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SOLVENT FOR RISPERDAL CONSTA

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Risperdal Consta™ 25 mg
Risperdal Consta™ 37.5 mg
Risperdal Consta™ 50 mg

2053/2054/2055
2056
08.01.14[20]

(risperidone)
Read all of this leaflet carefully before you start using this medicine.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or 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 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.
The name of your medicine is Risperdal Consta 25mg/ Risperdal Consta
37.5mg/ Risperdal Consta 50mg but it will be referred to as Risperdal
Consta throughout this leaflet.
In this leaflet:
1. What Risperdal Consta is and what it is used for
2. Before you use Risperdal Consta
3. How to use Risperdal Consta
4. Possible side effects
5. How to store Risperdal Consta
6. Further information
1. What Risperdal Consta is and what it is used for
Risperdal Consta belongs to a group of medicines called ‘anti-psychotics’.
Risperdal Consta is used to maintain the treatment of schizophrenia,
where you may see, hear or feel things that are not there, believe things
that are not true or feel unusually suspicious, or confused.
Risperdal Consta is intended for patients who are currently treated with
oral (e.g. tablets, capsules) antipsychotics.
2. Before you use Risperdal Consta
Do not take Risperdal Consta
 If you are allergic (hypersensitive) to risperidone or any of the other
ingredients of Risperdal Consta (listed in Section 6 below).
Take special care with Risperdal Consta
 If you have never taken any form of Risperdal, you should begin with
oral Risperdal before beginning treatment with Risperdal Consta.
Check with your doctor or pharmacist before using Risperdal Consta if:
 You have a heart problem. Examples include an irregular heart rhythm
or if you are prone to low blood pressure or if you are using medicines
for your blood pressure. Risperdal Consta may cause low blood
pressure. Your dose may need to be adjusted.
 You know of any factors which would favour you having a stroke, such
as high blood pressure, cardiovascular disorder or circulation disorders
of the brain
 You have ever experienced involuntary movements of the tongue,
mouth and face
 You have ever had a condition whose symptoms include high
temperature, muscle stiffness, sweating or a lowered level of
consciousness (also known as Neuroleptic Malignant Syndrome)
 You have Parkinson’s disease or dementia
 You know that you have had low levels of white blood cells in the past
(which may or may not have been caused by other medicines)
 You are diabetic
 You have epilepsy
 You are a man and have ever had a prolonged or painful erection
 You have difficulty controlling body temperature or overheating
 You have kidney problems
 You have liver problems
 You have an abnormally high level of the hormone prolactin in your
blood or if you have a possible prolactin-dependent tumour
 You or someone else in your family has a history of blood clots, as
medicines like these have been associated with formation of blood clots.
If you are not sure if any of the above applies to you, talk to your doctor or
pharmacist before using Risperdal or Risperdal Consta.
As dangerously low numbers of a certain type of white blood cell needed to
fight infection in your blood has been seen very rarely with patients taking
Risperdal Consta, your doctor may check your white blood cell counts.
Risperdal Consta may cause you to gain weight. Significant weight gain
may adversely affect your health. Your doctor should regularly measure
your body weight.
As diabetes mellitus or worsening of pre-existing diabetes mellitus have
been seen with patients taking Risperdal, your doctor should check for
signs of high blood sugar. In patients with pre-existing diabetes mellitus
blood glucose should be monitored regularly.
During an operation on the eye for cloudiness of the lens (cataract), the
pupil (the black circle in the middle of your eye) may not increase in size as
needed. Also, the iris (the coloured part of the eye) may become floppy
during surgery and that may lead to eye damage. If you are planning to
have an operation on your eye, make sure you tell your eye doctor that you
are taking this medicine.
Elderly people with dementia
Risperdal Consta is not for use in elderly people with dementia.
Medical treatment should be sought straight away if you or your carer
notice a sudden change in your mental state or sudden weakness or
numbness of your face, arms or legs, especially on one side, or slurred
speech, even for a short period of time. These may be signs of a stroke.
Using other medicines
Please tell your doctor or pharmacist if you are using or have recently
used any other medicines, including medicines obtained without a
prescription and herbal medicines.
It is especially important to talk to your doctor or pharmacist if you are
taking any of the following:
 Medicines that work on your brain to help you calm down
(benzodiazepines), or some medicines for pain (opiates), medicines for
allergy (some antihistamines), as Risperidone may increase the
sedative effect of all of these
 Medicines that may change the electrical activity of your heart, such as
medicines for malaria, heart rhythm problems, allergies (anti-histamines),
some antidepressants or other medicines for mental problems
 Medicines that cause a slow heart beat

