEA LOW BLOOD
9OUR MEDICINE MUST BE INJECTED SUBCUTANEOUSLY IE
PRESSURE RASH AND WEIGHT LOSS 4REATMENT WITH
INTO THE TISSUE UNDER THE SKIN 9OUR DOCTOR OR NURSE
/CTREOTIDE HELPS TO CONTROL THESE SYMPTOMS
WILL SHOW YOU HOW TO DO THIS )F YOU ARE UNSURE GO
s 4O PREVENT COMPLICATIONS FOLLOWING PANCREATIC
BACK AND ASK FOR ADVICE 9OU MUST USE A CLEAN STERILE
surgery
SYRINGE AND NEEDLE EVERY TIME
/CTREOTIDE CAN BE USED IN SOME PATIENTS WHEN
4HE UPPER ARMS THIGHS AND STOMACH ARE GOOD AREAS
THEY HAVE AN OPERATION ON THE PANCREAS )T MAY
HELP REDUCE SOME OF THE PROBLEMS WHICH CAN OCCUR FOR SUBCUTANEOUS INJECTION #HOOSE A DIFFERENT PLACE
EACH TIME SO THAT YOU DONT IRRITATE A PARTICULAR AREA
IN THE ABDOMEN AFTER THE OPERATION SUCH AS
+EEP CHANGING THE INJECTION SITE $ONT INJECT INTO THE
INFLAMMATION SWELLING AND INFECTION
SAME PLACE TOO FREQUENTLY
2 BEFORE OCTREOTIDE IS USED
4O AVOID SIDE EFFECTS LIKE STOMACH ACHE WIND
DIARRHOEA AND CONSTIPATION DO NOT INJECT AT MEALTIMES
9OU SHOULD ./4 BE GIVEN /CTREOTIDE
)NJECT BETWEEN MEALS OR BEFORE GOING TO BED
s IF YOU ARE ALLERGIC HYPERSENSITIVE TO OCTREOTIDE
ACETATE OR ANY OF THE OTHER INGREDIENTS OF
)N RARE CASES /CTREOTIDE WILL HAVE TO BE INJECTED
/CTREOTIDE SEE SECTION 
INTRAVENOUSLY INTO A VEIN  )F THIS IS NECESSARY THE
s IF YOU ARE BREAST FEEDING
DOCTOR OR NURSE WILL DO IT AND MONITOR YOU CLOSELY 9OU
MUST ./4 INJECT /CTREOTIDE INTO YOUR VEINS YOURSELF
4AKE SPECIAL CARE WITH /CTREOTIDE
s IF YOU ARE PREGNANT
4HE USUAL DOSAGES ARE GIVEN BELOW HOWEVER YOUR
s AS OCTREOTIDE MAY AFFECT YOUR BLOOD SUGAR LEVELS
DOCTOR WILL DECIDE WHAT DOSAGE TO GIVE TO YOU AS THIS
9OU OR YOUR DOCTOR SHOULD CLOSELY MONITOR YOUR
DEPENDS ON THE NATURE OF YOUR TREATMENT YOUR AGE
BLOOD SUGAR LEVELS
AND YOUR MEDICAL CONDITION
s IF YOU HAVE ANY THYROID PROBLEMS OR HAVE HAD A
For the treatment of acromegaly
DISEASE WHICH MAY HAVE AFFECTED YOUR THYROID
s IF YOU HAVE ANY PROBLEMS WITH YOUR LIVER OR HAVE YOU s 4HE USUAL DOSE IS  TO  MG THREE TIMES A DAY
BY SUBCUTANEOUS INJECTION $EPENDING ON HOW
HAD A DISEASE WHICH MAY HAVE AFFECTED YOUR LIVER
YOU RESPOND YOUR DOCTOR WILL ADJUST THE DOSE UNTIL
s IF YOU HAVE EVER SUFFERED FROM GALLSTONES OR OTHER
THEY FIND THE RIGHT DOSE
STOMACH PROBLEMS
s IF YOU HAVE A HISTORY OF 6ITAMIN " DEFICIENCY
4O RELIEVE SYMPTOMS CAUSED BY OVER PRODUCTION OF
9OUR DOCTOR MAY NEED TO MONITOR YOUR VITAMIN " some hormones
LEVELS DURING THERAPY WITH OCTREOTIDE
s 9OUR DOCTOR WILL USUALLY START YOUR TREATMENT WITH

PH - 151

9OUR DOCTOR MAY WANT TO GIVE YOU A CHECK UP FROM TIME
TO TIME WHILE YOU ARE BEING TREATED WITH /CTREOTIDE

 MG ONCE OR TWICE DAILY BY SUBCUTANEOUS
INJECTION $EPENDING ON HOW YOU RESPOND YOUR
DOCTOR MAY GRADUALLY INCREASE THE DOSE UNTIL THEY
FIND YOUR IDEAL DOSE

