DEPO 40 mg /Ml Injectable Suspension

Зміст інструкції

1. DEPO MEDROL 40 mg/ml injectable suspension
   1. What Depo Medrol is and what it is used for
   2. What you need to know before using/being administered Depo Medrol
   3. How to use/how it will be administered Depo Medrol
   4. Possible side effects
   5. How to store Depo Medrol
   6. Contents of the pack and other information
   7. Rheumatoid Arthritis and Osteoarthritis
   8. Bursitis
   9. Tendon cysts, tendinitis, epicondylitis
   10. Local treatment of dermatological conditions

DEPO MEDROL 40 mg/ml injectable suspension

methylprednisolone acetate

Read this leaflet carefully before you use/it is administered to you or your child
this medicine because it contains important information for you and/or your child.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or the doctor caring for your child, or your nurse or pharmacist.
• This medicine has been prescribed only for you or your child. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If you or your child experience any side effects, including those not listed in this leaflet, tell your doctor or the doctor caring for your child, or your nurse or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Depo Medrol is and what it is used for
• 2. What you need to know before you use/it is administered Depo Medrol
• 3. How to use/it will be administered Depo Medrol
• 4. Possible side effects
• 5. How to store Depo Medrol
• 6. Contents of the pack and other information

1. What Depo Medrol is and what it is used for

Depo Medrol contains the active ingredient methylprednisolone acetate. Methylprednisolone acetate
belongs to a category of medicines called corticosteroids. Corticosteroids are substances
produced naturally by the body and are important for many body functions.
Depo Medrol can be injected by a doctor or nurse, for example into a joint, a
lesion or nearby, to treat local symptoms caused by inflammatory or rheumatic conditions
such as:

• bursitis:inflammation of the fluid-filled sacs around the shoulder, knee and/or elbow joints;
• osteoarthritisand rheumatoid arthritis:localized inflammation between joints;
• skin problems:such as alopecia areata (bald patches), keloids (scar tissue), lichen planus or simplex (small, raised, purplish spots on the skin), discoid lupus (round patches, often on the face) or annular granuloma (rounded nodules);
• epicondylitis (tennis elbow)and tenosynovitis.

Alternatively, the medicine can be injected into a muscle to help treat:

• diseases in which the body is unable to produce a sufficient amount of natural corticosteroids, for example due to problems with the adrenal glandssuch as adrenal insufficiency;
• joint diseases(e.g. rheumatoid arthritis or psoriatic arthritis);
• skin diseases(e.g. pemphigus and severe psoriasis);
• allergic diseases(e.g. allergic rhinitis and bronchial asthma);
• eye diseases(e.g. diffuse posterior uveitis, optic neuritis, iritis and iridocyclitis);
• intestinal diseases(e.g. segmental enteritis and ulcerative colitis);
• lung diseases(e.g. sarcoidosis);
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• blood diseases(e.g. leukemia);
• brain diseases(e.g. tuberculous meningitis)
• blood cancers(Leukemia and lymphomas in adults, acute leukemia in children)
• diseases characterized by fluid accumulation(edematous states)

Depo Medrol may be prescribed to treat conditions other than those listed above.
Ask your doctor if you are not sure why this medicine has been prescribed to you or your
child.

2. What you need to know before using/being administered Depo Medrol

Do not use/be administered Depo Medrol if you and/or the child:

• are allergicto methylprednisolone or to any of the other ingredients of this medicine (listed in section 6);
• have an infectioncaused by fungithat has spread to some organs or throughout the body.

Depo Medrol will notbe administered to you/the child through injections into a vein (intravenous administration) or into the back (intrathecal/epidural administration).
You or your child should not be vaccinated with vaccines“live” or “live attenuated” during treatment with Depo Medrol. You can, however, be vaccinated with killedor inactivatedvaccines,
although the effectiveness of these vaccines may be reduced.

