Naloxone hydrochloride wzf

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Naloxonum Hydrochloricum WZF
400 micrograms/ml, solution for injection
Naloxoni hydrochloridum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Naloxonum hydrochloricum WZF is and what it is used for
2. Important information before using Naloxonum hydrochloricum WZF
3. How to use Naloxonum hydrochloricum WZF
4. Possible side effects
5. How to store Naloxonum hydrochloricum WZF
6. Contents of the packaging and other information

1. What Naloxonum hydrochloricum WZF is and what it is used for

Naloxonum hydrochloricum WZF contains naloxone as the active substance and belongs to a group of medicines called opioid antagonists.
Naloxonum hydrochloricum WZF reverses (blocks) the undesirable effects of strong painkillers – opioids (e.g. morphine), such as breathing difficulties and drowsiness.
Naloxonum hydrochloricum WZF is used:

• in cases of overdose of strong painkillers (opioids) resulting in severe breathing difficulties;
• to reverse the effects of opioids administered during surgery;
• to treat breathing difficulties in newborns whose mothers received opioids during childbirth;
• to determine whether opioids are the cause of poisoning.

Naloxonum hydrochloricum WZF is always administered by medical personnel.

2. Important information before using Naloxonum hydrochloricum WZF

When not to use Naloxonum hydrochloricum WZF:

• if the patient is allergic to naloxone or any of the other ingredients of this medicine (listed in section 6.).

Warnings and precautions
Before starting treatment with Naloxonum hydrochloricum WZF, discuss this with your doctor or pharmacist.
The doctor will exercise particular caution when using Naloxonum hydrochloricum WZF and will take appropriate measures:

• if the patient has taken an excessive dose of opioids or is opioid-dependent, acute withdrawal symptoms may develop, such as high blood pressure, rapid heartbeat, severe breathing difficulties, or cardiac arrest, which may occasionally lead to death;
• if withdrawal symptoms occur, such as nausea, vomiting, diarrhoea, weakness, rapid heartbeat, elevated blood pressure, fever, nasal discharge, sneezing, piloerection (goosebumps), sweating, yawning, nervousness, restlessness, irritability, tremors, cramping abdominal pain, or body aches; in newborns, seizures, excessive crying, and increased reflexes may occur;
• if Naloxonum hydrochloricum WZF is to be administered to a newborn whose mother used opioids before delivery or is opioid-dependent, as severe withdrawal symptoms may occur in the newborn;
• if the patient has heart disease or circulatory disorders, or is taking cardiac medications or drugs with adverse effects on the cardiovascular system, as these patients are at higher risk of adverse reactions such as irregular heartbeat, hypertension or hypotension, or breathing difficulties;
• if the patient has used the strong painkiller buprenorphine or pentazocine, as the effectiveness of Naloxonum hydrochloricum WZF may be limited in these cases;
• if breathing difficulties occur after administration of Naloxonum hydrochloricum WZF, which may result from the duration of action of naloxone being shorter than that of opioids;
• if Naloxonum hydrochloricum WZF is administered after surgery during which opioids were used, as symptoms such as nausea, vomiting, tremors, hypertension, and rapid heartbeat may occur (see section 4);
• if the patient has liver or kidney disease.

Naloxonum hydrochloricum WZF and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to use.
Inform your doctor if the patient has used or is using:

• strong painkillers (e.g. morphine, codeine, buprenorphine, pentazocine);
• sedatives and/or sleeping pills;
• medicines that may affect the heart or circulatory system (e.g. antihypertensives, tricyclic antidepressants, calcium antagonists, beta-blockers, digoxin, clonidine, cocaine, or methamphetamine). Severe hypertension has been reported during administration of hydrochloride naloxone in cases of clonidine-induced coma.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Inform your doctor if the patient:

• is pregnant;
• suspects she is pregnant;
• is planning a pregnancy;
• is breastfeeding. The decision to use Naloxonum hydrochloricum WZF during pregnancy or breastfeeding is made by the doctor. Naloxonum hydrochloricum WZF may cause withdrawal symptoms in newborns (see information above). Naloxone may be used in pregnant women only if, in the doctor's opinion, its use is absolutely necessary. Breastfeeding should be avoided for 24 hours after administration of the medicine.