 Medicines that cause low blood potassium (such as certain diuretics)
 Medicines for Parkinson's disease (such as levodopa)
 Medicines to treat raised blood pressure. Risperdal Consta can lower
blood pressure
 Water tablets (diuretics) used for heart problems or swelling of parts of
your body due to a build up of too much fluid (such as furosemide or
chlorothiazide). Risperdal Consta taken by itself or with furosemide, may
have an increased risk of stroke or death in elderly people with dementia.
The following medicines may reduce the effect of risperidone
 Rifampicin (a medicine for treating some infections)
 Carbamazepine, phenytoin (medicines for epilepsy)
 Phenobarbital
If you start or stop taking such medicines you may need a different dose
of risperidone.
The following medicines may increase the effect of risperidone
 Quinidine (used for certain types of heart disease)
 Antidepressants such as paroxetine, fluoxetine, tricyclic
antidepressants
 Medicines known as beta blockers (used to treat high blood pressure)
 Phenothiazines (such as medicines used to treat psychosis or to calm
down)
 Cimetidine, ranitidine (blockers of the acidity of stomach)
If you start or stop taking such medicines you may need a different dose
of risperidone.
If you are not sure if any of the above applies to you, talk to your doctor or
pharmacist before using Risperdal Consta.
Using Risperdal Consta with food and drink
You should avoid drinking alcohol when using Risperdal Consta.
Pregnancy and breast-feeding
 Talk to your doctor before using Risperdal Consta if you are pregnant,
trying to become pregnant or breast-feeding. Your doctor will decide if
you can use it
 The following symptoms may occur in newborn babies, of mothers that
have used Risperdal Consta in the last trimester (last three months of
their pregnancy): shaking, muscle stiffness, and/or weakness,
sleepiness, agitation, breathing problems, and difficulty in feeding. If
your baby develops any of these symptoms you may need to contact
your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Dizziness, tiredness, and vision problems may occur during treatment
with Risperdal Consta. Do not drive or use any tools or machines without
talking to your doctor first.
3. How to use Risperdal Consta
Risperdal Consta is given as an intramuscular injection either in the arm
or buttock every two weeks, administered by a health care professional.
Injections should be alternated between the right and left sides, and
should not be given intravenously.
Adults
Starting dose
If your daily dose of oral (e.g. tablets) risperidone was 4 mg or less for the last
two weeks, your starting dose should be 25 mg Risperdal Consta.
If your daily dose of oral (e.g. tablets) risperidone was more than 4 mg for the
last two weeks, you may be given 37.5 mg Risperdal Consta as a starting dose.
If you are currently treated with other oral antipsychotics than risperidone,
your starting dose of Risperdal Consta will depend on your current
treatment. Your doctor will choose Risperdal Consta 25 mg or 37.5 mg
Your doctor will decide on the dose of Risperdal Consta that is right for you.
Maintenance dose
 The usual dose is 25 mg every two weeks as an injection
 A higher dose of 37.5 or 50 mg may be necessary. Your doctor will
decide on the dose of Risperdal Consta that is right for you
 Your doctor may prescribe oral Risperdal for the first three weeks
following your first injection.
Children and adolescents
Risperdal Consta is not for people who are under 18 years old.
If you are given more Risperdal Consta than you should
 People who have been given more Risperdal Consta than they should
have experienced the following symptoms: sleepiness, tiredness,
abnormal body movements, problems with standing and walking,
dizziness from low blood pressure, and abnormal heart beats. Cases of
abnormal electrical conduction in the heart and convulsion have been
reported
 See a doctor right away.
If you stop using Risperdal Consta
You will lose the effects of the medicine. You should not stop this
medicine unless told to do so by your doctor as your symptoms may
return. Be sure not to miss your appointments when you are supposed to
receive your injections every two weeks. If you cannot keep your
appointment, be sure to contact your doctor right away to discuss another
date when you can come in for your injection. If you have any further
questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Risperdal Consta can cause side effects, although not
everybody gets them.
Tell your doctor immediately if you:
 Experience blood clots in the veins, especially in the legs (symptoms
include swelling, pain, and redness in the leg), which may travel
through blood vessels to the lungs causing chest pain and difficulty
breathing. If you notice any of these symptoms seek medical advice
immediately
 Have dementia and experience a sudden change in your mental state
or sudden weakness or numbness of your face, arms or legs, especially
on one side, or slurred speech, even for a short period of time. These
may be signs of a stroke
 Experience fever, muscle stiffness, sweating or a lowered level of
consciousness (a disorder called “Neuroleptic Malignant Syndrome”).
Immediate medical treatment may be needed
 Are a man and experience prolonged or painful erection. This is called
priapism. Immediate medical treatment may be needed
 Experience involuntary rhythmic movements of the tongue, mouth and
face. Withdrawal of risperidone may be needed
Tell your doctor immediately if you experience any of the side effects
above.