Warnings and precautions
Consult your doctor, nurse or pharmacist BEFOREusing/being administered this medicine to you or the child if:

• you have or have had in the past tuberculosis;
• you are undergoing particular situations of stress. In this case, the doctor will prescribe a higher dose of this medicine to you or your child;
• you have Cushing's syndrome, a disease characterized by excessive production of natural corticosteroids in the body. Depo Medrol may worsen your or your child's condition;
• your thyroid gland is functioning less than normal (hypothyroidism). In this case, the doses of Depo Medrol must be reduced;
• you have diabetes;
• you suffer from seizures;
• you suffer from myasthenia gravis, a disease that causes muscle weakness and fatigue or you are going to undergo general anesthesiathat involves the use of drugs that block the muscles (e.g. pancuronium). In this case, the risk that Depo Medrol causes muscle problems is greater;
• you have an eye infectioncaused by the Herpes simplexvirus;
• you suffer from high blood pressure (hypertension);
• you have high levels of fats in the blood (dyslipidemia);
• you have heart problems (heart failure);
• you suffer from or are predisposed to developing blood clotsin the veins;
• you have an ulcerin the stomachor other serious problems in the stomach or intestine;
• you have kidney problems;
• you have scleroderma(also known as systemic sclerosis, an autoimmune disease), as the use of corticosteroids may increase the risk of a serious complication called scleroderma renal crisis;
• you have a brain injurycaused by trauma;
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• you have liver cirrhosis, a liver disease;
• you are being treated with non-steroidal anti-inflammatory drugs(e.g. acetylsalicylic acid) (see section “Other medicines and Depo Medrol”) and suffer from reduced activity of prothrombin, a protein that helps the blood to clot;
• you have a type of tumor called pheochromocytoma;
• you have or have had a serious infectionor inflammationof the jointinto which Depo Medrol is to be administered.
• you suffer from peritonitis or other gastrointestinal diseases because glucocorticoid therapy may mask symptoms such as perforation, obstruction, or pancreatitis.

Tell the doctor or the doctor caring for your child if any of the following conditions occur or worsen DURINGtreatment with this medicine (see also section 4 “Possible side effects”):

• depression of the skin surfaceat the injection site. This effect usually disappears a few months after stopping treatment;
• infections. This medicine may increase susceptibility to infections or worsen ongoing infections. For example, chickenpox and measles may have a more serious course, sometimes fatal;
• Kaposi's sarcoma, a skin tumor. In this case stoptreatment with Depo Medrol;
• severe allergic reactions;
• onset or worsening of mental disorders(e.g. depression). Inform people who live with you about the possible effects of this medicine;
• fat accumulationthat compresses the spinal cord;
• eye problems;
• severe inflammation of the pancreasand liver;
• osteoporosis(fragile bones);
• swellingin various parts of the body, especially the legs and ankles, or changes in normal levels of blood mineral salts;
• hepatobiliary diseases(reversible after discontinuation);
• blurred visionor other visual disturbances.

For athletes
For those who engage in sports: the use of the drug without therapeutic necessity constitutes doping and may still result in a positive doping test.

Infants and children
Treatments with Depo Medrol for long periods of time or at high doses can cause delayed growth, increased pressure inside the skull, and inflammation of the pancreas in infants and children.

Elderly
If you are elderly, long-term treatment with Depo Medrol may increase the risk of developing osteoporosis, excessive fluid retention in the body, and increased blood pressure. The doctor will assess your condition and administer this medicine with caution.

Other medicines and Depo Medrol
Tell your doctor or pharmacist if you or the child are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of Depo Medrol and the doctor may want to keep you under close observation if you are taking these medicines.

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The following medicines can affect the activity of Depo Medrol or Depo Medrol can affect the effectiveness and/or toxicity of the following medicines:

• isoniazid, troleandomycin, clarithromycinand erythromycin(antibiotics);
• rifampicin(antibiotic against tuberculosis);
• phenobarbital, phenytoin, carbamazepine(medicines against seizures) and other barbiturates(sedative drugs that induce sleep);
• aprepitantand fosaprepitant(medicines against vomiting);
• itraconazole, ketoconazoleand amphotericin B(medicines against fungal infections);
• medicines for the treatment of HIVsuch as indinavir, ritonavirand cobicistat(medicines against the HIV virus);
• aminoglutethimide(medicine against the excessive production of natural corticosteroids);
• diltiazem(medicine used for the treatment of heart problems or high blood pressure);
• ethinylestradiol/norethindrone(hormones used in combination as oral contraceptives) and other estrogens;
• cyclosporine, cyclophosphamideand tacrolimus,medicines against rejection after organ transplantation and against autoimmune diseases;
• oral anticoagulants, medicines used to thin the blood;
• neuromuscular blockerssuch as pancuroniumand vecuronium(medicines that cause muscle relaxation);
• anticholinesterases(medicines against muscle diseases, such as myasthenia gravis, and Alzheimer's disease);
• antidiabetics(medicines against diabetes);
• aspirin(acetylsalicylic acid), salicylatesand other non-steroidal anti-inflammatory drugs(including indometacin);
• diuretics(medicines that increase urine production, such as thiazide diuretics, furosemideand ethacrinic acid);
• xanthinesand beta-2-agonists(medicines against asthma).

Depo Medrol with beverages
You or your child must notdrink grapefruit juiceduring treatment with Depo Medrol, because the effectiveness and toxicity of this medicine may increase.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using/being administered this medicine.

Pregnancy
If you use this medicine during pregnancy, especially at high doses and for a long period of time, your baby may experience undesirable effects at birth. Therefore, if you are pregnant, the doctor will prescribe Depo Medrol only if strictly necessary.

Breastfeeding
Depo Medrol passes into breast milk and this may cause undesirable effects in the baby. If you are breastfeeding, the doctor will prescribe Depo Medrol only if strictly necessary.

Fertility
Based on the information available so far, this medicine may reduce fertility.

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Driving and operating machinery
Do not drivevehicles or operate machinery if you experience dizziness, vertigo, visual disturbances and fatigue during treatment with Depo Medrol.

Depo Medrol contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say it is practically “sodium-free”.

3. How to use/how it will be administered Depo Medrol

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor, nurse or pharmacist.
The doctor will decide, based on the disease to be treated and its severity, where to perform
the injection, the amount of medicine and the number of injections that will be administered to you or your
child. During treatment with Depo Medrol, the doctor will carefully monitor you/the child and
may modify the dose and/or duration of treatment based on the side effects that you and/or the
child experience.
If the doctor is satisfied with the improvement of the disease, they will advise you to reduce the dose
gradually to reach the minimum most suitable dose (maintenance dose).

Adults

Administration by injection into a joint or lesion
This type of administration will be performed by specialized healthcare personnel.

Administration by injection into a muscle
The recommended dose ranges from 40 mg to 120 mg. The doctor will establish the dosage and frequency of
administration based on the disease to be treated and its severity.

Use in newborns and children
The doctor will adjust the dose in newborns and children, based on the severity of the child's condition, their response to therapy, their age and their body weight.

Instructions for use
Depo Medrol can be administered by injection into a muscle, into a joint or into a lesion.
In these latter two cases, Depo Medrol will be administered to you/the child only by specialized healthcare
personnel.
Do not use/do not administer Depo Medrol by routes other than those indicated above.
Before administration, the product must be inspected to visually assess the contents
to exclude the presence of particles or alteration of color.
Do not dilute or mix Depo Medrol with other solutions.
This product is not suitable for multidose use. After administering the dose indicated by
the doctor, the remaining suspension must be discarded.
It is necessary to operate with appropriate hygienic measures to prevent infections or contamination.

If you use/are administered more Depo Medrol than you should
If you use/are administered a dose of this medicine much higher than that prescribed,
you may experience, although rarely, acute toxicity and death.
Seek immediate medical attention or go to the nearest hospital if you and/or the child have
accidentally used excessive doses of Depo Medrol.

If you forget to use Depo Medrol
Do not use a double dose to make up for a missed dose.

