Indapamida Winthrop may be available in the countries listed below.
Indapamide is reported as an ingredient of Indapamida Winthrop in the following countries:
International Drug Name Search
Tilidin-ratiopharm may be available in the countries listed below.
Naloxone hydrochloride (a derivative of Naloxone) is reported as an ingredient of Tilidin-ratiopharm in the following countries:
Tilidine hydrochloride hemihydrate (a derivative of Tilidine) is reported as an ingredient of Tilidin-ratiopharm in the following countries:
International Drug Name Search
Koagulon may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Phytomenadione is reported as an ingredient of Koagulon in the following countries:
International Drug Name Search
Canitex may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Permethrin is reported as an ingredient of Canitex in the following countries:
Pyrethrin I is reported as an ingredient of Canitex in the following countries:
International Drug Name Search
Bucanest Sans Vasoconstricteur may be available in the countries listed below.
Articaine hydrochloride (a derivative of Articaine) is reported as an ingredient of Bucanest Sans Vasoconstricteur in the following countries:
International Drug Name Search
Parlomin may be available in the countries listed below.
Bromocriptine mesilate (a derivative of Bromocriptine) is reported as an ingredient of Parlomin in the following countries:
International Drug Name Search
Pentoxifilina Belmac may be available in the countries listed below.
Pentoxifylline is reported as an ingredient of Pentoxifilina Belmac in the following countries:
International Drug Name Search
Fluorouracilo Pfizer may be available in the countries listed below.
Fluorouracil is reported as an ingredient of Fluorouracilo Pfizer in the following countries:
International Drug Name Search
Tino may be available in the countries listed below.
Tiemonium Methylsulfate is reported as an ingredient of Tino in the following countries:
International Drug Name Search
Fludent may be available in the countries listed below.
Sodium Fluoride is reported as an ingredient of Fludent in the following countries:
International Drug Name Search
Gramicidina may be available in the countries listed below.
Gramicidina (DCIT) is known as Gramicidin in the US.
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
Lysozym Inpharzam may be available in the countries listed below.
Lysozyme hydrochloride (a derivative of Lysozyme) is reported as an ingredient of Lysozym Inpharzam in the following countries:
International Drug Name Search
Rec.INN
0054063-52-4
C22-H25-N-O4
367
Antispasmodic agent
Anticholinergic
2-[4-[2-(1-Piperidinyl)ethoxy]benzoyl]benzoic acid methyl ester
Methyl o-[p-(2-piperidinoethoxy)benzoyl]benzoate (WHO)
Methyl 2-[4-(2-piperidin-1-ylethoxy)benzoyl]benzoate (IUPAC)
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IUPAC | International Union of Pure and Applied Chemistry |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| WHO | World Health Organization |
Bernoflox may be available in the countries listed below.
Ciprofloxacin is reported as an ingredient of Bernoflox in the following countries:
International Drug Name Search
Betaclav may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Betaclav in the following countries:
Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Betaclav in the following countries:
International Drug Name Search
Mupirocin Calcium may be available in the countries listed below.
Mupirocin Calcium (BANM, USAN) is known as Mupirocin in the US.
International Drug Name Search
Glossary
| BANM | British Approved Name (Modified) |
| USAN | United States Adopted Name |
Lipitor PharmaCoDane may be available in the countries listed below.
Atorvastatin calcium (a derivative of Atorvastatin) is reported as an ingredient of Lipitor PharmaCoDane in the following countries:
International Drug Name Search
Fludin may be available in the countries listed below.
Indapamide is reported as an ingredient of Fludin in the following countries:
International Drug Name Search
Bromocriptine Sopharma may be available in the countries listed below.
Bromocriptine mesilate (a derivative of Bromocriptine) is reported as an ingredient of Bromocriptine Sopharma in the following countries:
International Drug Name Search
Lasilix may be available in the countries listed below.
Furosemide is reported as an ingredient of Lasilix in the following countries:
International Drug Name Search
Leuplin Depot may be available in the countries listed below.
Leuprorelin acetate (a derivative of Leuprorelin) is reported as an ingredient of Leuplin Depot in the following countries:
International Drug Name Search
Pantoprazole Teva may be available in the countries listed below.
Pantoprazole sodium (a derivative of Pantoprazole) is reported as an ingredient of Pantoprazole Teva in the following countries:
International Drug Name Search
Prochlorpérazine may be available in the countries listed below.
