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VORICONAZOLE ACTAVIS 200 MG POWDER FOR SOLUTION FOR INFUSION

Active substance(s): VORICONAZOLE

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Package leaflet:
Information for the user

Voriconazole 200mg
Powder for Solution for Infusion
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
• The full name of this medicine is Voriconazole 200mg Powder for
Solution for Infusion but within the leaflet it will be referred to as
Voriconazole.
What is in this leaflet
1. What Voriconazole is and what it is used for
2. What you need to know before you use Voriconazole
3. How to use Voriconazole
4. Possible side effects
5. How to store Voriconazole
6. Contents of the pack and other information
1. What Voriconazole is and what it is used for
Voriconazole 200mg Powder for Solution for Infusion contains the active
substance voriconazole. Voriconazole is an antifungal medicine. It works
by killing or stopping the growth of the fungi that cause infections.

It is used for the treatment of patients (adults and children over the age
of 2) with:
• invasive aspergillosis (a type of fungal infection due to Aspergillus sp)
• c andidaemia (another type of fungal infection due to Candida sp) in
non-neutropenic patients (patients without abnormally low white blood
cells count)
• s erious invasive Candida sp. infections when the fungus is resistant to
fluconazole (another antifungal medicine)
• s erious fungal infections caused by Scedosporium sp. or Fusarium sp. (two
different species of fungi).

• P imozide (used for treating mental illness)
•Q
 uinidine (used for irregular heart beat)
• R ifampicin (used for treating tuberculosis)
• E favirenz (used for treating HIV) in doses of 400mg and above once daily
• C arbamazepine (used to treat seizures)
• P henobarbital (used for severe insomnia and seizures)
• E rgot alkaloids (e.g., ergotamine, dihydroergotamine; used for migraine)
• S irolimus (used in transplant patients)
• R itonavir (used for treating HIV) in doses of 400mg and more twice daily
• S t. John’s Wort (herbal supplement).

Voriconazole is intended for patients with worsening, possibly lifethreatening, fungal infections.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Voriconazole

Prevention of fungal infections in high risk bone marrow transplant
recipients.

• if you have had an allergic reaction to other azoles.
• if you are suffering from, or have ever suffered from liver disease. If
you have liver disease, your doctor may prescribe a lower dose of
Voriconazole. Your doctor should also monitor your liver function while
you are being treated with Voriconazole by doing blood tests.
• if you are known to have cardiomyopathy, irregular heartbeat, slow
heart rate or an abnormality of electrocardiogram (ECG) called‘long QTc
syndrome’.

This product should only be used under the supervision of a doctor.
2. What you need to know before you use Voriconazole
Do not use Voriconazole
• if you are allergic to the active ingredient voriconazole, or to
hydroxypropylbetadex or any of the other ingredients of this medicine
(listed in section 6).
It is very important that you inform your doctor or pharmacist if you are
taking or have taken any other medicines, even those that are obtained
without a prescription, or herbal medicines.
The medicines in the following list must not be taken during your course
of Voriconazole treatment:
• T erfenadine (used for allergy)
• A stemizole (used for allergy)
• C isapride (used for stomach problems)

You should avoid any sunlight and sun exposure while being treated. It is
important to cover sun exposed areas of skin and use sunscreen with high
sun protection factor (SPF), as an increased sensitivity of skin to the sun’s
UV rays can occur. These precautions are also applicable to children.
While being treated with Voriconazole:
• t ell your doctor immediately if you develop
- s unburn
- s evere skin rash or blisters
- b one pain.