The following side effects may happen:
Very common side effects (affects more than 1 user in 10):
 Common cold symptoms
 Difficulty falling or staying asleep
 Depression, Anxiety
 Parkinsonism: This condition may include: slow or impaired movement,
sensation of stiffness or tightness of the muscles (making your
movements jerky), and sometimes even a sensation of movement
"freezing up" and then restarting. Other signs of parkinsonism include a
slow shuffling walk, a tremor while at rest, increased saliva and/ or
drooling, and a loss of expression on the face.
 Headache.
Common side effects (affects 1 to 10 users in 100):
 Pneumonia, Infection of the chest (bronchitis), Sinus infection
 Urinary tract infection, Feeling like you have the flu Anemia
 Risperdal Consta can raise your levels of a hormone called "prolactin"
found on a blood test (which may or may not cause symptoms). When
symptoms of high prolactin occur, they may include in men breast
swelling, difficulty in getting or maintaining erections, or other sexual
dysfunction. In women they may include breast discomfort, leakage of
milk from the breasts, missed menstrual periods, or other problems with
your cycle.
 High blood sugar, Weight gain, Increased appetite, Weight loss,
Decreased appetite
 Sleep disorder, Irritability, Decreased sexual drive, Restlessness,
Feeling sleepy, or less alert
 Dystonia. This is a condition involving slow or sustained involuntary
contraction of muscles. While it can involve any part of the body (and
may result in abnormal posture), dystonia often involves muscles of the
face, including abnormal movements of the eyes, mouth, tongue or jaw.
 Dizziness
 Dyskinesia: This is a condition involving involuntary muscle
movements, and can include repetitive, spastic or writhing movements,
or twitching.
 Tremor (shaking)
 Blurry vision
 Rapid heart rate
 Low blood pressure, Chest pain, High blood pressure
 Shortness of breath, Sore throat, Cough, Stuffy nose
 Abdominal pain, abdominal discomfort, Vomiting, Nausea, Stomach or
intestinal infection, Constipation, Diarrhea, Indigestion, Dry mouth,
Toothache
 Rash
 Muscle spasms, Bone or muscle ache, Back pain, Joint pain
 Incontinence (lack of control) of urine
 Erectile dysfunction
 Loss of menstrual periods
 Leakage of milk from the breasts
 Swelling of the body, arms or legs, Fever, Weakness,
 Fatigue (tiredness),
 Pain
 A reaction at the injection site, including itching, pain or swelling
 Increased liver transaminases in your blood, Increased GGT (a liver
enzyme called gamma-glutamyltransferase) in your blood
 Fall.
Uncommon side effects (affects 1 to 10 users in 1000):
 Infection of the breathing passages, Bladder infection, Ear infection
 Eye infection, Tonsillitis, Fungal infection of the nails, Infection of the
skin, Infection, An infection confined to a single area of skin or part of
