NASVICAL 30 mg /Ml Injectable Solution

Зміст інструкції

1. NASVICAL 30 mg/ml injectable solution
   1. What is Nasvical and what is it used for
   2. What you need to know before you take Nasvical
   3. How to use Nasvical
   4. Possible side effects
   5. How to store Nasvical
   6. Contents of the pack and other information

NASVICAL 30 mg/ml injectable solution

Ketorolac tromethamine
Generic medicine

Read this leaflet carefully before you are given this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Nasvical is and what it is used for
• 2. What you need to know before you are given Nasvical
• 3. How Nasvical is given
• 4. Possible side effects
• 5. How to store Nasvical
• 6. Contents of the pack and other information

1. What is Nasvical and what is it used for

Nasvical contains ketorolac tromethamine. It belongs to a group of medicines called
"non-steroidal anti-inflammatory/antirheumatic drugs (NSAIDs)" which perform numerous activities, including
an important function in pain control.
Nasvical is used:

• in the short-term (maximum 2 days) treatment of acute pain after surgery (post-operative pain), of moderate to severe degree, administered into a muscle (intramuscularly) or through a vein (intravenously);
• as a support to pain therapy based on opioid derivatives, in cases of major surgery or very intense pain, administered intravenously;
• in the treatment of pain due to renal colic.

2. What you need to know before you take Nasvical

Do not take Nasvical:

• if you are allergic to ketorolac trometamine or any of the other ingredients of this medicine (listed in section 6);
• if you have mild or continuous pain over time (chronic pain);
• if you are allergic to other NSAIDs;
• if you have had allergic reactions, even severe and sudden (anaphylactic reactions) to aspirin (acetylsalicylic acid) or other medicines of the same class (prostaglandin synthesis inhibitors);
• if you have nodule-like growths inside your nose (complete or partial nasal polyposis syndrome);
• if you have swelling of the legs, arms, face, mouth or tongue (angioedema);
• if you have difficulty breathing (bronchospasm, asthma);
• if you have a history of blood loss, perforation or lesion or have pain and burning in the stomach or intestines (active peptic ulcer);
• if you have severe heart problems (severe heart failure);
• if you have or have had bleeding in the brain or even suspected bleeding (cerebrovascular haemorrhage);
• if you have a reduced blood volume (hypovolemia) or water deficiency (dehydration);
• if you have moderate or severe kidney problems (moderate or severe renal insufficiency - serum creatinine less than 1.8 mg/dl);
• if you have a severe injury or inflammation of the liver (liver cirrhosis or severe hepatitis);
• if you have a tendency to bleed easily (haemorrhagic diathesis, coagulation disorders);
• if you are taking medicines that thin the blood (anticoagulants);
• if you are taking aspirin (acetylsalicylic acid), other NSAIDs, lithium salts (for mental health problems), probenecid (for the treatment of gout) or pentoxifylline (to improve blood circulation) at the same time (see “Other medicines and Nasvical”);
• if you are being treated with medicines that greatly increase urine production (diuretics);
• if you need to prevent pain (analgesia) before or during a surgical operation;
• if you have undergone surgery with a high risk of bleeding (haemorrhage or incomplete haemostasis);
• if you are a child or adolescent under the age of 16;
• if you are in the last three months of pregnancy (third trimester of pregnancy), in labour, are giving birth or are breastfeeding (see “Pregnancy, breastfeeding and fertility”);
• if a particular route of administration is required (neuroaxial use: epidural or intrathecal).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Nasvical:

• if you have or have had diseases of the stomach or intestines, as the risk of toxicity is high, especially if you use Nasvical outside the authorised indications and/or for prolonged periods (see also “What is Nasvical and what it is used for”, “Do not use Nasvical” and “How to take Nasvical”);
• if you are taking other anti-inflammatory medicines (see “Other medicines and Nasvical”);
• if you are elderly or very weak as you may more easily experience some of the unwanted effects caused by Nasvical such as bleeding and perforation of the stomach and intestines;
• if you have chronic inflammatory bowel diseases (ulcerative colitis and Crohn's disease);
• if you are taking anti-inflammatory hormones (oral corticosteroids), blood-thinning medicines (anticoagulants such as warfarin), medicines for depression (selective serotonin reuptake inhibitors) or medicines like aspirin or analogues (see “Other medicines and Nasvical”);
• if you have important allergic reactions (anaphylactic reactions, bronchospasm, skin redness, skin rashes, low blood pressure, swelling of the throat and swelling of the legs, arms, face, mouth or tongue) that can occur in patients with or without a history of allergy to Nasvical, other NSAIDs or aspirin;
• if you have a history of swelling of the legs, arms, face, mouth or tongue (angioedema) or difficulty breathing (bronchospasm, asthma) and the presence of nodule-like growths inside your nose (nasal polyps);
• if you have high blood pressure and/or your heart does not provide enough blood (congestive heart failure from mild to moderate);
• if you have problems with blood vessels in the heart (chronic ischaemic heart disease), legs (peripheral arteriopathy) and brain (cerebrovascular disease);
• if you have too much fat in your blood (hyperlipidaemia);
• if you have diabetes;
• if you smoke;
• if you have kidney problems;
• if you have liver problems;
• if you have bleeding problems;
• if you have skin reactions (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, skin rash, mucous membrane lesions) or any other signs of allergy;
• if you are planning a pregnancy;
• if you have fertility problems or are undergoing fertility investigations.

Tell your doctor if you have recently undergone or are about to undergo surgery on the
stomach or intestinal tract before receiving/using Nasvical, as Nasvical can sometimes
worsen wound healing in the intestine following surgery.
Nasvical does not cause dependence. No withdrawal symptoms have been observed following abrupt
discontinuation of treatment.
Although Nasvical has not been shown to cause an increase in events such as heart attack, such
risk cannot be excluded.

Caution: Nasvical cannot be considered a simple painkiller and requires
to be used under strict medical supervision.

Do not use Nasvical for the treatment of mild or chronic pain.
Children and adolescents
Nasvical is contraindicated in children and adolescents under the age of 16.

Other medicines and Nasvical
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The concomitant use of Nasvical with:

• non-steroidal anti-inflammatory drugs (NSAIDs) and medicines of the same class as aspirin (ASA) should be avoided as they increase the risk of serious side effects;
• corticosteroids (hormones used against inflammation) as they increase the risk of serious lesions and bleeding in the stomach and intestines (see “Warnings and precautions”);
• anticoagulants (medicines to thin the blood) as Nasvical may increase the effects of anticoagulants, such as warfarin, heparin and dextrans;
• antiplatelet agents (aspirin or similar medicines) and selective serotonin reuptake inhibitors (medicines for depression) as they may increase the risk of bleeding in the stomach and intestines and prolong bleeding time;
• pentoxifylline (medicine to improve blood circulation) as it causes a greater tendency to bleeding;
• probenecid (medicine for gout) as it increases the amount and duration of Nasvical in the body;
• methotrexate (medicine for tumours, arthritis and diseases of the body's defence system) as it remains longer in the body, with the possibility of increasing its toxicity;
• lithium (medicine for mental health problems) as its amount in the blood may increase following concomitant administration with Nasvical;
• diuretics, ACE inhibitors and angiotensin II antagonists (medicines to lower blood pressure) as they may have a reduced effect when taken together with Nasvical and increase the risk of kidney damage in some dehydrated or elderly patients who already have impaired kidney function;
• furosemide (medicine to increase the amount of urine) as its effect is reduced.

Nasvical reduces the need to use opioid-derived medicines to control pain following
surgery.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.
Do not take NASVICAL if you are in the last 3 months of pregnancy, as it may harm the unborn child or
cause problems at the time of delivery. It can cause problems with the kidneys and heart of the unborn child. It
can affect its tendency to bleed and that of your baby and make labour longer or more delayed than expected.
You should not take NASVICAL during the first 6 months of pregnancy unless absolutely necessary and
on your doctor's advice. If treatment is needed during this period or when trying to
become pregnant, the lowest dose should be used for the shortest possible time. If taken for more than
a few days from the 20th week of pregnancy, NASVICAL can cause kidney problems in the
foetus which can reduce the levels of amniotic fluid surrounding the baby (oligohydramnios) or constrict a blood vessel (ductus arteriosus) in the baby's heart. If you need
treatment for more than a few days, your doctor may recommend further monitoring.
The use of Nasvical is contraindicated during the last 3 months of pregnancy (third trimester of
pregnancy), during labour and delivery.
Do not use Nasvical during the first and second trimester of pregnancy unless in strictly
necessary cases.
If you are of childbearing potential, you should avoid a possible pregnancy before starting treatment and use
effective contraception during treatment.

