Aciclovir Hikma
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Package Leaflet: Information for the Patient
Aciclovir Hikma, 250 mg, Powder for Solution for Infusion
Aciclovir Hikma, 500 mg, Powder for Solution for Infusion
Aciclovir
Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.
- Keep this Package Leaflet, You May Need to Read it Again.
- In Case of Any Doubts, Consult a Doctor or Nurse.
- If the Patient Experiences Any Side Effects, Including Those Not Mentioned in this Package Leaflet, Inform the Doctor or Nurse. See Section 4.
Package Leaflet Contents
- 1. What is Aciclovir Hikma and What is it Used For
- 2. Important Information Before Using Aciclovir Hikma
- 3. How to Use Aciclovir Hikma
- 4. Possible Side Effects
- 5. How to Store Aciclovir Hikma
- 6. Package Contents and Other Information
1. What is Aciclovir Hikma and What is it Used For
Aciclovir Hikma Contains the Active Substance Aciclovir. It Belongs to a Group of Medicines Called Antiviral Medicines. Its Mechanism of Action Involves Killing Viruses or Inhibiting Their Growth.
Aciclovir Hikma Can be Used to:
- Treat Infections Caused by the Varicella-Zoster Virus (Chickenpox) and Herpes Zoster (Shingles);
- Treat Severe Cases of Genital Herpes;
- Prevent and Treat Infections Caused by the Herpes Simplex Virus (Cold Sores and Genital Herpes) in People with Reduced Immunity, Meaning Their Body Fights Infections Less Effectively;
- Treat Herpes Simplex Virus Infections in Children Under 3 Months of Age. This Type of Infection Can be Caused by the Virus Responsible for Cold Sores and Genital Herpes;
- Treat Herpes Simplex Encephalitis (a Rare Infection of the Brain Caused by the Virus Responsible for Cold Sores and Genital Herpes).
2. Important Information Before Using Aciclovir Hikma
When Not to Use Aciclovir Hikma:
- If the Patient is Allergic to Aciclovir or Valaciclovir, or Any of the Other Ingredients of this Medication (Listed in Section 6).
Warnings and Precautions
Before Starting Aciclovir Hikma, Discuss it with a Doctor or Nurse.
Consult a Doctor or Nurse Before Using Aciclovir Hikma if:
- The Patient Has Kidney Problems;
- The Patient is Over 65 Years Old. If it is Not Known if the Above Applies to the Patient, Consult a Doctor or Nurse Before Using Aciclovir Hikma.
Aciclovir Hikma and Other Medicines
Tell the Doctor About All Medicines the Patient is Currently Taking or Has Recently Taken, as Well as Any Medicines the Patient Plans to Take.
Inform the Doctor or Pharmacist if the Patient is Taking Any of the Following Medicines:
- Probenecid Used to Treat Gout;
- Cimetidine Used to Treat Stomach Ulcers;
- Tacrolimus, Cyclosporin, or Mycophenolate Mofetil Used to Prevent Transplanted Organs from Being Rejected by the Body;
- Lithium Used to Treat Manic-Depressive Disorders;
- Theophylline Used to Treat Certain Breathing Disorders.
Pregnancy and Breastfeeding
If the Patient is Pregnant or Breastfeeding, Thinks They May be Pregnant, or Plans to Have a Child, They Should Consult a Doctor Before Using this Medication.
Aciclovir Hikma Contains Sodium
Aciclovir Hikma Contains 37.8 mg of Sodium per Dose. This Information Should be Taken into Account by Patients on a Controlled Sodium Diet.
3. How to Use Aciclovir Hikma
The Patient Will Never Administer this Medication Themselves. It is Always Administered by a Trained Healthcare Professional.
Before Administration, the Medication Will be Reconstituted.
Aciclovir Hikma is Administered as a Continuous Intravenous Infusion. The Medication is Administered Slowly Over 1 Hour.
Aciclovir Hikma is Usually Administered Every 8 Hours.
The Patient May Receive Fluids to Prevent Dehydration.
The Dose, Frequency of Administration, and Duration of Treatment Will Depend on:
- The Type of Infection the Patient Has;
- The Patient's Body Weight;
- The Patient's Age.