If you develop skin disorders as described above, your doctor may refer
you to a dermatologist, who after consultation may decide that it is
important for you to be seen on a regular basis. There is a small chance
that skin cancer could develop with long-term use of Voriconazole.
Your doctor should monitor the function of your liver and kidney by
doing blood tests.
Children and adolescents
Voriconazole should not be given to children younger than 2 years of age.
Other medicines and Voriconazole
Tell your doctor or pharmacist if you are using, have recently used or
might use any other medicines.
Some medicines, when taken at the same time as Voriconazole, may
affect the way Voriconazole works or Voriconazole may affect the way
they work.
Tell your doctor if you are taking the following medicine, as treatment
with Voriconazole at the same time should be avoided if possible:
• R itonavir (used for treating HIV) in doses of 100mg twice daily.
Tell your doctor if you are taking either of the following medicines, as
treatment with Voriconazole at the same time should be avoided if
possible and a dose adjustment of voriconazole may be required:
• R ifabutin (used for treating tuberculosis). If you are already being treated
with rifabutin your blood counts and side effects to rifabutin will need to
be monitored.
• P henytoin (used to treat epilepsy). If you are already being treated
with phenytoin your blood concentration of phenytoin will need to be
monitored during your treatment with Voriconazole and your dose may
be adjusted.

Tell your doctor if you are taking any of the following medicines, as a dose
adjustment or monitoring may be required to check that the medicines
and/ or Voriconazole are still having the desired effect:
•W
 arfarin and other anticoagulants (e.g., phenprocoumon,
acenocoumarol; used to slow down clotting of the blood)
• C iclosporin (used in transplant patients)
• T acrolimus (used in transplant patients)
• S ulfonylureas (e.g. tolbutamide, glipizide, and glyburide) (used for
diabetes)
• S tatins (e.g. atorvastatin, simvastatin) (used for lowering cholesterol)
• B enzodiazepines (e.g. midazolam, triazolam) (used for severe insomnia
and stress)
•O
 meprazole (used for treating ulcers)
•O
 ral contraceptives (if you take Voriconazole whilst using oral
contraceptives, you may get side effects such as nausea and menstrual
disorders)
• V inca alkaloids (e.g. vincristine and vinblastine) (used in treating cancer)
• Indinavir and other HIV protease inhibitors (used for treating HIV)
•N
 on-nucleoside reverse transcriptase inhibitors (e.g. efavirenz,
delavirdine, nevirapine) (used for treating HIV) (some doses of efavirenz
can NOT be taken at the same time as Voriconazole)
•M
 ethadone (used to treat heroin addiction)
• A lfentanil and fentanyl and other short-acting opiates such as sufentanil
(painkillers used for surgical procedures)
•O
 xycodone and other long-acting opiates such as hydrocodone (used
for moderate to severe pain)
•N
 on-steroidal anti-inflammatory drugs (e.g. ibuprofen, diclofenac) (used
for treating pain and inflammation)
• F luconazole (used for fungal infections)
• E verolimus (used for treating advanced kidney cancer and in transplant
patients).

Pregnancy and breast-feeding
Voriconazole must not be used during pregnancy, unless indicated
by your doctor. Effective contraception must be used in women of
childbearing potential. Contact your doctor immediately if you become
pregnant while being treated with Voriconazole.
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
Voriconazole may cause blurring of vision or uncomfortable sensitivity to
light. While affected, do not drive or operate any tools or machines.
Tell your doctor if you experience this.
Voriconazole contains sodium
This medicinal product contains less than 1mmol sodium (23mg) per vial,
i.e. essentially‘sodium- free’.
3. How to use Voriconazole
Always use this medicine exactly as your doctor has told you. Check with
your doctor if you are not sure.
Your doctor will determine your dose depending on your weight and the
type of infection you have.
Your doctor may change your dose depending on your condition.
The recommended dose for adults (including elderly patients) is as
follows:
Intravenous
Dose for the first 24 hours
6mg/kg every 12 hours for the first
(Loading Dose)
24 hours
Dose after the first 24 hours 4mg/kg twice a day
(Maintenance Dose)

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Technical
Approval

S.Anson
20.09.16
06.10.16
S.Anson

Dimensions:
124 x 700
Min Body Text Size: 9pts
Supplier:
Actavis Nerviano

Date sent:
20.09.16 + 26.09.16
Date received: 29.09.16

Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

PAGE 1 TEXT TO BE CUT

Depending on your response to treatment, your doctor may
decrease the dose to 3mg/kg twice daily.