Breastfeeding
This medicine passes into breast milk. Do not use Nasvical during breastfeeding.

Fertility
The use of Nasvical may reduce fertility and is not recommended if you are planning a pregnancy. If you
have difficulty getting pregnant or are undergoing tests for infertility, you should consider
stopping Nasvical.

Driving and using machines
You may experience drowsiness, dizziness, vertigo, sleep disturbances (insomnia) or mood
disorders (depression) with the use of Nasvical. If you experience these or other similar side effects, avoid
performing activities that require attention.
Therefore, caution is advised when driving vehicles and using machines.

Nasvical contains ethanol
This medicine contains 100 mg of alcohol (ethanol) in each millilitre, corresponding to 10% v/v. The
alcohol content of a 1ml ampoule of this medicine is equivalent to 2.5 ml of beer and 1 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.
Nasvical contains less than 1 mmol (23mg) of sodium per ampoule, i.e. essentially ‘sodium-free’.

3. How to use Nasvical

Use this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
This medicine will be administered to you by a doctor or healthcare professional. The doctor will
prescribe the lowest effective dose in relation to the severity of the pain and your response to
treatment.

The duration of therapy should not exceed 2 days in case of rapid administration (bolus) and 1
day in case of slow administration (continuous infusion).
Intramuscular administration (into the muscle)
Adults
The recommended initial dose is 10 mg, followed by doses of 10-30 mg to be repeated every 4-6 hours, as
needed, up to a maximum of 90 mg per day, using the minimum effective dose.

The duration of therapy should not exceed 2 days.
The doctor will inform you how to switch from injectable therapy to oral therapy with Nasvical (the total dose
of 90 mg per day should not be exceeded, remembering that the maximum oral dose should not
exceed 40 mg).
The dose will be appropriately reduced by the doctor in patients weighing less than 50 kg.

Intravenous administration (into the vein)
The intravenous use of the preparation is reserved for hospitals and nursing homes.
Adults
In case of severe acute pain, the recommended initial dose is 10 mg, followed by doses of 10-30 mg to be
repeated every 4-6 hours, as needed, using the minimum effective dose. If necessary, the
treatment may continue at longer intervals, but the dose of
90 mg per day should not be exceeded.

Renal colic
If you suffer from renal colic, the recommended dose is one vial of 30 mg for intramuscular or
intravenous administration.

Elderly (aged 65 years or over)
The maximum daily dose should not exceed 60 mg per day.

Use in children and adolescents
The use of the medicine is contraindicated under the age of 16 years.

If you use more Nasvical than you should
In case of taking an excessive dose of Nasvical, immediately inform your doctor or go to the
nearest hospital.
Some of the symptoms of overdose may be abdominal pain, nausea, vomiting, frequent breathing
(hyperventilation), damage to the wall of the stomach or intestine and/or inflammation that
may be accompanied by blood loss (peptic ulcer and/or erosive gastritis, gastrointestinal
bleeding), kidney malfunction, severe and rapid general allergic reactions (anaphylactoid
reactions). Rarely, an increase in blood pressure, kidney problems (acute renal failure), difficulty
breathing (respiratory depression) and coma may occur.
Treatment: there are no specific antidotes. Symptomatic and supportive therapy should be adopted
eventually, adding the usual safety measures (inducing vomiting, gastric lavage,
administration of activated charcoal).
Dialysis does not eliminate ketorolac significantly from the bloodstream.