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If you stop taking Depo Medrol
You or your child must not suddenly stop taking Depo Medrol. Depo Medrol
can cause a reduction in the function of the adrenal glands that produce natural corticosteroids
and abrupt discontinuation can lead to death.
Furthermore, in case of abrupt discontinuation of treatment with Depo Medrol, you or your child may
develop withdrawal symptomssuch as: anorexia, nausea, vomiting, drowsiness, headache, fever,
muscle and joint pain, skin flaking, weight loss, low
blood pressure and mental disorders.
In case of discontinuation, the doses must be reduced gradually. The doctor will advise you on the correct way
to do this.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor if you experience any of the following side effects:

Frequency not known(frequency cannot be estimated from the available data):

• infections, including infections that occur when the body's immune defenses are very low
• inflammation of the abdomen (peritonitis)
• infection and reactions at the injection site
• increased number of white blood cells in the blood
• hypersensitivity to the medicine
• severe allergic reaction, e.g. swelling of the face, tongue and throat with difficulty swallowing and breathing (angioedema)
• round or moon-shaped face (cushingoid appearance)
• reduced hormone secretion by the pituitary gland (a gland at the base of the brain)
• withdrawal syndrome (see section 3 “If you stop taking Depo Medrol”)
• metabolic acidosis
• increased body fat
• accumulation of adipose tissue in localized parts of the body
• fluid and sodium retention in the body
• loss or increase of acidic substances from the body
• high levels of fats in the blood
• glucose metabolism abnormality and worsening of existing diabetes
• increased appetite and body weight
• mental disorders such as: disorders in experiencing emotions (depression, euphoria, emotional and drug dependence, suicidal ideation, manic behavior, delirium, hallucinations, schizophrenia, thought disorders, personality changes, confusion, anxiety, mood swings, abnormal behavior, insomnia, irritability
• fat accumulation compressing the spinal cord
• increased pressure of the fluid in the skull
• convulsions
• difficulty remembering
• disorders of thought that allow awareness of reality
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• dizziness
• headache
• reduced vision in the central part of the visual field, blindness (associated with intralesional therapy around the face and head)
• cataract
• increased intraocular pressure
• involuntary contraction of the eye muscle
• retinal and choroidal membrane disease
• protruding eyes
• vertigo
• heart's inability to pump enough blood to the rest of the body (congestive heart failure)
• formation of blood clots in the veins and lungs
• increased blood coagulation
• increase or decrease in blood pressure
• hiccups
• ulcer of the stomach and intestine with possible bleeding and perforation
• pancreatitis
• inflammation of the esophagus with or without ulcers
• distension and pain in the abdomen
• diarrhea
• nausea
• difficulty digesting
• increased hair growth
• appearance of small red spots or thin purple lines on the skin
• bruising
• skin atrophy
• redness of the skin, skin rashes
• excessive sweating
• itching
• urticaria
• patches on the skin of unusual color
• acne
• delayed wound healing
• thinning and fragility of the skin
• muscle weakness
• muscle and joint pain, muscle diseases, reduction of muscle mass
• fragile bones (osteoporosis), death and loss of bone tissue
• joint rupture (especially of the foot) causing pain and/or swelling
• irregular menstruation
• pus formation
• swelling
• fatigue, malaise
• reduced carbohydrate tolerance
• increased calcium levels in the urine
• alteration of laboratory tests to evaluate liver function
• possible liver damage, hepatitis, increased liver enzymes
• increased urea levels in the blood
• reduced response to skin tests
• decreased potassium levels in the blood
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• fractures of the vertebrae (from trauma or spontaneously), rupture of tendons, in particular the Achilles tendon
• blurred vision

Additional side effects in children
Frequency not known(frequency cannot be estimated from the available data):

• growth retardation

Reporting of side effects
If you or your child experience any side effects, including those not listed in this
leaflet, please tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-
segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Depo Medrol

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 package and vial after
“Expiry”. The expiry date refers to the last day of that month.
Do not freeze.
Do not use this medicine if you notice the presence of particles or a change in colour.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Depo Medrol contains

• The active ingredient is: methylprednisolone acetate. Each 1 ml vial contains 40 mg of methylprednisolone acetate
• The other ingredients are: macrogol 3350, sodiumchloride, sodiumhydroxide (see section 2 “Depo Medrol contains sodium”), myristyl gamma picolinium chloride, hydrochloric acid, water for injections.