The following information is intended for healthcare professionals only:

The doctor may decide to decrease the dose if you have mild to
moderate cirrhosis.

Reconstitution and Dilution information
• Voriconazole Powder for Solution for Infusion needs to first be reconstituted with either 19ml of Water for Injections or 19ml of 9mg/ml (0.9%)
Sodium Chloride for Infusion to obtain an extractable volume of 20ml of clear concentrate containing 10mg/ml voriconazole.
• Discard the Voriconazole vial if the vacuum does not pull the diluent into the vial.
• It is recommended that a standard 20ml (non-automated) syringe be used to ensure that the exact amount (19.0ml) of Water for Injections or of
9mg/ml (0.9%) Sodium Chloride for Infusion is dispensed.
• The required volume of the reconstituted concentrate is then added to a recommended compatible infusion solution listed below to obtain a final
Voriconazole solution containing 0.5 to 5mg/ml of voriconazole.
• This medicinal product is for single use only and any unused solution should be discarded and only clear solutions without particles should be used.
• For intravenous infusion only.
• For storage information, please refer to Section 5‘How to store Voriconazole.

Use in children and adolescents
The recommended dose for children and teenagers is as follows:
Intravenous
Children aged 2 to
Teenagers aged
less than 12 years
12 to 14 years
and teenagers aged weighing 50kg
12 to 14 years
or more; and all
weighing less than
teenagers older
50kg
than 14
Dose for the first 9mg/kg every 12 hours 6mg/kg every
24 hours
for the first 24 hours 12 hours for the
(Loading Dose)
first 24 hours
Dose after the first 8mg/kg twice a day 4mg/kg twice
24 hours
a day
(Maintenance Dose)
Depending on your response to treatment, your doctor may
increase or decrease the daily dose.
Voriconazole Powder for Solution for Infusion will be reconstituted
and further diluted to the correct concentration by your hospital
pharmacist or nurse. (Please refer to the end of this leaflet for further
information).
This will be given to you by intravenous infusion (into a vein) at a
maximum rate of 3mg/kg per hour over 1 to 3 hours.

Voriconazole 200mg Powder for Solution for Infusion

Required Volumes of 10mg/ml Voriconazole Concentrate
Volume of Voriconazole Concentrate (10mg/ml) required for:
Body Weight (kg)
3mg/kg dose
4mg/kg dose
6mg/kg dose
8mg/kg dose
(number of vials)
(number of vials)
(number of vials)
(number of vials)
10
4.0ml (1)
8.0ml (1)
15
6.0ml (1)
12.0ml (1)
20
8.0ml (1)
16.0ml (1)
25
10.0ml (1)
20.0ml (1)
30
9.0ml (1)
12.0ml (1)
18.0ml (1)
24.0ml (2)
35
10.5ml (1)
14.0ml (1)
21.0ml (2)
28.0ml (2)
40
12.0ml (1)
16.0ml (1)
24.0ml (2)
32.0ml (2)
45
13.5ml (1)
18.0ml (1)
27.0ml (2)
36.0ml (2)
50
15.0ml (1)
20.0ml (1)
30.0ml (2)
40.0ml (2)
55
16.5ml (1)
22.0ml (2)
33.0ml (2)
44.0ml (3)
60
18.0ml (1)
24.0ml (2)
36.0ml (2)
48.0ml (3)
65
19.5ml (1)
26.0ml (2)
39.0ml (2)
52.0ml (3)

9mg/kg dose
(number of vials)
9.0ml (1)
13.5ml (1)
18.0ml (1)
22.5ml (2)
27.0ml (2)
31.5ml (2)
36.0ml (2)
40.5ml (3)
45.0ml (3)
49.5ml (3)
54.0ml (3)
58.5ml (3)