Driving and operating machinery
Do not drive or operate machinery for at least 24 hours after administration of the medicine.
Naloxonum hydrochloricum WZF contains sodium
The medicine contains 3.36 mg of sodium (main component of table salt) in each ml of solution. This corresponds to 0.17% of the maximum recommended daily sodium intake in the adult diet.
The medicine contains 84 mg of sodium (main component of table salt) in the maximum daily dose of 10 mg naloxone (25 ml of solution). This corresponds to 4.2% of the maximum recommended daily sodium intake in the adult diet.
The medicine may be diluted – see below "Information intended exclusively for medical professionals". When calculating the total sodium content in the prepared, diluted solution, the sodium content originating from the diluent solution should be taken into account. For accurate information on the sodium content in the diluent solution, refer to the product characteristics of the medicinal product used as the diluent.

3. How to use Naloxonum Hydrochloricum WZF

Naloxonum Hydrochloricum WZF is always administered by medical personnel.
The medicine may be given:

• intravenously – injected directly into a vein or administered as an infusion;
• intramuscularly;
• subcutaneously.
  The dose of the medicine is determined by the doctor. The dose used depends on body weight, the patient's condition, and the type and amount of opioid administered.

Use of a higher than recommended dose of Naloxonum Hydrochloricum WZF

• After administration of higher naloxone doses, recurrence of pain and return of muscle rigidity may occur.
• As the medicine is administered by medical personnel, it is unlikely that a patient would receive more medicine than required.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
All medicines can cause allergic reactions, but severe allergic reactions following the use of this medicine are very rare. If you experience wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting the whole body), seek medical advice immediately.
The following adverse reactions have been reported:

Very common (occurring in more than 1 out of 10 patients):

• nausea

Common (occurring in less than 1 out of 10 patients):

• dizziness;
• headache;
• rapid heartbeat;
• hypotension or hypertension;
• vomiting;
• postoperative pain.

Uncommon (occurring in less than 1 out of 100 patients):

• tremor, sweating;
• heart rhythm disorders, bradycardia;
• diarrhoea;
• dry mouth;
• irritation of blood vessel walls after intravenous administration;
• local irritation, burning and redness at the site of intramuscular injection;
• too rapid and deep breathing.

Rare (occurring in less than 1 out of 1,000 patients):

• seizures;
• muscle tension.

Very rare (occurring in less than 1 out of 10,000 patients):

• severe heart disorders (ventricular fibrillation, cardiac arrest);
• pulmonary oedema (symptoms include fluid in the lungs, difficulty breathing, breathlessness);
• erythema multiforme (symptoms usually include widespread blistering skin lesions and rash, skin discoloration, and damage to mucous membranes and skin);
• allergic reactions (symptoms usually include urticaria, rhinitis, dyspnoea, facial swelling), anaphylactic shock (severe allergic reaction).

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, telephone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Naloxonum Hydrochloricum WZF

Keep the medicine out of sight and reach of children.
Store below 25°C.
Keep the ampoules in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Naloxonum Hydrochloricum WZF contains

• The active substance is naloxone hydrochloride. Each ml of solution contains 400 micrograms of naloxone hydrochloride (as naloxone hydrochloride dihydrate).
• The other ingredients are: sodium chloride, hydrochloric acid diluted (for pH adjustment), water for injections.

What Naloxonum Hydrochloricum WZF looks like and contents of the pack

Naloxonum Hydrochloricum WZF solution for injection is a colourless, transparent liquid. Glass ampoules containing 1 ml of solution are packed in a cardboard box. The cardboard box contains 10 ampoules.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Bulgaria, country of export:
Warszawskie Zakłady Farmaceutyczne Polfa S.A.
ul. Karolkowa 22/24
01-207 Warszawa, Poland

Manufacturer:
Warszawskie Zakłady Farmaceutyczne Polfa S.A.
ul. Karolkowa 22/24
01-207 Warszawa, Poland

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warszawa, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warszawa, Poland

Marketing Authorisation Number in Bulgaria, country of export: 20030166
Parallel Import Authorisation Number: 250/22

Information intended exclusively for healthcare professionals:

Naloxonum hydrochloricum WZF
400 micrograms/ml, solution for injection
Naloxoni hydrochloridum

Administration instructions for Naloxonum Hydrochloricum WZF

The medicinal product is administered intravenously, intramuscularly, subcutaneously, or by intravenous infusion after prior dilution.