Prochlorpérazine (DCF) is known as Prochlorperazine in the US.
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
Cementin may be available in the countries listed below.
Cimetidine is reported as an ingredient of Cementin in the following countries:
International Drug Name Search
Furosemida Klonal may be available in the countries listed below.
Furosemide is reported as an ingredient of Furosemida Klonal in the following countries:
International Drug Name Search
Amiphos may be available in the countries listed below.
Amifostine is reported as an ingredient of Amiphos in the following countries:
International Drug Name Search
Innovace may be available in the countries listed below.
UK matches:
Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Innovace in the following countries:
International Drug Name Search
Glossary
| SPC | Summary of Product Characteristics (UK) |
Lanizac may be available in the countries listed below.
Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Lanizac in the following countries:
International Drug Name Search
Mometasone Target may be available in the countries listed below.
Mometasone 17-(2-furoate) (a derivative of Mometasone) is reported as an ingredient of Mometasone Target in the following countries:
International Drug Name Search
Ampicillin + Sulbactam DeltaSelect may be available in the countries listed below.
Ampicillin sodium salt (a derivative of Ampicillin) is reported as an ingredient of Ampicillin + Sulbactam DeltaSelect in the following countries:
Sulbactam sodium salt (a derivative of Sulbactam) is reported as an ingredient of Ampicillin + Sulbactam DeltaSelect in the following countries:
International Drug Name Search
Eoxin may be available in the countries listed below.
Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Eoxin in the following countries:
International Drug Name Search
Colhidrol may be available in the countries listed below.
Doxorubicin hydrochloride (a derivative of Doxorubicin) is reported as an ingredient of Colhidrol in the following countries:
International Drug Name Search
In the US, Proplex T (factor ix complex systemic) is a member of the drug class miscellaneous coagulation modifiers and is used to treat Factor IX Deficiency, Factor VII Deficiency, Hemophilia A with Inhibitors and Hemophilia B.
US matches:
Prothrombin Complex, human is reported as an ingredient of Proplex T in the following countries:
International Drug Name Search
Perkapil may be available in the countries listed below.
Dipyrithione is reported as an ingredient of Perkapil in the following countries:
International Drug Name Search
In the US, Aliskiren (aliskiren systemic) is a member of the drug class renin inhibitors and is used to treat High Blood Pressure.
US matches:
Rec.INN
C09XA02
0173334-57-1
C30-H53-N3-O6
551
Antihypertensive agent
Renin Angiotensin system inhibitor
(2S,4S,5S,7S)-5-Amino-N-(2-carbamoyl-2-methylpropyl)-4-hydroxy-2-isopropyl-7-[4-methoxy-3-(3-methoxypropoxy)benzyl]-8-methylnonanamid (IUPAC)
(2S,4S,5S,7S)-5-Amino-N-(2-carbamoyl-2-methylpropyl)-4-hydroxy-2-isopropyl-7-[4-methoxy-3-(3-methoxypropoxy)benzyl]-8-methylnonanamide (WHO)
International Drug Name Search
Glossary
| IUPAC | International Union of Pure and Applied Chemistry |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
| WHO | World Health Organization |
Xanidil may be available in the countries listed below.
Xantinol Nicotinate is reported as an ingredient of Xanidil in the following countries:
International Drug Name Search
Confact F may be available in the countries listed below.
Coagulation Factor VIII, Human is reported as an ingredient of Confact F in the following countries:
International Drug Name Search
Inbumed may be available in the countries listed below.
Salbutamol is reported as an ingredient of Inbumed in the following countries:
International Drug Name Search
Allopurinol RPG may be available in the countries listed below.
Allopurinol is reported as an ingredient of Allopurinol RPG in the following countries:
International Drug Name Search
Megeide may be available in the countries listed below.
Ketoprofen is reported as an ingredient of Megeide in the following countries:
International Drug Name Search
Gadopril may be available in the countries listed below.
Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Gadopril in the following countries:
International Drug Name Search
Glyboral may be available in the countries listed below.
Glibenclamide is reported as an ingredient of Glyboral in the following countries:
International Drug Name Search
Meloxicam Ciclum may be available in the countries listed below.
Meloxicam is reported as an ingredient of Meloxicam Ciclum in the following countries:
International Drug Name Search
In the US, Furoxone is a member of the drug class miscellaneous antibiotics.