The Doctor May Adjust the Dose of Aciclovir Hikma if:
- The Patient Has Kidney Problems. If the Patient Has Kidney Problems, it is Essential to Drink Plenty of Fluids While Taking Aciclovir Hikma;
- The Patient is Overweight or Obese;
- The Patient is Elderly. If the Above Applies to the Patient, Consult a Doctor Before Using Aciclovir Hikma.
Use in Children
The Dose of Aciclovir Hikma Administered to:
- Children Aged 3 Months to 12 Years is Calculated Based on Body Surface Area;
- Infants Under 3 Months is Calculated Based on Body Weight. If the Child Has Kidney Problems, the Dose May be Reduced.
Overdose of Aciclovir Hikma
If it is Suspected that the Patient Has Taken Too Much Aciclovir Hikma, Inform a Doctor or Nurse Immediately.
If the Patient Has Taken Too Much Aciclovir Hikma, They May:
- Feel Confused or Agitated;
- Have Hallucinations (See or Hear Things that Do Not Exist);
- Have Seizures;
- Lose Consciousness (Coma).
4. Possible Side Effects
Like All Medicines, Aciclovir Hikma Can Cause Side Effects, Although Not Everybody Gets Them.
The Following Side Effects May Occur When Using this Medication:
Allergic Reactions(in Less Than 1 in 10,000 People)
If the Patient Experiences an Allergic Reaction, Stop Using Aciclovir Hikma and Seek Medical Attention Immediately. Symptoms May Include:
- Rash, Itching, or Hives on the Skin;
- Swelling of the Face, Lips, Tongue, or Other Parts of the Body;
- Wheezing, Whistling, or Difficulty Breathing;
- Fever (High Body Temperature) of Unknown Origin and a Feeling of Fainting, Especially When Standing.
Other Side Effects Include:
Common(in Less Than 1 in 10 People)
- Nausea or Vomiting;
- Itchy Rash Resembling Hives;
- Skin Reaction After Exposure to Light (Photosensitivity);
- Itching;
- Swelling; Redness and Tenderness at the Injection Site.
Uncommon(in Less Than 1 in 100 People)
- Nosebleeds and Easy Bruising.
Rare(in Less Than 1 in 10,000 People)
- Headache or Dizziness;
- Diarrhea or Abdominal Pain;
- Feeling Tired;
- Fever;
- Affecting Some Blood and Urine Test Results;
- Weakness;
- Agitation or Confusion;
- Shivering or Shaking;
- Hallucinations (Seeing or Hearing Things that Do Not Exist);
- Seizures;
- Feeling Unusually Drowsy;
- Difficulty Walking and Lack of Coordination;
- Difficulty Speaking;
- Difficulty Thinking Logically or Assessing the Situation;
- Losing Consciousness (Coma);
- Paralysis of Part or All of the Body;
- Behavioral, Speech, or Eye Movement Disorders;
- Stiff Neck and Sensitivity to Light;
- Hepatitis;
- Jaundice (Yellowing of the Skin and Eyes);
- Kidney Problems Related to Passing Small Amounts of Urine or Complete Inability to Pass Urine;
- Pain in the Lower Back, Kidney Area, or Above the Hip (Kidney Pain).
Reporting Side Effects
If Any Side Effects Occur, Including Those Not Mentioned in this Package Leaflet, Inform a Doctor or Nurse.
Side Effects Can be Reported Directly to:
Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Email: [email protected]
Side Effects Can Also be Reported to the Marketing Authorization Holder.
Reporting Side Effects Will Help Gather More Information on the Safety of this Medication.
5. How to Store Aciclovir Hikma
Store the Medication Out of Sight and Reach of Children.
Store in a Temperature Below 25°C.
Prepare the Medication Immediately Before Use. Discard Any Unused Medication.
Do Not Use this Medication After the Expiration Date Stated on the Label and Carton: Expiration Date (EXP). The Expiration Date Refers to the Last Day of the Specified Month.
6. Package Contents and Other Information
What Aciclovir Hikma Contains
- The Active Substance is Aciclovir. Each Vial Contains 250 mg of Aciclovir as a Sodium Salt. Each Vial Contains 500 mg of Aciclovir as a Sodium Salt.
- The Other Ingredient is Sodium Hydroxide.
What Aciclovir Hikma Looks Like and Package Contents
Aciclovir Hikma is Available in Type I Glass Vials Containing a White Powder, with a Bromobutyl Rubber Stopper and an Aluminum Cap.