the body, Viral infection, Skin inflammation caused by mites, Abscess
under the skin
 White blood cell count decreased, Decrease in platelets (blood cells
that help you stop bleeding), Decrease in red blood cells
 Allergic reaction
 Sugar in the urine, Diabetes or worsening of diabetes
 Loss of appetite resulting in malnutrition and low body weight
 High blood triglycerides (a fat), Increased cholesterol in your blood
 Elated mood (mania), Confusion, Inability to reach orgasm,
Nervousness, Nightmares
 Tardive dyskinesia (twitching or jerking movements that you cannot
control in your face, tongue, or other parts of your body). Tell your
doctor immediately if you experience involuntary rhythmic movements
of the tongue, mouth and face. Withdrawal of Risperdal Consta may be
needed
 Sudden loss of blood supply to brain (stroke or "mini" stroke)
 Loss of consciousness, Convulsion (fits), Fainting
 A restless urge to move parts of your body, Balance disorder, Abnormal
coordination, Dizziness upon standing, Disturbance in attention,
Problems with speech, Loss or abnormal sense of taste, Reduced
sensation of skin to pain and touch, A sensation of tingling, pricking, or
numbness of skin
 Eye infection or "pink eye", Dry eye, Increased tears, Redness of the
eyes
 Sensation of spinning (vertigo), Ringing in the ears, Ear pain
 Atrial fibrillation (an abnormal heart rhythm), An interruption in
conduction between the upper and lower parts of the heart, Abnormal
electrical conduction of the heart, Prolongation of the qt interval from
your heart, Slow heart rate, Abnormal electrical tracing of the heart
(electrocardiogram or ECG), A fluttering or pounding feeling in your
chest (palpitations)
 Low blood pressure upon standing (consequently, some people taking
Risperdal Consta may feel faint, dizzy, or may pass out when they
stand up or sit up suddenly
 Fast, shallow breathing, Congestion of breathing passages, Wheezing,
Nosebleeds
 Stool incontinence, Difficulty swallowing, Excessive passing of gas or
wind
 Itching, Hair loss, Eczema, Dry skin, Skin redness,
 Skin discoloration, Acne, Flaky, itchy scalp or skin
 An increase of CPK (creatine phosphokinase) in your blood, an enzyme
which is sometimes released with muscle breakdown
 Joint stiffness, Joint swelling, Muscle weakness,
 Neck pain
 Frequent passing of urine, Inability to pass urine, Pain when passing
urine
 Ejaculation disorder, A delay in menstrual periods, Missed menstrual
periods or other problems with your cycle (females), Development of
breasts in men, Sexual dysfunction, Breast pain, Breast discomfort,
Vaginal discharge
 Swelling of the face, mouth, eyes, or lips
 Chills, An increase in body temperature
 A change in the way you walk
 Feeling thirsty, Feeling unwell, Chest discomfort, Feeling "out of sorts"
 Hardening of the skin
 Increased liver enzymes in your blood
 Procedural pain.