PAGE 2 TEXT TO BE CUT

70
21.0ml (2)
28.0ml (2)
42.0ml (3)
75
22.5ml (2)
30.0ml (2)
45.0ml (3)
80
24.0ml (2)
32.0ml (2)
48.0ml (3)
85
25.5ml (2)
34.0ml (2)
51.0ml (3)
90
27.0ml (2)
36.0ml (2)
54.0ml (3)
95
28.5ml (2)
38.0ml (2)
57.0ml (3)
100
30.0ml (2)
40.0ml (2)
60.0ml (3)
Voriconazole is a single dose unpreserved sterile lyophilisate. Therefore, from a microbiological point of view, the reconstituted solution must be
used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally
not be longer than 24 hours at 2 to 8°C (in a refrigerator), unless reconstitution has taken place in controlled and validated aseptic conditions.
Compatible Infusion Solutions:
The reconstituted solution can be diluted with:

If you or your child are taking Voriconazole for prevention of fungal
infections, your doctor may stop giving Voriconazole if you or your child
develop treatment related side effects.
If a dose of Voriconazole has been forgotten
As you will be given this medicine under close medical supervision, it
is unlikely that a dose would be missed. However tell your doctor or
pharmacist if you think that a dose has been forgotten.
If you stop using Voriconazole
Voriconazole treatment will continue for as long as your doctor advises,
however duration of treatment with Voriconazole Powder for Solution for
Infusion should be no more than 6 months.
Patients with a weakened immune system or those with difficult infections
may require long-term treatment to prevent the infection from returning.
You may be switched from the intravenous infusion to tablets once your
condition improves.

Sodium Chloride 9mg/ml (0.9%) Solution for Injection
5% (50mg/ml) Glucose and Lactated Ringer’s Intravenous Infusion
5% (50mg/ml) Glucose and 0.45% (4.5mg/ml) Sodium Chloride Intravenous Infusion
5% (50mg/ml) Glucose Intravenous Infusion
5% (50mg/ml) Glucose in 20 mEq Potassium Chloride Intravenous Infusion
5% (50mg/ml) Glucose and 0.9% (9mg/ml) Sodium Chloride Intravenous Infusion

When Voriconazole treatment is stopped by your doctor you should not
experience any effects.

The compatibility of Voriconazole with diluents other than listed above (or listed below under‘Incompatibilities’) is unknown.
Incompatibilities:
Voriconazole must not be infused into the same line or cannula concomitantly with other drug infusions, including parenteral nutrition.
Infusions of blood products must not occur simultaneously with Voriconazole.
Infusion of total parenteral nutrition can occur simultaneously with Voriconazole but not in the same line or cannula.
Voriconazole must not be diluted with 4.2% (42mg/ml) Sodium Bicarbonate Infusion.
When reconstituted with Water for Injections, Voriconazole cannot be used in combination with Sodium Chloride 0.45%
(4.5mg/ml) Solution for Injection and Compound Sodium Lactate Intravenous Infusion, due to low osmolality.
Actavis, Barnstaple, EX32 8NS, UK
BBBA0023

Page 4

Page 3

If you have any further questions on the use of this medicine, ask your
doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
If any side effects occur, most are likely to be minor and temporary. However,
some may be serious and need medical attention.

Serious side effects – Stop using Voriconazole and see a doctor
immediately
• R ash
• J aundice; Changes in blood tests of liver function
• P ancreatitis.

•H
 eart rhythm problems including very fast heartbeat, very slow heartbeat,
fainting
• L ow blood pressure, inflammation of a vein (which may be associated with
the formation of a blood clot)
• A cute breathing difficulty, chest pain, swelling of the face (mouth, lips and
around eyes), fluid accumulation in the lungs
• C onstipation, indigestion, inflammation of the lips
• J aundice, inflammation of the liver and liver injury
• S kin rashes which may lead to severe blistering and peeling of the skin
characterised by a flat, red area on the skin that is covered with small
confluent bumps, redness of the skin
• Itchiness
•H
 air loss
• B ack pain
• K idney failure, blood in the urine, changes in kidney function tests.