Furazolidone is reported as an ingredient of Furoxone in the following countries:
International Drug Name Search
Mycota may be available in the countries listed below.
Undecylenic Acid free acid and zinc salt (a derivative of Undecylenic Acid) is reported as an ingredient of Mycota in the following countries:
International Drug Name Search
Cetirizine Biofarm may be available in the countries listed below.
Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Cetirizine Biofarm in the following countries:
International Drug Name Search
In the US, Amoclan (amoxicillin/clavulanate systemic) is a member of the drug class beta-lactamase inhibitors and is used to treat Aspiration Pneumonia, Bacterial Infection, Bronchitis, Febrile Neutropenia, Kidney Infections, Melioidosis, Otitis Media, Pneumonia, Sinusitis, Skin and Structure Infection, Skin Infection, Small Bowel Bacterial Overgrowth, Strep Throat, Upper Respiratory Tract Infection and Urinary Tract Infection.
US matches:
Amoxicillin is reported as an ingredient of Amoclan in the following countries:
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoclan in the following countries:
Clavulanic Acid is reported as an ingredient of Amoclan in the following countries:
Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Amoclan in the following countries:
International Drug Name Search
Mitoxantrone Baxter may be available in the countries listed below.
Mitoxantrone is reported as an ingredient of Mitoxantrone Baxter in the following countries:
Mitoxantrone dihydrochloride (a derivative of Mitoxantrone) is reported as an ingredient of Mitoxantrone Baxter in the following countries:
International Drug Name Search
Alfuzosine HCl PCH may be available in the countries listed below.
Alfuzosin hydrochloride (a derivative of Alfuzosin) is reported as an ingredient of Alfuzosine HCl PCH in the following countries:
International Drug Name Search
Cerex may be available in the countries listed below.
Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Cerex in the following countries:
International Drug Name Search
Edolglau may be available in the countries listed below.
Clonidine hydrochloride (a derivative of Clonidine) is reported as an ingredient of Edolglau in the following countries:
International Drug Name Search
Meloxicam La Santé may be available in the countries listed below.
Meloxicam is reported as an ingredient of Meloxicam La Santé in the following countries:
International Drug Name Search
Xetril may be available in the countries listed below.
Clonazepam is reported as an ingredient of Xetril in the following countries:
International Drug Name Search
Génac may be available in the countries listed below.
Acetylcysteine is reported as an ingredient of Génac in the following countries:
International Drug Name Search
Minatuss may be available in the countries listed below.
Butamirate citrate (a derivative of Butamirate) is reported as an ingredient of Minatuss in the following countries:
International Drug Name Search
PMS-Pramipexole may be available in the countries listed below.
Pramipexole dihydrochloride monohydrate (a derivative of Pramipexole) is reported as an ingredient of PMS-Pramipexole in the following countries:
International Drug Name Search
Carbazine may be available in the countries listed below.
Carbamazepine is reported as an ingredient of Carbazine in the following countries:
International Drug Name Search
Xilanic may be available in the countries listed below.
Paroxetine is reported as an ingredient of Xilanic in the following countries:
International Drug Name Search
Cromobene may be available in the countries listed below.
Cromoglicic Acid disodium salt (a derivative of Cromoglicic Acid) is reported as an ingredient of Cromobene in the following countries:
International Drug Name Search
Cimegast may be available in the countries listed below.
Cimetidine is reported as an ingredient of Cimegast in the following countries:
International Drug Name Search
Rudduck's Antiseptiv Intra-uterine Pessary may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Chlorhexidine dihydrochloride (a derivative of Chlorhexidine) is reported as an ingredient of Rudduck's Antiseptiv Intra-uterine Pessary in the following countries:
International Drug Name Search
Candistat may be available in the countries listed below.
Clotrimazole is reported as an ingredient of Candistat in the following countries:
Itraconazole is reported as an ingredient of Candistat in the following countries:
Nystatin is reported as an ingredient of Candistat in the following countries:
International Drug Name Search
Calmivet may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Acepromazine maleate (a derivative of Acepromazine) is reported as an ingredient of Calmivet in the following countries:
International Drug Name Search
Haloperidol Gemepe may be available in the countries listed below.
Haloperidol is reported as an ingredient of Haloperidol Gemepe in the following countries:
International Drug Name Search
Leucovorin Calcium Pfizer may be available in the countries listed below.