)F THE SOLUTION COMES INTO CONTACT WITH THE SKIN WASH
4HE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR WITH WATER AND SOAP )F THE SOLUTION COMES INTO CONTACT
WITH MEMBRANES WASH IRRIGATE THE AFFECTED AREA
HEALTHCARE PROFESSIONALS ONLY
WITH WATER
)NSTRUCTIONS FOR USE HANDLING AND DISPOSAL
4O REDUCE LOCAL DISCOMFORT LET THE SOLUTION REACH
ROOM TEMPERATURE BEFORE INJECTING !VOID MULTIPLE
&OR SINGLE USE ONLY
INJECTIONS AT SHORT INTERVALS AT THE SAME TIME
/CTREOTIDE IS AN INJECTION AND A CONCENTRATE FOR SOLUTION Storage:
FOR INFUSION 4HIS MUST BE HANDLED WITH CAUTION 4HE Storage conditions:
DILUTION MUST BE DONE UNDER ASEPTIC CONDITIONS BY
"EFORE OPENING 3TORE IN A REFRIGERATOR   #
TRAINED STAFF AND IN A SPECIFIC AREA 4HE CONTACT OF
PROTECTED FROM LIGHT $O NOT FREEZE
/CTREOTIDE WITH SKIN AND MEMBRANES SHOULD BE AVOIDED !FTER OPENING 4HE PRODUCT MUST BE USED IMMEDIATELY

PH - 151

PH - 151

Octreotide 50 micrograms/ml,
100 micrograms/ml and 500 micrograms/ml
Solution for injection or Concentrate for
solution for infusion

4ELL YOUR DOCTOR IF YOUR STOMACH OR BOWEL PROBLEMS
GET WORSE

PH - 151

4O PREVENT COMPLICATIONS FOLLOWING PANCREATIC SURGERY
s  MG THREE TIMES A DAY FOR SEVEN DAYS STARTING ON
THE DAY OF THE OPERATION