For intravenous infusion, the solution should be diluted with 0.9% sodium chloride solution or 5% glucose solution as follows: 2000 micrograms (5 ml of solution containing 400 micrograms/ml naloxone) in 500 ml of diluent. The resulting diluted solution contains 4 micrograms of naloxone per 1 ml. The solution should be prepared immediately before administration.

Note: Naloxonum Hydrochloricum WZF should not be administered in the same intravenous infusion line with other medicinal products.

During treatment, oxygen therapy and resuscitation measures should be readily available, along with equipment necessary for cardiopulmonary resuscitation.

Instructions for opening the ampoule

Before opening the ampoule, ensure that the entire solution is in the lower part of the ampoule. Gently shake the ampoule or tap it with your finger to help the solution flow downward.

Each ampoule has a white dot (see Figure 1) indicating the location of the score line beneath it.

• To open the ampoule, hold it vertically in both hands with the white dot facing you – see Figure 2. The upper part of the ampoule should be held so that the thumb is positioned above the white dot.
• Press according to the direction shown in Figure 3.

Ampoules are intended for single use only and should be opened immediately before use. Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

Figure 1.

Figure 2.

Figure 3.

Dosage of Naloxonum Hydrochloricum WZF

The dose of naloxone and the route of administration depend on the patient's condition, the type and amount of opioid administered.

Opioid poisoning

Adults
An initial intravenous dose of 400 to 2000 micrograms is usually administered.
If necessary, the intravenous dose may be repeated every 2 to 3 minutes until consciousness returns and breathing becomes regular and sustained. If no improvement in respiratory function or return of consciousness occurs after administration of 10 mg, the symptoms are unlikely to be due to opioid overdose.

The medicinal product may also be administered intramuscularly or subcutaneously. In life-threatening situations, the medicinal product should be given intravenously.

Children
The usual initial intravenous dose is 10 micrograms per kg body weight. If necessary, an additional dose of 100 micrograms per kg body weight may be administered.

If intravenous administration is not possible, the medicinal product should be given intramuscularly or subcutaneously in divided doses.

Reversal of opioid-induced anaesthesia

Adults
Typically, 100 to 200 micrograms (i.e. 1.5–3 micrograms per kg body weight) administered intravenously.

In some cases, especially when a long-acting opioid has been used, additional intramuscular doses of naloxone may be required within 1–2 hours. The medicinal product may also be administered by intravenous infusion.

Children
Intravenous dose of 10 micrograms per kg body weight. If necessary, an additional dose of 100 micrograms per kg body weight may be given.

If intravenous administration is not possible, administer the medicinal product intramuscularly or subcutaneously in divided doses. The medicinal product may also be given by intravenous infusion.

Reversal of respiratory depression in newborns caused by maternal administration of opioid analgesics during labour

Newborns
Before administering the medicinal product, ensure airway patency in case of apnoea.

Administer intravenously, intramuscularly, or subcutaneously at a dose of 10 micrograms per kg body weight. The dose may be repeated after 2–3 minutes if necessary.

Alternatively, a single intramuscular dose of naloxone 200 micrograms (approximately 60 micrograms per kg body weight) may be administered.

Differential diagnosis of opioid poisoning

An intravenous dose of 0.5 micrograms per kg body weight of naloxone may be used to determine whether respiratory depression or urinary tract spasm is caused by opioids. The naloxone dose may then be gradually increased to avoid excessive dosing. High doses eliminate all opioid effects, including analgesia, and may also cause sympathetic and cardiovascular system stimulation.