Description of the appearance of Depo Medrol and contents of the pack
Depo Medrol presents as a white-colored suspension. The suspension is contained in
1 ml glass vial closed with a rubber stopper.
Depo Medrol is available in packs of 1 vial of 1 ml or 3 vials of 1 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina

Manufacturer
Pfizer Manufacturing Belgium N.V.
Rijksweg 12 - 2870 Puurs

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Belgium
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The following information is intended exclusively for doctors or healthcare professionals
INCOMPATIBILITIES
Methylprednisolone acetate is incompatible in solution with various drugs. Compatibility in fact
depends on various factors such as, for example, the concentration of the drugs, the pH of the solution and the
temperature. Therefore, it is advisable not to dilute and not to mix Depo Medrol with other solutions.

POSOLOGY
Administration via local route
This therapy should be understood as symptomatic and not causal.

1. Rheumatoid Arthritis and Osteoarthritis

The dose for intra-articular administration depends on the size of the joint and varies
with the severity of the condition in the individual patient. In chronic cases, infiltrations may be
repeated at intervals ranging from 1 to 5 or more weeks, depending on the degree of improvement obtained
from the first administration. The doses in the following table are given as a general guide:
Table 1. Dosage of the medication

Method of administration: a review of the anatomy of the joint to be treated is recommended
before proceeding with the intra-articular infiltration. To obtain complete anti-inflammatory activity,
it is important that the infiltration is performed in the synovial space.
Using the same sterile technique used for lumbar puncture, quickly insert a sterile 20-24 gauge needle into the
synovial cavity, mounted on a dry syringe. Infiltration of procaine is
optional.
Aspiration of a few drops of synovial fluid ensures complete entry of the needle into the
articular space.

The injection site for each joint is determined by the location of the most superficial and least
rich in large vessels and nerves synovial cavity.
Leaving the needle in place, replace the syringe containing the drops of aspirated fluid with
another syringe containing the desired amount of Depo Medrol. Further check by
aspiration that the needle is still in place.
After infiltration, move the joint slightly to promote dispersion of the suspension
into the synovial fluid.
Cover the infiltration site with sterile gauze.
Suitable sites for intra-articular infiltration are the knee, ankle, wrist, elbow, shoulder,
finger joints and hip.

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Since difficulties in penetrating the hip joint may occasionally be encountered,
precautions must be taken to avoid the large vessels present in the area.
Joints unsuitable for infiltration are those anatomically inaccessible, such as the spinal
and sacroiliac joints lacking synovial space.
Treatment failures are most frequently due to the failed introduction of the drug
into the articular space.
Infiltration into the surrounding tissue leads to little or no benefit.
If failure occurs after an injection definitely performed within the synovial space (verified
by aspiration of fluid), repeating the infiltration is superfluous.
Local therapy is not able to modify the underlying disease process, therefore, when possible,
practice a global therapy including physiotherapy and orthopedic review.
After intra-articular therapy with corticosteroids, take particular care to avoid abuse
of the joint, favored by the symptomatic benefit obtained.
Neglect of this circumstance may allow an increase in joint damage that
cancels out the benefit of the steroid.
Infiltrations should not be performed in joints with inflammatory processes in progress.
Repeated infiltrations can sometimes induce inflammation of the joint.
In particular cases, it is advisable to check the damage by X-ray.
If a local anesthetic is used before the infiltration of Depo Medrol, read carefully first

2. Bursitis

Sterilize the area surrounding the infiltration site and anesthetize with a 1% procaine hydrochloride solution. Attach a 20-24 gauge needle to a dry syringe, insert it into the bursa and aspirate the fluid. Leave the needle in place and replace the syringe used for aspiration with a smaller syringe containing the desired dose of Depo Medrol. After the injection, withdraw the needle and apply a small dressing.
Use the same technique as indicated for intra-articular infiltration.

3. Tendon cysts, tendinitis, epicondylitis

In the treatment of these conditions, inject the suspension into the tendon sheath rather than into its
thickness. Appropriately sterilize the overlying skin before infiltration.
The tendon can be easily palpated when it is stretched.
To treat epicondylitis, it is advisable to carefully outline the area of greatest tenderness
for infiltration into the area.
Tendon cysts should be infiltrated directly.
In many cases, a single infiltration is sufficient to induce a significant reduction in the
size of the cysts and the elimination of the effect.
The dose to be administered in the treatment of these forms varies from 4 to 30 mg.
In chronic or recurrent conditions, multiple infiltrations may be necessary.
For each infiltration, the usual precautions for operating in a sterile manner must be observed.