Calcium Folinate is reported as an ingredient of Leucovorin Calcium Pfizer in the following countries:
International Drug Name Search
Lamidus may be available in the countries listed below.
Lamotrigine is reported as an ingredient of Lamidus in the following countries:
International Drug Name Search
Amertil may be available in the countries listed below.
Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Amertil in the following countries:
International Drug Name Search
Erlecit may be available in the countries listed below.
Nimesulide is reported as an ingredient of Erlecit in the following countries:
International Drug Name Search
Thymovar may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Thymol is reported as an ingredient of Thymovar in the following countries:
International Drug Name Search
Brogal may be available in the countries listed below.
Ambroxol hydrochloride (a derivative of Ambroxol) is reported as an ingredient of Brogal in the following countries:
International Drug Name Search
Adpas may be available in the countries listed below.
Pioglitazone is reported as an ingredient of Adpas in the following countries:
International Drug Name Search
Carbolitium may be available in the countries listed below.
Lithium carbonate (a derivative of Lithium) is reported as an ingredient of Carbolitium in the following countries:
International Drug Name Search
Clorprotixene may be available in the countries listed below.
Clorprotixene (DCIT) is also known as Chlorprothixene (Rec.INN)
International Drug Name Search
Glossary
| DCIT | Denominazione Comune Italiana |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
In the US, Colocort (hydrocortisone systemic) is a member of the drug class glucocorticoids and is used to treat Ulcerative Colitis and Ulcerative Proctitis.
US matches:
Hydrocortisone is reported as an ingredient of Colocort in the following countries:
International Drug Name Search
Levodopa/Carbidopa Cimex may be available in the countries listed below.
Carbidopa monohydrate (a derivative of Carbidopa) is reported as an ingredient of Levodopa/Carbidopa Cimex in the following countries:
Levodopa is reported as an ingredient of Levodopa/Carbidopa Cimex in the following countries:
International Drug Name Search
Homerat may be available in the countries listed below.
Alacepril is reported as an ingredient of Homerat in the following countries:
International Drug Name Search
Amciderm may be available in the countries listed below.
Amcinonide is reported as an ingredient of Amciderm in the following countries:
International Drug Name Search
Ibuprofene-Eurogenerics may be available in the countries listed below.
Ibuprofen is reported as an ingredient of Ibuprofene-Eurogenerics in the following countries:
International Drug Name Search
Metoclopramida Medinfar may be available in the countries listed below.
Metoclopramide hydrochloride (a derivative of Metoclopramide) is reported as an ingredient of Metoclopramida Medinfar in the following countries:
International Drug Name Search
Efumin may be available in the countries listed below.
Chlormadinone 17α-acetate (a derivative of Chlormadinone) is reported as an ingredient of Efumin in the following countries:
International Drug Name Search
Atenolol Kela may be available in the countries listed below.
Atenolol is reported as an ingredient of Atenolol Kela in the following countries:
International Drug Name Search
Propranolol Lek may be available in the countries listed below.
Propranolol hydrochloride (a derivative of Propranolol) is reported as an ingredient of Propranolol Lek in the following countries:
International Drug Name Search
Ibumultin may be available in the countries listed below.
Ibuprofen is reported as an ingredient of Ibumultin in the following countries:
International Drug Name Search
Paroxetin Alternova may be available in the countries listed below.
Paroxetine hydrochloride (a derivative of Paroxetine) is reported as an ingredient of Paroxetin Alternova in the following countries:
International Drug Name Search
Ronic may be available in the countries listed below.
Dexamethasone 21-(disodium phosphate) (a derivative of Dexamethasone) is reported as an ingredient of Ronic in the following countries:
International Drug Name Search
Cefuroxima Solasma may be available in the countries listed below.
Cefuroxime axetil (a derivative of Cefuroxime) is reported as an ingredient of Cefuroxima Solasma in the following countries:
International Drug Name Search
Methycobal may be available in the countries listed below.
Mecobalamin is reported as an ingredient of Methycobal in the following countries:
International Drug Name Search
Bromxin may be available in the countries listed below.
Bromhexine hydrochloride (a derivative of Bromhexine) is reported as an ingredient of Bromxin in the following countries:
International Drug Name Search
Maxima may be available in the countries listed below.
Esomeprazole is reported as an ingredient of Maxima in the following countries:
International Drug Name Search
Fluc may be available in the countries listed below.