The 250 mg Strength is Available in 10 ml Vials, in Packs of 5 or 10 Vials.
The 500 mg Strength is Available in 20 ml Vials, in Packs of 5 or 10 Vials.
Not All Pack Sizes May be Marketed.
Marketing Authorization Holder and Manufacturer
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, 8, 8A e 8B – Fervença
2705-906 Terrugem SNT
Portugal
This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:
Italy:
Aciclovir Hikma 250 mg and 500 mg Powder for Solution for Infusion
Germany:
Aciclovir Hikma 250 mg and 500 mg Powder for Solution for Infusion
Portugal:
Aciclovir Hikma, 250 mg and 500 mg, Powder for Solution for Infusion
Date of Last Revision of the Package Leaflet: 03/2017.
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Information Intended for Healthcare Professionals Only:
Shelf Life of the Solution After Reconstitution and Dilution
From a Chemical and Physical Perspective, the Solution Remains Stable for 12 Hours at a Temperature Between 15°C and 25°C.
From a Microbiological Point of View, the Medication Should be Used Immediately. If the Medication is Not Used Immediately, the User is Responsible for the Storage Time and Conditions After Reconstitution and Dilution.
Special Precautions for Disposal and Preparation of the Medicinal Product for Administration
Reconstitution:
A Solution of Aciclovir Hikma Containing 25 mg of Aciclovir per ml Should be Prepared by Adding the Following Volumes of Water for Injections or 0.9% Sodium Chloride Solution for Intravenous Infusion (0.9%):
Medication Form
Reconstitution Solution Volume
Vial Containing 250 mg
10 ml
Vial Containing 500 mg
20 ml
Based on the Calculated Dose, Determine the Appropriate Number and Size of Vials Needed for Use. To Reconstitute the Contents of the Vials, Add the Recommended Volume of Solution to Each Vial and Gently Shake the Vial Until the Contents are Completely Dissolved.
Administration Method:
The Required Dose of Aciclovir Hikma Should be Administered as a Slow Intravenous Infusion Over at Least 1 Hour.
After Reconstitution, Aciclovir Hikma Can be Administered Using an Infusion Pump with a Controlled Infusion Rate.
Additionally, it is Possible to Further Dilute the Reconstituted Solution to Administer Aciclovir in an Intravenous Infusion at a Concentration Not Exceeding 5 mg/ml (0.5% w/v).
Add the Required Volume of Reconstituted Solution to the Selected Infusion Solution According to the Following Recommendations and Shake Well to Ensure Complete Mixing of the Contents.
In the Case of Children and Infants, When the Smallest Volume of Infusion Solution is Indicated, it is Recommended to Dilute 4 ml of Reconstituted Solution (100 mg of Aciclovir) in 20 ml of Infusion Solution.
In the Case of Adults, it is Recommended to Use Infusion Bags Containing 100 ml of Infusion Solution, Even if this Results in an Aciclovir Concentration Significantly Below 5 mg/ml (0.5% w/v). Therefore, One Infusion Bag of 100 ml Can be Used for Any Dose Between 250 mg and 500 mg of Aciclovir (10 ml to 20 ml of Reconstituted Solution), While for Doses of 500 mg to 1000 mg, a Second Bag Must be Used.
After Dilution According to the Recommended Scheme, Aciclovir Hikma Shows Pharmaceutical Compatibility with the Following Infusion Solutions and Remains Stable for Up to 12 Hours at Room Temperature (15°C-25°C):
- 0.9% Sodium Chloride Solution
- 0.45% Sodium Chloride Solution and 4% Glucose Solution
- 0.9% Sodium Chloride Solution and 2.5% Glucose Solution
- Multicomponent Solution of Sodium Lactate (Hartmann's Solution) for Intravenous Infusion
After Dilution According to the Above Scheme, Aciclovir Hikma Will Ensure an Aciclovir Concentration Not Exceeding 5 mg/ml (0.5% w/v).
Given the Absence of Antimicrobial Preservatives, Reconstitution and Dilution of the Medication Should be Performed Under Aseptic Conditions Immediately Before Use, and Any Unused Solution Should be Discarded. Reconstituted or Diluted Solutions Should Not be Stored in the Refrigerator.
If Any Visible Particles or Crystals Appear in the Solution Before or During Infusion, the Solution Should Not be Used.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- ImporterHikma Farmaceutica S.A. Hikma Italia S.p.A.
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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