4. Local treatment of dermatological conditions

After adequate antiseptic treatment, infiltrate the lesion with doses of 20-60 mg. Sometimes it may be
useful to perform a series of small perilesional infiltrations of doses from 20 to 40 mg.
Be careful to avoid infiltrating material that could induce a reaction which could be followed by
a small eschar.
Normally, 1 to 4 infiltrations are performed at variable intervals depending on the type of lesion
to be treated and the duration of the improvement achieved with the first injection.

Systemic intramuscular administration
The dosage varies depending on the condition to be treated.

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When a prolonged effect is required, a single injection per week of Depo
Medrol can be performed intramuscularly, calculating the dosage by multiplying the daily oral
dose of methylprednisolone x 7.
The dosage must be determined for each patient. The fundamental criteria for determining the
dosage are the severity, prognosis, expected duration of the condition, and the patient's reaction to
treatment.
In childhood, the recommended dosage should be reduced, but prioritizing the severity of the condition over the age/body weight ratio when choosing the dosage.
Hormonal therapy is a support and not a substitute for conventional therapy.
After administering the drug for more than a few days, the dosage should be reduced or discontinued gradually.
If a period of spontaneous remission occurs during a chronic illness, treatment should be discontinued.
During prolonged therapy, normal blood and urine parameters, post-prandial blood sugar, blood pressure, and body weight should be monitored; furthermore, a chest X-ray is advisable at
regular intervals. In patients with a history of ulcers or significant dyspepsia, an X-ray examination of the upper gastrointestinal tract is suggested.
In patients with adrenogenital syndrome, a single intramuscular injection of 40 mg of Depo Medrol every two weeks may be sufficient. The weekly intramuscular maintenance dose of
Depo Medrol for patients with rheumatoid arthritis will range from 40 to 120 mg. The usual dosage for
patients with dermatological conditions is 40-120 mg intramuscularly at intervals of one week
for a period of one to four weeks.
In severe acute dermatitis caused by Canadian Ivy, intramuscular administration of
a single dose of 80-120 mg can provide relief within 8-12 hours.
In chronic contact dermatitis, repeated injections at intervals of 5-10 days may be necessary.
In seborrheic dermatitis, a weekly dose of 80 mg of Depo Medrol may be suitable to control
the pathological condition.
After intramuscular administration of 80-120 mg of Depo Medrol to asthmatic patients, relief may be obtained within a time frame of 6 to 48 hours with a persistent effect for several days and up to two
weeks. Similarly, in patients with allergic rhinitis, intramuscular administration of
80-120 mg of Depo Medrol can induce relief within 6 hours with a persistent effect for a period of
several days up to three weeks.
If the condition being treated is accompanied by symptoms of stress, the doses of Depo Medrol should be
increased. If a rapid and maximum intensity effect is desired, administration of the
soluble salt (methylprednisolone sodium succinate) by intravenous route is suggested.

Rectal administration in ulcerative colitis
The administration of Depo Medrol in dosages of 40-120 mg, by retention enema or
continuous drip from 3 to 7 times a week, for two or more weeks, has proven to be a useful
adjunctive therapy in the treatment of some cases of ulcerative colitis.
Many patients can be controlled with 40 mg of Depo Medrol administered in 30-300 ml of water
according to the extent of the inflamed colon mucosa. Other appropriate therapeutic measures must also be taken.

ADVERSE EFFECTS OBSERVED WITH ROUTES OF ADMINISTRATION NOT
RECOMMENDED
Intrathecal/epidural route
Arachnoiditis, meningitis, paraparesis, paraplegia, sensory disturbances, intestinal/vesical dysfunctions,
headache, seizures, convulsions, sensory disturbances. The frequency of these adverse reactions is unknown.

Intranasal route
Temporary/permanent visual disturbances including blindness, allergic reactions, rhinitis.

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Ophthalmic route
Temporary/permanent visual disturbances including blindness, increased intraocular pressure,
ocular and periocular inflammation including allergic reactions, infections, residues or eschars at the injection site.

Other injection sites (scalp, palatine tonsils, sphenopalatine ganglia)
Blindness.

For further information, consult the SmPC (Summary of Product Characteristics).

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