Fluconazole is reported as an ingredient of Fluc in the following countries:
International Drug Name Search
Corvitol may be available in the countries listed below.
Metoprolol tartrate (a derivative of Metoprolol) is reported as an ingredient of Corvitol in the following countries:
International Drug Name Search
In the US, Antara (fenofibrate systemic) is a member of the drug class fibric acid derivatives and is used to treat Hyperlipoproteinemia, Hyperlipoproteinemia Type IIa - Elevated LDL, Hyperlipoproteinemia Type IIb - Elevated LDL VLDL, Hyperlipoproteinemia Type IV - Elevated VLDL, Hyperlipoproteinemia Type V - Elevated Chylomicrons VLDL and Hypertriglyceridemia.
US matches:
Fenofibrate is reported as an ingredient of Antara in the following countries:
International Drug Name Search
Amiodaron-Mepha may be available in the countries listed below.
Amiodarone hydrochloride (a derivative of Amiodarone) is reported as an ingredient of Amiodaron-Mepha in the following countries:
International Drug Name Search
Gabapentina Cinfa may be available in the countries listed below.
Gabapentin is reported as an ingredient of Gabapentina Cinfa in the following countries:
International Drug Name Search
Rhophylac 300 micrograms / 2 ml, solution for injection in pre-filled syringe
Each pre-filled syringe contains 1500 IU (300 micrograms) human anti-D immunoglobulin.
One ml contains 750 IU (150 micrograms) human anti-D immunoglobulin.
The product contains a maximum of 30 mg/ml of human plasma proteins of which 10 mg/ml is human albumin as stabiliser. At least 95 % of the other plasma proteins are IgG.
The content of IgA is not more than 5 micrograms/ml.
For a full list of excipients, see section 6.1.
Solution for injection.
The solution is clear or slightly opalescent and colourless or pale yellow.
Rhophylac has an osmolality of at least 240 mosmol/kg.
Prevention of Rh(D) immunisation in Rh(D) negative women
• Antepartum prophylaxis
- Planned antepartum prophylaxis
- Antepartum prophylaxis following complications of pregnancy including:
Abortion/threatened abortion, ectopic pregnancy or hydatidiform mole, intrauterine foetal death (IUFD), transplacental haemorrhage (TPH) resulting from antepartum haemorrhage (APH), amniocentesis, chorionic biopsy, obstetric manipulative procedures e.g. external version, invasive interventions, cordocentesis, blunt abdominal trauma or foetal therapeutic intervention.
• Postpartum prophylaxis
- Delivery of a Rh(D) positive (D, Dweak, Dpartial) baby
Treatment of Rh(D) negative persons after incompatible transfusions of Rh(D) positive blood or other products containing red blood cells e.g. platelet concentrate.
Posology
The dose of anti-D immunoglobulin should be determined according to the level of exposure to Rh(D) positive red blood cells and based on the knowledge that 0.5 ml of packed Rh(D) positive red blood cells or 1 ml of Rh(D) positive blood is neutralised by approximately 10 micrograms (50 IU) of anti-D immunoglobulin.
The following doses are recommended based on the clinical studies performed with Rhophylac. For specific study details see section 5.1.
Consideration should also be given to dose and dose schedules for human anti-D immunoglobulin for intramuscular and intravenous use recommended in other official guidance.
Prevention of Rh(D) immunisation in Rh(D) negative women
• Antepartum prophylaxis: The recommended dose is a single dose of 300 micrograms (1500 IU) administered by intravenous or intramuscular injection.
- Planned antepartum prophylaxis:
A single dose of 300 micrograms at 28 - 30 weeks of gestation.
- Antepartum prophylaxis following complications of pregnancy:
A single dose of 300 micrograms should be administered as soon as possible and within 72 hours and if necessary repeated at 6 - 12 week intervals throughout the pregnancy.
• Postpartum prophylaxis: For intravenous administration, 200 micrograms (1000 IU) is a sufficient dose. If administered intramuscularly, 200 micrograms (1000 IU) to 300 micrograms (1500 IU) is recommended.
For postpartum use, the product should be administered to the mother as soon as possible within 72 hours of delivery of an Rh(D) positive (D, Dweak, Dpartial) infant. If more than 72 hours have elapsed, the product should not be withheld but administered as soon as possible.