Other side effects
Very common side effects (may affect more than 1 in 10 people):
• V isual impairment (change in vision including blurred vision, visual colour
alterations, abnormal intolerance to visual perception of light, colour
blindness, eye disorder, halo vision, night blindness, swinging vision, seeing
sparks, visual aura, visual acuity reduced, visual brightness, loss of part of
the usual field of vision, spots before the eyes)
• F ever
• R ash
•N
 ausea, vomiting, diarrhoea
•H
 eadache
• S welling of the extremities
• S tomach pains
• B reathing difficulties
• E levated liver enzymes.

Uncommon side effects (may affect up to 1 in 100 people):
• F lu-like symptoms, irritation and inflammation of the gastrointestinal tract,
inflammation of the gastrointestinal tract causing antibiotic associated
diarrhoea, inflammation of the lymphatic vessels
• Inflammation of the thin tissue that lines the inner wall of the abdomen
and covers the abdominal organ
• E nlarged lymph glands (sometimes painful), failure of blood marrow,
increased eosinophil
•D
 epressed function of the adrenal gland, underactive thyroid gland
• A bnormal brain function, Parkinson-like symptoms, nerve injury resulting
in numbness, pain, tingling or burning in the hands or feet
• P roblems with balance or coordination
• S welling of the brain
•D
 ouble vision, serious conditions of the eye including: pain and
inflammation of the eyes and eyelids, abnormal eye movement, damage
to the optic nerve resulting in vision impairment, optic disc swelling
•D
 ecreased sensitivity to touch

Common side effects (may affect up to 1 in 10 people):
• Inflammation of the sinuses, inflammation of the gums, chills, weakness
• L ow numbers of some types, including severe, of red (sometimes immunerelated) and/or white blood cells (sometimes with fever), low numbers of
cells called platelets that help the blood to clot
• A llergic reaction or exaggerated immune response
• L ow blood sugar, low blood potassium, low sodium in the blood
• A nxiety, depression, confusion, agitation, inability to sleep, hallucinations
• S eizures, tremors or uncontrolled muscle movements, tingling or
abnormal skin sensations, increase in muscle tone, sleepiness, dizziness
• B leeding in the eye

• A bnormal sense of taste
•H
 earing difficulties, ringing in the ears, vertigo
• Inflammation of certain internal organs- pancreas and duodenum, swelling
and inflammation of the tongue
• E nlarged liver, liver failure, gallbladder disease, gallstones
• J oint inflammation, inflammation of the veins under the skin (which may
be associated with the formation of a blood clot)
• Inflammation of the kidney, proteins in the urine, damage to the kidney
• V ery fast heart rate or skipped heartbeats, sometimes with erratic electrical
impulse
• A bnormal electrocardiogram (ECG)
• B lood cholesterol increased, blood urea increased
• A llergic skin reactions (sometimes severe), including life-threatening skin
condition that causes painful blisters and sores of the skin and mucous
membranes, especially in the mouth, inflammation of the skin, hives,
sunburn or severe skin reaction following exposure to light or sun, skin
redness and irritation, red or purple discoloration of the skin which may be
caused by low platelet count, eczema
• Infusion site reaction.

tissues, itchy or sore patches of thick, red skin with silvery scales of skin,
irritation of the skin and mucous membranes, life-threatening skin
condition that causes large portions of the epidermis, the skin´s outermost
layer, to detach from the layers of skin below
• Small dry scaly skin patches, sometimes thick with spikes or‘horns’.