Rare side effects (affects 1 to 10 users in 10,000):
 Decrease in the type of white blood cells that help to protect you
against infection
 Inappropriate secretion of a hormone that controls urine volume
 Low blood sugar
 Excessive drinking of water
 Lack of emotion
 Neuroleptic malignant syndrome (confusion, reduced or loss of
consciousness, high fever, and severe muscle stiffness)
 Low level of consciousness
 Shaking of the head
 Problems with movement of your eyes, Eye rolling, Oversensitivity of
the eyes to light
 Eye problems during cataract surgery. During cataract surgery, a condition
called intraoperative floppy iris syndrome (IFIS) can happen if you take or
have taken Risperdal Consta. If you need to have cataract surgery, be sure
to tell your eye doctor if you take or have taken this medicine.
 Irregular heart beat
 Dangerously low numbers of a certain type of white blood cell needed
to fight infection in your blood, Increase in eosinophils (a type of white
blood cell) in your blood, Blood clot in the legs, Blood clot in the lungs
 Trouble breathing during sleep (sleep apnea)
 Pneumonia caused by inhaling food, Lung congestion, Crackly lung
sounds, Voice disorder Breathing passage disorder
 Inflammation of the pancreas, A blockage in the bowels
 Very hard stool
 Rash on skin related to drug
 Hives (or "nettle rash"), Thickening of skin, Dandruff, Skin disorder,
Skin lesion
 Breakdown of muscle fibers and pain in muscles (rhabdomyolysis)
 Abnormal posture
 Breast enlargement, Discharge from the breasts
 Decreased body temperature, Discomfort
 Yellowing of the skin and the eyes (jaundice).
 Severe allergic reaction characterised by fever, swollen mouth, face, lip
or tongue, shortness of breath, itching, skin rash and sometimes drop in
blood pressure
 Dangerously excessive intake of water
 Increased insulin (a hormone that controls blood sugar levels) in your
blood
 Blood vessel problems in the brain
 Unresponsive to stimuli
 Coma due to uncontrolled diabetes
 Sudden loss of vision or blindness
 Glaucoma (increased pressure within the eyeball), Eyelid margin
crusting
 Flushing, Swollen tongue
 Chapped lips
 Priapism (a prolonged penile erection that may require surgical
treatment)
 Enlargement of the glands in your breasts
 A decrease in body temperature, Coldness in arms and legs
 Symptoms of drug withdrawal.
Very rare side effects (affects less than 1 user in 10,000):
 Life-threatening complications of uncontrolled diabetes.
 Serious allergic reaction with swelling that may involve the throat and
lead to difficulty breathing.
The following side effect has been seen with the use of another medicine
called paliperidone that is very similar to risperidone, so these can also be
expected with Risperdal Consta: Rapid heartbeat upon standing.
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. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. How to store Risperdal Consta
Store the entire dose pack in the refrigerator (2-8°C). If refrigeration is
unavailable, the pack can be stored at room temperature (below 25°C) for
a maximum of 7 days before use.
Protect from light. Store in the original package.
o
Use within 6 hours of reconstitution (if stored at or below 25 C).
Keep out of the sight and reach of children.
Do not use Risperdal Consta after the expiry date which is stated on the
carton. 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 Risperdal Consta contains
The active substance is risperidone.
Each Risperdal Consta powder and solvent for prolonged-release
suspension for injection contains either 25 mg, 37.5 mg or 50 mg of
risperidone.
The other ingredient in Risperdal Consta is Poly-(D,L-Lactide-CoGlycolide) 7525 DL JN1.
Solvent (solution) contains
Citric acid anhydrous, disodium hydrogen phosphate dihydrate,
polysorbate 20, carmellose sodium, sodium chloride, sodium hydroxide
and water for injections.
What Risperdal Consta looks like and contents of the pack
The Risperdal Consta package contains everything required to
reconstitute (make up) and administer the product:
 One vial containing Risperdal Consta extended release microspheres
 One Alaris SmartSite needle-free vial access device for reconstitution
 One prefilled syringe containing 2 ml solvent for Risperdal Consta
 Two needles for intramuscular injection (a 21G UTW 1-inch (0.8 mm x
25 mm) safety needle with Needle-Pro safety device for deltoid
administration and a 20G TW 2-inch (0.9mm x 50 mm) safety needle
with Needle-Pro safety device for gluteal administration).
Product Licence Holder and Manufacturer
The manufacturer is Janssen Pharmaceutica NV, Turnhoutseweg 30,
B-2340 Beerse, Belgium. Procured from within the EU by the Product
Licence holder: Tenolol Ltd, 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
POM