The postpartum dose must still be given even when antepartum prophylaxis has been administered and even if residual activity from antepartum prophylaxis can be demonstrated in maternal serum.
If a large foeto-maternal haemorrhage (>4 ml (0.7% - 0.8% of women)) is suspected, e.g. in the event of foetal/neonatal anaemia or intrauterine foetal death, its extent should be determined by a suitable method, e.g. Kleihauer-Betke acid elution test to detect foetal HbF or flow cytometry which specifically identifies Rh(D) positive cells.
Additional doses of anti-D immunoglobulin should be administered accordingly (10 micrograms or 50 IU) per 0.5 ml foetal red blood cells.
Incompatible transfusions of red blood cells (RBCs)
The recommended dose is 20 micrograms (100 IU) anti-D immunoglobulin per 2 ml of transfused Rh(D) positive blood or per 1 ml of RBC concentrate. The appropriate dose should be determined in consultation with a specialist in blood transfusion. Follow-up tests for Rh(D) positive RBCs should be done every 48 hours and further anti-D administered until all Rh(D) positive RBCs have cleared from the circulation.
A maximum dose of 3000 micrograms (15,000 IU) is sufficient in the case of larger incompatible transfusions independent of whether the transfusion volume is greater than 300 ml of Rh(D) positive blood.
Intravenous use is recommended as it will achieve adequate plasma levels immediately.
If given by intramuscular injection the large volume should be administered over a period of several days.
Method of administration
For intravenous use, administered by slow injection.
If a large volume (>2 ml for children or >5 ml for adults) is required and intramuscular injection is chosen, it is recommended to administer this in divided doses at different sites.
If intramuscular administration is contraindicated (bleeding disorders), Rhophylac should be administered intravenously.
Hypersensitivity to any of the components.
Hypersensitivity to human immunoglobulins.
The intramuscular route is contraindicated in persons with severe thrombocytopenia or other disorders of haemostasis.
In the case of postpartum use, the product is intended for maternal administration. It should not be given to the new-born infant.
The product is neither intended for use in Rh(D) positive individuals, nor for individuals already immunised to Rh(D) antigen.
True allergic reactions are rare, but allergic-type responses to anti-D immunoglobulin may occur.
Rhophylac contains a small quantity of IgA. Although anti-D immunoglobulin has been used successfully to treat selected IgA-deficient individuals, individuals who are deficient in IgA have the potential for developing IgA antibodies and may have anaphylactic reactions after administration of plasma-derived medicinal products containing IgA. The physician must therefore weigh the benefit of treatment with Rhophylac against the potential risks of hypersensitivity reactions.
Rarely, human anti-D immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who have tolerated previous treatment with human immunoglobulin.
Suspicion of allergic or anaphylactic-type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment for shock should be implemented.
Patients in receipt of incompatible transfusion, who receive very large doses of anti-D immunoglobulin, should be monitored clinically and by biological parameters, because of the risk of haemolytic reaction.
Information on safety with respect to transmissible agents
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV. They may be of limited value against non-enveloped viruses such as HAV and parvovirus B19.
There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
It is strongly recommended that every time that Rhophylac is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Interference with serological testing
After injection of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.
Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, D may interfere with some serological tests for red cell antibodies e.g. the antiglobulin test (Coombs' test), particularly in Rh(D) positive neonates whose mothers have received antepartum prophylaxis.
Live attenuated virus vaccines
Active immunisation with live virus vaccines (e.g. measles, mumps or rubella) should be postponed for 3 months after the last administration of anti-D immunoglobulin, as the efficacy of the live virus vaccine may be impaired.
If anti-D immunoglobulin needs to be administered within 2 - 4 weeks of a live virus vaccination, then the efficacy of such a vaccination may be impaired.
Fertility
No animal fertility studies have been conducted with Rhophylac. Nevertheless, clinical experience with human anti-D immunoglobulin suggests that no harmful effects on fertility are to be expected.
Pregnancy
This medicinal product is intended for use in pregnancy.
No study drug-related adverse events were reported in children delivered of 432 women who received antepartum administration of Rhophylac 300 micrograms.
Breastfeeding
This medicinal product can be used during breastfeeding.
Immunoglobulins are excreted in human milk. No study drug-related adverse events were reported in children delivered of 256 women who received postpartum administration of Rhophylac 300 micrograms, nor in children delivered of 139 women who received postpartum administration of Rhophylac 200 micrograms.