Rare side effects (may affect up to 1 in 1000 people):
•O
 veractive thyroid gland
•D
 eterioration of brain function that is a serious complication of liver disease
• L oss of most fibers in the optic nerve, clouding of the cornea, involuntary
movement of the eye
• B ullous photosensitivity
• A disorder in which the body’s immune system attacks part of the
peripheral nervous system
•H
 eart rhythm or conduction problems (sometimes life threatening)
• L ife threatening allergic reaction
•D
 isorder of blood clotting system
• A llergic skin reactions (sometimes severe), including rapid swelling
(oedema) of the dermis, subcutaneous tissue, mucosa and submucosal

As voriconazole has been known to affect the liver and the kidney, your
doctor should monitor the function of your liver and kidney by doing blood
tests. Please advise your doctor if you have any stomach pains or if your
stools have a different consistency.

N. 000000000.0

Voriconazole 200mg Powder for Solution 1 Vial PIL - UK
approved for print/date

Proof Round

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UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0023

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
20.09.16
06.10.16
S.Anson

Dimensions:
124 x 700
Min Body Text Size: 9pts
Supplier:
Actavis Nerviano

Date sent:
20.09.16 + 26.09.16
Date received: 29.09.16

Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Side effects with frequency not know (frequency cannot be estimated from
the available data):
• F reckles and pigmented spots.
Other significant side effects whose frequency is not known, but should be
reported to your doctor immediately:
• S kin cancer
• Inflammation of the tissue surrounding the bone
• R ed, scaly patches or ring-shaped skin lesions that may be a symptom of an
autoimmune disease called cutaneous lupus erythematosus.
Reactions during the infusion have occurred uncommonly with
voriconazole (including flushing, fever, sweating, increased heart rate and
shortness of breath). Your doctor may stop the infusion if this occurs.

There have been reports of skin cancer in patients treated with voriconazole
for long periods of time.
Sunburn or severe skin reaction following exposure to light or sun was
experienced more frequently in children. If you or your child develops
skin disorders, your doctor may refer you to a dermatologist, who after
consultation may decide that it is important for you or your child to be
seen on a regular basis. Elevated liver enzymes were also observed more
frequently in children.

If any of these side effects persist or are troublesome, please tell your doctor.
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 Website:
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 Voriconazole
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
immediate and outer label after EXP. The expiry date refers to the last day of
that month.
Do not store above 30°C. Store in the original package in order to protect
from light.

Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer required.
These measures will help protect the environment.
6. Contents of the pack and other information
What Voriconazole contains
• The active substance is voriconazole.
• The other ingredients are hydroxypropylbetadex, arginine hydrochloride,
sodium hydroxide (for pH adjustment), hydrochloric acid concentrated (for
pH adjustment).
Each vial contains 200mg voriconazole, equivalent to a 10mg/ml solution
when reconstituted as directed by your hospital pharmacist or nurse (see
the information at the end of this leaflet).
What Voriconazole looks like and contents of the pack
Voriconazole is a white or almost white powder for solution for infusion
presented in 30ml single use glass vials.

Once reconstituted, Voriconazole should be used immediately, but if
necessary may be stored for up to 24 hours at 2°C - 8°C (in a refrigerator) or
in room temperature (15°C‑25°C). Reconstituted Voriconazole needs to be
further diluted with a compatible infusion solution first before it is infused.
(Please refer to the end of this leaflet for further information).

Marketing Authorisation Holder
Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland

Once diluted, the solutions can be stored for up to 48 hours at 2°C - 8°C
(in a refrigerator) or up to 24 hours at 15-25°C (room temperature).

This leaflet was last revised in October 2016.

From a microbiological point of view, the product must be used
immediately. If not used immediately, in-use storage times and conditions
prior to use are the responsibility of the user and would normally not be
longer than 24 hours at 2°C to 8°C, unless reconstitution/dilution has taken
place in controlled and validated aseptic conditions.

Manufacturer
Actavis Italy S.p.A., Nerviano Plant , Via Pasteur 10, 20014 Nerviano (Milan)

Actavis, Barnstaple, EX32 8NS, UK
BBBA0023

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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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