Risperdal Consta 25mg
- PL No: 30900/2053
Risperdal Consta 37.5mg - PL No: 30900/2054
Risperdal Consta 50mg
- PL No: 30900/2055
Solvent for Risperdal Consta - PL No: 30900/2056

Leaflet revision and issue date 08.01.14[20]
Risperdal Consta is a trademark of Johnson & Johnson

IMPORTANT INFORMATION FOR HEALTHCARE PROFESSIONALS

7. Inject the entire contents of the syringe
containing the solvent into the vial.

Instructions for Needle-Free Vial Access Device
Risperdal Consta requires close attention to the step-by-step
"Instructions for Use" to help ensure successful administration and
help avoid difficulties in the use of the kit.
Risperdal Consta extended release microspheres in the vial must be
reconstituted only in the solvent in the syringe supplied in the dose pack,
and must be administered only with the appropriate needle supplied in
the dose pack for gluteal (2-inch (50 mm) needle) or deltoid (1-inch (25
mm) needle) administration. Do not substitute any components in the
dose pack. To assure that the intended dose of risperidone is delivered,
the full contents from the vial must be administered. Administration of
partial contents may not deliver the intended dose of risperidone. It is
recommended to administer immediately after reconstitution.

8. Shake the vial VIGOROUSLY while holding
the plunger rod down with the thumb for a
minimum of 10 seconds to ensure a
homogeneous suspension.
When properly mixed, the suspension
appears uniform, thick, and milky in colour.
The microspheres will be visible in liquid, but
no dry microspheres remain.
DO NOT STORE THE VIAL AFTER RECONSTITUTION OR
THE SUSPENSION MAY SETTLE.
9. Invert the vial completely and SLOWLY withdraw
the entire contents of the suspension from the
vial into the syringe.
Tear the section of the vial label at the
perforation and apply the detached label to the
syringe for identification purposes.

10. While holding the white collar of the syringe,
unscrew the syringe from the SmartSite
Needle-Free Vial Access Device. Discard
both the vial and vial access device
appropriately.

Remove the dose pack of Risperdal Consta from the refrigerator and
allow it to come to room temperature for approximately 30 minutes prior
to reconstitution.
Contents of the dose pack:
 One small bottle containing the powder for prolonged–release
suspension for injection (within this powder is the active substance,
risperidone). One syringe filled with 2 ml of clear, colourless liquid to be
added to the powder for prolonged–release suspension for injection.
®
 One Alaris™ SmartSite Needle-Free Vial Access Device for
reconstitution
 Two needles for intramuscular injection (a 21G UTW 1-inch (0.8 mm x
25 mm) safety needle with Needle-Pro safety device for deltoid
administration and a 20G TW 2-inch (0.9 mm x 50 mm) safety needle
with Needle-Pro safety device for gluteal administration).
1. Flip off the plastic coloured cap
from the vial. Do not remove
the grey rubber stopper. Wipe
the top of the grey rubber
stopper with an alcohol wipe
and allow to dry.
2. Peel back the blister pouch
and remove the SmartSite
Needle-Free Vial Access
Device by holding between the
white luer cap and the skirt.
Do not touch the spike tip of
the access device at any time.
3. It is very important that the
SmartSite Needle-Free Vial
Access Device be placed on
the vial correctly or the
diluent could leak upon
transfer to the vial.
Place the vial on a hard surface. Hold the base of the vial. Orient the
SmartSite Needle-Free Vial Access Device vertically over the vial so
that the spike tip is at the center of the vial’s rubber stopper.
With a straight downward push press
the spike tip of the SmartSite NeedleFree Vial Access Device through the
centre of the vial’s rubber stopper until
the device securely snaps onto the
vial top.
4. Hold the base of the vial and swab the
syringe connection point (blue circle) of the
SmartSite Needle-Free Vial Access Device
with an alcohol wipe and allow to dry prior
to attaching the syringe to the SmartSite
Needle-Free Vial Access Device.
5. The prefilled syringe has a white tip
consisting of 2 parts: a white collar and a
smooth white cap. To open the syringe,
hold the syringe by the white collar and
snap off the smooth white cap (DO NOT
TWIST OR CUT OFF THE WHITE CAP).
Remove the white cap together with the
rubber tip cap inside.
For all syringe assembly steps, hold the syringe only by the white
collar located at the tip of the syringe. Be careful not to overtighten
components when assembling. Holding the white collar will help to
prevent the white collar from getting detached and ensure a
good connection to the syringe. Overtightening connections may
cause syringe component parts to loosen from the syringe body.
6. While holding the white collar of the syringe, insert and press the
syringe tip into the blue circle of
the SmartSite Needle-Free Vial
Access Device and twist in a
clockwise motion to secure the
connection of the syringe to the
SmartSite Needle-Free Vial Access
Device (avoid over tightening).
Hold the skirt of the vial access
device during attachment to
prevent it from spinning.
Keep the syringe and the SmartSite Needle-Free Vial Access Device
aligned.