Uncommon:
s $EHYDRATION
s &AST HEART BEAT

Frequency not known:
s !NAPHYLAXIS A TYPE OF ALLERGIC REACTION WHICH
CAUSES DIFFICULTY IN BREATHING OR DIZZINESS
4HERE IS VERY LITTLE EXPERIENCE OF USING OCTREOTIDE IN
ALLERGYHYPERSENSITIVITY REACTIONS
CHILDREN
s )TCHY RASH
s )NFLAMMATION OF THE PANCREAS
)F YOU RECEIVE MORE /CTREOTIDE THAN YOU SHOULD
)F YOU ARE CONCERNED THAT YOU MAY HAVE BEEN GIVEN TOO s ,IVER INFLAMMATION HEPATITIS  SYMPTOMS MAY
INCLUDE YELLOWING OF THE SKIN AND EYES JAUNDICE
MUCH /CTREOTIDE TELL YOUR DOCTOR OR NURSE IMMEDIATELY
NAUSEA VOMITING LOSS OF APPETITE GENERALLY
FEELING UNWELL ITCHING LIGHT COLOURED URINE
If you miss a dose of Octreotide
s )RREGULAR HEART BEAT
!S YOU WILL BE GIVEN THIS MEDICINE UNDER CLOSE
s ,IVER DYSFUNCTION
SUPERVISION IT IS VERY UNLIKELY THAT YOU WILL MISS A
DOSE )F YOU THINK THAT YOU HAVE MISSED A DOSE OF
)F ANY OF THE SIDE EFFECTS GETS SERIOUS OR IF YOU NOTICE
TREATMENT TELL A DOCTOR OR NURSE AT ONCE
ANY SIDE EFFECTS NOT LISTED IN THIS LEAFLET PLEASE TELL
YOUR DOCTOR OR PHARMACIST
)F YOU HAVE ANY FURTHER QUESTIONS ON THE USE OF THIS
PRODUCT ASK YOUR DOCTOR OR PHARMACIST
5 HOW TO STORE OCTREOTIDE
4 POSSIBLE SIDE EFFECTS
+EEP OUT OF THE REACH AND SIGHT OF CHILDREN
,IKE ALL MEDICINES /CTREOTIDE CAN CAUSE SIDE EFFECTS
$O NOT USE /CTREOTIDE AFTER THE EXPIRY DATE WHICH IS
ALTHOUGH NOT EVERYBODY GETS THEM
STATED ON THE LABEL AFTER %80 4HE EXPIRY DATE REFERS
-OST PEOPLE WHO ARE PRESCRIBED /CTREOTIDE BENEFIT FROM TO THE LAST DAY OF THAT MONTH
TAKING IT BUT A FEW PEOPLE CAN BE UPSET BY IT )F YOU
ARE RECEIVING THIS MEDICINE ON A LONG TERM BASIS THEN Storage conditions:
"EFORE OPENING 3TORE IN A REFRIGERATOR   #
YOU WILL GO TO HOSPITAL FROM TIME TO TIME TO HAVE
PROTECTED FROM LIGHT $O NOT FREEZE
REGULAR CHECK UPS
4HERE IS NO NEED TO WORRY IF YOU SUFFER FROM ANY OF THE !FTER OPENING 4HE PRODUCT MUST BE USED IMMEDIATELY
AND ANY UNUSED DRUG PRODUCT MUST BE DISCARDED
FOLLOWING COMMON REACTIONS AT THE SITE OF INJECTION
s 0AIN STINGING TINGLING BURNING REDNESS AND SWELLING After dilution: 4HE CHEMICAL AND PHYSICAL STABILITY OF
4HESE RARELY LAST FOR MORE THAN  MINUTES AND WILL BE /CTREOTIDE SOLUTION DILUTED IN  MGML 
LESS IF YOU LET YOUR MEDICINE REACH ROOM TEMPERATURE SODIUM CHLORIDE SOLUTION FOR INFUSION HAS BEEN
BEFORE INJECTING
DEMONSTRATED FOR  HOURS WHEN STORED BELOW  #
3OME SIDE EFFECTS CAN BE SERIOUS 3TOP TAKING /CTREOTIDE &ROM A MICROBIOLOGICAL POINT OF VIEW THE PRODUCT
and tell your doctor straight away if you notice that: SHOULD BE USED IMMEDIATELY IF NOT USED IMMEDIATELY
STORAGE TIMES AND CONDITIONS ARE THE RESPONSIBILITY OF
s 9OUR FACE BECOMES FLUSHED OR SWOLLEN OR YOU
THE USER UNLESS DILUTION HAS TAKEN PLACE IN CONTROLLED
DEVELOP SPOTS OR A RASH
s 9OUR CHEST FEELS TIGHT YOU BECOME SHORT OF BREATH AND VALIDATED ASEPTIC CONDITIONS
OR WHEEZY
$O NOT USE UNLESS THE SOLUTION IS CLEAR AND FREE FROM
s 9OU FEEL FAINT POSSIBLY AS A RESULT OF A FALL IN BLOOD VISIBLE PARTICLES
PRESSURE
&OR SINGLE USE ONLY
4HESE MIGHT BE A RESULT OF AN ALLERGIC REACTION

2
Version:

231-30-61204-B LEA OCTREOTIDE A/S SOLN TEVAH
)F YOU DEVELOP ANY OF THE FOLLOWING SEE YOUR DOCTOR
immediately:
s 0ROLONGEDTROUBLESOME BLOATING OF THE STOMACH
WITH PAIN
s .AUSEAVOMITING ASSOCIATED WITH DROWSINESS
s &EELING RESTLESS OR GIDDY
s 9ELLOWING OF THE SKIN OR WHITES OF YOUR EYES
s !CUTE PANCREATITIS SUDDEN SEVERE BURNING PAINS
IN THE STOMACH  4HIS MAY HAPPEN WITHIN THE FIRST
FEW HOURS OR DAYS OF TREATMENT AND RESOLVES ITSELF
UPON DRUG WITHDRAWAL
4HE FOLLOWING SIDE EFFECTS HAVE ALSO BEEN REPORTED
AND THE APPROXIMATE FREQUENCIES SHOWN
6ERY COMMON •
#OMMON • TO 
5NCOMMON •  TO 
2ARE •  TO  
6ERY RARE  
.OT KNOWN CANNOT BE ESTIMATED FROM THE AVAILABLE DATA
Very common:
s 3TOMACH ACHE NAUSEA WIND DIARRHOEA OR
CONSTIPATION 4HESE WILL BE LESS IF YOU INJECT
BETWEEN MEALS OR BEFORE GOING TO BED
s #HANGES IN BLOOD SUGAR LEVELS HYPERGLYCAEMIA
s (EADACHE
s 'ALLSTONES
s ,OCAL PAIN AT THE SITE OF INJECTION

PH - 151

TEVA UK Ref:

Common:
s 3LOW HEART BEAT
s (AIR LOSS
s )TCHING
s 2ASH
s 3HORTNESS OF BREATH
s $IZZINESS
s ,OSS OF APPETITE
s #HANGES IN BLOOD SUGAR LEVELS HYPOGLYCAEMIA
s )MPAIRED GLUCOSE TOLERANCE
s 3TOMACH DISCOMFORT AFTER A MEAL
s 6OMITING
s "LOATED STOMACH
s ,OOSE FAECES STOOLS
s $ISCOLOURATION OF FAECES
s &AT IN YOUR FAECES PALE AND FATTY LOOSE STOOLS
s )NFLAMMATION OF THE GALLBLADDER
s "ILIARY SLUDGE
s 9ELLOW SKIN AND EYES
s !BNORMAL LIVER FUNCTION TEST RESULTS
s #HANGES IN ACTIVITY OF THE THYROID GLAND
HYPOTHYROIDISM CAUSING CHANGES IN HEART RATE
APPETITE OR WEIGHT TIREDNESS FEELING COLD OR
SWEATING TOO MUCH ANXIETY OR SWELLING AT THE
FRONT OF THE NECK
AND ANY UNUSED DRUG PRODUCT MUST BE DISCARDED
After dilution: 4HE CHEMICAL AND PHYSICAL STABILITY OF
/CTREOTIDE SOLUTION DILUTED IN  MGML 
SODIUM CHLORIDE SOLUTION FOR INFUSION HAS BEEN
DEMONSTRATED FOR  HOURS WHEN STORED BELOW  #
&ROM A MICROBIOLOGICAL POINT OF VIEW THE PRODUCT
SHOULD BE USED IMMEDIATELY IF NOT USED IMMEDIATELY
STORAGE TIMES AND CONDITIONS ARE THE RESPONSIBILITY OF
THE USER UNLESS DILUTION HAS TAKEN PLACE IN CONTROLLED
AND VALIDATED ASEPTIC CONDITIONS

-EDICINES SHOULD NOT BE DISPOSED OF VIA WASTEWATER
OR HOUSEHOLD WASTE !SK YOUR PHARMACIST HOW TO
DISPOSE OF MEDICINES NO LONGER REQUIRED 4HESE
MEASURES WILL HELP TO PROTECT THE ENVIRONMENT

6

FURTHER INFORMATION

What Octreotide contains
s 4HE ACTIVE SUBSTANCE IS OCTREOTIDE AS THE ACETATE 
%ACH ML OF SOLUTION FOR INJECTION OR CONCENTRATE FOR
SOLUTION FOR INFUSION CONTAINS  MICROGRAMS
 MICROGRAMS AND  MICROGRAMS OCREOTIDE
s 4HE OTHER INGREDIENTS ARE GLACIAL ACETIC ACID
SODIUM ACETATE TRIHYDRATE % MANNITOL %
AND WATER FOR INJECTIONS
7HAT /CTREOTIDE LOOKS LIKE AND CONTENTS OF THE PACK
/CTREOTIDE  MICROGRAMSML  MICROGRAMSML
AND  MICROGRAMSML 3OLUTION FOR INJECTION OR
#ONCENTRATE FOR SOLUTION FOR INFUSION IS A CLEAR AND
COLOURLESS SOLUTION 4HE SOLUTION IS SUPPLIED IN
COLOURLESS GLASS VIALS CLOSED WITH SERUM RUBBER
STOPPERS AND SEALED WITH ALUMINIUM FLIP OFF CAPS
FITTED WITH PLASTIC FLIP OFF DISCS 4HE PRODUCT IS PACKED
IN CARDBOARD BOXES
/CTREOTIDE  MICROGRAMSML  MICROGRAMSML
AND  MICROGRAMSML SOLUTION FOR INJECTION OR
CONCENTRATE FOR SOLUTION FOR INFUSION IS AVAILABLE IN
PACK SIZES OF       AND  VIALS
.OT ALL PACK SIZES MAY BE MARKETED
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
4EVA 5+ ,IMITED %ASTBOURNE ". !'
5NITED +INGDOM
Manufacturer
4EVA 0HARMACEUTICAL 7ORKS 0RIVATE ,IMITED #OMPANY
(  'ÚDÚLLÚ
4ÈNCSICS -IHÈLY ÞT 
(UNGARY
4HIS LEAFLET WAS LAST REVISED IN /CTOBER 
0, 
0,  

 "
 "

$O NOT USE UNLESS THE SOLUTION IS CLEAR AND FREE FROM
VISIBLE PARTICLES
$ISPOSAL
!NY UNUSED PRODUCT OR WASTE MATERIAL SHOULD BE
DISPOSED OF IN ACCORDANCE WITH LOCAL REQUIREMENTS

 "
 "

PH - 151

PH - 151

08 October 2014

0EOPLE WITH LIVER OR KIDNEY PROBLEMS MAY BE GIVEN A
SMALLER DOSE

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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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