If you forget to use Nasvical
Do not use a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With Nasvical the following side effects may occur:

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

• inflammation of the membranes surrounding the brain (aseptic meningitis)
• decrease in a type of cells present in the blood (thrombocytopenia)
• red spots on the body (purpura)
• nose bleeding
• severe and rapid general allergic reactions (anaphylaxis, anaphylactoid reactions)
• allergic reactions such as constriction of the bronchi causing difficulty breathing (bronchospasm)
• dilation of blood vessels
• hot flashes
• skin rash
• swelling of the throat (laryngeal edema)
• loss of appetite
• increased potassium levels and decreased sodium levels in the blood
• abnormal thinking
• mood disorders (depression)
• sleep disorders (insomnia)
• anxiety, irritability, nervousness
• severe disturbances of mental balance (psychotic reactions)
• abnormal dreams
• hallucinations
• euphoria
• reduced ability to concentrate
• decreased sensitivity and slowness of reflexes (states of torpor)
• confusion
• headache
• dizziness
• convulsions
• altered skin sensation, tingling (paresthesia)
• excessive movement (hyperkinesia)
• taste alterations
• vision disorders, altered vision
• ringing in the ears (tinnitus), hearing loss
• vertigo
• irregular or strong heartbeat (palpitations)
• decreased heart rate (bradycardia) reduced heart function (heart failure)
• swelling (edema)
• increase or decrease in blood pressure
• heart problems (heart failure)
• bruising (hematomas)
• redness
• pallor
• bleeding from the wound after surgery
• heart attack
• brain vessel injury (stroke)
• presence of fluid in the lungs (pulmonary edema)
• difficulty breathing (dyspnea, asthma)
• injury to the wall of the stomach or intestine which may also be perforated and accompanied by blood loss (peptic ulcer, ulcer, perforation or gastrointestinal bleeding)
• nausea
• vomiting
• diarrhea
• passage of gas from the anus (flatulence)
• constipation
• stomach area pain/discomfort (dyspepsia), abdominal pain, feeling of fullness
• blood in the stool (melena) and from the end of the intestine (rectal bleeding)
• vomiting blood
• inflammation of the mouth (stomatitis, ulcerative stomatitis) and esophagus
• belching
• pancreatitis
• dry mouth
• worsening of inflammation of a part of the intestine called the colon (exacerbation of colitis), or of the stomach (gastritis)
• worsening of a chronic inflammatory bowel disease (Crohn's disease)
• liver inflammation
• yellowing of the skin and eyes (cholestatic jaundice)
• poor liver function (hepatic insufficiency)
• rapid swelling of legs, arms, face or tongue (angioedema)
• skin inflammation with scaling (exfoliative dermatitis)
• sweating
• skin rash with redness and swelling (maculo-papular rash)
• urticaria, itching
• reactions with blisters including a disease called Stevens-Johnson syndrome with severe lesions on the skin, mouth and other parts of the body with high fever, vomiting, diarrhea and joint pain
• skin death (toxic epidermal necrolysis)
• muscle pain
• increased amount of urine, increased frequency of urination, decreased amount of urine
• kidney diseases (renal failure, uremic-hemolytic syndrome, interstitial nephritis, urinary retention, nephrotic syndrome, flank pain)
• infertility in women
• muscle weakness (asthenia)
• fever
• reactions at the injection site
• chest pain
• excessive thirst
• increased bleeding time and alteration of some blood tests (increased urea, increased creatinine, alteration of liver function tests).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Nasvical

Keep this medicine out of the sight and reach of children.
Keep this medicine in the original package to protect it from light.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 Nasvical contains

• The active ingredient is ketorolac tromethamine. One 1 ml vial contains 30 mg of ketorolac tromethamine.
• The other ingredients are ethanol, sodium chloride, water for injections.

Description of the appearance of Nasvical and contents of the pack
Nasvical is presented as an injectable solution for intramuscular or intravenous use.
It is available in the following pack:
30 mg/ml injectable solution: 3 vials of 1 ml.

Marketing Authorisation Holder
I.B.N. SAVIO S.r.l. – Via del Mare, 36 – 00071 Pomezia (RM)

Manufacturer and final control
Savio Industrial S.r.l. – Via E. Bazzano, 14 – Ronco Scrivia (GE)

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The following information is intended exclusively for doctors or healthcare professionals:

Warning: the injectable solution contains ethanol, therefore use via
neuroaxial (epidural or intrathecal) is contraindicated.
Nasvical is compatible with aminophylline, xylocaine, morphine, meperidine, dopamine, insulin and
heparin mixed together in a solution contained in an intravenous infusion bag for i.v. administration,

but cannot be mixed with morphine, meperidine, promethazine or hydroxyzine in a syringe.
Injections must be performed according to strict rules of sterilization, asepsis and antisepsis.
The administered dose must be the lowest effective dose in relation to the severity of the pain and the
patient's response.