11. Open the needle pack and select the
appropriate needle provided with the kit. Do
NOT touch the connection part of the needle,
only touch the transparent sheath of the
needle.
For GLUTEAL injection, select the 20G TW
2-inch (0.9 mm x 50 mm) needle (longer
needle with yellow coloured hub).
For DELTOID injection, select the 21G UTW
1-inch (0.8 mm x 25 mm) needle (shorter
needle with green coloured hub).
12. To prevent contamination, be careful not to
touch the orange Needle-Pro safety device’s
luer connector. While holding the white
collar of the syringe, attach the luer
connection of the orange Needle-Pro safety
device to the syringe with an easy clockwise
twisting motion.
13. While continuing to hold the white collar of
the syringe, grasp the transparent needle
sheath and seat the needle firmly on the
orange Needle-Pro safety device with a push
and a clockwise twist. Seating the needle
will help ensure a secure connection between the needle and the
orange Needle-Pro safety device while conducting the following
steps.
14. RESUSPENSION OF RISPERDAL CONSTA WILL BE
NECESSARY PRIOR TO ADMINISTRATION AS SETTLING WILL
OCCUR OVER TIME ONCE PRODUCT IS RECONSTITUTED.
RESUSPEND THE MICROSPHERES IN THE SYRINGE BY
SHAKING VIGOROUSLY.
15. While holding the white collar of the syringe,
pull the transparent needle sheath straight
away from the needle. DO NOT TWIST the
sheath as the luer connections may be
loosened.
16. Tap the syringe gently to make any air bubbles
rise to the top.
Remove air in syringe by depressing the
plunger rod carefully and slowly, while holding
the needle in an upright position. Inject the
entire contents of the syringe intramuscularly
into the selected gluteal or deltoid muscle of
the patient immediately. Gluteal injection
should be made into the upper-outer quadrant
of the gluteal area.
DO NOT ADMINISTER INTRAVENOUSLY.
WARNING: To avoid a needle stick injury with a contaminated
needle:
 Do not use free hand to press the Needle-Pro safety device over the
needle.
 Do not intentionally disengage the Needle-Pro safety device
 Do not attempt to straighten the needle or engage Needle-Pro safety
device if the needle is bent or damaged
 Do not mishandle the Needle-Pro safety device as it may cause the
needle to protrude from the Needle-Pro safety device.
17. After injection is complete, press the needle into the orange Needle-Pro
safety device using a one-handed technique. Perform a one-handed
technique by GENTLY pressing the orange Needle-Pro safety device
against a flat surface. AS THE ORANGE NEEDLE-PRO SAFETY
DEVICE IS PRESSED, THE NEEDLE WILL FIRMLY ENGAGE INTO
THE ORANGE NEEDLE-PRO SAFETY DEVICE. Visually confirm that
the needle is fully engaged into the orange Needle-Pro safety device
before discarding. Discard needle appropriately. Also discard the other
(unused) needle provided in the dose pack.

Do Not Reuse: Medical devices require specific material characteristics
to perform as intended. These characteristics have been verified for
single use only. Any attempt to reprocess the device for subsequent reuse may adversely affect the integrity of the device or lead to
deterioration in performance.

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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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