Rhophylac has no influence on the ability to drive and use machines.
The following adverse reactions have been reported from 592 patients in clinical studies and from post-marketing experience. The summary table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Frequency has been evaluated using the following criteria: very common (
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There have been spontaneous reports of severe intravascular haemolysis when anti-D has been administered intravenously to Rh(D) positive immune thrombocytopenic purpura (ITP) patients. Haemolysis resulting in death has been reported. The exact frequency of this adverse event is not known.
For safety with respect to transmissible agents, see section 4.4.
Consequences of an overdose are not known.
Pharmacotherapeutic group: immune sera and immunoglobulins: Anti-D (Rh) immunoglobulin. ATC Code: J06BB01.
Rhophylac contains specific antibodies (IgG) against the Rh(D) antigen of human erythrocytes. It can also contain antibodies to other Rh antigens, e.g. anti-Rh C antibodies.
During pregnancy, and especially at the time of childbirth, foetal red blood cells may enter the maternal circulation. When the woman is Rh(D) negative and the foetus Rh(D) positive, the woman may become immunised to the Rh(D) antigen and produce anti-Rh(D) antibodies which cross the placenta and may cause haemolytic disease of the new-born.
Passive immunisation with anti-D immunoglobulin prevents Rh(D) immunisation in more than 99% of cases provided that a sufficient dose of anti-D immunoglobulin is administered soon enough after exposure to Rh(D) positive foetal red blood cells.
The mechanism by which anti-D immunoglobulin suppresses immunisation to Rh(D) positive red cells is not known. Suppression may be related to the clearance of the red cells from the circulation before they reach immunocompetent sites or, it may be due to more complex mechanisms involving recognition of foreign antigen and antigen presentation by the appropriate cells at the appropriate sites in the presence or absence of antibody.
In Rh(D) negative healthy male volunteers, both the intravenous and intramuscular administration of 200 micrograms (1000 IU) of Rhophylac at 48 hours after injection of 5 ml of Rh(D) positive red blood cells resulted in an almost complete clearance of Rh(D) positive red blood cells within 24 hours.
While the intravenous administration of Rhophylac caused an instant onset of red blood cell disappearance, the onset of elimination of red blood cells following intramuscular administration was delayed as anti-D IgG had to be first absorbed from the injection site.
On an average, 70% of injected red cells were cleared 2 hours after intravenous administration of Rhophylac.
After intramuscular administration, a similar degree of red cell clearance was measured after 12 hours.
Furthermore, the efficacy, safety and pharmacokinetics of Rhophylac are supported by the results of three clinical studies in patients. Rhophylac 200 micrograms (1000 IU) were administered postpartum in 139 per protocol patients.
Rhophylac 300 micrograms (1500 IU) were administered antepartum as well as postpartum in 446 and 256 per protocol patients, respectively.
None of the patients included in these studies developed antibodies against the Rh(D) antigen.
Clinical studies with Rhophylac at doses below 200 micrograms (1000 IU) have not been performed.
The bioavailability of human anti-D immunoglobulin for intravenous use is complete and immediate. IgG is quickly distributed between plasma and extravascular fluid.
Human anti-D immunoglobulin for intramuscular administration is slowly absorbed into the recipients's circulation and reaches a maximum after a delay of 2 - 3 days.
Human anti-D immunoglobulin has a half-life of about 3 - 4 weeks. This half-life may vary from patient to patient.
IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.
There are no preclinical data of relevance for anti-D immunoglobulin.
Repeated dose testing and embryo-foetal toxicity studies have not been conducted and are impracticable due to induction of, and interference with antibodies.
The potential for mutagenic effects of immunoglobulins have not been studied.
Human albumin
Glycine
Sodium chloride
Water for Injections
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
3 years
Store in a refrigerator (+2°C to +8°C). Do not freeze.
Keep the syringe (originally blistered) in the outer carton in order to protect from light.
2 ml solution in a pre-filled syringe (type I glass) with 1 injection needle in a pack size of 1.
Rhophylac should be brought to room or body temperature before use.
Do not use solutions which are cloudy or have deposits.
Use only once (one syringe – one patient).
Any unused product or waste material should be disposed of in accordance with local requirements.
CSL Behring GmbH
Emil-von-Behring-Strasse 76
35041 Marburg
Germany
PL 15036/0019
01 June 2006
28 July 2011
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